Cancer-specific Health-related Quality Of Life Research Articles

Baseline financial distress and cost-related social risks among participants in the Cancer Financial Experience (CAFÉ) trial.

172 Background: Cancer Financial Experience (CAFÉ) is a multi-site, three-arm randomized controlled trial to test the impact of a novel financial navigation intervention on financial distress among cancer patients. We compared the baseline prevalence of financial distress among CAFÉ trial participants, using two instruments (InCharge and COST), and assessed cost-related social risks. Methods: Three hundred seventy one (n=371) participants were consented and randomized between August 2021-March 2023. Eligible participants (n=2033) included adults (18+ years of age), diagnosed with invasive cancer within 120 prior to a recent visit to a CAFÉ study clinic/site, members of Kaiser Permanente Northwest or Kaiser Permanente Washington, and spoke English or Spanish. Following consent, participants were randomized to one of three trial arms: enhanced usual care; brief intervention; enhanced intervention. The two primary trial outcomes were: financial distress, measured using the InCharge Financial Distress/Financial Well-Being scale, and cancer-specific health-related quality of life, measured by the FACT-G7 scale. Additionally, we collected the COST measure and cost-related social risks. All participant-reported outcomes, demographic, and socioeconomic data were collected via telephone survey at baseline and 12 months by trained interviewers. Survey data was stored in REDCap. Descriptive statistics were used to assess participant demographic, socioeconomic, and outcome data at baseline. Results: Among randomized participants (n=371), mean age was 61 years (standard deviation=14 years), 63% were female, 11% Hispanic, 9% Asian, 8% Black , 61% married or living with partner, 31% were employed full-time, 37% retired, 44% had annual income of $20000-$74999, 45% had Medicare, and 38% had breast cancer. At baseline, InCharge scores showed 31% (n=113) of participants had high, 19% had moderate, and 50% had low financial distress. Based on COST scores, 2.2% (n=16) of participants had high, 63% had moderate, and 39% had low financial distress. Forty percent (n=148) of participants reported any cost-related social risk, including heat and electricity (15%) and housing (15%). Conclusions: Baseline findings from the CAFÉ trial indicate that nearly one-third of patients with cancer may have high financial distress around the time of diagnosis, though this may vary by screening tool. The ideal screening tool for use at diagnosis is worthy of further study. Assessing and assisting patients with social risks, including financial distress, is essential to advancing cancer health equity. Clinical trial information: NCT05018000 .

Prospective comparative study of quality of life in patients with bladder cancer undergoing cystectomy with ileal conduit or bladder preservation

ObjectiveTo compare health-related quality of life (HRQOL) in patients undergoing radical cystectomy with ileal conduit (RC) or bladder preservation (BP) with (chemo)radiotherapy for bladder cancer.Methods and analysisPatients with bladder cancer,...

Abstract PS02-09: Nurse-led individualized follow-up versus regular physician-led visits after early breast cancer (MyHealth) - a randomized, controlled trial

Abstract Background: Follow-up after breast cancer with regular specialist-led visits has failed to prove superiority over other strategies in terms of recurrence detection and survival, but it is still a cornerstone in breast cancer follow-up in many healthcare systems. Follow-up provided by the general practitioner or a specialist nurse has been reported more cost-effective and non-inferior in terms of patient-reported health-related quality of life (HRQoL) and in meeting the needs of breast cancer survivors. However, no follow-up strategies have demonstrated indisputable superiority over other strategies. Methods: In this randomized controlled trial (MyHealth), patients who recently completed surgery, and chemo-/radiotherapy if indicated, for stage I–II breast cancer were randomly assigned to intervention or control follow-up at Zealand University Hospital, Denmark. The nurse-led intervention comprised three to five individual self-management sessions during the first six months, and regular reporting of symptoms with nurse navigation to relevant healthcare services during three years of follow-up. The control comprised outpatient visits with oncologist every six months for three years. The primary outcome was breast cancer-specific HRQoL measured by the Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) summary score of the Functional Assessment of Cancer Therapy-Breast (FACT-B) two years after randomization. Secondary outcomes were fear of recurrence, anxiety, depression, and healthcare utilization. Results: From January 2017 to January 2019, 503 patients were randomly assigned to intervention (n=251) or control (n=252) follow-up. At two years, patients in the intervention group reported a significantly higher HRQoL (mean 75·69 (SD 12·27)) than patients in the control group (mean 71·26 (SD 14·08)), a mean difference of 5·05 (95% CI; 3·30–6·79), which is considered clinically relevant. The intervention group also reported significantly less fear of recurrence, anxiety, and depression as shown in Table 1. Furthermore, patients in the intervention group had fewer physician consultations but more nurse contacts, and an unchanged diagnostic imaging pattern as shown in Table 2. The effect on all outcomes was stable through three years of follow up. Conclusions: The MyHealth study suggests a new strategy for follow-up after early breast cancer providing significant improvements in HRQoL, fear of recurrence, anxiety, and depression without inflicting extra expenses to the healthcare system. (Funded by the Danish Cancer Society, Region Zealand and Copenhagen University Hospital; Clinicaltrials.gov number; NCT02949167.) Table 1: Outcome findings by study group at baseline, 6, 12, 24, and 36 months Data are mean (SD) unless otherwise stated. The effect estimates are based on the mixed model assuming no difference between groups at baseline. The QoL and fear of recurrence variables are continuous, and the estimates describe the mean difference in score between patients in the two groups. For anxiety and depression, data were zero-inflated. These estimates describe the exponential coefficients of anxiety and depression scores in the intervention group compared to the control group. Cohen’s d is a measure of effect size, and interpreted as small for Cohen’s d = 0·2, medium for Cohen’s d = 0·5, and large for Cohen’s d = 0·8 Table 2: Number of contacts and diagnostic imaging examinations during the first three years of follow-up by study group Data are numbers and mean (SD) per patient during the first three years of follow-up. 1 Most telephone consultations were scheduled as outpatient visits according to the protocol, but changed to telephone consultations due to the COVID-19 pandemic Citation Format: Lena Saltbæk, Pernille Bidstrup, Randi Karlsen, Beverley Høeg, Trine Horsboel, Federica Belmonte, Elisabeth Andersen, Vibeke Zoffmann, Anne Friberg, Mads Svendsen, Helle Christensen, Vesna Glavicic, Dorte Nielsen, Susanne Dalton, Christoffer Johansen. Nurse-led individualized follow-up versus regular physician-led visits after early breast cancer (MyHealth) - a randomized, controlled trial [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 PS02-09.

EORTC QLQ-C30 general population normative data for the United States

ObjectiveThe European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 is a frequently used cancer-specific health-related quality of life (HRQoL) questionnaire. To aid interpretation of data obtained via EORTC QLQ-C30, general population norm data have been published for many countries. However, despite its frequent use in the United States, no normative data by sex and age exist to date. Therefore, this study aimed to generate sex- and age-specific EORTC QLQ-C30 normative data for the United States. MethodsRecruitment and data collection were carried out via online panels as part of a larger cross-sectional study. For the recruitment, the sample was stratified by sex and age (18–39, 40–49, 50–59, 60–69, ≥ 70 years) to achieve a balanced distribution, with n = 100 per subgroup. Descriptive statistics are presented by age and age/sex. ResultsA total of N = 1009 respondents completed the survey (n = 508 females, n = 501 males). More than two thirds of participants (72.5%) reported at least one health condition, e.g., arthritis (26%). Across EORTC QLQ-C30 scales, women and men 60 years and older reported generally better/higher functioning and better/lower symptom scores compared to the younger age groups. ConclusionTo date, no specific EORTC QLQ-C30 general population normative data have been published for the United States. This paper provides these important normative data, which will greatly support the interpretation of EORTC QLQ-C30 scale scores obtained from US cancer patients, and also enable comparison with European norms.

EORTC QLQ-C30 normative data for the United Kingdom: Results of a cross-sectional survey of the general population

ObjectiveThe cancer-specific health-related quality of life (HRQoL) questionnaire of the European Organisation for Research and Treatment of Cancer (EORTC), the EORTC QLQ-C30, is a frequently applied questionnaire to assess cancer patients’ self-reported health used as part of research and clinical practice. Normative data obtained from the general population can facilitate the interpretation of these data. Despite its frequent application, no detailed EORTC QLQ-C30 normative data have yet been published for the United Kingdom (UK). This study presents detailed EORTC QLQ-C30 normative data for the United Kingdom overall and by sex and age. MethodsThe data are drawn from a larger published, international, cross-sectional online survey. For the recruitment, the sample was stratified by sex (males, females) and age in five age groups with a sample size of n = 100 per subgroup. ResultsA total of N = 1026 UK respondents completed the survey (n = 517 females, n = 509 males). There were no clear subgroup patterns by sex or age; however, older patients tended to show higher (i.e., better) scores in emotional and social functioning; they also reported some of the lowest (i.e., best) scores for symptoms, such as insomnia, appetite loss, diarrhoea, nausea/vomiting or financial difficulties. ConclusionThis paper provides EORTC QLQ-C30 general population normative data for the UK, further stratified by sex and age. These data will greatly support the interpretation of EORTC QLQ-C30 scale scores obtained from UK cancer patients, and also enable comparison with other detailed national normative datasets collected in the same project, across several other European countries and the US.

Prospective Comparative Study of Quality of Life in Bladder Cancer Patients Undergoing Cystectomy or Bladder Preservation

Health-related Quality of life (HRQOL) may be decisive when different treatments yield comparable survival outcomes. We compared QOL in patients undergoing radical cystectomy with ileal conduit (RCIC) or bladder preservation (BP) with (chemo)radiotherapy for bladder cancer. Patients with histological diagnosis of bladder cancer, stage T1-T4, N0-N1, M0 with a minimum follow-up of 6 months from the last treatment intervention (RCIC or BP) and alive without disease at the time of QOL assessment were eligible for inclusion. After ethics committee approval, two HRQOL instruments were translated, validated and administered: Bladder cancer index (BCI) for bladder cancer-specific HRQOL, which includes 36 items under three domains - bladder, bowel and sexual function and the EORTC QLQ C30 which includes 30 items under three domains - functional, symptom and global health. The mean QOL scores across various domains and specific questions were compared between the two treatment groups using the independent t-test. Of the 104 patients enrolled, 56 had RCIC, and 48 received BP, and included 95 (91.3%) males. The median time from treatment completion to QOL assessment was 22 months (IQR 10-56). The median age for the entire cohort was 62 years (IQR 55-68), 65.5 years (IQR 55-71) in BP and 59.5 years (IQR 55-66) in RCIC. Overall, mean BCI urinary scores and bowel scores were high in both groups, with no significant difference in function or bother subdomains between the two groups (Table 1). Overall, BCI sexual scores were low in both the groups but significantly better after BP (BPmean 56.9, RCICmean 41.5, p = 0.01). Mean scores for sexual function BPmean 38.4 and RCIC mean 25 p (0.07) and sexual bother BPmean 81 RCICmean 62 (p 0.02) subdomains. There was no significant difference in EORTC QOL outcomes in functional (BPmean 91.4, RCICmean 88.7 p 0.23), symptom (BPmean 89.8, RCICmean 89, p = 0.68) and global health scale (BPmean 76.8, RCICmean 78.5, p = 0.69) in both groups. On question-wise assessment, the ability to perform an exercise (BPmean 94.2, RCICmean 85, p = 0.06) and urinary leakage at night time (BPmean 91.7, RCICmean 77.6, p = 0.01) were better in the BP group, while scores for blood in the urine (BPmean 89.1, RCICmean 97, p = 0.05) were better in the RCIC group compared to BP. Overall, QOL was good in both groups in the urinary and bowel domains while it was low in the sexual domain. However, bladder preservation performed significantly better in the sexual domain than RCIC.

The association between hospital variation in curative treatment for esophagogastric cancer and health-related quality of life and survival

BackgroundAs previous studies showed significant hospital variation in curative treatment of esophagogastric cancer, this study assesses the association between this variation and overall, cancer-specific and recurrence-free survival, and Health-Related Quality of Life (HRQoL). MethodsPatients diagnosed with potentially curable esophageal or gastric cancer between 2015 and 2018 as registered in the Netherlands Cancer Registry were included. Data on overall survival was available for all patients, data on cancer-specific and recurrence-free survival and HRQoL was available for subgroups. Patients were classified according to diagnosis in hospitals with low, medium or high probability of treatment with curative intent (LP, MP or HP). Multivariable models were used to assess the association between LP, MP and HP hospitals and HRQoL and survival. ResultsThis study includes 7,199 patients with esophageal, and 2,407 with gastric cancer. Overall and cancer-specific survival was better for patients diagnosed in HP versus LP hospitals for both esophageal (HR = 0.82, 95%CI:0.77–0.88 and HR = 0.82, 95%CI:0.75–0.91, respectively), and gastric cancer (HR = 0.82, 95%CI:0.73–0.92 and HR = 0.74, 95%CI:0.64–0.87, respectively). These differences disappeared after adjustments for treatment. Recurrence-free survival was worse for gastric cancer patients diagnosed in HP hospitals (HR = 1.50, 95%CI:1.14–1.96), which disappeared after adjustment for radicality of surgery. Minor, but no clinically relevant, differences in HRQoL were observed. ConclusionsPatients diagnosed in hospitals with a high probability of treatment with curative intent have a better overall and cancer-specific but not recurrence-free survival, while minor differences in HRQoL were observed.

Effect of a Nurse Navigation Intervention on Mental Symptoms in Patients With Psychological Vulnerability and Breast Cancer

The unmet needs regarding symptom management of psychological distress among patients with breast cancer must be addressed. However, little evidence exists on effective interventions, such as nurse navigation. To compare the long-term effects of the REBECCA (Rehabilitation After Breast Cancer) nurse navigation intervention vs usual care in patients with breast cancer who were psychologically vulnerable. This parallel randomized clinical trial recruited and evaluated for eligibility adult female patients with newly diagnosed breast cancer and symptoms of psychological distress (distress score of ≥7 points on Distress Thermometer) at Rigshospitalet in Copenhagen, Denmark, from August 2017 to October 2019. This study continued the work of a pilot study, extending the follow-up to 18 months. Patients who met the inclusion criteria were randomized to either standard care or the REBECCA intervention. Intention-to-treat analyses were performed from June 2021 to October 2022. Patients who were randomized to the REBECCA intervention received nurse navigation and symptom screening as well as standard care. Standard care included regular treatment, nurse support at chemotherapy and radiotherapy appointments, and municipality-based rehabilitation. The primary outcome was distress, as measured using the Distress Thermometer. The secondary outcomes included symptoms of anxiety, symptoms of depression, breast cancer-specific health-related quality of life, fear of recurrence, sleep, cognitive function, patient activation, pain, health behavior, body mass index, and need for support. Long-term effects at 6, 12, and 18 months were examined using mixed-effect models, adjusting for randomization strata of age and treatment modality. A total of 309 female patients were included in the analysis, with 153 patients randomized to the standard care group and 156 patients randomized to the REBECCA intervention group. Mean (SD) age was 56 (11) years with only small between-group differences. Patients receiving the REBECCA intervention compared with standard care had reduced (although not significant) symptoms of distress, especially at the 12-month follow-up (estimated effect = -0.51 [95% CI, -1.05 to 0.04]; effect size [ES] = -0.49). Significant effects were seen for symptoms of depression at 6 months (estimated effect = -1.39 [95% CI, -2.33 to -0.44]; ES = -0.27), and breast cancer-specific health-related quality of life at 12 months (estimated effect = 4.03 [95% CI, 1.28- 6.77]; ES = 0.31). Nonsignificant reductions were seen for symptoms of anxiety at 6 months (estimated effect = -1.00 [95% CI, -1.95 to -0.06]; ES = -0.21) and 12 months (estimated effect = -1.01 [95% CI, -1.97 to -0.04]; ES = -0.21), and a nonsignificant increase was seen for patient activation at 18 months (estimated effect = 3.52 [95% CI, -0.09 to 7.12]; ES = 0.25). Stronger intervention effects were observed for younger age, low patient activation, less education, and low social support. Results of this study indicate that patients with breast cancer who were psychologically vulnerable (ie, having moderate to high psychological distress) did not experience significant reduction in distress with nurse navigation. Further research is needed to develop the intervention's framework and investigate its potential use in clinical practice. ClinicalTrials.gov Identifier: NCT03254875.

Evaluation of health-related quality of life and its domains in pediatric patients with cancer

BackgroundHealth-related quality of life has emerged as a significant component in pediatric oncology research during the last several decades. Measures of health-related quality of life provide a thorough assessment of the child’s response to medical therapy, disease course, and adjustment outcomes in the context of pediatric oncology.MethodsThe aim of the present study was to assess the cancer-specific health-related quality of life in cancer pediatric patients and to evaluate the contribution of its domains and some of the anthropometric, sociodemographic, and treatment-related variables on the overall quality of life, by using the PedsQL™ 3.0 Cancer Module.ResultsThe study included 110 cases. The mean value of the PedsQL™ 3.0 Cancer Module score was 49.3 ± 12.0. The lowest mean score of quality of life was for the “procedure anxiety” (8.7 ± 23.9), followed by the “worry” domains (16.6 ± 28.5). Higher “frequency of hospital visits” was associated with increased feeling of pain and treatment anxiety yet decrease in suffering from nausea and vice versa. The longer period of hospital admission for more than half of the recommended treatment period was associated with reduced pain suffering on the expense of increase in feeling of worry as well as communication problems. The perceived physical appearance was better among those patients who spent a treatment period for 3–6 months when compared to those who spent a treatment period less than 3 months or more than 6 months. There was a highly significant association between all the eight-cancer-specific quality-of-life domains except the pain domain- and the overall quality-of-life log scores. Nausea problem followed by worry and cognitive problems was the most effective domains on the overall quality-of-life score.ConclusionCancer pediatric patients suffered low quality of life especially for anxiety procedure and worry domains with special consideration for the impact of nausea, worry, and cognitive problems on their perception of quality of life.

Prospective analysis of the impact of adjuvant treatment with external beam radiation therapy and vaginal brachytherapy on health-related quality of life in patients with early-stage endometrioid endometrial carcinoma.

Our study evaluates the impact of adjuvant treatment with external beam radiotherapy (EBRT) combined with vaginal high dose rate brachytherapy (HDR BT) on health related quality of life (HRQL) in patients with early stage endometrioid endometrial carcinoma. From March 2019 to February 2021, 60 patients were enrolled with early stage endometrioid endometrial carcinoma, and qualified to adjuvant treatment after hysterectomy. HRQL was assessed using the EORTC QLQ-C30 questionnaire, with the endometrial cancer-specific HRQL module EORTC QLQ-EN24. Questionnaires were completed in four timepoints during adjuvant radiotherapy. A significant decrease in mean global health status / quality of life (p < 0.001) and role functioning (p = 0.028) was noted, as assessed in EORTC QLQ-C30 scale. Among the EORTC QLQ-C30 symptoms scales, significant differences were noted in the fatigue scale (p = 0.003), pain scale (p = 0.001), constipation scale (p < 0.001) and diarrhea scale (p < 0.001) over time. The EORTC QRQ-EN24 analysis showed significant deterioration in the urological symptoms scale (p < 0.001), gastrointestinal symptoms scale (p < 0.001) and in the mean pain in back and pelvis scale (p = 0.003). Adjuvant radiotherapy in patients with early-stage endometrioid endometrial cancer after hysterectomy is associated with worse quality of life, especially due to the toxicity of the treatment in relation to the gastrointestinal tract and urinary system.

Effects of a Pretend Play Intervention on Health-Related Quality of Life in Children With Cancer: A Swedish-German Study.

Background: Cancer diagnosis can lead to massive physical, emotional, and social burdens on children and their families. Although children have the right to be informed and participate in their care, research shows that children's views are often not considered in care situations. Thus, it is essential to strengthen children's communication and self-efficacy (SE) to convey desires and needs. The present study explores whether a play intervention is associated with improved health-related quality of life (HrQoL) and SE for communication in care situations. We hypothesize that HrQoL and SE for communication will increase from the beginning to after the pretend play intervention. Methods: Children with cancer from Germany and Sweden were enrolled. The pretend play intervention consisted of six to 10 play sessions. A heterogenic selection of questionnaires was used to measure children's HrQoL and SE before the first pretend play session and after the last play intervention. Results: Nineteen families were included in the presented analyses, including 14 self-reports of children and 19 proxy reports of parents. We found improvements in child-reported communication, and emotional and psychosocial well-being using generic and cancer-specific HrQoL measurements. Further, children's SE in care situations improved during the play intervention. Parents also reported minor improvements in the physical dimensions in both generic and chronic-generic HrQoL, along with improvements in independence. Discussion: Overall, the cancer-specific pretend play intervention offers young children with cancer a secure environment and can contribute to their well-being, and communication skills, during or after cancer treatment.

Quality of Life in Adolescents and Young Adults: The Role of Symptom Burden.

Adolescents and young adults (AYAs) with cancer report worse health-related quality of life (HRQOL) than other age groups. Symptom burden is a modifiable predictor of HRQOL. The objective of this study was to identify which symptoms are most burdensome to AYAs with advanced cancer. In this observational study, English-speaking individuals aged 12-25 years undergoing treatment for advanced cancer completed assessments of symptom burden (Memorial Symptom Assessment Scale) and HRQOL (Pediatric Quality of Life Inventory Generic Form and Cancer Module; minimal clinically important difference 4.4). We dichotomized participants as having low (<7) or high (≥7) symptom prevalence. Mixed regression models estimated HRQOL differences between groups. For individual symptoms, unadjusted mixed models estimated HRQOL reductions. N=58 AYAs completed baseline surveys. The median age was 17 years (IQR 15-19), 58% were male, 59% identified as white, and 44% were diagnosed with leukemia/lymphoma. High symptom prevalence was associated with a mean generic HRQOL 7 points lower (95% CI: -11, -3; P < 0.01) and cancer-specific HRQOL score 12 points lower (95% CI: -17, -7; P < 0.01) than low symptom prevalence. The most prevalent symptoms were fatigue (71%), pain (58%), and difficulty sleeping (58%). Fatigue (-8), difficulty concentrating (-7), and mouth sores (-6) were associated with the greatest generic HRQOL score reductions. Dysphagia (-12), difficulty concentrating (-12), and sadness (-11) were associated with the greatest cancer-specific HRQOL score reductions. The symptom experience among AYAs with advanced cancer is unique. Separate evaluation of AYA's symptoms may optimize management and improve HRQOL.

Long-term Health-related Quality of Life (HRQOL) After Radical Cystectomy and Urinary Diversion - A Propensity Score-matched Analysis.

Radical cystectomy (RC) and urinary diversion by ileal conduit (IC) or ileal orthotopic neobladder (ONB) is the standard-of-care for surgical treatment of muscle-invasive bladder cancer. Yet, it is unclear how urinary diversion affects the patient's health-related quality of life (HRQOL) in the longer-term. HRQOL was assessed preoperatively, 3mo postoperatively and then annually until a maximum follow-up of 48 months using the validated EORTC QLQ-C30- as well as the bladder cancer-specific FACT-BL- and QLQ-BLM30-questionnaires. A propensity-score matching for the variables "age," "ASA-classification," "cardiovascular co-morbidity," "sex" as well as "tumor stage," and "preoperative physical functioning score" was performed. Hypothetical predictors for decreased general HRQOL were analyzed using multivariable logistic regression models. After propensity-score matching, 246 patients were analyzed. HRQOL assessment revealed significant differences regarding preoperative QLQ-C30 symptoms which diminished during the postoperative time course. Similarly, we did not find significant differences based on bladder cancer-specific FACT-BL and QLQ-BLM HRQOL assessment including body image (48 months: 29.6.4 [IC] vs. 40.7 [ONB]; P=.733). Regarding general HRQOL, we found increased global health status scores for ONB throughout the whole observational period without reaching statistical significance (48 months: 55.0 [IC] vs. 70.1 [ONB]; P=.079). In multivariate analysis, cardiovascular comorbidity was an independent predictor of impaired HRQOL 24 months (HR 2.20; CI95% 1.02-5.72, P=.044) and 36 months (HR 6.84; CI95% 1.61-29.14, P=.009) postoperatively. We did not observe significant differences in bladder-specific as well as generic HRQOL in the longer-term and consequently, the type of urinary diversion was not an independent predictor of good general HRQOL in a follow-up period of 4 years.

Systematic Review of Comparative Patient Reported Outcomes and Health-Related Quality of Life After Management of Localized Renal Masses or Renal Cell Carcinomas

Objective: To perform a systematic review assessing the impact of the different management options on health-related quality of life (HRQoL) of patients with localized renal masses or renal cell carcinomas (LRM/LRCC). Materials and Methods: Searches covering PubMed, Embase (Ovid), CENTRAL, PsycINFO (Ovid), CINAHL (EBSCO), and Cochrane Central Register of Controlled Trials (CENTRAL) databases was conducted for papers published up to 25 April 2021. Methods as per Cochrane Handbook were followed. “Modality” of treatment included radical nephrectomy (RN), nephron-sparing surgery (NSS), thermal ablation (TA), and active surveillance (AS). “Approach” was categorized as open incision and minimally invasive surgery (MIS). Risk of bias was assessed by ROBINS-I and Cochrane RoB 2 for observational studies and randomized controlled trials, respectively and certainty of the evidence by GRADE. Results: Sixteen observational studies and 1 randomized controlled trial (2.370 patients) met inclusion criteria. Fifteen different patient reported outcome measures (PROMs) were identified. Heterogeneity prevented quantitative analysis. Generic HRQoL decreases after RN and NSS, recovers within 6 to 12 months, and mostly overlaps with baseline values, irrespective of modality. Cancer-specific HRQoL improve faster after open-NSS than open-RN. The detrimental effect of RN may persist long-term in cross-evaluations. QoL scales significantly decrease after open surgery and MIS during the first weeks but improve faster after MIS. They are similar for both approaches at 1-year. Long-term cancer-specific QoL is similar for MIS and open procedures. Fear of recurrence is lower in older patients and affected by neither modality nor approach. Conclusions: Low quality evidence supports the use of MIS over the open approach when HRQoL is considered in the management of LRMs/LRCCs; data regarding the effect of the treatment modality of the LRM/LRCC show contradictory outcomes.

Health-related quality of life, psychological distress, and fatigue in metastatic castration-resistant prostate cancer patients treated with radium-223 therapy

BackgroundRadium-223 is a registered treatment option for symptomatic bone metastatic castration-resistant prostate cancer (mCRPC). Aim of this multicenter, prospective observational cohort study was to evaluate health-related quality of life (HR-QoL), psychological distress and fatigue in mCRPC patients treated with radium-223.MethodsPrimary endpoint was cancer-specific and bone metastases-related HR-QoL, as measured by the EORTC QLQ-C30 and BM-22 questionnaires. Secondary endpoints were psychological distress and fatigue, evaluated by the HADS and CIS-Fatigue questionnaires. Outcomes were analyzed for the total cohort and between subgroups (1-3 versus 4-5 versus 6 radium-223 injections). A trajectory analysis was performed to explore HR-QoL patterns over time.ResultsIn total, 122 patients were included for analysis. Baseline HR-QoL, pain intensity, psychological distress and fatigue were worse in patients who did not complete radium-223 therapy. In patients who completed therapy, stabilization of HR-QoL was perceived and psychological distress and fatigue remained stable, whereas clinically meaningful and statistically significant deterioration of HR-QoL, psychological distress and fatigue over time was observed in patients who discontinued radium-223 therapy. Trajectory analysis revealed that HR-QoL deterioration over time was more likely in patients with baseline opioid use, low hemoglobin and high alkaline phosphatase levels.ConclusionsPatients who discontinued radium-223 therapy showed worse HR-QoL, psychological distress and fatigue at baseline and more frequent deterioration of HR-QoL, psychological distress and fatigue over time when compared to patients who completed therapy. Specific attention with regard to HR-QoL during follow-up is indicated in patients with opioid use, low hemoglobin and high alkaline phosphatase levels before radium-223 therapy initiation.Clinical trial registration numberNCT04995614.

Patient reported outcomes and health related quality of life in localized prostate cancer: A review of current evidence.

Oncological outcomes after localized prostate cancer (CaP) treatment are excellent and generally considered equivalent across treatment modalities. Thus, short, and long-term patient health related quality of life (HRQoL) is an important factor in treatment discussions. The purpose of this review was to assess the impact of treatment modality for localized CaP on HRQoL as reflected by recent published trials. We conducted a literature review using the PubMed database for studies published between January 2010 and January 2021. We included randomized control trials and observational cohort studies examining HRQoL in patients with localized CaP treated with active surveillance, radical prostatectomy, external beam radiotherapy or brachytherapy. Four randomized control trials and 15 prospective cohort studies were reviewed. Current evidence suggests that surgery has the largest short and long-term negative effect on sexual function and incontinence but advantages with regards to bowel function and irritative-obstructive urinary symptoms. Radiation therapy mainly impacts urinary irritative symptoms and bowel bother. Short-term HRQoL outcomes for active surveillance are most favorable, however, during long-term follow up, there is no significant difference in comparison to radiation. Long-term global quality of life impact regarding anxiety, mental, emotional well-being, and fatigue seem to be equivalent between treatment modalities. The choice of primary treatment modality for localized CaP results in a unique impact profile on cancer specific HRQoL in both the short and long-term periods. Understanding the different adverse events profiles can provide a basis for informing patients and clinicians regarding the impact of disease and treatments on quality of life and allow for a better patient centered discussion.

The Promoting Resilience in Stress Management (PRISM) intervention for adolescents and young adults receiving hematopoietic cell transplantation: a randomized controlled trial protocol

BackgroundPsychological distress is prevalent among adolescents and young adults (AYAs) receiving hematopoietic cell transplantation (HCT). The Promoting Resilience in Stress Management (PRISM) intervention is a resilience-coaching program that has been shown to mitigate distress and improve quality of life among AYAs receiving chemotherapy for newly diagnosed or advanced cancer. This article describes the protocol of an ongoing randomized-controlled trial (RCT) examining the efficacy of PRISM among AYAs receiving HCT for cancer and/or blood disorders.Methods/designThe goal of this multi-site, parallel, RCT is to evaluate the effect of PRISM compared to psychosocial usual care (UC) among AYAs receiving HCT. Our primary hypothesis is that AYAs who receive PRISM will report lower depression and anxiety 6-months following enrollment compared to those who receive UC. The PRISM program includes four scripted coaching sessions targeting skills in stress-management, goal setting, cognitive-restructuring, and meaning-making, followed by a facilitated family meeting. Sessions are delivered one on one, 1–2 weeks apart, in-person or via videoconference. We aim to recruit 90 AYAs from 4 US pediatric AYA oncology centers. Eligible AYAs are aged 12–24 years; receiving HCT for malignancy or a bone marrow failure syndrome associated with cancer predisposition; < 4 weeks from their HCT date; able to speak English and read in English or Spanish; and cognitively able to complete sessions. Enrolled AYAs are randomized 1:1 within each site to receive PRISM+UC or UC alone. AYAs on both study-arms complete patient-reported outcome surveys at baseline, 3- and 6-months. Age-valid instruments assess depression and anxiety, overall and cancer-specific health-related quality of life, symptom burden, resilience, and hope. Covariate-adjusted regression models will compare AYA-reported depression and anxiety at 6-months in the PRISM versus UC groups. Secondary and exploratory objectives include assessments of PRISM’s cost-effectiveness and its impact on (i) parent and caregiver quality of life and mental health, (ii) pharmaco-adherence to oral graft-versus-host disease (GVHD) prophylaxis, (iii) biologic outcomes such as transplant engraftment and graft-versus-host disease, and (iv) biomarkers of stress such as heart rate variability and the Conserved Transcriptional Response to Adversity (CTRA) gene expression profile.DiscussionIf successful, this study has the potential to address a critical gap in whole-patient care for AYAs receiving HCT.Trial registrationClinicalTrials.gov Identifier NCT03640325, August 21, 2018.

MP03-05 HOW DOES THE TYPE OF URINARY DIVERSION AFFECT HEALTH RELATED QUALITY OF LIFE (HRQOL) IN THE COURSE OF FOUR YEARS AFTER RADICAL CYSTECTOMY? - A PROPENSITY SCORE-MATCHED ANALYSIS

You have accessJournal of UrologyCME1 May 2022MP03-05 HOW DOES THE TYPE OF URINARY DIVERSION AFFECT HEALTH RELATED QUALITY OF LIFE (HRQOL) IN THE COURSE OF FOUR YEARS AFTER RADICAL CYSTECTOMY? - A PROPENSITY SCORE-MATCHED ANALYSIS Yannic Volz, Lennert Eismann, Benedikt Ebner, Paulo Pfitzinger, Jan-Friedrich Jokisch, Gerald Schulz, Thilo Westhofen, Alexander Karl, Boris Schlenker, Christian Stief, and Alexander Kretschmer Yannic VolzYannic Volz More articles by this author , Lennert EismannLennert Eismann More articles by this author , Benedikt EbnerBenedikt Ebner More articles by this author , Paulo PfitzingerPaulo Pfitzinger More articles by this author , Jan-Friedrich JokischJan-Friedrich Jokisch More articles by this author , Gerald SchulzGerald Schulz More articles by this author , Thilo WesthofenThilo Westhofen More articles by this author , Alexander KarlAlexander Karl More articles by this author , Boris SchlenkerBoris Schlenker More articles by this author , Christian StiefChristian Stief More articles by this author , and Alexander KretschmerAlexander Kretschmer More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002515.05AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Radical cystectomy (RC) and urinary diversion by ileal conduit (IC) or ileal orthotopic neobladder (ONB) is the standard-of-care for surgical treatment of muscle-invasive bladder cancer. Yet, it remains unclear how the patient’s health-related quality of life (HRQOL) is affected by the choice of urinary diversion in long-term. The current study tries to provide further insight on the quality of life up to four years after RC. METHODS: HRQOL was assessed preoperatively, 3mo postoperatively and annually until a maximum follow-up of 48mo using the validated EORTC QLQ-C30- as well as the bladder cancer-specific FACT-BL- and QLQ-BLM30-questionnaires. The variables “age”, “ASA classification” and “cardiovascular co-morbidity” were used for a propensity-score matching. Potential predictors for decreased general HRQOL were assessed using multivariable logistic regression models. RESULTS: After propensity-score matching, patient cohorts were well-balanced and a total of 260 patients were included. We were able to reveal significant differences regarding preoperative QLQ-C30 symptoms and functioning scores between IC and ONB patients which diminished during the postoperative time course. Similarly, we did not observe significant differences based on bladder cancer-specific FACT-BL and QLQ-BLM HRQOL assessment including body image [48mo: 28.4 (IC) vs. 43.7 (ONB); p=0.439). General HRQOL may increase as we found increased global health status scores for ONB throughout the whole observational period without reaching statistical significance [48mo: 57.1 (IC) vs. 67.7 (ONB); p=0.200]. In multivariate analysis, cardiovascular co-morbidity was an independent predictor of impaired HRQOL 24mo (HR 2.45; CI95% 1.16-5.17, p=0.019) and 36mo (HR 4.84; CI95% 1.39-16.92, p=0.013) postoperatively. CONCLUSIONS: Up to four years after RC we did not observe significant differences between both types of urinary diversion in bladder cancer-specific subscores as well as generic HRQOL. Consequently, the type of urinary diversion was not an independent predictor of good general HRQOL. Source of Funding: None © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e21 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Yannic Volz More articles by this author Lennert Eismann More articles by this author Benedikt Ebner More articles by this author Paulo Pfitzinger More articles by this author Jan-Friedrich Jokisch More articles by this author Gerald Schulz More articles by this author Thilo Westhofen More articles by this author Alexander Karl More articles by this author Boris Schlenker More articles by this author Christian Stief More articles by this author Alexander Kretschmer More articles by this author Expand All Advertisement PDF DownloadLoading ...

The impact of adjuvant treatment with external beam radiotherapy and vaginal brachytherapy on health-related quality of life in patients with early-stage endometrioid endometrial carcinoma - initial results of a prospective study.

Our study evaluates the impact of adjuvant treatment with external beam radiotherapy (EBRT) combined with vaginal high-dose-rate brachytherapy (HDR BT) on health-related quality of life (HRQL) in patients with early-stage endometrioid endometrial carcinoma. We assessed HRQL of patients based on the EORTC QLQ-C30 questionnaire, with endometrial cancer specific HRQL module - EORTC QLQ-EN24. From March 2019 to April 2020 we enrolled 20 patients with early-stage endometrioid endometrial carcinoma, qualified for adjuvant treatment after hysterectomy. We compared the scores measured with the questionnaires at the beginning and at the end of the treatment. There was a statistically significant decrease in the mean of global health status/quality of life assessed according to the EORTC QLQ-C30 scale, from 62.25 ± 13.12 at the beginning of the adjuvant radiotherapy to 55.85 ± 14.68 at the end of the treatment (p = 0.047). The mean appetite loss score was higher at the onset of the treatment as compared to its value after EBRT, 19.9 ± 27.33 vs 11.6 ± 19.52 (p = 0.043). Similarly to the mean constipation score, which was 29.85 ± 30.40 vs 11.6 ± 19.52 (p = 0.013). The mean diarrhoea symptom scale increased from 16.55 ± 20.16 to 56.75 ± 36.10 (p = 0.001). In the EORTC QLQ-EN24 scales, gastrointestinal symptoms scores were higher at the end of the treatment, (with the mean of 26.45 ± 22.76) as compared to 14.30 ± 16.52 at the beginning of EBRT (p = 0.003). Patients who receive adjuvant radiotherapy have decreased quality of life during the treatment reporting more serious gastrointestinal symptoms. The potential risk of treatment-related toxicity should be taken into account during the treatment planning process in order to minimize the deterioration of HRQL.

AdvanTIG-203: A randomized phase 2 study comparing anti-TIGIT ociperlimab plus tislelizumab versus tislelizumab plus placebo as second-line treatment in patients with advanced or recurrent esophageal squamous cell carcinoma (ESCC) expressing programmed death-ligand 1 (PD-L1).

TPS370 Background: The programmed death-1 (PD-1)/PD-L1 pathway plays an important role in tumor induced immunosuppression. PD-L1 overexpression is observed in approximately 30–60% of esophageal cancers and is associated with poor prognosis. Anti-PD-1 agents demonstrate moderate efficacy in PD-L1-positive esophageal cancer in terms of response rate and overall survival, however, long-term outcomes remain poor due to primary and secondary resistance driven by tumor immune escape. The T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domain (TIGIT) is upregulated on T-cells and natural killer cells in multiple solid tumors, which can inhibit anticancer immune responses. Ociperlimab (BGB-A1217) is a novel, humanized, monoclonal antibody that binds TIGIT with high specificity and affinity, blocking the interaction with its ligands on tumor cells. Preclinical and clinical studies suggest that dual targeting with anti-TIGIT and anti-PD-1 antibodies produces synergistic immune cell activation and enhanced antitumor activity. Methods: AdvanTIG-203 is a Phase 2, global, randomized, double-blind, placebo-controlled study (NCT04732494) of patients with unresectable, locally advanced, recurrent or metastatic ESCC, who progressed on or after 1st line systemic therapy and whose tumors express PD-L1 (visually-estimated combined positive score ≥ 10%). After stratification by Eastern Cooperative Oncology Group performance status (0 or 1), number of metastatic sites (≤ 1 or ≥ 2) and region (Asian or non-Asian), 280 patients will be randomized (1:1) to either ociperlimab 900 mg intravenous (IV) plus tislelizumab 200 mg IV every 3 weeks (Q3W), or tislelizumab plus placebo Q3W, until disease progression (per RECIST v1.1), unacceptable toxicity, death or withdrawal of consent. Co-primary endpoints are investigator-assessed overall response rate (ORR) and overall survival (OS) in the intention-to-treat population. A sample size of 280 patients was estimated to provide approximately 94.8% power to detect a 20% difference in ORR at a one-sided significance level of 0.025. With 198 deaths, the study was estimated to provide approximately 86% power to detect a hazard ratio of 0.65 for OS. Secondary endpoints are ORR by independent review, progression-free survival, duration of response, disease control rate, and clinical benefit rate per investigator and independent assessment, cancer-specific health-related quality of life (HRQoL), and safety. Exploratory endpoints include but are not limited to expression of TIGIT, CD226, CD155, CD112, and PD-L1, pharmacokinetics, immunogenicity, and generic HRQoL measures. Clinical trial information: NCT04732494.