EORTC QLQ Research Articles

Prospective Evaluation of Patient-Reported Outcome up to 10 Years after Allogeneic Stem Cell Transplantation Using FACT-G/BMT and EORTC-QLQ30 Questionnaires

Introduction Increasing outpatient care in all medical departments will pose a challenge for daily routines and force us to rethink established processes. In hemato-oncology there is good evidence for the continuous improvement of overall survival after allogeneic stem cell transplantation (allo-HCT) during the last decades. However, the chronic character of the underlying hematopoietic malignancy and the accompanying long-lasting consequences of an allo-HCT are often not properly addressed in follow-up care. The health care status of this population should be determined on physical and mental condition and serious longer-term sequelae need to be monitored more closely than on quarterly basis. Patient-reported outcome measurements (PROMs) are able to address this issue in clinical routine and capture the multidimensional construct of quality of life (QoL). PROMs focus mainly on how a patient survives after a treatment, and not only on whether she/he survives and how long. Patients and Methods We performed a cross-sectional survey including all adult allo-HCT recipients who attended follow-up care in the period from March to July 2023 at the University Hospital Tübingen, Germany. Eligible participants completed both, the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) and the Functional Assessment of Cancer Therapy General (FACT-G) with the subscale for Bone Marrow Transplantation (FACT-BMT). We built 8 cohorts (day 30, day 100, month 6, month 12, year 3, year 5, year 10 and >10 years) to evaluate QoL after allo-HCT and to identify predictors like age, performance status (PS), conditioning regime, graft-versus-host disease (GvHD) development and relapse. Results We included 200 recipients (93 women, average age 54.2 years) who received allo-HCT between 2004 and 2022. The majority was treated for acute leukemia (n=95), followed by chronic leukemia (n=16), myelofibrosis (n=25), myelodysplastic neoplasm (n=20), lymphoma/myeloma (n=14) and others (n=30). 82.5% (n=165) received reduced-intensity conditioning (RIC) and 17.5% (n=35) myeloablative conditioning (MAC). 75.5% (n=151) of allogeneic donors were HLA-matched, 14.5% (n=29) HLA-mismatched and 8.5% (n=17) haplo-identical. The median follow-up was 43.4 months with the following patient numbers in the 8 cohorts: n=25 (d30), n=21 (d100), n=24 (m6), n=34 (m12), n=32 (y3), n=30 (y5), n=23 (y10) and n=11 (>10y). 73% (n=146) showed complete remission at last follow up, 14% (n=28) relapsed. Acute GvHD was observed in 39% (n=78) with additional 6.5% (n=13) suspected to have one. Chronic GvHD was observed in 39.5% (n=79). Average GHS in the EORTC QLQ-30 was 59.2%, average total scores in the FACT-G and FACT-BMT were 77.68 (max. score 108) and 105.37 (max. score 148), respectively. Both PROMs (EORTC QLQ30, FACTs) demonstrated the same biphasic course with a significant QoL recovery over time (Figure 1), comparing for example the global health status (GHS) on d30 (50%) with y10 (68,8%, p=0.07). Interestingly, allo-HCT recipients again experience a drastic decrease achieving y3, mainly caused by worse emotional and physical well-being. The median ECOG PS before allo-HCT was 0 and degraded to 1 in all cohorts until y10, where a return to baseline was seen. Current PS and PRO results showed a significant correlation (p<0.001). No correlations between QoL and age, GvHD or conditioning regime were found. Conclusion Allo-HCT recipients manage to regain a good QoL in long-term follow-up over 10 years but experience a significant low around y3. PROMs are able to detect such developments and can help to improve patient management. As indicated by our data, a higher degree of support in y3 could improve QoL and well-being of allo-HCT patients. However, until today, we lack the implementation of efficient strategies to do so in clinical routine.

Exploring Symptom Burden, Treatment Bother, Physical Function, and Quality of Life By Frailty Status in Patients with Acute Myeloid Leukemia

Introduction: Evidence-based guidelines for patients with Acute Myeloid Leukemia (AML) acknowledge the importance of frailty status when deciding on treatment. Frailty status may also influence patient outcomes throughout cancer treatment. Electronic Patient Reported Outcomes (ePROs) effectively capture the real-world patient experience as it relates to frailty status and health outcomes. Using ePROs, this study explored symptom burden, treatment bother, physical function, and quality of life across fit, intermediate, and frail patients with AML . Methods: All consenting adult patients with an AML diagnosis and current evidence of treatment were enrolled in the Carevive PROmPT® remote symptom monitoring platform between September 1, 2020 and March 10, 2023. Demographic and clinical characteristics were captured at baseline, including age, sex, race, frailty status, comorbidities, and social determinants of health. Classification of a patient's frailty status (fit, intermediate, or frail) involved triangulating data from three separate sources: Carevive's electronic Geriatric Assessment (eGA), the Cancer and Aging Resilience Evaluation (CARE) geriatric survey, and self-reported activity level. Validated psychometric tools were also used weekly to capture each outcome of interest, including symptoms (PRO-CTCAE), treatment bother (FACT-GP5), physical function (PROMIS-4a) and quality of life (EORTC QLQ #29-30). All results were stratified by frailty status. Results: A total of 124 patients were included in the analysis. The median age of patients was 66 (range 21-88), half were male (50%), a majority were white (76%), and most had at least one comorbidity (69%). The median follow up time was 12 weeks (range 1-89). Frailty status was successfully classified for 117 (94%) patients and 98% of patients with 12+ weeks of follow up; among those classified, 38 (32%) were fit, 63 (54%) were intermediate, and 16 (14%) were frail. Across all patients, the most frequently reported symptoms were fatigue (23% across all patient-weeks), decreased appetite (18% across all patient-weeks), and general pain (18% across all patient-weeks) (See Figure). Symptom burden was considerably lower for fit patients at the start of their treatment (12%) compared to intermediate (18%) and frail (20%) patients. Fit patients also had a consistent reduction in symptom burden over time (Week 1: 11%; Week 12: 4%), as did intermediate patients (Week 1: 20%; Week 12: 11%). However, frail patients had intermittent spikes of symptom burden across the same time period (Week 5: 17%, Week 11: 17%). Treatment bother, physical function, and quality of life were comparable between fit and intermediate patients but consistently worse for frail patients. Conclusions: This study illustrates the feasibility of using remote symptom monitoring for gathering data on frailty status, symptom burden, treatment bother, physical function, and quality of life for patients with AML. Findings suggest there may be functional differences in the overall patient experience at different levels of frailty. This further supports the importance of using frailty status in oncology care, especially to identify actionable risk factors for poor health outcomes during cancer treatment.

A Whole Foods Plant-Based Weight Loss Intervention Improves Quality of Life, Metabolic, Microbiome and Immune Profile in MGUS/SMM As Well As Progression Trajectory in a Subset - the Nutrivention Trial

Introduction Obesity, low adiponectin, high leptin, high insulin, and diets lacking plant-based foods are risk factors for plasma cell disorders (PCDs). Patients (pts) with monoclonal gammopathy (MGUS) and smoldering myeloma (SMM) and an elevated body mass index (BMI) are twice as likely to progress to myeloma (MM). There is evidence of microbiome dysbiosis in pts with PCDs and dietary changes can induce large microbial shifts. Therefore, there is a rationale to study a whole food plant-based dietary (WFPBD) intervention to improve modifiable biomarkers and disease trajectory. Methods This was a pilot, single-arm trial of WFPBD (self-selected prepared frozen lunch/dinner provided by Plantable with breakfast/snack guidance and no calorie restriction) for 12-weeks (w) and health coaching for 24w (by Plantable coach and a research dietitian) in pts with MGUS/SMM and BMI ≥25 (NCT04920084). The primary endpoint was feasibility (mean BMI reduction ≥5% and mean dietary adherence [kcal % unprocessed plant food intake] ≥70%) at 12w; secondary endpoints included quality of life (QoL) (EORTC QLQ C30 survey using a linear-mixed effect model), metabolic markers (plasma insulin, adiponectin leptin (AL) ratio via ELISA), gut microbiome (inverse Simpson index α-diversity and relative abundance of butyrate producers (RABP) via stool 16S sequencing), peripheral blood immune profile (leukocyte subsets via 36 color flow cytometry), secreted biomarkers (plasma via Olink inflammation panel) and change in monoclonal (M)-spike concentrations. Rate of change of M-spike/year (y) measured by slope with 95% CI was calculated for up to 20 months (m) pre-intervention and 20m post intervention start (baseline (BL)). A p-value for difference in M-spike rates was calculated. Results The study enrolled 23 pts of which 20 completed the 12w intervention and 16 completed 1y. The median age was 62y with 43% male, 43% non-White, 52% MGUS, 74% obese, and 26% prediabetic/diabetic. The study met feasibility endpoints with 90% mean and 92% median adherence during 12w intervention and 77% median at 24w. There was an 8.3% mean and 6.6% median BMI reduction at 12w and 8.6% median at 24w. There was an improvement in global health status/QoL (median increase 16.7 points, p=0.03), a reduction in dyspnea (median decrease -33.3 points, p=0.001), fatigue (median decrease -11.1 points, p=0.06), and insulin (median decrease 0.791 mU/L; p=0.01), and an increase in AL ratio (median increase 0.09; p=0.0002), α-diversity (median increase 6.18 to 8.42; p= 0.03) and RABP (median increase 0.03 to 0.08; p=0.042) at 12w. Prelim results at 12w suggest a measurable, albeit not significant change in immune subsets such as an increase in monocytes, regulatory T cells, and a decrease in dendritic cells, trends previously associated with anti-inflammatory diets, as well as increase in butyrate. A decrease in proinflammatory cytokines IL8 (p=0.065), IL12B (p=0.068), and TNFB (p=0.082) and an increase in FGF21 (p=0.043) (promoter of insulin sensitivity) was also observed. Butyrate is known to reduces pro-inflammatory cytokines and increase anti-inflammatory proteins, including FGF21. Further immune and microbiome analysis is ongoing. Of 16 pts followed for 1y, 2 with significant BMI reduction had significant improvement in M-spike trajectory: Case 1: Mayo Int Risk IgGκ/IgGλ MGUS achieved a 1y BMI reduction of 19%. Pre-intervention M-spike changed +0.28g/dL/y (6 M-spike values), and during intervention M-spike changed +0.03g/dL/y (11 M-spike values); p=0.008. BL M-spike 1.2g/dL and bone marrow plasma cells (BM PC) <5%; 1.5y BM PC 5-9%. Case 2: IMWG Int Risk IgGκ SMM achieved a 1y BMI reduction of 13%. Pre-intervention M-spike changed +0.11g/dL/y (8 M-spike values), and during intervention M-spike changed -0.05g/dL/y (8 M-spike values); p=0.04. BL M-spike 1.2g/dL and BM PC 20-30%; 1y BM PC 10-15%. Two pts without significant BMI reduction (-4% and -1% at 1y) had rising M-spikes. The remaining 12 pts had median 7.5% BMI reduction at 1y with stable M-spike. Conclusions This is the first dietary intervention trial in PCDs with insights into the mechanisms by which a WFPBD may delay progression. The intervention improves QoL, metabolic (BMI, insulin resistance), microbiome (α-diversity and butyrate producers) as well as immune (reduced inflammation) profile with potentially slowing progression trajectory in a subset. A larger trial is underway (NCT05640843).

Patient-Reported Improvements in Fatigue and Health-Related Quality of Life in the Phase 3 Studies Apply-PNH and Appoint-PNH Evaluating the Use of Iptacopan in C5 Inhibitor-Treated and Treatment-Naïve Patients with Paroxysmal Nocturnal Hemoglobinuria

Introduction: Iptacopan is a first-in-class, oral, selective complement factor B inhibitor that recently demonstrated efficacy and safety as monotherapy in both C5 inhibitor-treated (APPLY-PNH [NCT04558918], Peffault de Latour et al) and treatment-naïve (APPOINT-PNH [NCT04820530], Risitano et al) patients with paroxysmal nocturnal hemoglobinuria (PNH). The primary results of active-comparator controlled APPLY-PNH and single-arm APPOINT-PNH have been reported, showing clinically meaningful increases in hemoglobin levels while controlling intravascular hemolysis and preventing extravascular hemolysis. As patient-perceived benefits of therapies are increasingly important, we present here additional results of the patient-reported outcomes measures (PROMs) including responder analyses of changes from baseline in these two studies based on meaningful within-patient thresholds. Methods: The PROMs included an assessment of fatigue (FACIT-Fatigue) as the basis of a secondary endpoint, a health-related quality of life questionnaire (EORTC QLQ-C30), and a Patient Global Impression of Severity (PGIS) of Fatigue. Both studies analyzed change from baseline in PROMs between Day 1 and Day 168. In APPLY-PNH, another focus was on comparing treatments on the average of model-derived estimates for visits between Day 126 and Day 168. While 5 points on the FACIT-Fatigue was prespecified in the protocol, anchor-based meaningful within-patient change analyses utilizing the PGIS as the anchor determined the range for the magnitude of meaningful change for the FACIT-Fatigue to be 7.5 to 9.5 points (derived from APPLY-PNH); 9 points within the upper segment of the range was chosen as the threshold value used in this analysis. Analyses of the EORTC QLQ C-30 focused on the Physical and Role Functioning subscales and symptoms subscales evaluating Fatigue and Dyspnea. Responder analysis thresholds were determined for all 4 subscales using a combination of anchors including PGIS to determine meaningful change thresholds for each subscale. The ranges and threshold choices were based on the assessment of empirical cumulative distribution function (eCDF) of the scores by scale levels of the anchor and used the visit median values as representative levels to determine the range supporting threshold choices. Results: Ninety-five patients were from APPLY-PNH, of whom 62 received iptacopan and 33 received anti-C5 treatment, and 40 patients were from APPOINT-PNH. In APPLY-PNH, responder analysis showed that more patients in the iptacopan group achieved the threshold of ≥9 points compared with the anti-C5 group (51% vs 11%) ( Table 1). The strength of this result was confirmed by a non-parametric Mann-Whitney test with P values ≤0.0039. In APPOINT-PNH, 56% (95% CI, 43-68) achieved the threshold of ≥9 points and approximately half reached a higher threshold of 11 points ( Table 1). Analyses of EORTC QLQ-C30 further corroborated the results for both trials. Responder analyses in APPLY-PNH of the four subscales using internally derived thresholds showed average proportions of responders in the iptacopan group 39% to 49% and in the anti-C5 group ranging from 9% to 20% ( Table 2). The strength of these results was confirmed by a non-parametric assessment of cumulative distribution functions and Mann-Whitney with P values ≤0.0088. In APPOINT-PNH, the estimated average proportions of responders for EORTC QLQ C30 ranged from 41% to 55% ( Table 2). Conclusion: Both anti-C5-experienced and treatment-naïve patients receiving iptacopan exhibited clinically meaningful improvements in fatigue, health-related quality of life, and disease-related symptoms as measured by predetermined meaningful thresholds of response in FACIT-Fatigue and EORTC QLQ-C30. Together with previous presented primary efficacy data from APPLY-PNH and APPOINT-PNH, these results indicate that iptacopan not only results in clinically meaningful improvements in markers of disease control but provides meaningful improvements in aspects that are important to patients (ie, fatigue and other aspects of health-related quality of life, such as physical functioning and role functioning).

Health-Related Quality of Life (HRQoL) in Fit, Unfit and Frail Patients Enrolled in Fitness (UK-MRA Myeloma XIV): A Cross Sectional Study

Introduction In the UK in 2016-2018, more than 4 in 10 new diagnoses of multiple myeloma (MM) were in people aged at least 75 years old. Transplant-ineligible (TNE) patients are a heterogeneous group that is not well-defined by age, but by the interplay of age, physical function, cognition and comorbidity better defined as ‘frailty’. There is little evidence on the effect of frailty on HRQoL in patients with MM. We examined patient-reported outcomes from participants enrolled in the FiTNEss study to understand HRQoL according to frailty group and the contribution of different elements of the International Myeloma Working Group (IMWG) frailty score (FS) to HRQoL. Methods FiTNEss (UK-MRA Myeloma XIV, NCT03720041) is a phase III, multi-centre, randomised controlled trial for newly diagnosed TNE MM patients. Patients receive lenalidomide, ixazomib, and dexamethasone induction and maintenance, comparing frailty score-adjusted up-front dose reductions and standard up-front dosing followed by toxicity dependent reactive dose adjustments. Frailty was defined using the IMWG FS. It includes age (<75y, 75-80y, >80y), Katz Activity of Daily Living (ADL<=4), Lawton Instrumental Activity of Daily Living (IADL<=5), and the Charlson Comorbidity Index (CCI<=1). The UK-MRA Myeloma Risk Profile (MRP) 1 was scored using age, performance status (PS), ISS and CRP. HRQoL was measured by EORTC QLQ C30 and MY20 completed at trial entry. We used a one-way ANOVA and two-sample unequal variance t-tests to compare subscales in different frailty groups. We sought minimally important differences that were at least medium size 2, and adjusted p-values using the Bonferonni correction for the 19 subscales (adjusted P = 0.05/19 = 0.0026). Results Baseline HRQoL was available for 559 trial participants. Median age was 77y (<75y: 183 [32.7%], 75-80y: 248 [44.4%], >80y 128 [22.9%]), 307 (54.9%) were male and 427 (76.2%) ECOG PS0-1. 160 (28.6%) patients were classified as Fit, 182 (32.6%) were Unfit and 217 (38.8%) were Frail according to IMWG FS. 105 (18.8%) patients had CCI <=1, 60 (10.7%) had ADL<=4 and 115 (20.6%) had IADL <=5. 167 (31.0%) patients were classified as low risk, 180 (33.5%) were intermediate risk and 191 (35.5%) were high-risk according to MRP. Contrasting IMWG fit, unfit and frail patients, significant differences were evident in 7 of 15 C30 subscales (Global Health Status [QL], Physical [PF], Role [RF], Cognitive [CF] and Emotional Functioning [EP], Appetite loss [AP], Dyspnoea [DY]) and 1 of 4 MY20 subscales (Side Effects [MYSE]) (Figure A). The largest differences in subscales were between the Fit/Unfit and Frail groups with only a single nominally different subscale (PF) between Fit and Unfit. When comparing the frailty score elements, age group and CCI were not significantly different using C30 or MY20 subscales. However, when considering ADL: 11 of 15 C30 (QL, PF, RF. CF, Social Functioning [SF], Fatigue [FA], Pain [PA], AP, Constipation [CO], DY, Financial Problems [FP]) subscales and 2 of 4 MY20 subscales (Disease Symptoms [MYDS], MYSE) were significantly different. Similarly, when considering IADL: 10 of 15 C30 subscales (QL, PF, RF, CF, SF, FA, PA, AP, CO and DY) and 4 of 4 MY20 subscales (MYDS, MYSE, Body Image, Future Perspective Worries) were significantly different (Figure B). When comparing between MRP risk groups, 10 of 15 C30 subscales (QL, PF, RF, CF, SF, FA, PA, AP, CO and DY) and 2 of 4 MY20 subscales (MYDS, MYSE) were significantly different. Unlike IMWG FS, 5 subscales were nominally significantly different between low and medium risk groups (QL, PF, RF, SF, DY). Conclusion The IMWG FS is associated with several domains from EORTC QLQ-C30 and MY20 at baseline with worse function and symptomatology among frail patients. Examining FS elements show that age and comorbidities do not contribute to heterogeneity in HRQoL. However, ADL and IADL are significantly associated with HRQoL. ADL elements may identify components of frailty that are potentially modifiable through supportive care and rehabilitation and could enhance HRQOL and treatment tolerability in older patients. The MRP risk profile is associated with baseline HRQoL as shown previously and with a number of other subscales as shown here. There is evidence that the MRP can delineate subscales, including QL better than the IMWG FS. 1. Cook G, et al, The Lancet Haematology, 6(3): E154-E166. 2. Cocks K, et al, Journal of Clinical Oncology, 29(1): 89-96.

Edukasi terhadap Self Efficacy dan Kualitas Hidup Pasien Kanker Kolorektal yang Menjalani Kemoterapi

This study aims to identify the effect of education on self-efficacy and quality of life in colorectal cancer patients undergoing chemotherapy. The method used is quantitative, using a quasi-experimental design with a nonequivalent control group pre-posttest-only design method with a sample size of 56 people, using the GSE (General Self Efficacy) questionnaire instrument and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ). -C30). The results of the research show that education affects the self-efficacy of colorectal cancer patients undergoing chemotherapy with a p-value <0.05, and education affects the quality of life of colorectal cancer patients undergoing chemotherapy with a p-value <0.05. The conclusion is that educational interventions positively increase self-efficacy and quality of life in colorectal cancer patients undergoing chemotherapy.
 
 Keywords: Education, Colorectal Cancer, Quality of Life, Self Efficacy

Immunotherapy for advanced or metastatic urothelial carcinoma.

Immunotherapy for advanced or metastatic urothelial carcinoma.

Quality of life of carcinoma cervix patients attending tertiary care hospital: A cross-sectional study

Abstract Background: In 2012, cervical cancer became the leading cause of cancer-related deaths among women in India, with an estimated 123,000 new cases and 67,477 reported fatalities. Besides its considerable impact on mortality rates, cervical cancer also results in long-term disability, leading to a loss of productive years. Despite the development of various diagnostic and treatment approaches for cervical cancer, survivors still face significant morbidity, which significantly impacts their quality of life (QOL). The primary objective of this study is to assess the QOL of cervical cancer patients to identify and address issues within the current healthcare system. Objective: To investigate the QOL of cervical cancer patients as per the stage of their disease and the type of therapy they receive. Materials and Methods: A cross-sectional study was conducted between January 2023 and August 2023. During this period, patients who visited the Department of Obstetrics and Gynecology and agreed to take part in the study were included in interviews. The European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire for cervical cancer (EORTC QLQ CX24) was employed to assess the QOL of cervical cancer patients. Results: The participants had an average age of 52.4 years, with a standard deviation of 10.5. Most were diagnosed at advanced disease stages (III and IV), while only approximately one-fourth were at stage I. The predominant treatment modality administered was radiotherapy, followed by surgery and chemotherapy. When examining the QOL, it was observed that individuals at stages I and II of the disease tended to experience more significant concerns related to body image and sexual worries. Additionally, patients in stages I and II and those receiving chemotherapy reported higher scores in terms of sexual activity and sexual enjoyment, indicating a better QOL in these aspects. Conclusion: As the disease stage progressed, there was a decline in QOL. In the early stages of the disease, QOL related to body image and sexual worries was notably lower. In contrast, QOL about sexual activity and sexual enjoyment was comparatively better for these patients. Patients who received chemotherapy or a combination of treatment modalities reported poorer QOL.

Patient-Reported Outcomes Evaluating the Impact of Hypo-Fractionated Palliative Quadshot Radiotherapy and Concurrent CDDP Treatment on Health-Related Quality of Life in Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck

In locally advanced squamous cell carcinoma of the head and neck (LAHNSCC), the main goal of treatment remains survival while improving quality of life (QOL). In recent decades, there has been a paradigm shift in the measurement of clinical outcomes in patients diagnosed with cancer, focusing on the patient perspective by incorporating patient-reported outcomes (PROs). The primary objective of this study was to evaluate the improvement in quality of life with the use of cyclic hypo-fractionated palliative QUAD SHOT radiotherapy (RT) with concurrent cisplatin (CDDP) in previously untreated patients with incurable LAHNSCC. In this prospective interventional phase- II study, 60 patients with locally advanced squamous cell carcinoma of the head and neck, majority stage IVB, ECOG PS ≤ 3, were treated with QUAD SHOT RT (14 Gy/4 fractions/2 days - BD with 6-hour interval and concurrent CDDP at 6 mg/m2. This treatment was repeated at 4-week intervals for 2 additional cycles if tumor progression did not occur. Serial changes in HR -QoL were assessed using EORTC QLQ C-30 and H&N-35) at 4 different time points. Statistical methods such as the Wilcoxon signed-rank test and Friedman test were used to compare QoL values at different time points with Bonferroni correction for multiple comparisons to control for type I errors. The median global health score (GHS) at baseline was 41.667, with an initial increase in score at 4 weeks (50.00) and at 8 weeks (54.167) that did not continue at 12 weeks (41.667). Symptoms related to toxicities (speech, social contact, sticky saliva, dry mouth, senses in H&N 35) were lower after 4 weeks. Application of the Friedman test for four time points revealed significant improvement in role function at 4 weeks, which remained constant at 8 weeks but was not sustained at 12 weeks. Comparison of HN-35 symptom scores between the four time points showed improvement in symptoms such as pain, swallowing, and mouth opening at 4 and 8 weeks. The mean QLQ C30 summary score for these patients improved at four weeks but did not remain constant at 8 and 12 weeks. Our study showed significant improvement in quality-of-life parameters and reduction in symptom burden at 4 and 8 weeks due to disease control and symptom palliation by QUADSHOT CTRT, while quality-of-life scores worsened and symptom scores were not maintained at 12 weeks due to disease progression and occurrence of acute toxicities. This phase II study may serve as the basis for designing a phase III randomized control trial to compare quality of life changes with QUADSHOT CTRT and other palliative CTRT regimens.

Association between Regular Vaginal Dilation and/or Sexual Activity and Long-Term Vaginal Morbidity in Cervical Cancer Survivors

To evaluate the association between regular vaginal dilation and/or sexual activity and vaginal morbidity in locally advanced cervical cancer patients after definitive radiochemotherapy and image-guided adaptive brachytherapy from the EMBRACE I study. Physician-assessed vaginal morbidity (CTCAE v.3), vaginal dilation and patient-reported sexual activity (EORTC QLQ CX24) were assessed at baseline, every 3 months in the 1st year, every 6 months in the 2nd and 3rd year and yearly thereafter. For this longitudinal analysis, a subgroup of patients was selected with at least 3 follow-ups with information on vaginal dilation and/or sexual activity. Vaginal penetration summarized either the use of vaginal dilators or sexual activity or both. Regular vaginal penetration was defined if reported in ≥50%, infrequent if reported in <50% and absent if reported in 0% of follow-ups. Actuarial estimates of vaginal morbidity were calculated with Kaplan-Meier method and included the individual symptoms: vaginal dryness, stenosis, mucositis and bleeding. Group comparisons were evaluated with the log-rank test. The EMBRACE I study included 1416 patients overall (2008-2015); the subgroup of patients for this longitudinal evaluation consists of 882 patients, with a median follow-up of 60 months (IQR 47-77). Of those, 565 (64%) reported regular, 205 (23%) infrequent and 112 (13%) no penetration. Reporting regular penetration was associated with a significantly lower risk of vaginal stenosis G≥2 of 23% at 5 years, compared to reporting of infrequent (37%) and no penetration (36%, p≤0.001). However, reporting regular penetration was associated with a significantly higher risk for vaginal dryness G≥1 (72% vs. 69% vs. 62%, respectively, p = 0.038) and bleeding G≥1 (61% vs. 40% vs. 25%, respectively, p≤0.001). No associations were seen for G≥1 vaginal stenosis, G≥2 dryness, G≥2 bleeding and G≥1/G≥2 mucositis. Regular penetration (defined as vaginal dilation and/or sexual activity) was associated with lower risk for vaginal stenosis G≥2, but higher risk for vaginal dryness G≥1 and bleeding G≥1. Mild vaginal dryness seems to become apparent in particular for patients experiencing vaginal penetration. Minor vaginal blood loss during dilation and/or sexual activity is commonly reported by patients, resulting from atrophy of the vaginal mucosa and/or telangiectasia. While both of these G≥1 symptoms can be managed with lubricants, moisturizer and/or hormonal replacement therapy, G≥2 vaginal stenosis represents an irreversible fibrotic adverse event that can cause dyspareunia in many cancer patients. These long-term data support clinical recommendations for dilation and/or sexual activity after radiotherapy.

Effects of Comprehensive Geriatric Assessment (CGA) Guided Care vs. Usual Care on Overall Survival (OS) and Health-Related Quality of Life (HRQL) for Older Adults with Cancer: A Systematic Review of Randomized Trials (RCTs)

There is evidence from RCTs demonstrating that our current models of CGA guided care can reduce treatment related toxicity effectively. However, it is unclear if CGA guided care can improve OS and HRQL. We aimed to determine the effect of CGA guided care compared with usual care on OS and HRQL. We searched MEDLINE, EMBASE, CENTRAL and CINAHL from date of inception to October 2022 for RCTs comparing CGA guided care with usual care for patients with cancer who were 60 years old and greater on OS and HRQL. We assessed the risk of bias using Cochrane ROB 2 tool. We performed the meta-analysis using random-effects models. The I2 statistic was adopted to assess heterogeneity between studies. We adopted the Synthesis without meta-analysis approach for data not amenable for meta-analysis. The certainty of evidence was rated using the GRADE approach. This study is registered with Cochrane Database of Systematic Reviews. We found 15 eligible RCTs including 3507 participants. There are variations in types of CGA used with 4 trials using CGA to recommend oncology treatment regimen and 10 trials making no recommendation on oncology treatment. The implementation of CGA recommendations were carried out by a geriatrician in 14 trials, but by the primary oncologist in 1 trial. Six, five and four RCTs were judged to have low, unclear and high risk of bias respectively. Eleven and six RCTs reported OS and HRQL outcomes respectively. There was no significant difference between CGA guided and usual care for OS (Hazard Ratio 1.02, 95% CI (0.90 to 1.15), I2 = 0%; moderate certainty). There was significant variation in the measurement of HRQL in terms of instruments, summary measures and time points. EORTC QLQ C30 and ELD 14 were used in 3 RCTs. The effects of CGA guided care on HRQL were inconsistent. Two trials using FACT-G or Elderly Functional Index (ELFI) reported significant improvement in HRQL at 3 and 6 months post randomization. Meta-analysis of the mean difference in the change of the EORTC QLQ C30 and E14 HRQL scores relative to baseline at 6 months post randomization demonstrated no significant difference between CGA guided and usual care for HRQL across various domains (moderate certainty evidence). The current models of CGA guided care did not improve OS and had variable effects on HRQL when compared to usual care in older patients with cancer. The inconsistent effects of CGA guided care on HRQL suggest that CGA guided care may have more significant effects on the social and functional outcomes domains, aspects of HRQL that is predominantly measured in FACT-G and ELFI score respectively. There is also heterogeneity in how CGAs are performed and implemented. Future research should focus on developing new models of CGA guided care to improve OS and HRQL.

Change in Quality of Life after Stereotactic Body Radiation Therapy (SBRT) on a Prospective Trial of Peripheral Stage I or II Non-Small Cell Lung Cancer Predicts Survival

We previously reported the results of a randomized, multi-institutional phase II clinical trial evaluating one versus three fractions of SBRT for peripheral Stage I to II non-small cell lung cancer (NSCLC). A secondary objective to compare quality of life (QOL) data and its association with survival outcomes is reported. Medically inoperable patients with biopsy-proven peripheral T1-2N0M0 NSCLC were enrolled. Patients were randomized to 30 Gy in 1 fraction (arm 1) or 60 Gy in 3 fractions (arm 2) and stratified by performance status. QOL scores from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and EORTC QLQ Lung Cancer-Specific Module (EORTC QLQ-LC13) questionnaires were required at baseline and each follow-up visit. Univariate models were generated to evaluate associations between QOL scores and survival with 95% confidence intervals (CI) calculated at each time point. Among 98 patients enrolled (49 in each arm), 88 patients had data available for QOL analysis. At 6 month follow up, patients with stable or decreased (n = 49) versus those with increased global QOL scores (n = 27) had worse progression-free survival (HR [Hazards' Ratio] 2.32 [CI, 1.14-4.73], p = 0.021) and overall survival (HR 2.13 [CI, 1.01-4.51], p = 0.048). Similar results persisted at the 12 month follow up for progression-free survival (HR 3.90 [CI, 1.52-10.04], p = 0.016) and overall survival (HR 3.25 [CI, 1.25-8.43], p = 0.016). Median overall survival for patients with stable or decreased global QOL versus increased global QOL at 6 month follow up was 39.0 vs 60.3 months (p = 0.032). Change in QOL is an early predictor of survival following SBRT for patients with peripheral early-stage NSCLC.

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.

Quality of Life in Prostate Cancer Patients Undergoing Daily Adaptive Versus Non-Adaptive Radiation Therapy Utilizing A 1.5 Tesla MR-Linac

Using adaptive radiation therapy (ART) physicians can re-contour normal organs (such as bladder and rectum) before each fraction. While ART may result in more reliable dosimetry to regional organs at risk, the process is time consuming and more expensive than non-ART. We evaluated differences in patient reported quality of life (PR-QOL) between daily ART and non- ART. Patients with prostate cancer from 3 centers in the Netherlands and United States were treated using a 1.5 Tesla MR Linear accelerator. Patients consented to the Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study (MOMENTUM, NCT04075305) between 2019 and 2022. PR-QOL was prospectively collected using the EORTC QLQ-C30 and PR-25 at baseline (before RT), and at 3 and 6 months after RT. Patients without complete QOL data were excluded. QOL differences were compared between patients undergoing daily ART vs. non-ART. A linear mixed effect model was performed to account for repeated measurements. Analyses were performed using R Studio. One hundred thirty-six patients underwent RT with QOL were analyzed. Median follow up was 13 months (6-26 months). Patients were treated without daily ART (n = 94) or with daily ART (n = 42). The median age was 70 (range 53-83) years and 65.4% had intermediate risk disease, 35% of patients received hormonal therapy. Fractionation schedules included 36 Gy/6 (n = 16), 36.25 Gy/5 (n = 103), 60 Gy/20 (n = 6), 62 Gy/20 (n = 8), and 70 Gy/28 (n = 3). Compared to baseline scores, EORTC QLQ C30 diarrhea scores at 6 months post-treatment were significantly worse for patients treated without daily ART compared to those treated with daily ART (p < 0.05). Other QLQ PR25 bowel scores were not significantly different at 3 or 6 months. Both PR25 urinary and treatment-related symptoms were improved with daily ART compared to non-ART at the 3 (p < 0.001 and p < 0.01, respectively) and 6 (p < 0.01 and p < 0.001, respectively) month time points. Magnitude of improvements can be found in Table 1. Among prostate cancer patients treated using 1.5 Tesla MRI-guided RT, daily ART was associated with improved PR-QOL in urinary and bowel domains compared to non-ART. These hypotheses generating preliminary results provide the first indications (to our knowledge) that adapting contours to daily anatomy may improve short-term urinary and bowel PR-QOL. Updated results will be presented at ASTRO 2023.

P08.04.B DOES PSYCHO-ONCOLOGICAL CARE AFFECT HEALTH-RELATED QUALITY OF LIFE AND PATIENT AND CAREGIVER SATISFACTION IN IDH WILD-TYPE GLIOMA? - A PROSPECTIVE STUDY

Abstract BACKGROUND Isocitrate dehydrogenase wild-type (IDHwt) gliomas are uncurable primary tumors of the brain and impose a high burden on affected patients and caregivers. In addition to neurological symptoms, changes in cognition and personality are common and should be diagnosed and treated early. About 75% of patients with brain tumors suffer from psychosocial distress at their first consultation. Health-related quality of life (HR-QoL) is significantly reduced by anxiety and negative mood, following glioma diagnosis. Brain tumor diagnosis also affects caregivers negatively. Recent publications show that caregiver and patient satisfaction influence each other, with caregivers generally being less satisfied than patients. In addition to specific tumor and symptomatic therapy, psycho-oncological care is an important element in a comprehensive treatment approach and may lead to increased HR-QoL and patient and caregiver satisfaction. However, there are few prospective datasets focusing on these aspects. MATERIAL AND METHODS We investigated the impact of psycho-oncological care on HR-QoL and patient and caregiver satisfaction in a large brain tumor center. Data from the regional brain tumor registry and electronic medical charts were used to compile the prospective patient cohort. Standardized questionnaires were used to investigate HR-QoL (EORTC QLQ C-30 and BN-20) and satisfaction (EORTC PATSAT-C33). Univariable and multiple linear regression analysis was applied to test the influence of psycho-oncological care on both aspects. RESULTS A homogenous cohort of 61 patients was investigated, of whom 29 (47.5%) received psycho-oncological care. We analyzed 141 EORTC QLQ-C30, 139 EORTC QLQ-BN20, 129 EORTC PATSAT-C33 questionnaires from patients, and 115 EORTC PATSAT-C33 questionnaires from caregivers. We show that patients who received at least one psycho-oncological consultation had significantly worse role functioning (p = 0.001) and a negatively influenced global health status (p = 0.038). Psycho-oncological care had no significant correlation with the satisfaction of patients. Caregivers of patients with psycho-oncological care documented inferior satisfaction with information exchange of doctors (p = 0.036). CONCLUSION We conclude that receiving psycho-oncological care is associated with changes in HR-QoL and patient and caregiver satisfaction. Utmost efforts should be made to integrate intensively and frequently psycho-oncological care on a daily-practice basis. It will be subject of future prospective studies to investigate kind and frequency of interventions that are suited to improve HR-QoL and treatment satisfaction in patients with IDHwt gliomas and their caregivers, and how to complement supportive therapies better to achieve optimal psychosocial outcomes for these patients and their caregivers.

P09.05.A IMPACT OF A 16-WEEK SUPERVISED EXERCISE INTERVENTION ON CANCER-RELATED FATIGUE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA UNDERGOING ADJUVANT CHEMOTHERAPY

Abstract BACKGROUND Cancer-related fatigue (CRF) is considered one of the most prevalent symptoms in brain tumor patients undergoing concurrent chemoradiation (approx. 80 % of those affected). Several studies have identified beneficial effects of physical activity on reducing CRF. However, few studies have examined the reduction of CRF by exercise in glioma patients. Here we present prospective data showing the effect of an intensive 16-week supervised exercise intervention on CRF in neuro-oncological patients. MATERIAL AND METHODS Between July 2020 and April 2023, patients with newly diagnosed glioblastoma and after surgery and concomitant radiochemotherapy have been recruited for this single-arm trial in progress. Participants have received a 16-week supervised training intervention on a 1:1-basis consisting of two intensive 50-minute sessions per week (bicycle ergometry at an average of 75 % of maximum heart rate and progressive whole-body resistance training). CRF has been assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30). We calculated change scores (scores: 0-100; 100=max. fatigue) from baseline, after 8 weeks, and post-intervention (week 16). RESULTS So far, 26 glioblastoma patients (13 women) aged 35-84 years (mean 59 years) participated in the exercise intervention. All patients received adjuvant chemotherapy (50 % Stupp, 42 % CeTeG, 8 % other). Paired t-test indicated a statistically significant reduction in CRF from baseline to post-intervention (p=.030; 95 % CI: -0.5 - 24.2). Mean scores reduced from 40.4 to 36.2 (week 8) to 26.9 (week 16). However, the decrease between week 0 and week 8 was not yet significant (p=.281; 95 % CI: -7.6 - 13.6). CONCLUSION The present trial shows that a 16-week supervised exercise program can reduce CRF in glioblastoma patients despite adjuvant chemotherapy. Thus, and consistent with studies of exercise interventions in patients of other tumor types, glioblastoma patients have the opportunity to actively contribute to the reduction of tumor- and therapy-induced side effects through intensive physical training.

A Review of Commonly used Health-Related Quality of Life instruments in Gynecological Cancer Survivors.

The number of cancer survivors is increasing steadily due to an aging population, continuing improvement in early detection, and treatment. Comparative effectiveness studies and clinical trials are being done to assess late effects of treatment and health-related quality of life. This is in addition to long-term follow-up to assess survival. The aim of the review was to summarize the literature on commonly used quality of life instruments for patients with gynecological cancers with special focus on patient reported outcomes. A literature review was done to summarize the commonly used health-related quality of life instruments in gynecological cancer survivors. Most items assess general quality of life, sexual function, and/or treatment-related toxicity. The commonly reported instruments are the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30) with disease specific modules for cervix, ovary, and endometrium. Another tool is the Functional Assessment of Cancer Therapy (FACT) questionnaire with similar disease specific modules. The questionnaires were accessed with permission from these organizations. These instruments typically have about 10-30 questions that assess treatment related bowel and bladder toxicity. This is connected to the patients' self-reported quality of life, generally ranked using a 5-point scale. Length and emphasis vary in different questionnaires. The validated tools in cancer populations allow better quantification and assessment of quality of life. However, there may be limitations. Some of the general instruments may be too broad to assess treatment-related long-term side effects. Others may be too narrow to generalize closely related patient groups. Also, some questions may not be culturally appropriate in certain situations.

Assessment of Quality of Life among Colorectal Cancer Survivors

Background The concepts of quality of life and patient-centered outcomes have become popular in medical communities; however, the wide application of Quality-of-life investigations remains an obstacle for most clinicians due to the limited validation studies performed to date and the lack of disease-specific measuring instruments. Health-related quality of life has become an indispensable component of research outcomes, particularly for cancer therapy. Colorectal cancer (CRC) ranks the third in terms of incidence, but second in terms of mortality, and its incidence is steadily rising in developing nations. The burden of colorectal cancer is rapidly increasing due to the high incidence and consequences of cancer therapy. Patients who survived colorectal cancer therapies may continue to suffer from physical or psychological problems. Objective Validating a tool for Assessment of quality of life among colorectal cancer survivors using EORTC CR29 questionnaire, by assessment of construct Validity of the Egyptian version of the questionnaire. Methods This is a cross-sectional study was held in Ain Shams University Hospitals and Nasser Institute Cancer Centre for 6 months between January 2020 and July 2020 on 85 patients with colorectal cancer, received neo- adjuvant, adjuvant or palliative Therapy (Chemo or Radiotherapy), underwent palliative or radical surgery and not on treatment at time of study. Results 85 patients (62.4% males and 37.6% females) participated in the study. All patients were diagnosed with colorectal cancer. Age was ≤ 60 years among 52.9% of patients while age was &amp;gt; 60 years among 47.1%. after assessing the quality of life (symptoms scale) in our studied patients using EORTC QLQ-CR29 scoring Manual, mean urinary frequency during day score was 28.47± 8 out of 100, mean Urinary Frequency during night score was 31.87 ± 10 out of 100, mean Urinary incontinence score was 32.94 ± 7 out of 100, mean Dysuria score was 16 ± 5 out of 100, mean Abdominal pain score was 25.86 ± 9 out of 100, mean Buttock pain score was 39 ± 12 out of 100, mean Bloated feeling score was 34 ± 11 out of 100, mean Blood and mucus in stool score was 18 ± 7 out of 100, mean Dry mouth score was 30.8 ± 5 out of 100, mean Trouble with taste score was 19.31 ±5.7 out of 100 &amp; mean Hair loss score was 34.8 ± 16 out of 100. We assessed Quality of life (functional scale Table 5).Mean Anxiety for health in our studied patients was 70 ± 18 while Mean Anxiety for weight was 65.8 ± 9. Mean Body image - Attractive was 63.5 ± 8, Mean Body imageSatisfaction was 60.4 ± 12. Conclusion This study shows that the Egyptian version of the EORTC QLQ- CR29 is a valid tool for measuring QOL, as determined by application to a sample of Egyptian colorectal cancer patients.

Nutritional status and quality of life among breast Cancer patients undergoing treatment in Addis Ababa, Ethiopia

BackgroundThe prevalence of malnutrition in cancer patients ranges from 30 to 60%. While it is known that malnutrition is prevalent among cancer patients, the relationship between undernutrition and quality of life among breast cancer patients has not been adequately explored. Therefore, the present study was aimed at assessing the association between undernutrition and quality of life among Breast Cancer patients under treatment in Addis Ababa, Ethiopia.MethodsA cross-sectional study on breast cancer patients under treatment at the outpatient and in-patient departments of oncology centers of two tertiary hospitals in Addis Ababa – Tikur Anbessa Specialized Hospital (TASH) and St. Paul Millennium Medical College (SPHMMC) oncology was conducted from May 12 to August 26,2020. Nutritional status was assessed using Subjective Global Assessment (SGA) screening tool. Quality of life was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Cancer 30 (EORTC QLQ C30) a standard quality of life measurement scale for cancer patients. To determine the relationship between quality of life scores and nutritional status multivariable linear regression was fitted.ResultsA total of 411 breast cancer patients with mean age of 44.4 (± 11.47) years. And 393 (95.6%) of them female were included in the study. A high prevalence of moderate 127 (30.9%) and severe 106 (25.8%) malnutrition was observed. Moderate (β = −9.21 CI (− 14.59, − 4.67)) and severe (β = −17.81 CI (− 16.6, 2 − 2.91)) malnutrition were negatively associated with the overall quality of life. Malnutrition also showed negative associations with all domains of functional status (P < 0.05) and strong positive associations with symptom scores covered in the EORTC QLQ C-30 (P < 0.05).ConclusionThis study indicated that malnutrition is a major problem among breast cancer patients and the nutritional status breast cancer patients was related to their quality of life….

Comparative effectiveness of verbal instruction versus video-based education (VIVid) among family caregivers for improving the quality of life in advanced head and neck cancer patients receiving palliative care in Eastern India: a randomized controlled trial.

To determine if video-based educational intervention compared to the standard verbal guidelines, provided to caregivers on home-based palliative care could enhance the quality of life (QoL) in advanced head and neck cancer (HNC) patients. The study employed a prospective, two-arm parallel-group, randomized controlled trial design. Investigators prepared a real-world demonstrational video of ten minutes duration regarding home-based care for family caregivers, with voice-over in Odia language (Eastern India). The contents of the video addressed the management of common problems in palliative care among HNC patients. This study included 180 participants, 90 patient & caregiver dyads randomized to interventional (video-based education) or control (verbal instruction) groups. Patients' QoL was measured at baseline and 3weeks follow-up using EORTC QLQ C30. Data were analyzed descriptively, and the Chi-square, Mann-Whitney U, T-test, spearman correlation, and multiple hierarchical regression analyses were employed for statistical analysis, with a significance level of p < 0.05. Seventy participant dyads completed the planned two assessments: baseline and at the end of 3rd week (Intervention = 37; Control = 33). The intervention group showed a significant improvement in the patient's health-related QoL, physical, emotional, and social functioning. Symptom burden reduction was observed for pain, nausea, and fatigue. A significant increase in the change in QoL with the video-based education group (VBE) compared to the verbal instruction (VI) group after adjusting for age, gender, physical functioning, and pain symptomology (adjusted R2 = 0.402) was noted. VBE intervention using smart-phone may offer caregivers a viable means of enhancing self-management while improving patients' QoL within the socio-cultural challenges for home-based palliative care in India. Further research on training caregivers using digital interventions and home-based visits is recommended. CTRI/2021/06/034473 [Registered on: 30/06/2021].