Functional Assessment Of Cancer Therapy-General Scores Research Articles

Patient perceptions underlying ctDNA molecular surveillance for HPV(+) oropharyngeal squamous cell carcinoma

ObjectiveCirculating tumor DNA assays have robust potential as molecular surveillance tools. They may also exacerbate patient distress without improving outcomes. We investigate patient acceptability of a validated ctHPVDNA assay (NavDx) during cancer surveillance for HPV(+) oropharyngeal cancer (OPC). MethodsConsented HPV(+) OPC participants completed the NCCN Distress Thermometer, the Hospital Anxiety Depression Scale (HADS), and the Functional Assessment of Cancer Therapy-General (FACT-G) scale both (1) before NavDx blood draw, and (2) after results were provided. Patients then completed a series of focused questions related to their perceptions of the assay. ResultsOverall, 55 patients completed the study, with 98.2 % showing no recurrence. For the NCCN Distress Thermometer, median patient distress decreased (2.0 (IQR 1–5) vs. 1.0 (IQR 0–3)) (p < 0.001) in association with NavDx. Using scores ≥ 4 as a cutoff point to define clinically elevated distress, scores also improved (36.4 % vs. 18.2 %, p = 0.031). For HADS, anxiety significantly improved (5.0 (IQR 2.0–7.0) vs. 3.0 (IQR 1.0–6.5)) (p = 0.037), but not depression (3.0 (IQR 1.0–7.0) vs. 3.0 (IQR 1.0–6.5)) (p = 0.870). FACT-G scores showed no substantial differences. On survey questionnaires, 95.5 % of patients believed the test to be helpful, and 100 % felt “somewhat” or “extremely” confident in the assay as a monitoring tool. While 59.1 % felt that it reduced anxiety, 88.4 % concordantly felt that it did not introduce anxiety. ConclusionctHPVDNA as a molecular surveillance tool reduced distress levels in HPV(+) OPC patients, with notably high patient confidence in the approach. Further investigation is warranted to judiciously incorporate this emerging modality in surveillance guidelines.

Relationship between hope and quality of life in patients with advanced cancer in Uruguay: An observational analysis.

e24055 Background: International research suggests a beneficial effect of hope on quality of life in advanced-stage cancer patients. Specific evidence for Latin America and Uruguay is limited, highlighting the need to explore this relationship for regional clinical strategies. Objective: To evaluate the correlation between hope and quality of life in Uruguayan patients with advanced cancer. Methods: This observational, analytical-descriptive, and cross-sectional study used the Herth Hope Index (HHI) and the Functional Assessment of Cancer Therapy - General (FACT-G) Quality of Life questionnaire. It included 59 patients aged 18 or older, diagnosed with advanced, non-curable cancer. Results: There was a positive but non-significant correlation between HHI and FACT-G scores (Pearson coefficient of 0.05). Hope significantly correlated with support from oncology services (p = 0.044), family support (p = 0.003), and spiritual beliefs (p = 0.029). Factors like bone metastases, diagnostic delay, and being accompanied at consultations significantly impacted quality of life (p = 0.041, p = 0.035, p = 0.012). Conclusions: The study observed a positive association between hope and quality of life, but the lack of statistical significance indicates the need for more research. Clinically, results highlight the importance of comprehensive care addressing spiritual and emotional needs, in addition to medical treatment. It also underscores the potential impact of supportive services on patient well-being. Future research should include larger sample sizes and consider longitudinal designs to better understand hope's effects over time in advanced cancer patients.

Evaluating the psychometric properties of the simplified Chinese version of PROMIS-29 version 2.1 in patients with hematologic malignancies

The Patient-Reported Outcomes Measurement Information System 29-item Profile version 2.1 (PROMIS-29 V2.1) is a widely utilized self-reported instrument for assessing health outcomes from the patients’ perspectives. This study aimed to evaluate the psychometric properties of the PROMIS-29 V2.1 Chinese version among patients with hematological malignancy. Conducted as a cross-sectional, this research was approved by the Medical Ethical Committee of the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (registration number QTJC2022002-EC-1). We employed convenience sampling to enroll eligible patients with hematological malignancy from four tertiary hospitals in Tianjin, Shandong, Jiangsu, and Anhui province in China between June and August 2023. Participants were asked to complete a socio-demographic information questionnaire, the PROMIS-29 V2.1, and the Functional Assessment of Cancer Therapy-General (FACT-G). We assessed the reliability, ceiling and floor effects, structural, convergent discriminant and criterion validity of the PROMIS-29 V2.1. A total of 354 patients with a mean age of 46.93 years was included in the final analysis. The reliability of the PROMIS-29 V2.1 was affirmed, with Cronbach’s α for the domains ranging from 0.787 to 0.968. Except sleep disturbance, the other six domains had ceiling effects, which were seen on physical function (26.0%), anxiety (37.0%), depression (40.4%), fatigue (18.4%), social roles (18.9%) and pain interference (43.2%), respectively. Criterion validity was supported by significant correlations between the PROMIS-29 V2.1 and FACT-G scores, as determined by the Spearman correlation test (P < 0.001). Confirmatory factor analysis (CFA) indicated a good model fit, with indices of χ2/df (2.602), IFI (0.960), and RMSEA (0.067). The Average Variance Extracted (AVE) values for the seven dimensions of PROMIS-29 V2.1, ranging from 0.500 to 0.910, demonstrated satisfactory convergent validity. Discriminant validity was confirmed by ideal √AVE values. The Chinese version of the PROMIS-29 V2.1 profile has been validated as an effective instrument for assessing symptoms and functions in patients with hematological malignancy, underscoring its reliability and applicability in this specific patient group.

Health-related quality of life over chemotherapy course among individuals with early-stage breast cancer: the association of social determinants of health and neighborhood socioeconomic disadvantage.

This study aimed to examine relationships between health-related quality of life (HRQOL), social determinants of health, and neighborhood socioeconomic disadvantage in individuals with early-stage breast cancer (ESBC) during chemotherapy. This is a longitudinal study that recruited Black and White women with ESBC receiving chemotherapy. Participants completed questionnaires recording their sociodemographic information at baseline and the Functional Assessment of Cancer Therapy-General (FACT-G) to report their HRQOL before each chemotherapy cycle. Linear mixed modeling was employed to examine the associations between FACT-G scores, self-reported race, and area deprivation index (ADI) before and at the last chemotherapy cycle, with the duration of chemotherapy treatment as a covariate. A total of 84 Black and 146 White women with ESBC completed the surveys. Linear mixed modeling results suggested that women with ESBC who reported being Black experienced significantly worse physical well-being than those who reported being White throughout chemotherapy, with a 0.22-point lower average (p = 0.02). Both Black and White women with ESBC experienced decreased functional well-being over the chemotherapy, and Black women consistently reported lower scores than White women, with the change in functional well-being over time differing between racial groups (p = 0.03). Participants' ADI national percentiles were not significantly associated with their HRQOL throughout chemotherapy. These findings underscore possible racial differences in some dimensions of HRQOL during chemotherapy among women with ESBC. Future research should consider further assessing life stressors and past experiences of discrimination and racism that may contribute to these disparities and guide proactive interventions.

Quality of life after melphalan percutaneous hepatic perfusion for patients with metastatic uveal melanoma.

Recent studies indicate that melphalan percutaneous hepatic perfusion (M-PHP) for liver metastases from ocular melanoma (mUM) improves survival. Importantly, this benefit must be carefully balanced with changes in a patient's quality of life (QoL). This study examines the QoL changes post-M-PHP. Retrospective analysis of the change in QoL using the Functional Assessment of Cancer Therapy-General (FACT-G) with mUM patients receiving M-PHP ( n = 20). The FACT-G scores, which comprise physical (PWB), social (SWB), emotional (EWB) and functional (FWB) wellbeing were measured pre-procedure and at day 1, day of discharge (mean = 2.4 days), 7, 14 and 28 days after M-PHP therapy. Wilcoxon signed-rank test gauged QoL domain changes. Baseline FACT-G median (IQR) scores were 101.8 (21.8). QoL scoring significantly decreased immediately after the procedure [day 1; 85 (27.5); P = 0.002] and gradually improved over time. By day 28, QoL almost returned to pre-procedure levels [100.3 (13.8); P = 0.31]. Subscore analysis revealed that the initial drop in QoL at day 1 post-procedure was attributable to the PWB (28 vs. 24; P = 0.001) and FWB domains (26 vs. 18.5; P < 0.001). By day 28 there was a statistically significant improvement in EWB ( P = 0.01). QoL following M-PHP decreases immediately after therapy and is not significantly different from baseline by the day of discharge. By day 28 there is improved emotional well-being. This study could help to optimize the time between treatment cycles when combined with toxicity data and blood count recovery.

Quality of Life and Global Response Score in Cutaneous T-Cell Lymphoma

Background: Cutaneous T-cell lymphoma (CTCL) encompasses a heterogenous group of conditions that are typically incurable and managed as chronic, life-long diseases. Clinically, CTCL is associated with pruritus, and skin lesions that can cause pain and cosmetic discomfort, resulting in reduced health-related quality of life (HRQoL) for patients. As these patients often receive life-long therapy, any proposed therapy should maximize therapeutic safety and efficacy as well as patient HRQoL. Improvement in HRQoL may provide an indication to continue therapy, even for patients with partial response. Clinical trial response assessments for CTCL utilize a global response score, which includes skin, nodal and blood assessments (Olsen et al, JCO 2011). Dermatology-specific instruments, such as Skindex-29 (Chren 2012, Dermatol Clin 30), and oncology-specific instruments such as the Functional Assessment of Cancer Therapy - General (FACT-G) (Cella et al, JCO 1993), have been used to assess quality of life in this population. Disease entity, stage, age, sex, education, and treatment regimen are related to the extent of HRQOL impairment in patients with CTCL (Porkert et al, EJC 2018). Correlation between clinical response and HRQoL response has been reported in other cancers, such as renal cell carcinoma (Grimm Oncol Ther 2017) and other dermatologic conditions such as psoriasis (Acta Derm Venereol 2017), but has not been reported in CTCL. We evaluated changes in HRQoL in relation to the global response score in CTCL. Methods: Global response data, as well as Skindex-29 and FACT-G scores, were obtained from the phase III MAVORIC study (Kim et al, Lancet Oncol 2018). Patients with stage IB-IVB mycosis fungoides or S ézary syndrome were prospectively enrolled. Global response score was assessed every 8 weeks. Skindex-29 and FACT-G questionnaires were administered every 8 weeks. Patients with at least a baseline value for Skindex-29 or FACT-G score, at least one subsequent visit with both Skindex-29 or FACT-G value, and an overall response value were included. Changes in scores were calculated from baseline to the first visit with best overall response. A higher score in Skindex-29 indicated worse HRQoL. A higher score on FACT-G indicated improvement in HRQoL. Wilcoxon rank-sum test was performed. Correlation was calculated by Pearson coefficient. Results: 324 patients were evaluable for total Skindex-29 analysis. First visit with best overall response for patients with PD/SD occurred at a median of 1.26 cycles (IQR; 1.26, 14.26); 5.98 cycles (IQR; 1.26, 48.98) for PR; and 10.98 cycles (IQR; 3.98, 36.98) for CR. Patients with CR/PR as best response (n=121) had median change in Skindex-29 of -16 (IQR; -31, -8) and patients with SD/PD as best response rate had median change in Skindex-29 of -4 (IQR; -12, 3) (p &amp;lt;0.001) (Table 1). 333 patients were evaluable for total FACT-G analysis. Patients with CR/PR as best response rate had median change in FACT-G of 6 (IQR; -2, 16) and patients with SD/PD as best response rate had median change in FACT-G of 2 (IQR; -6, 8) (p &amp;lt;0.001) (Table 1). Skindex-29 correlates with global response score overall and across all domains. FACT-G correlates with global response score overall and across all domains, with the exception of social well-being. There was a moderate reverse correlation between change in total Skindex-29 and change in total FACT-G score (R=-0.61, p&amp;lt;0.001) (Figure 1). Conclusion: HRQoL as measured by the Skindex-29 and FACT-G correlate with complete or partial response to therapy in the global response score in patients with CTCL. There is moderate correlation between skin-specific quality of life and general quality of life in this population. Further exploration of factors affecting social well-being in patients with CTCL is warranted. Incorporation of QOL scales in global response score criteria should be considered.

Frontline Management Strategy and Quality of Life in Follicular Lymphoma: A Multi-Institutional Prospective Cohort Study

Background: Understanding the symptoms and quality of life (QOL) over time of adults with follicular lymphoma (FL) is important for treatment decision-making and clinical management. However, there are limited population-level data on the long-term QOL of adults with FL. We aim to describe the real-world, long-term QOL of adults with newly diagnosed FL up to 5/6 years after diagnosis. Methods: We used the Mayo Clinic/Iowa Molecular Epidemiology Resource (MER) and the multi-institutional Lymphoma Epidemiology of Outcomes (LEO) to identify adults with grade 1-3A FL who completed QOL surveys at baseline and follow-up. Participants with lymphoma were prospectively enrolled within 9 months of diagnosis in the MER cohort from 2002-2015 and within 6 months of diagnosis in the multi-institutional LEO cohort study across 8 cancer centers from 2015-2020. The LEO/MER cohort studies systematically collected information on disease status, QOL, health behaviors, and functional assessment. Treatments, disease relapses, and deaths were verified by medical record review. Treating physicians determined clinical management. QOL was measured using the Functional Assessment of Cancer Therapy-General (FACT-G) at years 1, 2, 3, and 5/6 post-diagnosis. A higher FACT-G total score (range 0-108) indicated better QOL across 4 subscales (range): physical (0-28), social/family (0-28), emotional (0-24), and functional (0-28) well-being. We categorized participants based on their frontline management at time of diagnosis: “observation” (surveillance), “treatment” (systemic treatment with immunotherapy +/- chemotherapy), and “local” (radiation) groups. We employed a generalized linear mixed model to evaluate and compare the changes in QOL scores (as a continuous variable) from baseline for the observation, treatment, and local groups, adjusting for sex, race/ethnicity, age, FLIPI risk, and cohort (i.e., LEO or MER). We also evaluated QOL changes by FLIPI risk. Results: Our study included 1,544 participants with FL and QOL data. At the time of enrollment, median age was 61 years (range 19-91), 88% were non-Hispanic White, and 49% were female. Based on initial management, 529 (34%) were in the observation group, 880 (57%) were in the treatment group, and 135 (9%) were in the local group. FLIPI risk was high for 17% in the observation group, 29.3% in the treatment group, and 3% in the local group. The mean (standard deviation) baseline FACT-G total score was lowest in the treatment group with the following baseline scores: 86 (13) for the observation group, 83 (14) for the treatment group, and 88 (12) for the local group (Table 1). The observation and local groups reported a greater worsening of their baseline FACT-G total score vs the treatment group at both the 2-year (-1.2, -0.8 vs +1.8, respectively) and 5/6 year (-5.4, -6 vs. -1.6, respectively) timepoints (Figure 1). This appeared to be driven by worsened physical and functional well-being in the observation (-1.3, -2.2, respectively) and local (-0.9, -2.4, respectively) groups vs the treatment group (0, -0.3, respectively). These differences were statistically significant between the observation vs treatment groups. There were no statistically significant differences in the other subscales, i.e., social/family and emotional well-being, by frontline management. Social/family well-being decreased across all groups by 5/6 years (-2.3 in observation, -2.2 in treatment, and -3 in local, p&amp;lt;0.05). Regardless of FLIPI risk, the total FACT-G scores decreased within each FLIPI risk group at 5/6 years (-4.4 for low, -3.8 for intermediate, and -4.9 for high, p&amp;lt;0.05). This was primarily due to worsened social/family well-being (-2.4 for low, -2.2 for intermediate, and -3 for high, p&amp;lt;0.05) at 5/6 years. There was no statistically significant difference in QOL between FLIPI risk groups. Conclusion: This is one of the first and largest studies with real-world longitudinal QOL data for FL. Our study suggests that frontline systemic treatment initially improved QOL and resulted in a lower degree of QOL decline over time. Social/family well-being decreased over time regardless of frontline management or FLIPI risk. Further research is warranted to explore the impact of timing and specific systemic treatments on QOL, incorporate the patient/caregiver experience to address social/family well-being, and identify the clinical significance of our findings.

Financial toxicity among adult cancer survivors in Singapore: does it exist?

Abstract Introduction: Cancer survivors may experience financial toxicity (FT) arising from diagnosis, treatment and potential employment loss. The prevalence of FT in the context of Singapore healthcare model is unknown. We investigate whether higher out-of-pocket (OOP) expenditure correlates positively with FT, and whether higher FT correlates with a worse quality of life (QoL). Methods: In this pilot study, a cross-sectional survey was conducted on survivors of nasopharyngeal or breast cancer at the National University Hospital Singapore. Patients’ FT and QoL were measured using the COmprehensive Score on financial Toxicity (COST) and Functional Assessment of Cancer Therapy-General (FACT-G) questionnaires. Two multivariate regression models estimated (a) the association between FT and a range of variables, and (b) the association between FT and QoL. Results: Sixty-three percent of our cohort of 76 patients experienced mild–moderate FT. Overall, the mean COST and FACT-G scores were 18.0 (out of 44) and 68.3 (out of 108), respectively. There was a positive correlation between COST and FACT-G scores (r = 0.45). We did not find any significant association between OOP expenditure and FT. Predictors for FT included government-subsidised housing, lower education levels, hire of a formal caregiver and the need for household members to take on extra employment. Conclusion: Greater FT correlated with a decline in QoL. Patients of lower socioeconomic status were at higher risk of FT. OOP expenditure was not directed related to FT, likely in view of the effective means-tested subsidies. Additional resources should be considered for this at-risk population. Based on this pilot study, our methodology to quantify FT and OOP expenditure can be scaled up to other cancer primaries.

Health-Related Quality of Life in Chronic Lymphocytic Leukemia Patients in Active Surveillance and Active Treatment in Israel

Background: Newly diagnosed chronic lymphocytic leukemia (CLL) patients are monitored regularly for disease progression to delay the impact of treatments on the patients' quality of life (QoL). However, studies have reported mixed results on the QoL between active surveillance patients compared to active treatment patients. Herein we performed a cross-sectional study to examine the impact of active surveillance and active treatment on health-related QoL in CLL patients. Methods: We included 210 CLL patients in Israel, who completed an online survey with demographic and disease characteristics questions; the Functional Assessment of Cancer Therapy-General (FACT-G), a general health scale including the following subscales: physical well-being, social well-being, emotional well-being, and functional well-being; symptoms and concerns related to leukemia (FACT-LeuS); and FACT-Leukemia (FACT-LEU), a total score derived from the FACT-G and FACT-LeuS scores. Among participants, 63 were in active surveillance, 115 in active treatment (71 in BTKi based treatment and 44 in venetoclax based treatment), and 32 completed their treatments. We compared CLL patients in the surveillance group versus the active treatment group using the Student's T test. Analyses were also stratified by sex. In addition, we compared CLL patients in four groups: active surveillance, treated with BTKi, treated with Venetoclax based treatments, and completed treatments, using ANOVA, and the Hochberg's adjusted P value. For all analyses we estimated the effect size between each two groups using the Cohen's d measure and 95% confidence intervals (CI). Results: Overall, the mean age of participants was 64 (SD=10) with 40% males in the active surveillance group, and mean age of 67 (SD=10) with 54% males in the active treatment group. Patients in the surveillance group reported lower QoL scores compared to the active treatment group in the social/family well-being subscale (19.0±6.7 vs 22.1±4.7, P=0.002) with a medium effect size [-0.56, CI:(-0.87,-0.25)], however, in the physical well-being subscale they reported a higher QoL scores (22.8±5.5 vs 20.5±6.3, P=0.017), with a small effect size [0.38, CI:(0.07,0.69)]. Among males, patients in the surveillance group reported higher QoL scores compared to the active treatment group in the physical well-being subscale (25.2±3.8 vs 19.7±7.0, P=0.0), with a high effect size [0.87, CI:(0.38,1.35)], FACT-LeuS score (51.5±9.7 vs 42.8±12.1, P=0.002), with a medium effect size [0.76, CI:(0.28-1.23)], and the FACT-LEU score (135.9±26.1 vs 120.5±27.8, P=0.02), with a medium Effect size [0.56, CI:(0.09-1.03)]. Among females, patients in the surveillance group reported lower Qol scores compared to active surveillance in the social/family well-being subscale (18.9±7.1 vs 22.5±5.7, P=0.008), with a medium effect size [-0.58, CI):-1.0,-0.15)]; emotional well-being subscale (15.5±4.5 vs 18.2±3.9, P=0.003), with a medium effect size [-0.66, CI):-1.09,-0.23)]; FACT-G (74.6±15.2 vs 83.3±15.2, P=0.009), with a medium effect size [-0.58, CI):-1.0,-0.14)]; and FACT-LEU (116.7±20.7 vs 128.3±22.5, P=0.014), with a medium effect size [-0.53, CI):-0.96,-0.11)]. When comparing the four groups of treatments, we found significant differences in the physical well-being subscale (P=0.029), which was driven by the lower score in the Venetoclax based treatment group compared to the surveillance group [19.6±7.3 vs 22.8±5.5, medium effect size 0.49, CI:(0.10,0.88)]; and social/family well-being subscale (P=0.005), which was driven by the higher score in the BTKi based treatment group compared to the surveillance group [22.3±4.3 vs 19.0±6.7, medium effect size -0.53, CI:(0.87,-0.19)]. Conclusions: In general, males in active surveillance reported better health-related QoL than those in active treatment, while females in active treatment reported better health-related QoL than those in active surveillance. Interventions for improving QoL in CLL patients should include gender-based perspectives.

Quality of Life and Real-time Patient Experience During Neoadjuvant Therapy: A Prospective Cohort Study.

To use a customized smartphone application to prospectively measure QOL and the real-time patient experience during neoadjuvant therapy (NT). NT is increasingly used for patients with localized gastrointestinal (GI) cancers. There is little data assessing patient experience and quality of life (QOL) during NT for GI cancers. Patients with GI cancers receiving NT were instructed on using a customized smartphone application through which the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire, a validated measure of health-related QOL, was administered at baseline, every 30 days, and at the completion of NT. Participants also tracked their moods and symptoms and used free-text journaling functionalities in the application. Mean overall and subsection health-related QOL scores were calculated during NT. Among 104 enrolled patients, the mean age was 60.5 ± 11.5 years and 55% were males. Common cancer diagnoses were colorectal (40%), pancreatic (37%), and esophageal (15%). Mean overall FACT-G scores did not change during NT ( P = 0.987). While functional well-being scores were consistently the lowest and social well-being scores the highest, FACT subscores similarly did not change during NT (all P > 0.01). The most common symptoms reported during NT were fatigue, insomnia, and anxiety (39.3%, 34.5%, and 28.3% of patient entries, respectively). Qualitative analysis of free-text journaling entries identified anxiety, fear, and frustration as the most common themes, but also the importance of social support systems and confidence in health care providers. While patient symptom burden remains high, results of this prospective cohort study suggest QOL is maintained during NT for localized GI cancers.

Efficacy of Comedy on Health-Related Quality of Life and Oxidative Stress in Cancer Survivors.

Cancer survivors have reduced health-related quality of life (HRQOL) due to impaired daily functioning. In addition, daily stress leads to worsening oxidative stress. The purpose of this study is to investigate the efficacy of laughter therapy on HRQOL and oxidative stress in cancer survivors. This before-and-after study asked cancer survivors to watch a 15-minute or longer comedy video over a four-week period to assess the Functional Assessment of Cancer Therapy-General (FACT-G), EuroQOL 5 dimension 3-level (EQ-5D-3L), Hospital Anxiety and Depression Scale (HADS), biological Antioxidant Potential (BAP), Reactive Oxygen Metabolites-derived compounds (d-ROMs), Oxidative Stress Index (OSI), and the antioxidant/oxidative stress ratio. The nonparametric Friedman test showed significant increases from baseline in FACT-G and EQ-VAS scores and significant decreases in HADS-Anxiety and HADS-Depression scores. Post hoc analyses showed that these items commonly differed significantly at baseline versus three and four weeks after Bonferroni correction. T-test results in the biological analysis revealed small and moderate effects with significant differences in BAP (p < 0.01, d = 0.49), OSI (p = 0.03, d = 0.33), and BAP/d-ROMs (p < 0.01, d = 0.51). These results suggest that daily comedy viewing may be an effective intervention to improve quality of life and antioxidant capacity in cancer survivors. Considering its safety, convenience, and low cost, it should be considered a high-value intervention for cancer survivors.

Financial well-being as a mediator of the relationship between multimorbidity and health-related quality of life in people with cancer.

It is unknown whether financial well-being mediates the impact of multimorbidity on the health-related quality of life (HRQoL) of cancer patients. Participants were recruited from three outpatient oncology clinics of Hong Kong public hospitals. Multimorbidity was assessed using the Charlson Comorbidity Index. Financial well-being, the mediator of the association between multimorbidity and HRQoL outcomes, was assessed using the Comprehensive Score for Financial Toxicity Functional Assessment of Chronic Illness Therapy. The HRQoL outcomes were assessed using the Functional Assessment of Cancer Therapy - General (FACT-G) and its four sub-dimensions. Mediation analyses were conducted using SPSS PROCESS v4.1. Six-hundred and forty cancer patients participated in the study. Multimorbidity had a direct effect on FACT-G scores independent of financial well-being (β for path c' = -0.752, p < 0.001). In addition, multimorbidity had an indirect effect on FACT-G scores through its effect on financial well-being (β for path a = -0.517, p < 0.05; β for path b = 0.785, p < 0.001). Even after adjustments were made for the covariates, the indirect effect of multimorbidity on FACT-G via financial well-being remained significant, accounting for 38.0% of the overall effect, indicating partial mediation. Although there were no statistically significant associations between multimorbidity, social well-being, and emotional well-being, the indirect effects of multimorbidity on physical and functional well-being through financial well-being remained significant. Poor financial well-being attributable to multimorbidity partially mediates the direct impact of chronic conditions on HRQoL in Chinese cancer patients, particularly their physical and functional well-being.

Sleep health and quality of life in African American cancer survivors: The Detroit ROCS Cohort.

10556 Background: Sleep disturbances are particularly prevalent among cancer survivors, likely attributed in part to anxiety over prognosis, treatment, and associated financial concerns. We know little about prevalence, patterns and predictors of poor sleep health in African American (AA) cancer survivors. Sleep problems may contribute in part to the observed disparities in outcomes in this high-risk population and represents a modifiable target to improve quality of life and longer-term health problems. Methods: The Detroit Research on Cancer Survivors (ROCS) study is a large cohort of AA cancer survivors diagnosed with female breast, prostate, colorectal, endometrial, lung or any other early onset cancer on or after 01/01/2013 in Metropolitan Detroit. We have enrolled 5,073 survivors into the study, each completing a baseline survey with annual follow-up to update medical history, health related quality of life (QoL), and other prognostic factors. In 2021, a supplemental sleep survey was administered to all eligible survivors. The current investigation analyzes sleep, QoL (measured using the Functional Assessment of Cancer Therapy - General (FACT-G) survey), and relevant health behavior data from 716 survivors who completed the sleep survey. Sleep health was measured using the Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS) and the Pittsburgh Sleep Quality Index (PSQI). Block regression was used to estimate the contribution of clustered factors to QoL. Five blocks were evaluated: sleep health, demographics, cancer characteristics, comorbidities, and health behaviors. Results: Nearly 60% of AA cancer survivors in the study reported symptoms indicative of poor sleep quality (PSQI score 6-21) with 17% reporting excessive daytime sleepiness (ESS score 11-24) and 11% reporting moderate to severe insomnia (ISI score ≥ 15). Sleep disturbances and poor quality of sleep were associated with clinically meaningful declines in QoL, where survivors with ISI scores in the clinical range reported adjusted FACT-G scores 19 points lower than those with ISI score below the clinical range (95% CI -14.7, -22.6). Sleep health accounted for the largest proportion of variability in FACT-G scores (R2= 0.28) and accounted for an additional 19% of the variance over and above the other 4 blocks. Finally, AA survivors reporting regular physical activity also reported better sleep quality in all 3 sleep scales (p &lt; 0.001). Conclusions: A substantial proportion of AA cancer survivors reported poor sleep quality which impacted their QoL. Understanding the determinants of sleep health in this population will lead to the development of interventions aimed at improving quality of life and downstream health consequences in AA cancer survivors.

Health-related quality of life and economic burden in Chinese patients with cutaneous T-cell lymphoma.

e19533 Background: Cutaneous T-cell lymphoma (CTCL) is a rare type of non-Hodgkin lymphoma. As described in European Organization for Research and Treatment of Cancer Consensus, the subtypes of mycosis fungoides (MF) and Sézary Syndrome (SS) comprised roughly 55% and 5% of CTCL, respectively. The clinical presentations of MF and SS include skin lesion, tumors, ulcerations, systemic involvements and even death. This study aimed to measure the overall HRQoL and economic burden of MF and SS patients in China. Methods: A cross-sectional survey was conducted from 21 July 2022 to 24 October 2022. Eligible adult participants with a pathologically confirmed diagnosis of either MF or SS were recruited from specialty or general hospitals across China. All participants were asked to complete a questionnaire that assessed HRQoL and annual economic burden. Validated instruments in Chinese, specifically the EuroQoL Group’s five-level QoL five-dimensional questionnaire (EQ-5D-5L), Functional Assessment of Cancer Therapy-General (FACT-G), and Skindex-29, were used to assess general, cancer and skin-related HRQoL. All HRQoL outcomes were calculated using the scoring system provided by the institutions, and EQ-5D utility scores were mapped using the China time trade-off value sets. As for economic burden, it was investigated from the societal perspective, as the direct medical costs, direct non-medical costs, and productivity loss were all calculated. Results: A total of 61 patients were recruited and completed the survey. Patients resided in 38 cities of 21 provinces across China. 56 patients (92%) were diagnosed with MF and 5 (8%) with SS. 56% were male, with a mean age of 39 years. Half of the patients had early-stage disease (defined as less than stage IIB, patch or plaque), with the remainder having late-stage disease. Among the recruited patients, 43 (70%) received skin-directed therapy, and 55 (90%) received systemic therapy. As for HRQoL measures, EQ-5D utility score was 0.79 (±0.18), FACT-G score was 61.3 (±12.4), and the Skindex-29 score was 43.4 (±24.2). Comparison between patients with early-stage disease and late-stage is presented in the table. As for economic burden, the annual per capita cost for MF and SS patients was CNY 86,729 (USD 12,428), which greatly exceeded the annual disposable income in 2022 (CNY 36,883, equals USD 5,440). Conclusions: This was the first study investigating economic burden and HRQoL using patient-reported outcomes conducted in mainland China. The findings suggested that MF and SS has significantly compromised patients’ HRQoL and posed substantial economic burden. [Table: see text]

Significantly longer time to deterioration of quality of life due to CANKADO PRO-React eHealth support in HR+ HER2− metastatic breast cancer patients receiving palbociclib and endocrine therapy: primary outcome analysis of the multicenter randomized AGO-B WSG PreCycle trial

The multicenter, randomized, phase IV, intergroup AGO-B WSG PreCycle trial (NCT03220178) evaluated the impact of CANKADO-based electronic patient-reported outcome (ePRO) assessment on quality of life (QoL) in hormone receptor-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer (MBC) patients receiving palbociclib and an aromatase inhibitor or palbociclib+ fulvestrant. CANKADO PRO-React, a European Union-registered medical device, is an interactive autonomous application reacting to patient self-reported observations. Between 2017 and 2021, 499 patients (median age 59 years) from 71 centers were randomized (2 : 1, stratified by therapy line) between an active version of CANKADO PRO-React (CANKADO-active arm) and a version with limited functionality (CANKADO-inform arm). A total of 412 patients (271 CANKADO-active; 141 CANKADO-inform) were available for analysis of the primary endpoint, time to deterioration (TTD) of QoL [10-point drop on the Functional Assessment of Cancer Therapy-General (FACT-G) score], using an Aalen-Johansen estimator for cumulative incidence function of TTD DQoL (QoL deterioration) with 95% pointwise confidence intervals (CIs). Secondary endpoints included progression-free survival (PFS), overall survival (OS), and DQoL. In all patients [intention-to-treat (ITT)-ePRO], cumulative incidence of DQoL was significantly more favorable (lower) in the CANKADO-active arm (hazard ratio 0.698, 95% CI 0.506-0.963). Among first-line patients (n= 295), the corresponding hazard ratio was 0.716 (0.484-1.060; P= 0.09), and in second-line patients (n= 117) it was 0.661 (0.374-1.168; P= 0.2). Absolute patient numbers declined in later visits; FACT-G completion rates were 80% and higher until about visit 30. Mean FACT-G scores showed a steady decline from baseline and an offset in favor of CANKADO-active. No significant differences in clinical outcome were observed between arms: median PFS (ITT population) was 21.4 (95% CI 19.4-23.7) (CANKADO-active) and 18.7 (15.1-23.5) months (CANKADO-inform); median OS was not reached (CANKADO-active) and 42.6 months (CANKADO-inform). PreCycle is the first multicenter randomized eHealth trial demonstrating a significant benefit for MBC patients receiving oral tumor therapy when using an interactive autonomous patient empowerment application.

Effects of Specialist Palliative Care for Patients Undergoing Major Abdominal Surgery for Cancer

Specialist palliative care benefits patients undergoing medical treatment of cancer; however, data are lacking on whether patients undergoing surgery for cancer similarly benefit from specialist palliative care. To determine the effect of a specialist palliative care intervention on patients undergoing surgery for cure or durable control of cancer. This was a single-center randomized clinical trial conducted from March 1, 2018, to October 28, 2021. Patients scheduled for specified intra-abdominal cancer operations were recruited from an academic urban referral center in the Southeastern US. Preoperative consultation with palliative care specialists and postoperative inpatient and outpatient palliative care follow-up for 90 days. The prespecified primary end point was physical and functional quality of life (QoL) at postoperative day (POD) 90, measured by the Functional Assessment of Cancer Therapy-General (FACT-G) Trial Outcome Index (TOI), which is scored on a range of 0 to 56 with higher scores representing higher physical and functional QoL. Prespecified secondary end points included overall QoL at POD 90 measured by FACT-G, days alive at home until POD 90, and 1-year overall survival. Multivariable proportional odds logistic regression and Cox proportional hazards regression models were used to test the hypothesis that the intervention improved each of these end points relative to usual care in an intention-to-treat analysis. A total of 235 eligible patients (median [IQR] age, 65.0 [56.8-71.1] years; 141 male [60.0%]) were randomly assigned to the intervention or usual care group in a 1:1 ratio. Specialist palliative care was received by 114 patients (97%) in the intervention group and 1 patient (1%) in the usual care group. Adjusted median scores on the FACT-G TOI measure of physical and functional QoL did not differ between groups (intervention score, 46.77; 95% CI, 44.18-49.04; usual care score, 46.23; 95% CI, 43.08-48.14; P = .46). Intervention vs usual care group odds ratio (OR) was 1.17 (95% CI, 0.77-1.80). Palliative care did not improve overall QoL measured by the FACT-G score (intervention vs usual care OR, 1.09; 95% CI, 0.75-1.58), days alive at home (OR, 0.87; 95% CI, 0.69-1.11), or 1-year overall survival (hazard ratio, 0.97; 95% CI, 0.50-1.88). This randomized clinical trial showed no evidence that early specialist palliative care improves the QoL of patients undergoing nonpalliative cancer operations. ClinicalTrials.gov Identifier: NCT03436290.

Psychological distress is involved in CRCI in breast cancer survivors via mediating cytokine levels.

Cancer-related cognitive impairment (CRCI) is a frequent consequence in breast cancer survivors after chemotherapy and lowers their quality of life (QOL). Psychological distress is frequently experienced by breast cancer survivors. There are currently few studies investigating the role of psychological distress in the genesis of CRCI. In total, 122 breast cancer survivors after standard chemotherapy within a year were recruited and assessed using the Psychological Distress Thermometer (DT). Sixty breast cancer survivors had non-psychological distress (NPD group) and sixty-two breast cancer survivors with psychological distress (PD group). The scores of the Mini-Mental State Examination (MMSE), prospective and retrospective memory (PM and RM) Questionnaire (PRMQ), and Functional Assessment of Cancer Therapy-General (FACT-G) and the levels of cytokines including interleukin-1 beta (IL-1β), tumor necrosis factor-alpha (TNF-α), and interleukin-4 (IL-4) were compared between the two groups. Using PROCESS, we investigated whether psychological distress predicted cognitive function based on MMSE through IL-1β, TNF-α, and IL-4. The PD group had higher scores on RM, PM, and FACT-G and lower scores on MMSE than the NPD group (t=-11.357, t=-10.720, t=-15.419, t=10.162, respectively; p < 0.05). Meanwhile, a higher level of IL-1β, TNF-α, and IL-4 was observed in the PD group than in the NPD group (t=-3.961, t=-3.396, t=-3.269, respectively; p < 0.05). The link between psychological distress and cognitive function as measured by the MMSE was also mediated by IL-1β, TNF-α, and IL-4 (effect size: 26%, 25%, and 24%). Breast cancer patients with psychological distress displayed poor cognitive function, poor memory, and inferior quality of life, which was accompanied by higher cytokine levels of IL-1β, TNF-α, and IL-4. This study demonstrated IL-1β, TNF-α, and IL-4 as potential pathways to CRCI in response to ongoing psychological distress, which provided evidence for the involvement of psychological distress in CRCI in breast cancer survivors.

Abstract P5-07-13: Effect of a 12 Week Virtual Supervised Exercise Program on Cardiorespiratory Fitness in Breast Cancer Patients Undergoing Chemotherapy: Results from the STRENGTH Trial

Abstract Background: Chemotherapy (CTX) for breast cancer (BC) can have a detrimental effect on cardiorespiratory fitness (CRF), as measured by VO2max. This decline may be attenuated by physical activity, which can also reduce mortality risk and improve quality of life (QoL) for patients (pts) with BC. During the COVID-19 pandemic, many have pivoted to home-based exercise routines, which have been shown to be safe and feasible for pts with BC receiving CTX. We conducted the STRENGTH Trial to evaluate the effect of a 12-week virtual supervised exercise program in BC pts receiving CTX on CRF. Methods: This is a single-center, prospective, single-arm study designed to evaluate the effect of a 12-week virtual supervised exercise training program on CRF in BC pts receiving CTX. Participants aged ≥18 years with stage I-IV BC who were planned to receive at least 12 weeks of CTX of investigator’s choice were eligible for inclusion. Participants were asked to complete a total of 150 minutes (min) of moderate intensity physical activity/week, as a combination of a 45 min weekly virtual personal training session and workout classes streamed from the Peloton® Digital platform (i.e. walking, running, cardio, yoga, strength training, and cycling). The primary endpoint was the distance walked on a Six-Minute Walk Test (6MWT), an accepted surrogate marker for VO2max, at the start and completion of the program. Secondary endpoints included assessment of QoL using the Functional Assessment of Cancer Therapy - General (FACT-G) and symptom assessment using the MD Anderson Symptom Inventory (MDASI) questionnaires at the beginning, middle and end of the study. Exploratory endpoints included treatment adherence, toxicities, completion and response. Results: 33 participants signed consent for the clinical trial and 2 withdrew voluntarily prior to beginning the program. 5 participants discontinued prematurely due to a diagnosis of COVID-19 (N=3) and pulmonary embolism (N=2) and were not included in the primary endpoint. One participant remains on study at this time. Median age 49 yrs; range 33-68. Mean BMI 29.55; range 18.1-46.5. 13 HR+/HER2-, 7 HR-/HER2-, 11 HER2+. 14 (45%) pts had Stage I, 11 (35%) pts had Stage 2, 5 (16%) pts had Stage 3, 1 (3%) pt had Stage 4. 23 pts (70%) received either an anthracycline or HER2-based therapy. 19 pts (61%) received neoadjuvant CTX on study, 11 pts (35%) received adjuvant CTX and 1 pt (3%) received treatment in metastatic setting. The average number of exercise min per week per participant was 123.2 min (95% CI, 104.1-142.2), with a relative dose intensity of 82%. In the pts that completed the study thus far (N=25), there was no statistically significant difference between the distance walked during the 6MWT at the start and end of the study (median difference= -10m, range: -129-150m, p= 0.67). There was no statistically significant difference in the FACT-G score at the start and end of the study (median difference= -1.0, range -17.83- 30.0, p=0.54). Pts scored higher on the MDASI (median difference= 0.33, range -1.55-4.62, p=0.04) at the end of the exercise program compared to the beginning. There were no new or unexpected treatment toxicities observed. Conclusion: Pts who participated in a 12-week virtual supervised exercise program during CTX for BC did not experience a statistically significant difference in the distance walked during the 6MWT between the beginning and end of the exercise program. Exercise may attenuate the decline in cardiorespiratory function that has historically been observed with CTX for BC. Some pts were not able to adhere to the recommended 150 min of exercise/week suggesting a potential need for modified exercise targets for pts with BC undergoing CTX. This study is limited by a small sample size and larger, randomized clinical trials are needed to further evaluate optimal exercise recommendations for patients with BC undergoing CTX in order to maintain and potentially, even improve, cardiorespiratory function. Citation Format: Eleonora Teplinsky, Amanda Podolski, Kasey Bessada, John Rutledge, Benita Burke, Moira Christoudias, Laura Klein, Kariann Abbate. Effect of a 12 Week Virtual Supervised Exercise Program on Cardiorespiratory Fitness in Breast Cancer Patients Undergoing Chemotherapy: Results from the STRENGTH Trial [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P5-07-13.

Associations between symptoms with healthcare utilization and death in advanced cancer patients

IntroductionThere is limited data about assessments that are associated with increased utilization of medical services among advanced oncology patients (AOPs). We aimed to identify factors related to healthcare utilization and death in AOP.MethodsAOPs at a comprehensive cancer center were enrolled in a Center for Medicare and Medicaid Innovation program. Participants completed the Edmonton Symptom Assessment Scale (ESAS) and the Functional Assessment of Cancer Therapy–General (FACT-G) scale. We examined factors associated with palliative care (PC), acute care (AC), emergency room (ER), hospital admissions (HA), and death.ResultsIn all, 817 AOPs were included in these analyses with a median age of 69. They were generally female (58.7%), white (61.4%), stage IV (51.6%), and represented common cancers (31.5% GI, 25.2% thoracic, 14.3% gynecologic). ESAS pain, anxiety, and total score were related to more PC visits (B=0.31, 95% CI [0.21, 0.40], p<0.001; B=0.24 [0.12, 0.36], p<0.001; and B=0.038 [0.02, 0.06], p=0.001, respectively). Total FACT-G score and physical subscale were related to total PC visits (B=−0.021 [−0.037, −0.006], p=0.008 and B=−0.181 [−0.246, −0.117], p<0.001, respectively). Lower FACT-G social subscale scores were related to more ER visits (B=−0.03 [−0.53, −0.004], p=0.024), while increased tiredness was associated with fewer AC visits (B=−0.039 [−0.073, −0.006], p=0.023). Higher total ESAS scores were related to death within 30 days (OR=0.87 [0.76, 0.98], p=0.027).ConclusionsThe ESAS and FACT-G assessments were linked to PC and AC visits and death. These assessments may be useful for identifying AOPs that would benefit from routine PC.

Exploring Perception of Terminally Ill Cancer Patients about the Quality of Life in Hospice based and Home based Palliative Care: A Mixed Method Study.

The objectives of the study were to evaluate the perceptions and performance of terminally ill cancer patients regarding the quality of palliative care at different settings and to measure their quality of life (QOL) at the end of life. This comparative, parallel and mixed method study was conducted at the Community Oncology Centre, Ahmedabad, among 68 terminally ill cancer patients as per inclusion criteria; who were receiving hospice (HS)-based and home (HO)-based palliative care under 2 months permitted by the Indian Council of Medical Research. In this parallel and mixed method study, qualitative findings were supplemented by quantitative data with both components executed simultaneously. Interview data were recorded by taking extensive notes during interviews along with an audio recording. Interviews were transcribed verbatim and a thematic approach was adopted. QoL questionnaire ('FACIT© System') was used for the assessment of QOL in terms of four dimensions. Data were analysed using the appropriate statistical test on Microsoft Excel. The qualitative data (primary component) analysed under five themes - staff behaviour, comfort and peace, enough and consistent care, nutrition and moral support, in the present study favours a HS-based setting more than a HO-based setting. Among all four subscale scores, physical well-being and emotional well-being subscale scores were statistically significantly associated with the place of palliative care. Functional Assessment of Cancer Therapy-General (FACT-G) total score was high among patients getting HO-based palliative (mean = 67.64) care than HS-based palliative care (mean = 56.56) and the difference between total FACT-G scores was statistically significant (unpaired t-test = 2.20, P = 0.03). Overall, with the primary component favouring HS care and higher scores obtained in HO-based patients, the present study advocates the necessity for palliative services to expand their coverage regardless of whether they are provided at HS or HO, as it has improved the QOL of cancer patients significantly.