Functional Assessment Of Cancer Therapy-General Research Articles

Quality of life of older adults diagnosed with cancer in Palestine: A cross sectional study

The majority of new cancer diagnoses and cancer deaths occur in the elderly making cancer primarily a disease of older adults. Due to the heterogeneous ageing process and complications resulting from therapy and toxicity, the treatment of older patients with cancer remains challenging. The current study aims to evaluate the quality of life (QOL) of cancer patients over the age of 60 and identify the factors associated with QOL in Palestine. A cross-sectional and descriptive design was employed for this study. The sample included 136 older patients with cancer attending hospitals in East Jerusalem and the West Bank. Data were collected between June and July 2022 using self-reported questionnaires, including socio-demographic data and the Functional Assessment of Cancer Therapy - General (FACT-G). Binary logistic regression was used to identify factors associated with QOL. The age of patients ranged from 60 to 90 years (mean 66.62 years, SD ± 5.46) of which 64.7% (n=88) were females, and 35.3% (n=48) were males. More than half of the participants (64.7%, n=88) had good QOL whereas 35.3% (n=48) had poor QOL. The overall QOL of participants was reported as 2.34 (SD = 0.47), which indicates a good QOL. The highest mean score was found in the social and family well-being domain (2.93 ± 0.76) followed by the physical well-being (2.31 ± 0.82). The difference was significant for functional well-being (t= -2.86, P=.005). Gender was significantly associated with the QOL. Males were about 0.40 times more likely to have lower QOL than females (OR: 0.40; 95 CI%: 0.20-0.98; P = 0.04). In contrast, no significant associations were found for the other factors. A deeper understanding of older patients' QOL and its predictors is essential for comprehending the issues facing the ageing population, and being aware of these variables may be useful for establishing programs to promote QOL.

A Review of Meaningful Change Thresholds for EORTC QLQ-C30 and FACT-G Within Oncology

ObjectivesThis literature review provides an overview of meaningful change thresholds for the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) and the Functional Assessment of Cancer Therapy – General (FACT-G) used across hematological cancers and solid tumors (melanoma, lung, bladder, and prostate). MethodsEmbase, MEDLINE, and PubMed were searched to identify relevant oncology publications from 2016 to 2021. Label claims from the US Food and Drug Administration and the European Medicines Agency for 7 recently approved drugs (pembrolizumab, atezolizumab, glasdegib, gilteritinib, tisagenlecleucel, axicabtagene ciloleucel, and daratumumab plus hyaluronidase-fihj) were reviewed. ResultsPublications providing guidance on meaningful change thresholds for the QLQ-C30 displayed a growing trend away from broad “legacy” thresholds of 10 points for all QLQ-C30 scales), toward deriving “contemporary” thresholds (eg, subscale specific, population specific). Contemporary publications generally provide guidance on selecting thresholds for specific scales that account for improved or worsening thresholds (eg, QLQ-C30 subscales). This trend was not clear for FACT-G, with less new guidance available. Most clinical trials used in regulatory label submissions have used thresholds of 10 points for the QLQ-C30 subscales and 3 to 7 points for the FACT-G total score. Despite the availability of more recent guidelines, contemporary meaningful change thresholds seem slow to emerge in the published literature and regulatory labels. ConclusionsTrialists should consider using contemporary thresholds, rather than legacy thresholds, for QLQ-C30 endpoints. Thresholds derived for a similar patient-population should be used where available. Further work is required to provide these across a broader range of cancer sites.

Quality of life and its predictors among patients with metastatic cancer in Bangladesh: the APPROACH survey

BackgroundThis study aimed to assess the health-related quality of life (HRQOL) (physical, functional, emotional, social, spiritual) and psychological (anxiety and depression) well-being and their associations with patient characteristics among patients with metastatic cancer in Bangladesh.MethodsA convenience sample of 386 Bangladeshi patients with stage IV solid cancers was recruited from a palliative care outpatient department and an inpatient palliative center. Dependent variables included the physical, functional, emotional, social, and overall scores of the Functional Assessment of Cancer Therapy-General (FACT-G) scale, the Functional Assessment of Chronic Illness Therapy-Spiritual Well-being (FACIT-SP) scale, the anxiety, depression, and overall scores of the Hospital Anxiety and Depression (HADS) scale. Linear regressions examined the association between dependent variables and patient characteristics.ResultsA substantial proportion of Bangladeshi patients reported anxiety (59% of outpatients and 55% of inpatients) and depression (60% of outpatients and 73% of inpatients) symptoms. Generally, greater financial difficulty and symptom burden scores were associated with worse health outcomes. Older patients reported poorer functional and spiritual well-being but better anxiety scores. Females reported worse anxiety and depressive symptoms and physical well-being but better spiritual outcomes.ConclusionsAdditional efforts must be directed at improving the HRQOL of patients with metastatic cancer in Bangladesh. Furthermore, assistance should be made more accessible to vulnerable groups, including women, the elderly, and those with financial difficulty.

Religious Coping in the Indian Scenario

Religious coping plays a crucial role in how individuals manage stress and trauma, particularly within the diverse cultural context of India. This study explores the interrelationships between religious coping, post-traumatic growth (PTG), and psychological well-being (PWB) among a sample of 150 cancer patients aged 30-50 years admitted to Acharya Tulsi Regional Cancer Institute and Research Centre, Bikaner. Using the Brief RCOPE (Religious Coping Scale), the Functional Assessment of Cancer Therapy-General (FACT-G), and the PostTraumatic Growth Inventory (PTGI), we found that positive religious coping strategies are significantly associated with higher levels of PTG and PWB, whereas negative religious coping correlates with poorer psychological outcomes. These findings highlight the beneficial impact of positive religious coping on psychological resilience and growth while emphasising the detrimental effects of negative religious coping. The results underscore the importance of integrating spiritual and religious dimensions into mental health interventions to foster holistic healing and well-being. Despite its contributions, the study is limited by its reliance on selfreport measures and a cross-sectional design. Future research should focus on longitudinal studies and qualitative approaches to deepen understanding and develop culturally sensitive mental health practices that incorporate religious coping mechanisms.

Relationship between Hope and Quality of Life in Patients with Advanced Cancer in Uruguay: An Observational Analysis

Introduction: 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. Materials and 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.

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.

Health-Related Quality of Life (HRQL) in Cutaneous T-Cell Lymphoma: Psychological Burden and Influencing Factors from Mycosis Fungoides and Sézary Syndrome Patients in China

Introduction: Mycosis fungoides (MF) and Sézary syndrome (SS) are the most common subtypes of cutaneous T-cell lymphomas (CTCL). However, beyond the clinical and economic burden, psychological burden from CTCL patients in China has not been reported and requires further evaluation. Methods: The analysis used data from adults (≥18 years) clinically diagnosed with MF or SS, and have been receiving or have received disease-related treatment in the past year. MF patients with stage IA-IIA, patch or plaque phase were categorized into early stage, while stage IIB-IVA, tumor phase were late stage. All SS patients are late stage. HRQL data from the EQ-5D-5L, Skindex-29 and Functional Assessment of Cancer Therapy - General (FACT-G) were analysed at the item level and scored according to instrument guidelines. Multivariate analyses were used to identify factors associated with poor HRQL. Results: Data were collected from a quantitative survey of 56 MF patients and 5 SS patients residing in 38 cities of 21 provinces across China: 56% were male, with a mean (SD) age of 39 (13) years (median was 38, ranged 19 to 74 years old). 51% were late stage. Based on emotional domain questions of Skindex-29, among all patients, 39% always or often worried about the disease progression, while 45% of late-stage patients were always and often worried. 36% of all patients often or always felt CTCL was annoying. Based on FACT-G, in physical well-being domain, 39% of all patients, and 48% of late-stage patients felt they were ill in “quite a bit” or “very much” scale, respectively. In social well-being domain, 35% of all, and 39% of early-stage patients felt “not at all” or only “a little bit” satisfied with their sex life. In emotional well-being domain, 38% of all patients were “not at all” or “a little bit” satisfied with their coping with the disease, while 36% of all patients “quite a bit” or “very much” worried about the condition getting worse. In the functional well-being domain, 29% of all patients felt they were “not at all” or “a little bit” able to work. In multivariate analysis, regression on EQ-5D-5L score showed that younger patients were more likely to report severe anxiety and depression. Skindex-29 score showed that female patients worried more that the disease get more serious and causing scars on their skin. Conclusions: In China, psychological burden with MF and SS, included anxiety, depression, worrying about disease progression, unable to work, and unsatisfied sex life. Younger patients and female patients reported greater psychological impact of the disease. Optimal medical management of MF and SS should address psychological impacts of the disease.

Impact of Frontline Treatment Strategy on Quality of Life in the First Decade after a Diagnosis of Marginal Zone Lymphoma

Background: Marginal Zone Lymphoma (MZL) is considered indolent but incurable, with a variety of initial treatment strategies including observation. Quality of life (QOL) can be affected by disease burden, side effects of treatment, and psychosocial effects of living with an incurable cancer. However, little is known about long-term QOL in patients with MZL. We investigated QOL at baseline (BL), and up to nine years after a diagnosis of MZL. Methods: Newly diagnosed MZL patients aged 18 years and older were prospectively enrolled within 9 months of diagnosis in the Iowa/Mayo Clinic Molecular Epidemiology Resource from 9/2002 - 6/2015. Pathology was reviewed by a hematopathologist. All MZL participants with both BL and at least one follow-up (FU) QOL questionnaire were eligible for this analysis. QOL was measured at BL and years 1-, 2-, 3-, 6- and 9-year FU with the Functional Assessment of Cancer Therapy-General (FACT-G) scale (range 0-108), which measures 4 QOL domains (range): physical (0-28), social/family (0-28), emotional (0-24), and functional (0-28) well-being (WB). Clinical data were abstracted according to a standard protocol and patients were systematically followed for events (progression, re-treatment, and death). Patients were grouped into initial management with active surveillance (observation), local/antibiotic therapy (including radiation, surgery, and anti- H. pylori therapy), or systemic therapy (including chemotherapy, targeted agents, or antibody therapy). Change in QOL scores over time was analyzed using mixed models for repeated measurements, and comparisons were made according to initial treatment group. Results: Of 324 participants in the analysis, 59% were female, 98% were White and the median age was 63 years. For initial management, 36% (N=118) were observed, 30% (N=96) received local/antibiotic therapy and 34% (N=110) received systemic therapy. Across the initial treatment groups, there were no statistically significant differences by age, gender, or performance status, while there were differences for Ann Arbor Stage IV (observation 50%, local/antibiotic 27%, systemic 67%, p&amp;lt;0.001) and MALT-IPI score 2+ (observation 23%, local/antibiotic 18%, systemic 28%, p&amp;lt;0.001). At BL, mean FACT-G total score was 85.7 (SD 13.1), and physical, social/family, emotional, and functional WB scores were 20.3 (SD 4.2), 24.4 (SD 3.9), 18.9 (SD 3.5), 22.1 (SD 5.3); these scores were similar across initial treatment groups (all p&amp;gt;0.05). FACT-G total score was largely stable over time by treatment group (Panel 1). However, it declined at years 6 (mean -4.0, p&amp;lt;0.05) and 9 (mean -3.7, p&amp;lt;0.05) in the observation group (Panel 2), driven by a decline in functional WB, although this change was not significantly different from the other treatment groups. Further, in comparison with other treatment groups, local therapy was associated with a short-term 1-year improvement of FACT-G total score (mean +2.8, p=0.04), driven by improvements in both functional and emotional WB. For the subscales, we identified two major trends irrespective of treatment group: an overall improvement from BL of emotional WB at years 1 (mean +0.6, p&amp;lt;0.05), 2 (mean +0.7, p&amp;lt;0.05), 3 (+1.3, p&amp;lt;0.05), 6 (+1, p&amp;lt;0.05), and 9 (+1.3, p&amp;lt;0.05) and an overall decline of social/family WB at years 1 (mean -1.1, p&amp;lt;0.05), 2 (mean -1.7, p&amp;lt;0.05), 3 (-2.1, p&amp;lt;0.05), 6 (-2.7, p&amp;lt;0.05), and 9 (-2.2, p&amp;lt;0.05). There was no notable change from BL for physical or functional WB. Conclusions: This analysis is the first to provide prospective real-world QOL data on a longitudinal cohort of MZL patients with long follow-up. At BL, initial treatment was associated with stage and MALT-IPI score, but not QOL. Except for the transient 1-year QOL improvement in patients under local/antibiotic therapy, initial treatment groups had no impact on QOL over time. Irrespective of treatment group, emotional WB showed improvement over time, suggesting psychosocial adaptation by the patient, as it was found in aggressive lymphomas (Thompson et al., 2018). Further, emotional WB over time did not vary across treatment groups, suggesting that being initially observed did not lead to more emotional stress than being actively treated. Finally, decline in social/family WB (support from friends, family, family acceptance of illness, family communication, close to partner) suggests a need to consider interventions to patients and families to address these needs.

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.

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 &amp;gt;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 (&amp;gt;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&amp;lt;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.

Health-Related Quality of Life (HRQL) in Cutaneous T-Cell Lymphoma: A Post Hoc Analysis Examining Disease Burden and Patient Characteristics from the Phase 3 Mavoric Trial in Mycosis Fungoides and Sézary Syndrome

The MAVORIC phase 3 study (NCT01728805) evaluated the efficacy of mogamulizumab compared with vorinostat in patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) - the most common subtypes of cutaneous T-cell lymphoma (CTCL). This retrospective analysis of baseline (pre-treatment) data from the large well-defined population in the MAVORIC study describes the burden of CTCL on HRQL and identifies characteristics that are associated with poorer HRQL. The MAVORIC study enrolled patients with stage IB-IVB relapsed or refractory MF/SS that had failed to respond to one or more systemic therapies. HRQL data from the Skindex-29, ItchyQOL, and Functional Assessment of Cancer Therapy - General (FACT-G) were analysed at the item level and scored according to instrument guidelines. Bivariate analysis was used to identify factors associated with relatively poorer HRQL and guided selection of variables for the multivariate analysis. 372 participants were enrolled, 55% with MF and 45% with SS; 77% had advanced (stage IIB-IV) disease. The mean (SD) age was 63 (13.0) years and 42% were female. Disease involved the skin in all participants, blood in 66%, nodes in 66%, viscera in 2%, and other sites in 5%. ECOG performance status was 0, 1, and 2 in 56%, 43%, and 1%, respectively. The domains and total scores for Skindex-29, ItchyQoL and FACT-G are shown in table 1 For individual items, the greatest impairments were seen in skin itch, skin sensitivity, worry of worsening, annoyed by skin condition, sleep, and need to buy special soaps. In bivariate analysis, worse total score across all three HRQL measures was related to being younger, female, having moderate or severe itch, ECOG performance status 1 or 2, and higher Modified Severity-Weighted Assessment Tool (mSWAT) scores. On the Skindex-29 and ItchyQol, worse total scores were also related to Black/African American ethnicity, having disease involving nodes, and higher affected body surface area (BSA). Worse Emotional domain scores across all three HRQL measures was related to being female and having severe itch; worse Functional domain scores were related to disease involving nodes, ECOG performance status 1 or 2, higher mSWAT score, higher affected BSA, and moderate or severe itch. Worse Symptom domain scores (Skindex-29 and ItchyQol) were related to being female, ECOG performance status 1 or 2, higher mSWAT score, higher affected BSA, and severe itch. Differences across HRQL measures will also be reported. In multivariate analysis, worse HRQL was associated with being younger, female, or Black/African American, and with moderate or worse itch and ECOG stage 1 or 2 but was not generally associated with disease stage. In participants with advanced MF/SS, HRQL was most impacted by symptoms with the impact varying by patient characteristics rather than disease stage. Assessing patients' individual disease concerns may inform treatment goals and therapeutic choice.

Title: The Impact of Recent Vaso-Occlusive Crisis on Health-Related Quality of Life in Adults with Sickle Cell Disease

Introduction: Sickle cell disease (SCD) is characterized by vaso-occlusive crises (VOCs) and a progressive clinical course, often leading to end organ damage and mortality. Individuals living with SCD with recurrent VOCs experience daily life disruptions due to recurrent pain crises, debilitating chronic pain and fatigue, which substantially impair health-related quality of life (HRQoL). The impact of a recent VOC on HRQoL has not been quantified. We investigated HRQoL impacts in adults with SCD who experienced a recent VOC (&amp;lt; 1 week) in comparison to overall adults with SCD with recurrent VOCs. Methods: A mixed-methods study was conducted to quantify the HRQoL, work impacts, and perceived health inequalities of individuals with SCD with recurrent VOCs. The study consisted of qualitative interviews and an online longitudinal survey administered at 3 timepoints (month 0, 3, and 6) in the US, UK, France, Germany, and Italy. Patient advocacy groups used multi-channel outreach to invite participants, who were required to meet the eligibility criteria and provide consent. Key eligibility criteria included recurrent VOCs defined as ≥ 2 VOCs/year in each of the 2 years prior to enrollment requiring a medical facility interaction and administration of pain medication or red blood cell transfusion. The survey included multiple patient-reported outcome (PROs) measures: the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) inclusive of the FACT-General (FACT-G), EuroQol- 5 Dimension 5-Level (EQ-5D-5L), 11-point pain numerical rating scale (NRS), Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me), and the Work Productivity and Activity Impairment (WPAI) questionnaire. In this post-hoc analysis study participants with a current or recent VOC (&amp;lt; 1 week ago) were identified based on ASCQ-Me responses (herein referred to as recent VOC). The HRQoL impact of a recent VOC was assessed by descriptively comparing PRO scores between those with a recent VOC and the overall population of adults with SCD with recurrent VOCs (herein referred to as overall population). Results: The survey was completed by 142 participants with SCD (≥ 18 years) with 139 providing time since last VOC living in the US (n=82) and UK, Germany, France, and Italy (n=57). Fifty-six (40.3%) reported a recent VOC and had a similar mean age (35.7 vs. 35.3 years) and hydroxyurea use in the past month (58.9% vs. 61.9%) compared with the overall population. A higher proportion of those with a recent VOC were unemployed or unable to work due to SCD (76.8% vs. 64.7%). The mean EQ-5D VAS (0-100 scale, 100=best health) among those with a recent VOC was 49.2 (SD: 14.2), which was 16.2% and 38.8% lower relative to the overall study population (58.7 [SD: 19.4]) and the US general population (80.4 [SD: 15.6]), respectively. The overall mean EQ-5D health utility US index score (0.59 [SD: 0.27]) was much lower than the US general population (0.85 [SD: 0.21]) and further reduced among those with a recent VOC by 0.11 (0.48 [SD: 0.25]). The FACT-G total mean score was 53.6 (SD: 14.3) (0-108 scale, 108=best HRQoL) among those with a recent VOC representing a clinically meaningful reduction compared with the overall population (62.5 [SD:18.1]); with all FACT-G domain scores negatively impacted by a recent VOC. Based on the WPAI, those employed with a recent VOC (n=15) reported a mean of 35.4% (SD: 35.8%) absenteeism and 62.5% (SD: 21.8%) presenteeism, which were higher than the overall study population (24.7% [SD: 27.1%] and 42.0% [SD: 27.8%)], respectively). In the past 12 months, those with a recent VOC had a greater mean number of emergency room visits (9.6 [SD: 12.6] vs 6.2 [SD: 8.8]), hospitalizations with overnight stays (6.0 [SD: 5.7] vs. 4.0 [SD: 4.5]), and days overnight in the hospital (21.8 days [SD: 32.9] vs. 14.7 [SD: 24.7]) compared to the overall population. Conclusions: Despite current treatments, nearly 40% of adults with SCD in the surveyed population experienced a recent VOC (&amp;lt; 1 week), which has significant negative impacts on HRQoL and functional status, including the ability to work. These results demonstrate the substantial humanistic burden of those living with SCD with recurrent VOCs and the additional impairment of a recent VOC. Novel treatments that reduce or eliminate VOCs may provide an opportunity to improve health inequalities, HRQoL, and address unmet needs in this patient population.

Equipercentile equating of scores from common patient-reported outcome measures of physical function in patients with cancer

ObjectiveTo provide equipercentile equating of physical function (PF) scores from frequently used patient-reported outcome measures (PROMs) in cancer patients to facilitate data pooling and comparisons. Study Design and SettingAdult cancer patients from five European countries completed the European Organization for Research and Treatment of Cancer (EORTC) computer adaptive test (CAT) Core, EORTC Quality of Life Questionnaire Version 3.0 (QLQ-C30), Functional Assessment of Cancer Therapy - General (FACT-G), 36-item Short Form Health Survey (SF-36), and the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function 20a short form. The R package “equate” was used to establish conversion tables of PF scores on those measures with a bivariate rank correlation of at least 0.75. ResultsIn total, 953 patients with cancer (mean age 58.9 years, 54.7% men) participated. Bivariate rank correlations between PF scores from the EORTC CAT Core, EORTC QLQ-C30, SF-36, and PROMIS were all above 0.85, but below 0.69 for the FACT-G. Conversion tables were established for all measures but the FACT-G. These tables indicate which score from one PROM best matches the score from another PROM and provide standard errors of converted scores. ConclusionOur analysis indicates that linking of PF scores from both EORTC measures (CAT and QLQ-C30) with PROMIS and SF-36 is possible, whereas the physical domain of the FACT-G seems to be different. The established conversion tables may be used for comparing results or pooling data from clinical studies using different PROMs.

Associations of the gut microbiome with psychoneurological symptom cluster in women with gynecologic cancers: a longitudinal study.

The present study aimed to evaluate the associations between the gut microbiome and psychoneurological symptoms (PNS) cluster in women with gynecologic cancers over time. In this secondary data analysis, 19 women with cervical and endometrial cancers treated with radiotherapy were followed at pre-treatment, 6-8 weeks, and 6 months post-treatment. To measure symptoms, Functional Assessment of Cancer Therapy-General (FACT-G) and Patient Health Questionnaire-9 (PHQ-9) were used. An average Z score of at least three out of five symptoms was computed as the PNS cluster total score. Rectal swabs were also collected at the same time points and sequenced using 16S rRNA V4 regions. The Kruskal-Wallis and permutational multivariable analysis of variance tests were used to compare α- and β-diversity between patients with high and low PNS cluster. The linear discriminant analysis effect size (LEfSe) tested taxa differences between study groups. Also, the linear mixed-effect model was used to evaluate the association of the gut microbiome and the PNS cluster over cancer treatment. The patients' mean age was 58 years, 47% Black, 52% single/divorced, and 66% had college or above education. Among the participants, 63% had endometrial cancer with stage I disease. There was a different taxonomy profile between patients with high and low PNS. Patients with high PNS had a lower α-diversity than those with low PNS (Shannon, p = 0.03, evenness, p = 0.03). The mixed effects model results showed that low α-diversity and abundance of Fusicatenibacter and Ruminococcus were associated with high PNS cluster over cancer treatment. The association between the gut microbiome and PNS cluster suggest that the gut microbiota plays a role in developing the PNS cluster. Future larger studies are required to shed light on the gut microbiota role in symptom development in gynecologic cancer patients.

Algorithm for the provision of comprehensive psychotherapeutic support to women experiencing neuropsychiatric symptoms during rehabilitation following the treatment of malignant neoplasms of the reproductive system

Background. Radical treatment of malignant neoplasms (MNs) of female reproductive system often has serious consequences. Chronic pain syndrome, distress, anxiety and depression, decreased self-esteem, sexual dysfunction and social maladjustment reduce quality of life (QoL) and require psychotherapeutic support.Objective: to create an algorithm for the provision of comprehensive psychotherapeutic support during rehabilitation following the treatment of reproductive system MNs and to evaluate its effect on QoL indicators in women with neuropsychiatric disorders.Material and methods. The algorithm for the provision of comprehensive psychotherapeutic support included clinical interview, cognitive behavioral therapy, visualization, audio therapy, art therapy, group and individual psychotherapy, family psychotherapy, image therapy. The QoL indicators were determined by questionnaires using the Functional Assessment of Cancer Therapy – General (FACT-G) with nosology-specific extensions (subscales of physical well-being, social/family well-being, emotional wellbeing and functional well-being), Hospital Anxiety and Depression Scale (HADS), Kupperman–Uvarova Modified Menopausal Index (MMI). The follow-up period was 1 year after radical surgical treatment of reproductive system MNs in different localizations. The main group received the algorithm for the provision of comprehensive psychotherapeutic support as part of active medical rehabilitation, the comparison group received basic rehabilitation.Results. The study included 47 women with vulvar cancer (VC): active rehabilitation group (VC-1) – 24 patients and basic rehabilitation group (VC-2) – 23 patients; 61 women with endometrial cancer (EC): active rehabilitation group (EC-1) – 29 patients and basic rehabilitation group (EC-2) – 32 patients; 103 women with cervical cancer (CC): active rehabilitation group (CC-1) – 51 patients and basic rehabilitation group (CC-2) – 52 patients; 62 women with stages I–II ovarian cancer (OC) and low malignant potential tumor (LMPT): active rehabilitation group (LMPT-1) – 29 patients and basic rehabilitation group (LMPT-2) – 33 patients. Differences in physical, social/family and functional well-being (FACT-G) were significant from the 6th month and in emotional well-being – by the end of follow-up. Neurovegetative and psycho-emotional disorders, as assessed by Kupperman–Uvarova MMI, showed significant positive dynamics in women who received the algorithm for the provision of comprehensive psychotherapeutic support, in contrast to the comparison group, where these indicators remained without significant dynamics or worsened by the end of the follow-up period. The HADS scores during psychotherapeutic support decreased to normal values at the 6–12th months of follow-up, while those who received the basic rehabilitation continued to have subclinical anxiety and depression.Conclusion. The developed algorithm for psychotherapeutic support as part of active medical rehabilitation of women who underwent radical treatment for reproductive system MNs (VC, EC, CC, OC, and LMPT) has demonstrated its effectiveness, justifuing its implementation in clinical practice.

Psychometric Properties of the Chinese Version of the Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal) in Patients With Advanced Cancer

ContextThe Functional Assessment of Chronic Illness Therapy-Palliative Care (FACIT-Pal) has been widely used in assessing the quality of life (QOL) of patients with life-limiting illness. However, the Chinese version of the FACIT-Pal has not been psychometrically validated yet. ObjectivesThe purpose of this study was to psychometrically validate the FACIT-Pal in Chinese patients with advanced cancer. Methods160 patients with advanced cancer in mainland China participated in this cross-sectional study. The scalability of the instrument was determined by the item-total correlations and the reliability was tested by examining the Cronbach's alpha coefficients. The construct and concurrent validity of the FACIT-Pal were also examined. ResultsThe item-total correlation coefficients ranged from 0.25 to 0.72 (P < .01). Cronbach's alpha coefficient of the Chinese version of the FACIT-Pal was 0.94, ranging from 0.78 to 0.89 for subscales. Confirmatory factor analysis (CFA) results provided support for the measurement structure of the 26-item Functional Assessment of Cancer Therapy-General (FACT-G). Exploratory factor analysis (EFA) of the 19-item palliative care subscale identified five factors accounting for 62.21% of the total variance. Total/subscale scores of the FACIT-Pal were positively correlated with that of the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 Item Scale (FACIT-Sp-12) (r = 0.338–0.811, P < .01), as well as with the Karnofsky Performance Scale (KPS) scores (r = 0.163–0.273, P < .05), except for the correlation between social/family well-being subscale score and KPS score. ConclusionThe Chinese version of the FACIT-Pal demonstrates desirable psychometric properties for evaluating QOL in Chinese patients with advanced cancer.

Effects of an Integrative Day Care Clinic Program with a Focus on Nature Therapy in a Hospital Park Setting on Quality of Life in Oncological Patients-A Non-Randomized Controlled Study.

Cancer often causes long-term physical and psychological impairments. Lifestyle modification and nature-based interventions (NBIs) can have a positive impact on patients' quality of life (QOL). This participants-blinded, non-randomized controlled study assessed parameters at weeks 0, 12, and 24, including, as a primary endpoint, QOL in cancer patients on the Functional Assessment of Cancer Therapy-General (FACT-G) at week 12. QOL in breast cancer patients, fatigue, well-being, stress, anxiety/depression, socio-psychological well-being, benefits of nature interaction, insomnia, self-efficacy, mindfulness, and self-compassion were assessed as secondary endpoints. N = 107 cancer patients (96.3% women; 52.5 ± 9.3 years, 80.4% breast cancer) were assigned to either a 12-week nature-based (NDC; n = 56) or conventional (DC; n = 51) oncology day care clinic program, whereby the assignment group was not known to the participants. There was no significant group difference for the primary endpoint. At week 24, QOL, fatigue, mindfulness and self-compassion scores were significantly higher, and at weeks 12 and 24, the insomnia score was significantly lower in NDC compared to DC. In conclusion, this study indicates positive and clinically relevant effects of the program on QOL, fatigue, and psychological parameters. NBIs seem to have a more pronounced effect.