Trial Outcome Index Research Articles

Nurse‐Led Screening‐Triggered Early Specialized Palliative Care Program for Patients With Advanced Lung Cancer: A Multicenter Randomized Controlled Trial

ABSTRACTBackgroundWe aimed to examine the effectiveness of a nurse‐led, screening‐triggered early specialized palliative care intervention program for patients with advanced lung cancer.MethodsPatients with advanced lung cancer who underwent initial chemotherapy were randomized to intervention and usual care groups between January 2017 and September 2019. The intervention comprised comprehensive needs assessments, counseling, and service coordination by advanced‐level nurses. Patients in the usual care group received the usual oncological care. The primary end point was a change in the trial outcome index (TOI) scores from baseline to 12 weeks. The secondary end‐points were TOI scores at week 20, depression, anxiety, and survival.ResultsIn total, 102 patients were assigned to each group. Compared with the usual care group, no significant improvement in TOI scores was observed at 12 weeks in the intervention group (mean group difference: 2.13; 90% confidence interval: −0.70, 4.95; p = 0.107, one‐sided), whereas significant improvement was observed at 20 weeks (3.58; 90% confidence interval: 0.15, 7.00; p = 0.043). There were no significant differences in the change from baseline depression and anxiety between the groups from baseline at week 12 and 20 weeks (depression: p = 0.60 and 0.10, anxiety: p = 0.78 and 0.067). Survival did not significantly differ between the groups (median survival time: 12.1 vs. 11.1 months; p = 0.302).ConclusionsNurse‐led, screening‐triggered, early specialized palliative care did not show significant superiority over usual care during the 12‐week study period. However, it may have yielded delayed clinical benefits, such as improved quality of life and this feasible model can be acceptable in clinical practice.Trial Registration: The University Hospital Medical Information Network Clinical Trials Registry: UMIN000025491

Quality of Life Determinants in Patients with Metastatic Prostate Cancer: Insights from a Cross-Sectional Questionnaire-Based Study.

Prostate cancer is one of the most prevalent malignancies affecting men globally, with a significant impact on health-related quality of life (HRQOL). With the recent therapeutic advancements and improvements in survival, there is a need to understand the determinants of HRQOL in metastatic prostate cancer patients to optimize treatment strategies for quality of life as the number of survivors increases. The aim of this study was to identify clinical variables that affect HRQOL and its domains in patients with metastatic prostate cancer. We conducted a cross-sectional questionnaire-based study in patients diagnosed with metastatic prostate cancer at a tertiary cancer center in India. Baseline clinical features, treatment details, and completed Functional Assessment of Cancer Therapy-Prostate (FACT-P), composed of FACT-general (FACT-G) and prostate cancer-specific concerns subscale (PCS) and FACT-P Trial Outcome Index (FACT-P TOI) questionnaires, were collected. The mean total, as well as individual domain scores, were calculated. Additionally, these were stratified by the current treatment being received by patients. Linear regression was used to identify independent factors affecting HRQOL in these patients. Of the 106 enrolled patients, 84 completed the FACT-P questionnaire and were included in the analysis. The median age was 66 years, and at the time of assessment, 3 patients (3.6%) were receiving androgen deprivation therapy only, 53 patients (63.1%) were on ADT + androgen receptor-targeted agents (ARTAs), and 18 patients (21.4%) patients received ADT + chemotherapy. The mean (±standard deviation) of the FACT-P TOI score was 70.33 (±15.16); the PCS subscale was the most affected, followed by functional well-being. Patients on chemotherapy scored significantly higher on PCS, but the composite scores were not significantly different. Univariable regression identified obesity (body mass index > 25 kg/m2) and duration of first-line treatment as significant predictors of better HRQOL; however, obesity was the only independent predictor in multivariable analysis (β = 8.2; 95% confidence interval, 1.2 to 15.0; p = 0.022). Obesity also independently predicted a better FACT-P and its physical well-being domain score and PCS. Prostate cancer patients experience impaired QoL, especially in the prostate cancer-specific and functional well-being domains. Lower BMI is an independent predictor of poor QoL, and this requires efforts to assess the impact of strategies to manage the nutritional status of patients with metastatic disease on QoL outcomes.

Validity of a single-item indicator of treatment side effect bother in patients with head and neck cancer.

Patients with head/neck squamous cell carcinomas (HNSCC) experience significant tumor- and treatment-related side effects. No efficient summary measure capturing the totality of side effect burdencurrently exists. We examined associations between a single patient-reported outcome (PRO) item evaluating side effect bother (FACT GP5, "I am bothered by side effects of treatment") with overall side effects in HNSCC. We performed a retrospective secondary analysis of development of the Functional Assessment of Cancer Therapy (FACT) Head/Neck Symptom Index (FHNSI-10), which included completing FACT-HN (including Head/Neck Cancer Subscale (HNCS) and Trial Outcome Index (TOI)) and the pain intensity numeric rating scale (NRS). We calculated Spearman's correlations between GP5 and these measures of patient-reported global health, head/neck side effects, and pain intensity NRS. A correlation of > 0.4 was considered sufficient evidence of association. Ninety-seven patients completed baseline and 85 completed 3-month follow-up surveys. GP5 was highly correlated with FACT-HN total score (baseline r = 0.66, 3months r = 0.67) and FHNSI-10 (baseline r = 0.63, 3months r = 0.65). GP5 correlated with multiple FACT-HN subscales including FACT-G, physical well-being, functional well-being, HNCS, and TOI (range baseline r = 0.53-0.77, range 3months r = 0.49-0.77). Worsening GP5 score was associated with worsening overall HNCS (p = 0.002), worsening FHNSI-10 score (p < 0.001), and worsening mean pain intensity (p < 0.001). GP5 exhibited validity within HNSCC, exhibiting substantial correlations with a number of HNSCC-related PRO measures including FACT-HN and FHNSI-10. Worsening GP5 was associated with worsening HNCS, FHNSI summary score, and pain intensity. GP5 has promise as a summary indicator of symptom and side effect bother in HNSCC.

Hyperthermic intraperitoneal chemotherapy (HIPEC) vs. postoperative intraperitoneal (IP) chemotherapy – Impact on health-related quality of life in primary ovarian cancer patients after cytoreductive surgery

PurposeTo compare health-related quality of life (HRQL) in primary ovarian cancer (OC) patients with peritoneal metastases (PM) after undergoing upfront cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) as part of a phase 2 trial (NCT-02124421). MethodsPatients with stage III/IV high-grade serous OC were randomized (1:1) to either CRS/HIPEC with carboplatin followed by 6 cycles of adjuvant systemic chemotherapy (carboplatin/paclitaxel) or CRS followed by 6 cycles of combination intraperitoneal/intravenous chemotherapy (cisplatin/paclitaxel). The trial outcome index (TOI) of the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) questionnaire was used to assess HRQL. The FACT-O was administered at randomization and postoperatively at 6 weeks and 6, 12, and 24 months, or until disease recurrence/death. HRQL was analyzed using a linear mixed model. ResultsSixteen patients were enrolled in each group. All (32/32) patients completed questionnaires at baseline and 53.1 % (17/32) at 24 months. Reasons for missing scores were similar between groups. Average TOI was similar between treatment arms at each time point. In both arms, mean TOI was below baseline at 6 weeks (p = 0.798) and 6 months (p = 0.821) after CRS, but recovered at 12 months (p = 0.518). No significant differences were found in FACT-O total score or FACT-O individual dimensions over time between groups. ConclusionsNo long-term HRQL impairment was observed when HIPEC was added to CRS in primary OC. Access to CRS/HIPEC as primary treatment of PM in OC should not be solely limited by concerns for patient HRQL. SynopsisHealth-related quality of life (HRQL) was evaluated in primary ovarian cancer patients participating in a phase 2 trial comparing cytoreductive surgery (CRS)/HIPEC vs CRS + intraperitoneal (IP) chemotherapy. No differences between groups or long-term HRQL impairment were observed.

Validation of Patient-Reported Outcomes in Patients With Nonmetastatic Breast Cancer Receiving Comprehensive Nodal Irradiation in the RadComp Trial

Our purpose was to evaluate the measurement properties of patient-reported outcome (PRO) measures used in the ongoing RadComp pragmatic randomized clinical trial (PRCT). The deidentified and blinded data set included 774 English-speaking female participants who completed their 6-month posttreatment assessment. Eleven PRO measures were evaluated, including the Trial Outcome Index from the Functional Assessment of Cancer Therapy-Breast (FACT-B), Satisfaction with Breast Cosmetic Outcomes, the BREAST-Q, and selected Patient-Reported Outcomes Measurement Information System (PROMIS) measures. PROs were measured at 3 timepoints: baseline, completion of radiation therapy (RT), and 6 months post-RT. Ten variables were used as validity anchors. Pearson or Spearman correlations were calculated between PROs and convergent validity indicators. Mean PRO differences between clinically distinct categories were compared with analysis of variance methods (known-groups validity). PRO change scores were mapped to change in other variables (sensitivity to change). Most correlations between PROs and validity indicators were large (≥0.5). Mean score for Satisfaction with Breast Cosmetic Outcomes was higher (better) for those with a lumpectomy compared with those with a mastectomy (P < .001). Mean scores for the FACT-B Trial Outcome Index and for PROMIS Fatigue and Ability to Participate in Social Roles and Activities were better for those with good baseline performance status compared with those with poorer baseline performance status (P < .05). At completion of RT and post-RT, mean scores for Satisfaction with Breast Cosmetic Outcomes and BREAST-Q Radiation were significantly different (P < .001) across categories for all Functional Assessment of Chronic Illness Therapy -Treatment Satisfaction - General items. There were medium-sized correlations between change scores for FACT-B Trial Outcome Index, Fatigue, Anxiety, and Ability to Participate in Social Roles and change scores in the Visual Analog Scale. For patients with nonmetastatic breast cancer receiving radiation in the RadComp PRCT, our findings demonstrate high reliability and validity for important PRO measures, supporting their psychometric strength and usefulness to reflect the effect of RT on health-related quality of life.

Abstract PO2-11-07: Early Integration of Exercise into Breast Cancer Care: The MSK Healthy Living Program

Abstract Background: In patients with early-stage breast cancer, quality of life (QoL) worsens within 3-6 months following diagnosis. Physical activity (PA) can mitigate the adverse effects of treatment and improve QoL, and low PA level is associated with cancer recurrence and mortality. However, PA interventions are not included in standard cancer care. Early intervention to increase PA levels may improve QoL during active cancer therapy. The Healthy Living Program (HLP) at Memorial Sloan Kettering Cancer Center (MSK) is a lifestyle and survivorship program that engages early-stage breast cancer patients at the time of diagnosis using lifestyle risk stratification and matched referrals. We investigated whether early exercise intervention through the MSK HLP impacts QoL within the first months after cancer diagnosis. Methods: At the time of diagnosis, patients complete a lifestyle questionnaire (LQ), which is a composite of validated instruments, including the Godin Leisure Time Exercise Questionnaire (GLTEQ). Patients not meeting PA guidelines per the GLTEQ are offered a referral to an exercise physiologist (EP). The EP creates an individualized, home-based exercise program using the FITT Principle (Frequency, Intensity, Time, and Type). Patients meet with the EP every 4 weeks for 16 weeks; if exercise recommendations continue to be unmet, the program is extended. The Functional Assessment of Cancer Therapy-Breast (FACT-B) and 36-Item Short Form Survey Instrument (SF-36) were completed at baseline and the 16-week follow-up. Results: 252 patients enrolled between April 2020 – February 2023, of whom 92 volunteered to complete the QoL assessments. Median age was 53 years [range 23-84]; 12/252 (13.0%) of patients had ductal carcinoma in situ, 60/252 (65.2%) had Stage 1 disease, 17/252 (18.5%) had Stage 2 disease, and 3/252 (3.1%) had Stage 3 disease. 29/252 (31.5%) received chemotherapy, 62/252 (67.4%) received radiation, and 79/252 (85.9%) received hormone therapy. The mean baseline FACT scores were FACT-B: 116, FACT-G: 87, and FACT-B Trial Outcome Index (TOI): 73. At the 16-week follow-up, all QOL scores remained stable from baseline (means FACT-B: 118, FACT-G: 89, and TOI: 75). Improvements were observed among the subscales of the SF-36 from baseline to follow-up. The largest improvements were observed in physical and emotional role function scores, with 22% and 13% improvements from baseline to follow-up, respectively. Conclusions: A clinically implemented exercise intervention embedded in standard of care prevented decreases in QoL and improved physical and emotional functioning during the initial course of adjuvant breast cancer therapy. These findings support early implementation of lifestyle modification after a breast cancer diagnosis. Citation Format: Kylie Rowed, Sherry Shen, Andrea Smith, Bridget Kelly, Rocco Magnoli, Stacie Corcoran, Melissa Emerzian, Cynthia Cruz, Erica Salehi, Cara Anselmo, Mark Robson, Neil Iyengar. Early Integration of Exercise into Breast Cancer Care: The MSK Healthy Living Program [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-11-07.

Abstract PO4-11-03: Impact of Short Term Fasting (STF) on Fatigue developing in primary breast cancer (BC) patients receiving the Henderson or Sparano Scheme in the prospective multicentre FIT2- cohort

Abstract Background: Experimentally, it has been shown that short-term fasting (STF) induces a “protective mode” in healthy cells against chemotherapeutic toxicity while it enhances the susceptibility of tumor cells to chemotherapy. In healthy cells, fasting triggers distinct protective metabolic and gene expression changes, such as upregulation of DNA repair mechanisms, autophagy, and downshift of metabolic pathways including IGF-1-dependent signaling. This study was conducted to assess feasibility, quality of life (QoL) including chemotherapy-induced fatigue (CTF) comparing STF around each chemotherapy (4xAC or 4xEC) to a plant-based low-sugar diet (PBD). Methods: Newly diagnosed BC-patients treated by the Henderson or Sparano scheme were included in this randomised, controlled, multicenter study. CTF was assessed by the FACIT-F questionnaire before (day 0) and after chemotherapy (day 7) as well as at months 4 (V1) and 6 (V2). Results: Of the included n=106 patients, 52 were randomized to STF and 54 to PBD. n=90 (84.9%) patients obtained AC/EC+Pac and 16 (15.1%) AC/EC+Doc. FACIT-F showed no significant difference at baseline (STF 42.8; PBD 41.3; p=0.708). The differences between the corresponding FACIT-F Trial Outcome Index resp. Total FACIT-F at cycle 4 day 7 were 13.1 (SE 4.7) resp. 15.8 (SE 5.6), both in favor of STF (statistically significant (p &amp;lt; 0.007) and clinically relevant (minimal important difference (MID) &amp;gt; 5). This difference was visible for all breast cancer subtypes, i.e. luminal A &amp; B, as well as HER2 overexpressed and triple negative tumors, with the STF group showing no clinically relevant fatigue after 4 cycles of chemotherapy (FACIT-F &amp;gt; 34), across all subtypes. The opposite was true for the PBD group (FACIT-F &amp;lt; 34) across all subtypes. FACIT-F (22.7) for PBD in HER2 overexpressed and triple negative tumors was significantly worse than those in luminal A and B patients (FACIT-F= 29.1; difference 6.4 &amp;gt; MID=3). STF was well tolerated and there were no serious adverse effects. Conclusion: STF during chemotherapy is well tolerated and appears to improve QoL including fatigue during chemotherapy compared to a plant-based low-sugar diet, independent of intrinsic subtypes. Citation Format: Daniela Koppold, Christian Kessler, Manfred Wischnewsky, Ixquic Alvarado, Nico Steckhan, Cornelia Kempter, Marion Paul, Barbara Brückner, Dorothea Fischer, Aysen Wunschel, Rainer Stange, Etienne Hanslian, Michael Jeitler, Andreas Michalsen. Impact of Short Term Fasting (STF) on Fatigue developing in primary breast cancer (BC) patients receiving the Henderson or Sparano Scheme in the prospective multicentre FIT2- cohort [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-11-03.

Prospective Trial of Functional Lung Avoidance Radiation Therapy for Lung Cancer: Quality of Life Report

PurposeA novel form of lung function imaging has been developed that uses 4DCT data to generate lung ventilation images (4DCT-ventilation). Functional avoidance uses 4DCT-ventilation to reduce doses to functional lung with the aim of reducing pulmonary side-effects. A 4DCT-ventilation functional avoidance, phase II, multi-center clinical trial was completed. The purpose of this work is to quantify patient reported outcomes (PRO) changes for patients treated with functional avoidance and to determine which metrics are predictive of PRO changes. Materials and MethodsPatients with locally advanced lung cancer receiving curative intent radiotherapy were accrued. Each patient had a 4DCT-ventilation image generated using 4DCT data and image processing. PRO instruments included the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire, administered pre-treatment, 3, 6, and 12 months post-treatment. FACT-TOI (Trial Outcome Index) and the FACT-LCS (Lung Cancer Subscale) percentage of clinically meaningful declines (CMD) were determined. A linear mixed-effects model was used to determine which patient, clinical, dose, and dose-function metrics were predictive of PRO decline. Results59 patients completed baseline PRO surveys. 83% of patients had non-small-cell lung cancer, with 75% having stage III disease. The median dose was 60 Gy in 30 fractions. CMD FACT-TOI decline was 46.3%, 38.5%, and 26.8%, at 3, 6, and 12 months, respectively. CMD FACT-LCS decline was 33.3%, 33.3%, and 29.3%, at 3, 6, and 12 months, respectively. While an increase in most dose and dose-function parameters was associated with a modest decline in PROs, none of the results were significant (all p>0.053). ConclusionThe current work provides an innovative combination of functional avoidance and PROs and is the first report of PROs for patients treated with prospective 4DCT-ventilation functional avoidance. Approximately 30% of patients had clinically significant decline in PROs at 12 months. The study provides additional data on outcomes with 4DCT-ventilation functional avoidance.

Hematopoietic Stem Cell Transplantation Impact on Patients' Perceived Quality of Life: A Longitudinal Study.

The aim of this paper was to evaluate the quality of life of adult patients with onco-hematological disease treated with hematopoietic stem cell transplantation up to two years post-transplantation. A quantitative, observational, longitudinal, and analytical study was conducted with 121 participants diagnosed with onco-hematological cancer who underwent hematopoietic stem cell transplantation between October 2017 and September 2019, with a 2-year post-transplantation follow-up, of whom only 39 completed the study. The Functional Assessment of Cancer Therapy-Bone Marrow Transplantation (FACT-BMT) questionnaire and its subscales, Functional Assessment of Cancer Therapy-General (FACT-BMT) and Functional Assessment of Cancer Therapy Trial Outcome Index (FACT-TOI), developed by the Functional Assessment of Chronic Illness Therapy (FACIT) and validated for Spain, were used to assess quality of life. The average age for hematopoietic stem cell transplantation was 54 years, with a majority of male participants. The evaluation of quality of life showed a decrease at the time of hospital discharge, followed by a progressive improvement up to one year after the transplantation. There was a significant difference in the quality of life questionnaire scores between both sexes during all stages of the research, with higher scores in male participants. The length of hospital stay significantly affected patients' physical and functional well-being, and marital status was related to differences in the perception of quality of life. Despite the initial decrease in quality of life for patients undergoing hematopoietic stem cell transplantation, levels of quality of life similar to baseline are regained one year after the transplantation. Sociodemographic variables are related to how these patients perceive their quality of life. However, further studies with a larger sample size are needed for more precise results.

Prospective Longitudinal Assessment of Quality of Life After Stereotactic Ablative Radiotherapy for Oligometastases: Analysis of the Population-based SABR-5 Phase II Trial

AimsTo evaluate longitudinal patient-reported quality of life (QoL) in patients treated with stereotactic ablative radiotherapy (SABR) for oligometastases. Materials and methodsThe SABR-5 trial was a population-based single-arm phase II study of SABR to up to five sites of oligometastases, conducted in six regional cancer centres in British Columbia, Canada from 2016 to 2020. Prospective QoL was measured using treatment site-specific QoL questionnaires at pre-treatment baseline and at 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months after treatment. Patients with bone metastases were assessed with the Brief Pain Inventory (BPI). Patients with liver, adrenal and abdominopelvic lymph node metastases were assessed with the Functional Assessment of Chronic Illness Therapy-Abdominal Discomfort (FACIT-AD). Patients with lung and intrathoracic lymph node metastases were assessed with the Prospective Outcomes and Support Initiative (POSI) lung questionnaire. The two one-sided test procedure was used to assess equivalence between the worst QoL score and the baseline score of individual patients. The mean QoL at all time points was used to determine the trajectory of QoL response after SABR. The proportion of patients with ‘stable’, ‘improved’ or ‘worsened’ QoL was determined for all time points based on standard minimal clinically important differences (MCID; BPI worst pain = 2, BPI functional interference score [FIS] = 0.5, FACIT-AD Trial Outcome Index [TOI] = 8, POSI = 3). ResultsAll enrolled patients with baseline QoL assessment and at least one follow-up assessment were analysed (n = 133). On equivalence testing, the patients' worst QoL scores were clinically different from baseline scores and met MCID (BPI worst pain mean difference: 1.8, 90% confidence interval 1.19 to 2.42]; BPI FIS mean difference: 1.68, 90% confidence interval 1.15 to 2.21; FACIT-AD TOI mean difference: –8.76, 90% confidence interval –11.29 to –6.24; POSI mean difference: –4.61, 90% confidence interval –6.09 to –3.14). However, the mean FIS transiently worsened at 9, 18 and 21 months but eventually returned to stable levels. The mean FACIT and POSI scores also worsened at 36 months, albeit with a limited number of responses (n = 4 and 8, respectively). Most patients reported stable QoL at all time points (range: BPI worst pain 71–82%, BPI FIS 45–78%, FACIT-AD TOI 50–100%, POSI 25–73%). Clinically significant stability, worsening and improvement were seen in 70%/13%/18% of patients at 3 months, 53%/28%/19% at 18 months and 63%/25%/13% at 36 months. ConclusionsTransient decreases in QoL that met MCID were seen between patients' worst QoL scores and baseline scores. However, most patients experienced stable QoL relative to pre-treatment levels on long-term follow-up. Further studies are needed to characterise patients at greatest risk for decreased QoL.

Older Adults with Acute Myeloid Leukemia (AML) Experience Improvement in Health-Related Quality of Life (HRQoL) Scores with Intensive Therapy: Prospective Study from ECOG-ACRIN (EA) E2906 Phase 3 Trial

Background There is limited prospective or comparative data evaluating the HRQoL impact of intensive chemotherapy (IC) in older adults (age ≥60 years) with AML. In the recent EA E2906 phase 3 study of '7&amp;3' (daunorubicin &amp; cytarabine) vs. clofarabine (CLO), a putative lower intensity therapy, we incorporated a prospective patient-reported outcomes (PRO) assessment of HRQoL and fatigue to understand treatment impact from the patients' (pts) perspective. Methods E2906 study design and results have been presented previously [n=727, med. age 68 years (range 60-86), randomized 1:1 to ‘standard’ ‘7&amp;3‘ &amp; high dose cytarabine (Arm A) vs. single agent CLO (Arm B), as remission induction (Step 1) and consolidation (Step 2), respectively]. There was no difference in composite complete remission (CCR, 50%) or 30-day mortality rates (8.5%), and in primary analysis CLO was inferior for Overall Survival. HRQoL was a key secondary protocol endpoint. PROs assessed HRQoL and leukemia-specific symptoms and concerns using Functional Assessment of Cancer Therapy-Leukemia scale (FACT-Leu), &amp; Fatigue using FACT-Fatigue subscale. PROs were administered at prespecified time points: (1) Baseline; (2) Cycle 1 at nadir (approx. Day 15); (3) End of Step 1 restaging (approx. D 40); (4) Beginning of Step 2 (1 st consolidation, approx. D 45); and (5) 2 nd cycle consolidation/End Step 2 (approx. D 60). The FACT-Leu Trial Outcome Index ( TOI) was calculated by summing physical well-being, functional well-being, and leukemia-specific concerns subscales to create a single composite score. Higher TOI scores correspond to better HRQoL. The primary endpoint was to evaluate TOI difference from randomization to day 30 after induction therapy between arms, evaluated using Wilcoxon rank sum test. We also compared Clinically Meaningful differences (CMiD) in TOI (defined as patient change ≥½ standard deviation from baseline TOI) between arms, using the X2 test. Pts not completing at least 2 assessment forms (including baseline) were excluded. Testing of constructs of Physical Well-being (PWB), Functional, Leukemia &amp; Fatigue scales demonstrated high Cronbach's a values (a &amp;gt;0.7) except for PWB (a=0.672) at a single time point (End of Step 2). Results Baseline TOI was available for n=489, and 364 pts (n=182 each Arm) were evaluable in this planned analysis. Evaluating CMiD during Cycle 1 induction, pts in Arm B were less likely to experience ‘Worse’ TOI score (32% vs. 40.7%, Arm A), more likely to maintain stable TOI scores (49.1% vs. 39%, Arm A), and had a similar proportion of ‘Better’ TOI scores (20.3%, A vs. 18.9%, B) although differences were not significant (p=0.1389). Conversely in cycle 1 consolidation, more patients in Arm A experienced Better TOI (45.1% vs. 29.2%, Arm B), fewer had stable TOI (45.1% vs. 58.3%, Arm B), and rates of ‘Worse’ TOI were similar (9.8%, A vs 12.5%, Arm B), again differences were not significant (p=0.2616). There was no difference in Fatigue scores between Arms (p=0.49). We evaluated whether TOI and Fatigue scores could predict the ability to complete protocol therapy. In univariate analysis baseline TOI (p=0.0059) and Fatigue (p=0.0057) were associated with Step 1 completion, however on multivariate analysis (adjusting for age, sex, and Arm) were no longer significant [TOI, Odds Ratio (OR) 1.03 (0.98-1.08, p=0.27); Fatigue, OR 1.03 (0.96-1.11, p=0.42)]. There was a borderline association of TOI with Step 2 completion [TOI OR 1.10 (1.00-1.23, p=0.06)]. Using a multivariable linear mixed effects model, we observed similar and significant changes in TOI scores in both Arms, demonstrating the effect of IC &amp; CLO on HRQoL (Figure). Comparing to baseline, TOI scores decreased significantly at C1 induction nadir (-4.0873, p&amp;lt;0.0001), and increased by 5.0762 (p=0.0004) at end Step 1, by 6.9047 at cycle 1 consolidation (p&amp;lt;0.0001), and by 11.4601 (p&amp;lt;0.0001) at end Step 2. Differences were mainly apparent in those who achieved CCR, and there was significant attrition in PRO responses in non-CCR pts. Conclusions Older adults experienced significant improvement in HRQoL after nadir regardless of therapy, and those achieving CCR report significantly higher scores. We did not observe differences in leukemia specific HRQoL or fatigue between treatment Arms (7&amp;3 vs. CLO). Patient-reported HRQoL &amp; Fatigue was not predictive of completion of protocol therapy. These results serve as a benchmark for expectations with IC in older adults.

Health-Related Quality of Life and Symptoms in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma Treated with Odronextamab Monotherapy in the Phase 2 ELM-2 Study

Background. Patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) have poor prognosis and significant impairment of health-related quality of life (HRQoL). CD20xCD3 bispecific antibodies show promise in the management of R/R DLBCL. ELM-2 (NCT03888105), a Phase 2, open-label, multicohort, multicenter study of the CD20xCD3 bispecific antibody odronextamab, demonstrated deep and durable responses and generally manageable safety in patients with R/R DLBCL. We report herein, for the first time, patient-reported outcome (PRO) results for patients in the R/R DLBCL cohort in ELM-2. Methods. In ELM-2, patients with R/R DLBCLafter 2 or more prior lines of therapy received odronextamab IV weekly in 21-day cycles in Cycles (C) 1-4. Revisions to the step-up dosing regimen to mitigate cytokine release syndrome (CRS) were reported previously. Odronextamab was administered with steroid prophylaxis and step-up doses of 0.7/4/20 mg in C1, then 160 mg on Days 1, 8, and 15 of C2-4 (the DLBCL 160 mg cohort). After C4, odronextamab maintenance treatment continued at 320 mg every 2 weeks until disease progression or unacceptable toxicity. Patients with durable complete response for ≥9 months transitioned to dosing every 4 weeks. PRO data were collected via the FACT-Lym, EORTC QLQ-C30, and EQ-5D-3L questionnaires at Weeks 1 (baseline), 2, 3, 4, and 10, then every 8 weeks in the first year and every 12 weeks in the second year. Pre-specified PRO analyses reported here are FACT-Lym lymphoma symptoms (LymS), FACT-G total, Trial Outcome Index (TOI), FACT-Lym total, EORTC QLQ-C30 general health status/quality of life (GHS/QoL), and EQ-5D-3L visual analog scale (VAS). PRO longitudinal analysis using mixed models for repeated measures (MMRM) were conducted through Week 42, the last visit with ≥10 patients with PRO data, and changes from baseline were statistically significant if the 95% confidence interval did not contain zero. No adjustment for multiplicity was performed, hence all statistical significance is nominal. Published ranges for minimum important difference (MID) for clinically meaningful thresholds are: GHS/QoL, 10; LymS, 2.9-5.4; FACT-G total, 3-7; TOI: 5.5-11; FACT-Lym total, 6.5-11.2; and EQ-5D-3L VAS, 7-12. Responder analysis and time to definitive deterioration (TTDD) used the upper end of these MID ranges to define clinically meaningful changes. Results. The final analysis of the DLBCL 160 mg cohort in ELM-2 assessed 141 patients. Median age was 66.0 (range, 24-88) years, with 56.0% ≥65 years, 59.6% male, 43.3% White, 47.5% Asian, 32.6% ECOG=0, and 67.4% ECOG=1. Median duration of follow-up was 26.2 (range, 8.5-34.3) months. PRO completion rates for FACT-Lym, EORTC QLQ-C30, and EQ-5D-3L were high at baseline and for most assessments through Week 42. Patients reported statistically significant and clinically meaningful improvements from Weeks 10 through 42 for FACT-Lym LymS (Figure), and from Weeks 18 through 42 for FACT-G total, FACT-Lym TOI, and FACT-Lym total (except Week 34 for FACT-G total and FACT-Lym total). Additionally, patients reported statistically significant and clinically meaningful improvements for EORTC QLQ-C30 GHS/QoL at Week 42, and for EQ-5D-3L VAS at Week 26. In responder analyses, the proportion of patients reporting clinically meaningful improvement or stability was higher than the proportion reporting meaningful worsening at each assessment through Week 42 for all scales/summary scores. Median TTDD was not reached for FACT-Lym LymS, FACT-Lym TOI, or EQ-5D-3L VAS. Conclusions. In the Phase 2 ELM-2 study, patients with R/R DLBCL reported favorable HRQoL during odronextamab treatment; patient-reported symptoms, functioning, and overall quality of life were maintained or improved from baseline through Week 42. Odronextamab treatment until disease progression may have benefits on HRQoL for heavily pretreated patients with R/R DLBCL and potentially addresses unmet needs in a challenging treatment setting. Collection of PROs was consistently high and the results offer important patient-centered insights into the overall benefit-risk profile of odronextamab in R/R DLBCL.

Health-Related Quality of Life in Polish Patients with Multiple Myeloma Treated in the Phase 3 ATLAS Trial of Post-Transplant Maintenance with Carfilzomib, Lenalidomide, Dexamethasone or Lenalidomide Alone

Introduction Results of the unplanned interim analysis of the ATLAS trial (Dytfeld, Lancet Oncology 2023) suggest a progression-free survival benefit of carfilzomib, lenalidomide, and dexamethasone (KRd) post-transplant maintenance over single-agent lenalidomide (R). Use of triplet combination, with frequent hospital visits and repeated intravenous infusions raises questions about its long-term tolerability and the impact on health-related quality of life (HRQoL) compared with relatively convenient and well-tolerated single-agent oral lenalidomide. Here, we present a descriptive, longitudinal assessment of HRQoL in Polish patients with multiple myeloma treated in the ATLAS trial. Methods ATLAS is an ongoing phase 3 trial that randomized 180 patients with newly-diagnosed multiple myeloma after ASCT to receive maintenance therapy with KRd or R. In the KRd arm, patients with standard-risk cytogenetics who achieved MRD-negativity after cycle 6 de-escalated therapy to receive R alone after cycle 8. HRQoL assessment was not required by the study protocol, however, the FACT/GOG-Ntx questionnaires were collected according to local protocols for post-transplant data collection at 7 Polish sites at screening (approximately 3 months post-transplant) and after cycles (C) 6, 12, 18, 24, 30, and 36. Therefore, the modified intention-to-treat (mITT) population in this analysis consisted of 134 patients enrolled in these sites. The domains evaluated by the FACT/GOG-Ntx questionnaire include physical well-being (PWB), social well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and neurotoxicity (Ntx). The outcomes are summarized in FACT/GOG-Ntx Trial Outcome Index (TOI, combining PWB, FWB, and Ntx), FACT-G Total Score (PWB, SWB, EWB, and FWB), and FACT/GOG-Ntx Total Score (all five domains). Based on previous reports, the minimally important difference (MID) was defined as a change of at least 10% of the instrument range (Tremblay, BMC Cancer 2021). Student's t-test was used for comparisons between normally distributed variables and Wilcoxon rank-sum test for not normally distributed. Rates of patients experiencing MID were compared using chi-square test. Results HRQoL questionnaires were available for 123 out of 134 patients (92%). The numbers of completed questionnaires at screening, C6, C12, C18, C24, C30, C36 were 115 (86% of randomized patients / 86% of expected patients), 111 (83%/86%), 102 (76%/85%), 93 (69%/85%), 82 (61%/86%), 74 (55%/87%), and 56 (42%/80%), respectively. Throughout the analyzed timepoints, the mean PWB, SWB, EWB, FWB, NTx scores (Figure 1), FACT/GOG-NTx TOI, FACT-G Total Score, and FACT/GOG-Ntx Total Score (Figure 2) did not differ between the two study arms. A similar pattern was observed in the changes in individual patient scores compared to baseline. During the treatment course, the rates of patients experiencing a decrease in HRQoL scores, reaching the MID threshold in at least one evaluation, were consistent in both groups - 19 out of 59 (32%) patients treated with KRd and 20 out of 52 (38%) patients in the R arm (p=0.49) in the FACT/GOG-NTx TOI, 23/59 (39%) in the KRd arm and 21/52 (40%) in the R arm in the FACT-G Total Score (p=0.88), and 24/59 (41%) in the KRd arm and 19/52 (37%) in the R arm in the FACT/GOG-Ntx Total Score (p=0.65). Similarly, there were no differences in the respective results in terms of patients experiencing an increase in HRQoL scores, reaching the MID threshold in at least one evaluation - 8 out of 59 (14%) patients treated with KRd and 11 out of 52 (21%) patients in the R arm (p=0.28) in the FACT/GOG-NTx TOI, 10/59 (17%) in the KRd arm and 13/52 (25%) in the R arm in the FACT-G Total Score (p=0.29), and 8/59 (14%) in the KRd arm and 6/52 (12%) in the R arm in the FACT/GOG-Ntx Total Score (p=0.75). Conclusions The results of this analysis do not imply a negative impact of post-transplant maintenance with carfilzomib, lenalidomide, and dexamethasone compared to single-agent lenalidomide on the HRQoL.

Lymphoma-Related Quality of Life (QOL) Is Not Impacted By Initial Treatment Choice in Patients with Marginal Zone Lymphoma (MZL): Results from the Prospective Lymphoma Epidemiology of Outcomes (LEO) Cohort

Background: QOL can be affected by disease burden, side effects of treatment, and psychosocial effects of living with cancer. Although MZL is considered incurable, we previously found that patients diagnosed from 2002-2015 had a good QOL both at baseline (BL) and the first decade after diagnosis, regardless of treatment choice (Bommier et al., submitted). Here, we evaluate whether these findings can be extended to the 2015-2020 treatment era and a more diverse US cohort. Methods: Adults with newly diagnosed MZL from 8 academic centers were prospectively enrolled within 6 months of diagnosis from 2015-2020 in the LEO cohort (NCT02736357). Participants were actively followed for disease progression/relapse, retreatment and death. QOL was measured at BL, and at 1, 2, 3 and 5 years after diagnosis using the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) scale (range 0-164), which consists of the FACT-General (FACT-G, range 0-104) plus a lymphoma-specific scale (range 0-60). Total FACT-G measures 4 QOL domains (range): physical (0-28), social/family (0-28), emotional (0-24), and functional (0-28) well-being (WB). We also used the Trial Outcome Index (TOI; range 0-112), which consists of FACT-G physical and functional WB plus the lymphoma-specific scale and is commonly used as an endpoint in treatment trials. All MZL patients with both BL and at least one follow-up QOL questionnaire were eligible for analysis. Patients were grouped by initial management: active surveillance (observation), local/antibiotic therapy (radiation, surgery, or anti- H. pylori therapy), or systemic therapy (chemotherapy, targeted agents, or antibody therapy). Change in QOL scores over time was analyzed using mixed models for repeated measurements, and initial treatment groups were compared. Results: Of 384 patients, 60% were female, 91% were White, 6.6% were Black/African American, and 13% were Hispanic (all races). The median age was 64 years (range 19-94). For initial management, 28% (N=106) were observed, 31% (N=118) received local/antibiotic therapy, and 42% (N=160) received systemic therapy. Across treatment groups, there were no significant differences by age, gender, race, or performance status, while there were differences by Hispanic ethnicity (p=0.006), Ann Arbor stage (p&amp;lt;0.001) and MALT-IPI score (p&amp;lt;0.001) (Table). At BL, patients receiving systemic therapy had lower physical WB (p=0.008), emotional WB (p=0.04), functional WB (p=0.03), FACT-G total score (p=0.008), lymphoma subscale (p&amp;lt;0.001), FACT-Lym (p=0.001) and TOI (p&amp;lt;0.001) compared to observation and local/antibiotic therapy (Table). While FACT-G total scores were largely stable through 5 years after diagnosis, social/family WB declined from BL for patients initially receiving either local/antibiotic therapy (mean at 1-year -1.4, p&amp;lt;0.05; 2-year -2.1, p&amp;lt;0.05; 3-year -1.6, p&amp;lt;0.05; 5-year-2.9, p&amp;lt;0.05) or systemic therapy (mean at 2-year -1.2 , p&amp;lt;0.05; 3-year -1.4, p&amp;lt;0.05; and 5-year -1.2, p&amp;lt;0.05), while this was stable for observed patients. In patients receiving initial systemic therapy, there was a transient improvement in the lymphoma-specific scale (mean +1.7, p&amp;lt;0.05) and TOI (mean +3.7, p&amp;lt;0.05). Otherwise, QOL remained stable over time and global QoL (FACT-G, FACT-Lym), TOI, Lymphoma-specific scale (Figure), and the other FACT-G subscales (physical, emotional, or functional WB) did not differ by initial treatment strategy. Conclusions: In the diverse LEO cohort from the recent treatment era, we confirm our prior findings for newly diagnosed MZL patients that QOL is globally stable over the first 5 years after diagnosis; emotional WB is not associated with initial treatment type, providing evidence that being initially observed does not negatively impact emotional health; and there is a decline in social/family WB (support from friends and family, family acceptance of illness, family communication, close to partner), which supports the need to consider interventions for patients to address these unmet needs. In addition, this study extends these findings to the lymphoma-specific scale, FACT-Lym, and TOI, which all showing largely stable trends in the 5 years after diagnosis and suggest that recent MZL treatment strategies, including systemic therapies, neither impair nor improve QOL.

Effectivity of Palliative Care Bundle on Advanced Gallbladder Cancer: A Randomised Controlled Trial.

The main aim of this study was to develop, test, and compare palliative care bundles to improve functional recovery, resilience, and quality of life among advanced gallbladder cancer patient with their routine palliative care. This study was to test a palliative care bundle, a single-center, and two-arm randomised controlled trial done on a total of 116 participants (58 in each arm) from July 2019 to December 2021 at All India Institute of Medical Sciences, Rishikesh. By the end of 4th month, the recruitment rate was 96.7%, retention rate acceptance rate was 95%, and adherence rate was 85%. The palliative care bundle showed that a significant difference in trial outcome index score (P = 0.014*) indicates the effectiveness of the palliative care bundle related to improvement in physical mobility, resilience, and quality of life of patients and reduced caregiver burden. Reported barriers faced by participants were physical exhaustion (65%), psychological factors (25%), social factors (15%) and unfamiliar surroundings (5%). Caregivers reported barriers that their job (40%), physical fatigue related to the care of their patient (40%), their education (10%), and lack of support for their other family members (10%) were some reasons forcing them not to practice palliative care bundle. The palliative care bundle did not interfere with the palliative treatment plan of any patients and significantly improved physical mobility, resilience, quality of life of patients, and reduced caregiver burden. Hence, a palliative care bundle can be considered in the palliative care of advanced cancer patients during their palliative treatment to provide holistic care.

Comprehensive Quality of Life Report from a Prospective Clinical Trial of 4DCT-Ventilation Functional Lung Avoidance Radiation Therapy

Functional imaging has been developed that uses 4DCT images and image processing to generate lung ventilation maps (4DCT-ventilation). 4DCT-ventilation functional avoidance uses 4DCT-images to generate plans that avoid functional regions of the lung with the goal of reducing pulmonary toxicity. A 4DCT-ventilation functional avoidance, phase II, multi-center clinical trial was completed, and patient reported outcomes (PRO) measured. PROs are an essential measure of quality-of-life following radiotherapy. The purpose of this work is to quantify PRO changes for lung cancer patients treated with functional avoidance and to compare PROs against clinical pneumonitis. Patients with locally advanced lung cancer receiving curative intent radiotherapy (prescriptions of 45-75 Gy) and chemotherapy were accrued. Each patient had a 4DCT-ventilation image generated using 4DCT data. Favorable arc geometry and optimization techniques were used to generate functional avoidance plans. PRO instruments included the Functional Assessment of Cancer Therapy Lung (FACT-L) questionnaire and the Visual Analog Scale (VAS) administered pre-treatment and 3-, 6-, and 12-months post-treatment to gather data on physical, social, emotional, functional, and pulmonary well-being. The percentage of patients with clinically significant decline was calculated using the FACT-TOI (Trial Outcome Index), FACT-LCS (Lung Cancer Subscale), and VAS instruments. To evaluate the correlation between PROs and clinical toxicity, the percentage of clinically significant FACT-LCS decline was compared (Chi-square test) for patients who did or did not experience grade 2+ pneumonitis. Fifty-nine patients completed baseline PRO surveys. Median age was 65, 83% of patients had non-small-cell lung cancer, with 75% having stage III disease. Clinically significant FACT-TOI decline at, 3, 6, and 12 months was 46.3%, 38.5%, and 26.8%, respectively. The percentage of patients with clinically significant FACT-LCS decline was 33.3%, 33.3%, and 29.3%, at 3 months, 6 months, and 12 months, respectively. The percentage of patients with clinically significant VAS decline at 3, 6, and 12 months was 18.9%, 20.0%, and 18.6%, respectively. Patients who experienced grade 2+ pneumonitis had a greater percentage of clinically significant decline at all time-points with the results reaching significance (p = 0.045) at 6 months. The study presents the first comprehensive evaluation of PROs for patients treated with 4DCT-ventilation functional avoidance. The data show that 20-40% of patients had clinically significant decline and that PROs had a strong correlation with pneumonitis. The PRO data demonstrate that functional avoidance results in low rates of patient reported outcome clinical decline and provide seminal results to be used in phase III studies.

Determining the Minimal Clinically Important Difference of the FACT-E to Evaluate the Change in the Quality of Life of Patients with Esophageal Cancer Treated with Curative Radiotherapy

Patients with esophageal cancer (EC) are often treated with radiotherapy (RT). The Functional Assessment of Cancer Therapy-Esophageal (FACT-E) is a health-related quality of life (QOL) instrument validated in patients with EC. The aim of this study was to determine the minimal clinically important difference (MCID) for FACT-E subscales, to allow for meaningful evaluation of the effect of RT on EC patient's QOL. We evaluated patients with EC, treated with curative intent RT, who completed the FACT-E at baseline and end of treatment (EOT). We calculated the MCID for the FACT-E subscales using anchor-based and distribution-based approaches. In the anchor-based approach we determined improvement and deterioration based on the overall health assessment from the PROMIS-10 as the anchor. We modeled the change in domain scores with age-adjusted regressions to determine the difference in classifications. For distribution-based analysis, we considered 0.3 and 0.5 standard deviation (SD). We averaged MCID for improvement and deterioration separately across timepoints, by approach, and we report MCID ranges as the minimum and maximum values across methods. Our cohort included 210 patients with EC, 96.7% white, 85.7% males, and 32.9% treated with photon with a median dose of 50 Gy (IQR 50-50) and a median fraction number of 25(IQR 25,25). The median age at RT was 67.6 years (IQR 60.9,73.7). The social domain had the lowest MCID (deterioration and improvement 0.9-1.9), while the widest MCID range, proportionally to the measure, was associated with the Fact-E total score (2.1-5.6 for improvement, and 3.7-5.6 for deterioration). MCID estimates from 0.3 SD were in exact agreement with the anchor-based deterioration estimates for the physical domain (2.3), and improvement estimates for the Trial Outcome Index (6.1). We determined the MCID for the FACT-E domains, using a combination of anchor- and distribution-based approaches. These findings are critical to determine whether there is meaningful change in the QOL of individuals with EC treated with curative RT.

Prospective Longitudinal Assessment of Quality of Life after Stereotactic Ablative Radiotherapy for Oligometastases: Analysis of the Population-Based SABR-5 Phase II Trial

To evaluate longitudinal patient-reported quality of life (QoL) in patients treated with stereotactic ablative radiotherapy (SABR) for oligometastases. The SABR-5 trial was a population-based single-arm phase II study of SABR to up to 5 sites of oligometastases, conducted in 6 regional cancer centers in British Columbia from 2016 to 2020. Prospective QoL was measured using treatment site-specific QoL questionnaires at pre-treatment baseline and 3, 6, 9, 12, 15, 18, 21, 24, 30, and 36 months after treatment. Patients with bone metastases were assessed with the Brief Pain Inventory (BPI). Patients with liver, adrenal, and abdominopelvic lymph node metastases were assessed with the Functional Assessment of Chronic Illness Therapy-Abdominal Discomfort (FACIT-AD). Patients with lung and intrathoracic lymph node metastases were assessed with the Prospective Outcomes and Support Initiative (POSI) lung questionnaire. The two one-sided test procedure was used to assess equivalence between the worst QoL score and baseline score of individual patients. Mean QoL at all time points was used to determine the trajectory of QoL response after SABR. The proportion of patients with "stable," "improved," or "worsened" QoL was determined for all time points based on standard minimal clinically important differences (MCID; BPI worst pain = 2, BPI Functional Interference Score [FIS] = 0.5, FACIT-AD Trial Outcome Index [TOI] = 8, POSI = 3). All enrolled patients with baseline QoL assessment and at least 1 follow-up assessment were analyzed (n = 135). On equivalence testing, patients' worst QoL scores were clinically different from baseline scores and met MCID (BPI worst pain mean difference: 1.8, 90% CI [1.19 to 2.42]; BPI FIS mean difference: 1.68, 90% CI [1.15 to 2.21]; FACIT-AD TOI mean difference: -8.76, 90% CI [-11.29 to -6.24]; POSI mean difference: -4.61, 90% CI [-6.09 to -3.14]). However, the mean FIS transiently worsened at 9, 18 and 21 months but eventually returned to stable levels. The mean FACIT and POSI scores also worsened at 36 months, albeit with a limited number of responses (n = 4 and 8, respectively). The majority of patients reported stable QoL at all time points (range: BPI worst pain 71-82%, BPI FIS 45-78%, FACIT-AD TOI 50-100%, POSI 25-73%). Clinically significant stability, worsening, and improvement were seen in 70%/13%/18% of patients at 3 months, 53%/28%/19% at 18 months and 63%/25%/13% at 36 months. SABR in the oligometastatic setting can lead to transient decreases in QoL. However, most patients experienced stable QoL relative to pre-treatment levels on long-term follow-up. Further studies are needed to characterize patients at greatest risk for decreased QoL.

Electro-acupuncture for health-related quality of life and symptoms in patients with gastric cancer undergoing adjuvant chemotherapy (EAGER): a protocol for a multicenter randomized controlled trial

BackgroundPatients with local gastric cancer experience a decline of Health-related quality of life (HRQOL) during adjuvant chemotherapy following gastrectomy. Our previous pilot study has indicated the potential of acupuncture to improve HRQOL and control cancer-related symptoms burden. This full-scale trial will focus on confirming the effect of acupuncture for patients with gastric cancer.MethodsA multicenter, open-label, three-arm randomized controlled trial with 249 patients will be conducted in China. Patients will be randomly assigned, in a ratio of 1:1:1, to receive high-dose acupuncture (HA, 7 times each chemo-cycle for 3 cycles), low-dose acupuncture (LA, 3 times each chemo-cycle for 3 cycles), or no acupuncture. The acupoints prescription consisted of bilateral ST36, PC6, SP4, DU20, EX-HN3, and selected Back-shu points. Patients-reported Functional Assessment of Cancer Therapy-Gastric (FACT-Ga) and modified Edmonton Symptom Assessment Scale (mESAS) during the therapy will be recorded. Area under curve (AUC, 21 days/cycle × 3 cycles) and average trajectory of FACT-Ga and mESAS will be calculated. The primary outcome will be the differences in AUC of the FACT-Ga Trial Outcome Index (TOI) between HA and LA versus control groups. Secondary outcomes include AUCs and average trajectory of other FACT-Ga subscales and mESAS scores.DiscussionThis study aims to assess the effect of acupuncture and to compare the difference between LA and HA groups on HRQOL and symptom burden controlling in gastric cancer patients by an adequately powered trial.Trial registrationThis study was approved by the Ethics Committee of the Guangdong Provincial Hospital of Traditional Chinese Medicine (approval number: BF2018-118) with registration at ClinicalTrials.gov (identifier: NCT04360577).

P50 Exploring unmet needs and attitudes to skin self-examination in melanoma survivors: EUNASS study

Abstract A melanoma diagnosis can have significant emotional and psychosocial impact, yet little guidance exists on how best to support individuals following initial diagnosis. This multicentre UK study aimed to evaluate the baseline needs of melanoma survivors and assess attitudes towards practising skin self-examination (SSE) to inform the development of intervention(s) that best support patients with melanoma beyond diagnosis. A prospective multicentre questionnaire study was conducted across four UK sites, including adults diagnosed with American Joint Cancer Committee (AJCC version 8) stage I–III primary cutaneous melanoma. Participants were invited within 3–12 months of their initial diagnosis to self-complete an electronic questionnaire (using Qualtrics software) evaluating unmet needs, which included the Functional Assessment of Cancer Therapy—Melanoma (FACT-M), Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF), Melanoma specific unmet needs (SF-36), Sun Protection Behaviour Scale (SPBS), Skin Self-Examination (SSE) benefits and barriers scale, and European Quality of Life 5 Dimensions (EQ-5D). STATA 17 was used for the data analysis. Overall, 252 participants were recruited and 55 excluded for failure to provide any responses. The sample was predominantly male (56.3%) and White (100%), with high educational qualifications (52.1%) and not in paid/self-employment (53.2%). Sites of primary melanoma included the trunk (n = 61; 31.0%), head/neck (n = 45; 22.8%), arm (n = 44; 22.3%), leg (n = 33; 16.8%), hands/feet (n = 10; 5.1%) and genitals (n &amp;lt; 5; &amp;lt; 2.5%). SSE barrier and benefit scales had median scores of 29 [interquartile range (IQR) 27–32] and 27 (IQR 22–32), respectively, indicating positive attitudes towards SSE; however, several barriers exist, including identifying abnormal moles and associated anxiety. The majority of participants (56.4%) were identified as having at least one unmet care need, most commonly with regard to information on recurrence risk (37.1%) and SSE (33.0%). The FACT-M, FACT-M trial outcome index and FACT-G (general) had median scores of 26 (IQR 12–38; n = 180), 16 (IQR 6–22, n = 183) and 21 (IQR 8–29; n = 180), respectively. Participants had a median EQ-5D score of 0.92 [IQR 0.86–1.0; full health = 1.0 (n = 189)] and 59.9% were identified as having less than full health. This multicentre UK study indicates that melanoma survivors experience low quality of life within the first year of their diagnosis. Routine collection of melanoma-specific patient-reported outcome measures could improve the patient experience by stratifying patients to receive appropriate supportive care. Focused educational tools guiding sun protection habits and SSE are needed to reduce the risk of further melanomas. Future qualitative data will support an evidence base to develop supportive tools, enabling patients to take an active role in self-management.