Functional Assessment Of Cancer Therapy Research Articles

JS06.5.A TUCATINIB, TRASTUZUMAB, AND CAPECITABINE WITH STEREOTACTIC RADIOSURGERY IN PATIENTS WITH BRAIN METASTASES FROM HER-2 POSITIVE BREAST CANCER (TUTOR): A MULTICENTER PHASE 1 CLINICAL TRIAL

Abstract BACKGROUND 20-40% of HER-2-positive breast cancer patients develop brain metastases (BMs), for which stereotactic radiosurgery (SRS) is used for local disease control. Tucatinib, an oral HER-2-selective tyrosine kinase inhibitor (TKI), has been demonstrated to be safe and efficacious in HER-2-positive breast cancer in combination with capecitabine and trastuzumab. The synergism between these three drugs and radiation may potentially enhance DNA damage, causing increased apoptosis. We hypothesize that this 3-drug therapy, in combination with SRS in patients with HER-2 positive breast cancer BM (BCBM), may be safe and provide superior long-term control of intracranial and systemic disease. METHODS This is a prospective, single-arm, multicenter, ongoing, phase 1 clinical trial that aims to determine the safety of the combination therapy in patients with HER-2 positive BCBM. Patients aged 18-80 years, ECOG score 0-2, normal organ function, and up to 10 newly-diagnosed BMs are being enrolled at six centers in the US. Any number of prior systemic therapies are allowed, except tucatinib and capecitabine. Key exclusion criteria include leptomeningeal metastases documented by MRI or CSF evaluation, evidence of intra-tumoral or peri-tumoral hemorrhage, and BMs within 5 mm of the optic chiasm/nerve. The primary study endpoint is maximum tolerated dose (MTD) of tucatinib with SRS. This de-escalation study starts tucatinib at a dose level of 300 mg twice daily (BID). Dose level -1 is 250 mg BID, and dose level -2 is 200 mg BID. Up to 40 patients will be enrolled in this study based on a 3 + 3 design. We plan to expand the cohort at MTD to total of 40 patients to assess the safety and efficacy of drug combination. Secondary endpoints include efficacy as determined by response rate, intracranial progression-free survival (PFS), extracranial PFS, and overall survival. Neurocognitive outcomes are being assessed by Hopkins Verbal Learning Test, Controlled Oral Word Association, Trail Making Test Part A and B, and Grooved Pegboard Test. Acute and late toxicity is assessed using CTCAE v5.0. Quality of life is assessed by Functional Assessment of Cancer Therapy, including Brain Tumor module (FACT-Br). Patients are administered oral tucatinib with SRS as per the treating radiation oncologist, followed by oral tucatinib for two weeks which is the dose-limiting toxicity (DLT) period. This is followed by tucatinib, trastuzumab, and capecitabine until progression or intolerable toxicity. DLTs are defined by Grade 3 or 4 thrombocytopenia, grade 4 anemia, grade 4 neutropenia lasting more than seven days, febrile neutropenia, and any non-hematologic toxicity of grade 3 or greater (excluding alopecia). RESULTS Patient enrollment started in February 2023. CONCLUSION Findings from this trial will demonstrate the safety and efficacy of this combination treatment in BCBM (Clinical Trial Information: NCT05553522).

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.

Hippocampal avoidance whole brain radiotherapy in brain metastasis using volumetric modulated arc therapy: experience from a Regional Cancer Centre of Eastern India.

Whole-brain radiotherapy is associated with neurocognitive decline and decreased quality-of-life (QOL) among survivors of brain metastasis. Hippocampal-avoidance whole-brain radiotherapy (HA-WBRT) has shown advantage in delaying or preventing the neurocognitive decline while maintaining disease control. This study was done to assess the benefits and feasibility of HA-WBRT in patients with cerebral metastasis in terms of preservation of neurocognitive function and quality of life. 27 patients with brain metastasis treated by HA-WBRT and having the records of detailed neurocognitive-assessments were analysed from the database of our hospital. The patients were treated with HA-WBRT to a total dose of 30 Gy in 10 fractions with LINAC based IMRT using the VMAT technique. Cognitive function assessment was carried out using "Examination of the Cognitive Functions" scale provided by Bangur-Institute-of-Neurosciences, Kolkata, 2 weeks prior to radiotherapy and post-treatment two-monthly up to 6 months followed by every 3 months till the last follow up. QOL was assessed at the same interval using the Functional Assessment of Cancer Therapy with Brain Subscale (FACT-BR). Follow-up was done till the date of death. Mean relative cognitive decline percentage decreased over subsequent follow-up visits and was 13% (SD ± 6%), 5% (SD ± 5%), 5% (SD ± 9%) and 2% (SD ± 12%) at 2 months, 6 months, 9 months and 12 months, respectively (p ≤ 0.05). Statistically significant improvement was seen in the mean social-wellbeing (SWB) parameter of QOL (8%. ± 13%, 12%. ± 16%, 7%. ± 20%, no change at 2 months, 4 months, 6 months and 9 months, respectively) (p ≤ 0.05). Mean relative decline in the Emotional-Well Being (EWB) parameter was significant only at 12 months and was 20% (SD ± 35%) (p = 0.04). Mean FACT-BR total Score showed a slight decrease till 9 months from baseline, and then showed a slight improvement up to 12 months. HA-WBRT is feasible with LINAC-based IMRT using the VMAT technique and beneficial to the patients in preserving neurocognitive function and quality of life without compromising disease control.

Psychometric properties of the Chinese version of the functional assessment of chronic illness therapy–fatigue (FACIT–F) among patients with breast cancer

BackgroundFatigue is the most frequent and distressing symptom affecting the physical, cognitive, and affective domains of breast cancer patients. The Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT–F) has been widely used in patients with chronic diseases and has shown satisfactory reliability and validity. This study aimed to examine the psychometric properties of the FACIT–F among Chinese patients with breast cancer.MethodsUsing a convenience sampling method, a cross–sectional survey (January 2020 and September 2022) was used with patients recruited from two tertiary hospitals in Shanghai, Mainland China, and a total of 597 patients completed a demographic information questionnaire, the FACIT–F and the Functional Assessment of Cancer Therapy for Breast Cancer (FACT–B). Convergent validity was estimated by calculating the Pearson correlation coefficient of the FACIT–F with the FACT–B. Measurement invariance across age was performed by examining differential item functioning (DIF) across age groups (≤ 60 and > 60 years). The internal consistency and split–half reliability were performed for reliability analysis. Unidimensionality of the scale was evaluated by the principal component analysis by Rasch analysis. Additionally, Rasch analysis was performed for item difficulty levels, and an item–person map was used.ResultsNo floor/ceiling effects were observed for the FACIT–F. Moderate correlations were found between FACIT–F and FACT–B (r = − 0.342, p < 0.01). Most items showed an absence of DIF regarding age, except for one item. In addition, the FACIT–F showed acceptable internal consistency. Principal component analysis of Rasch residuals showed that the proportion of variance explained by the FACIT–F was 53.3%, and the outfit mean square statistics for the items ranged from 0.68 to 1.90 and the infit MNSQ from 0.63 to 1.73. Additionally, an acceptable response between items and persons was found.ConclusionsThe findings indicate that the Chinese version of the FACIT–F is a valid tool for the measurement of fatigue in breast cancer patients.

Quality of life and symptom burden after rectal cancer surgery: a randomised controlled trial comparing patient-led versus standard follow-up

PurposeAfter curatively intended rectal cancer (RC) surgery, new follow-up strategies are warranted, seeking more individualised care and targeting health-related quality of life (HRQoL) and functional outcomes. The FURCA trial aimed to investigate the effect of patient-led follow-up on HRQoL and symptom burden 3 years after surgery.MethodsRC patients from four Danish centres were randomised 1:1 to intervention (patient-led follow-up with patient education and self-referral to a specialist nurse) or control (standard follow-up with five routine doctor visits). Patients in both groups had a computed tomography (CT) at 1 and 3 years. The primary outcome (HRQoL) was assessed by the Functional Assessment of Cancer Therapy – colorectal (FACT-C) score (Ward et al. in Qual Life Res. 8(3):181-95, 18). Secondary outcomes were functional measures, patient involvement and satisfaction and cancer recurrence at 3 years.ResultsFrom Feb 2016 to Aug 2018, 336 patients were included of whom 248 completed 3 years of follow-up. Between-group differences were found neither for the primary endpoint, nor for functional outcomes. The recurrence rate did not differ between the groups. Patient involvement and satisfaction were higher in the intervention group with statistical significance in almost half of the items.ConclusionsWe found no effect on HRQoL and symptom burden from patient-led follow-up, although it may improve patient-perceived involvement and satisfaction.Implications for Cancer SurvivorsThe findings in this study suggest that patient-led follow-up is a more tailored approach to meet cancer survivors’ needs and might improve their ability to cope with survivorship.ClinicalTrials.gov identifierR97-A6511-14-S23.

Validating the PROMIS cognitive function short form in cancer survivors.

The Patient-Reported Outcome Measurement Information System Cognitive Function Short Form 8a (PROMIS Cog) could provide a shorter, useful alternative to the often used Functional Assessment of Cancer Therapy - Cognition (FACT-Cog) in researchand clinical care. This study aimed to determine the convergent validity and internal reliability of the PROMIS Cog in 3 separate samples of breast cancer survivors and to explore clinical cut points. Data from three samples of breast cancer survivors were used for this secondary analysis. Convergent validity was determined by evaluating correlation strength among the derived PROMIS Cog and measures of depression, anxiety, stress, fatigue, sleep, loneliness, the FACT-Cog . Clinical cut-points for the PROMIS Cog were determined by plotting the receiver operating characteristic curves. 3 samples of breast cancer survivors (N = 471, N = 132, N = 90) were included. Absolute values of correlations demonstrating convergent validity ranged from 0.21 to 0.82, p's < 0.001, and were comparable to correlations with the full FACT-Cog 18 item perceived cognitive impairments(PCI) scale. ROC curve plots indicated a clinical cut off < 34 for the combined sample. The 8-item PROMIS Cog demonstrated good convergent validity and internal reliability in breast cancer survivors, comparable to the 18-item FACT-Cog PCI. The PROMIS Cog 8a is a brief self-report measure that can be easily incorporated into cancer-related cognitive impairment research designs or used in clinical settings.

Effect of Multimodal Intervention on Cancer-Related Fatigue and Quality of Life among Patients Undergoing Cancer Treatment—Pilot Study (Part 1)

Abstract Background Cancer-related fatigue (CRF) is the most common and devastating problem in cancer patients even after successful treatment. CRF has a severe impact on daily activities, social relationships, reintegration, and overall quality of life (QOL). Objective This study was done to evaluate the effect of multimodal intervention (MMI) on CRF and QOL among cancer patients undergoing cancer treatment. Materials and Methods One group before-and-after study (pre-experimental design) was conducted among cancer patients undergoing cancer treatment who met inclusion criteria and were selected using a purposive sampling technique, in selected hospitals. MMI consisted of exercise program, acupressure, and home care management guide. Pre-test CRF and QOL were assessed on first day using a FACIT-F scale (Functional Assessment of Chronic Illness Therapy: Fatigue) and Functional Assessment of Cancer Therapy: Fatigue (FACT-G) Version 4, respectively. Post- test for CRF was further determined after 7 days, 21 days, and 3months and QOL was determined after 21 days and 3 months. Statistical Analysis Demographic and clinical characteristics of the participants are presented as frequency and percentage. Comparison of pre- test and post-test means of CRF and QOL is done by repeated measures analysis of variance (ANOVA). Correlation between fatigue and QOL of cancer patients was found by using Pearson correlation test. Results The mean pre-test fatigue score of the cancer patients (pre-test mean= 25.21) was lower than their mean post-test fatigue scores (post-test 1 =25.83, post-test 2 = 28.28, and post-test 3 = 34.72). There was a significant difference in CRF and QOL scores between before and after the MMI. In the repeated measures ANOVA, p-value is less than 0.05 (level of significance p &lt; 0.05). Conclusion Regardless of mechanism of occurrence of fatigue, most patients living with cancer suffer with persistent CRF. Yet it is often not assessed, has limited treatment options, there is a need to assess the state of fatigue in cancer patients. They do need intervention to reduce the fatigue and to improve the QOL. Nonpharmacological therapies are the best strategies to manage the fatigue among cancer patients without any safety issue.

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

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

Financial toxicity and quality of life in patients undergoing bone marrow transplant evaluation: A single center analysis.

7052 Background: The impact of pre-transplant financial toxicity on quality of life (QOL) outcomes following bone marrow transplant (BMT) is unknown. We investigated the prevalence of financial toxicity in a population undergoing evaluation for BMT and its impact on post-transplant clinical and health-related QOL outcomes. Methods: This is a cross-sectional study in patients undergoing evaluation for allogeneic BMT between 1/1/2018 and 9/23/2020 at a large academic medical center. Financial health at baseline was measured via the comprehensive score for financial toxicity (COST) survey. The cohort was divided into three groups: none, mild, and moderate-high financial toxicity. QOL was measured using Functional Assessment of Cancer Therapy (FACT)-based questionnaires at multiple timepoints. Multivariate logistic regression analysis evaluated factors associated with financial toxicity. Kaplan-Meier curves and log-rank tests evaluated overall survival and non-relapse survival. Results: Of 245 patients evaluated for BMT, 176 (71.8%) completed both questionnaires with 63.1% male, 72.2% white, and median age 57 years. Common diagnoses were myelodysplastic syndrome (39.2%), leukemia (38.1%), and lymphoma (13.6%). Overall, 83 (47.2%) patients reported no financial toxicity, 51 (29.0%) mild, and 42 (23.9%) with moderate-high financial toxicity at initial evaluation for BMT. Compared to those with no financial toxicity, those with mild or moderate-high financial toxicity reported significantly reduced spending on leisure, food/clothing, used all or a portion of savings, borrowed money or accumulated debt using a credit card, and did not fill a prescription due to costs (p &lt; 0.0001 for all). In patients with baseline moderate-high financial toxicity, FACT-BMT scores were lower at 6 months (126 none vs 122 mild vs 92 moderate-high; p = 0.0007) and 1 year (133 none vs 117 mild vs 112 moderate-high; p = 0.0075) following BMT. Older age (&gt;62) (OR 0.4; 95% CI [0.17 – 0.94], p = 0.03) and income equal or greater than $60,000 (OR 0.16; 95% CI [0.07 – 0.36], p = &lt; 0.001) were associated with lower odds of financial toxicity. No association was noted between financial toxicity and selection for BMT, overall survival, or non-relapse mortality. Conclusions: Financial toxicity was highly correlated with patient-reported changes in behavior affecting their daily activities and transplant care, with notable impact on QOL following transplant for up to 1 year. Early interventions by physician and social work-led teams may benefit patients who are at risk for financial toxicity. [Table: see text]

Uncertainty and coping in patients with newly diagnosed indolent non-Hodgkin’s lymphoma (iNHL).

7568 Background: iNHLs are a heterogenous group of incurable diseases with prolonged illness courses requiring intermittent periods of surveillance and treatment. Due to illness uncertainty, patients with iNHL struggle with immense psychological distress. Yet, studies exploring coping, prognostic uncertainty and distress in this population are limited. Methods: We conducted a cross sectional study of adults (age ≥ 18) newly diagnosed with iNHL at a single academic center. We enrolled consecutive patients who were diagnosed ≤ 3 months prior to study enrollment. At baseline, we collected patient reported outcomes to assess QOL (Functional Assessment of Cancer Therapy), psychological symptoms (Hospital Anxiety and Depression Scale), prognostic understanding (Prognostic Awareness Impact Scale), and coping (Brief COPE). We categorized coping as approach-oriented (active coping, use of emotional support, positive reframing, acceptance) and avoidant (behavioral disengagement, denial, and self-blame). We used median split to differentiate between low and high utilizers of approach or avoidant coping. Results: We enrolled 70.6% (48/68) of eligible patients newly diagnosed with iNHL (mean age 66.8 yrs; 39.6% chronic lymphocytic leukemia/ lymphoma; 33.3% follicular lymphoma). At baseline, nearly one-third (31.2%) experience clinically significant symptoms of anxiety and depression. 45.8% of patients identified prognostic uncertainty as the “the most stressful part of being a patient,” and 31.2% reported having “difficulty letting go of thoughts about their prognosis.” Notably, patients had significant misperceptions about their prognosis with incurable iNHL, as 47.9% reporting that a cure was at least ‘somewhat’ likely. Patients with iNHL most often used acceptance (56.3%), denial (47.9%), and emotional support (47.9%) as coping strategies. Patients who were high utilizers of multiple approach-oriented coping strategies experienced fewer anxiety (B = -2.66, p = 0.01) and depression (B = -1.73, p = 0.02) symptoms and improved QOL (B = 9.43, p = 0.001). Patients who highly utilized any avoidant-oriented coping strategies experienced increased anxiety symptoms (B = 2.16, p = 0.05), but no difference in depression symptoms or QOL. Conclusions: Patients with iNHL report immense prognostic uncertainty and psychological distress. Use of multiple approach oriented coping strategies was associated with decreased psychological distress and improved QOL. Interventions to address prognostic uncertainty and to promote approach oriented coping in patients with iNHL are sorely needed and have the potential to ameliorate psychological distress and improve QOL in this vulnerable population.

Effect of Exercise Training on Functional Capacity Head and Neck Cancer Patients Receiving Various Anticancer Therapies: An Interventional Study.

Anticancer therapies causes decreased respiratory function, quality of life and functional capacity in head and neck cancer patients. Patients receiving these cancer therapies suffer from fatigue which causes decrease in functional capacity and quality of life. The objective of this present study was to determine and compare the effect of exercise training on fatigue, functional capacity and quality of life in head and neck cancer patients receiving various anticancer therapies. A total of 45 subjects were included based on inclusion and exclusion criteria. 6-minute walk test, brief fatigue inventory (BFI) and functional assessment of cancer therapy- general (FACT-G) was used to measure the functional capacity, fatigue and quality of life respectively at baseline and post intervention. Participants received exercise intervention for six weeks (three days a week) for 40 min. Exercise intervention is delivered by a qualified physiotherapist from the Department of Physiotherapy. The result of this study shows that there was highly significant improvement in six-minute walk distance pre and post intervention in chemotherapy (33.75+21.55, p=0.000), radiation therapy (39.69+25.46, p=0.000) and chemoradiotherapy (32.06+16.49, p=0.000) within the group. Similarly, significant improvement was also seen in quality of life within the groups, chemotherapy (2.92+2.43, p=0.002), radiation therapy (6.06+3.13, p=0.000) and chemo radiotherapy (5.65+6.93, p=0.004). There was significant reduction in fatigue in chemotherapy (6.92+11.07, p=0.045), radiation therapy (12.38+7.28, p=0.000) and chemo radiotherapy (11.47+8.89, p=0.000). No significant improvement was noted between the groups for six- minute walk distance (p=0.784), quality of life (p= 0.058) and reduction in fatigue (p=0.065). This study concluded that exercise training is effective in improving functional capacity, quality of life and reducing fatigue in head and neck cancer patients receiving various anticancer therapies.

Interpersonal concerns of young adult surgical oncology patients with advanced cancer diagnoses: A mixed methods study.

e24225 Background: Incidence of cancer in young adults (YA) is increasing. YA patients with advanced cancer are more likely than elderly counterparts to undergo elective or palliative surgeries. A diagnosis of advanced malignancy poses unique social and emotional burdens on YA. This study aims to understand the experiences of YA cancer patients in managing interpersonal relationships and social expectations. Methods: This mixed-methods study consisted of cross-sectional patient quality of life (QOL) surveys (Functional Assessment of Cancer Therapy: General [FACT-G]), caregiver QOL surveys (Caregiver QOL – Cancer [CQOLC]), and semi-structured qualitative interviews with patients. Participants were YA ages 18-45 years with advanced-stage cancers, recruited from surgical oncology clinic at a tertiary academic institution. Interviews were transcribed and analyzed by two independent reviewers to describe themes (italicized) on social and interpersonal impacts of patients’ cancer diagnosis. Results: Interviews and patient surveys were conducted with 18 YA patients. Median time since cancer diagnosis was 15 months, 44% of patients had metastatic disease at diagnosis, and 89% of patients had previously undergone both chemotherapy and surgery for cancer treatment. 56% of patients identified their spouse or significant other as the person they were closest to, and 28% were closest to a parent or sibling. 56% of patients had children of their own who lived in the household. Median FACT-G scores were 23/28 for social/family well-being (IQR: 18-25) and 13/28 for emotional well-being (IQR: 8-17). Caregiver surveys were completed for 12 of 18 patients, revealing that most developed a closer relationship with their loved one (67%) and felt informed about their disease (92%). Qualitative interview analysis revealed themes of: information-sharing about cancer, where patients shared concerns of withholding prognostic information to give loved ones hope; impacted relationships with friends and colleagues, as patients struggled with who to disclose their cancer diagnosis to; social/physical perceptions by others, as patients worried about changes in their physical appearance (e.g. weight loss) as a result of cancer; financial concerns as a result of treatment and its future impact on the patient’s loved ones. Conclusions: This mixed methods study highlights the interpersonal concerns of YA with advanced cancers. At a phase where identity formation, social perceptions, and personal relationships may be threatened by cancer, unique psychosocial and emotional challenges arise. Programmatic changes are needed to provide appropriate support, resources, and empathetic care to this distinct population of cancer patients.

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

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

Does EQ-5D Tell the Whole Story? Statistical Methods for Comparing the Thematic Coverage of Clinical and Generic Outcome Measures, With Application to Breast Cancer

ObjectivesThis study aimed to develop the following: (1) methods for assessing claims in any specific application that a generic outcome measure, such as EQ-5D is deficient in its coverage of 1 or more specified domains, and (2) a simple method of judging whether any such deficiency is likely to be quantitatively important enough to call into question evaluations based on the generic instrument. Also to demonstrate the applicability of the methods in the important area of breast cancer. MethodsThe methodology requires a data set with observations from a generic instrument (eg, EQ-5D) and also a more comprehensive clinical instrument (eg, FACT-B [Functional Assessment of Cancer Therapy – Breast]). A standardized 3-component statistical analysis is proposed for investigating the claim that the generic measure inadequately captures some specified dimension covered by the latter instrument. A theoretically based upper bound on the bias induced by deficient coverage is derived based on the assumption that the designers of the (k-dimensional) generic instrument did succeed in identifying the k most important domains. ResultsData from the MARIANNE breast cancer trial were analyzed and results suggested that impacts on personal appearance and relationships may be inadequately represented by EQ-5D. Nevertheless, the indications are that the bias in quality-adjusted life-year differences from deficient coverage by EQ-5D is likely to be modest. ConclusionsThe methodology offers a systematic approach to determining whether there is clear evidence consistent with any claim that a generic outcome measure such as EQ-5D misses an important specific domain. The approach is readily implementable using data sets that are available in many randomized controlled trials.

Influence of ovarian function supression on quality of life in breast cancer survivors during adjuvant endocrine therapy.

560 Background: Adding ovarian function suppression to adjuvant endocrine therapy (AET) lowers the disease recurrence rates among premenopausal women with hormone receptor-positive (HR+) early breast cancer (EBC). However, a detrimental effect on endocrine symptoms burden (ESB) is expected. Therefore, this study aimed to investigate differences in Quality of life (QoL) and endocrine symptoms in premenopausal women prescribed AET, with/without gonadotropin-releasing hormone agonist (GnRH). Methods: This cross-sectional study included women, with HR+ EBC, premenopausal at diagnosis, treated with AET for more than 3 months, with and without GnRH. The research was conducted with institutional Ethics Committee approval at the University Hospital Centre Zagreb, General Hospital Šibenik, and with online survey. A validated instrument, the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES), was used. The collected data were analysed using SPSS v. 29 (p≤0.05). Results: Overall, 314 eligible BC survivors with a median age of 45 years (22-65) and a median duration of AET of 2 years (3 months -12 years) responded to FACT-ES and were included in the analysis. Altogether 45.2% (n=142) of participants were prescribed tamoxifen (TAM), 25.8% (n=81) GnRH+TAM, and 29% (n=91) GnRH+aromatase inhibitor (AI); exemestane (9%), letrozole (13.6%) and anastrozole (6.4%). The total QoL (FACT-ES) score was higher in patients treated with TAM as opposed to patients treated with AI+GnRH (p=0.01). Adding GnRH to TAM did not significantly change QoL when compared to TAM alone or AI+GnRH. In addition, patients on AI+GnRH had lower physical well-being (PWB) score than patients on TAM+GnRH (p=0.03) or TAM alone (p=0.05) and lower endocrine subscale score (ESS-19) than patients on TAM (p=0.01), indicating more endocrine symptoms in premenopausal women treated with AI+GnRH. Among patients treated with AI+GnRH letrozole had lower PWB (p=0.03) and ESS-19 score (p=0.01) than exemestane. Conclusions: This study showed that GnRH+AI in premenopausal women with HR+ EBC results in greater ESB and lower QoL compared to patients treated with TAM or GnRH+TAM. Therefore, interventions helping decrease the ESB in patients treated with AI+GnRH should be explored and developed to help patients adhere to and persist in AET. [Table: see text]

Validation of the Tagalog and Ilokano translations of the Functional Assessment of Cancer Therapy-General (FACT-G) scale for adult cancer center patients in a state-funded tertiary hospital.

e18524 Background: Patient reported outcomes such as the health related quality of life (HRQOL) is a significant variable that should be used in clinical decision making and health policy. The Functional Assessment of Cancer Therapy - General (FACT-G), is one of the most widely used HRQOL questionnaires and to make it more accessible globally translation to local dialects are imperative for inclusive service delivery. Prior to use, the validity and reliability of these tools should be established for the population it is intended to cater. Consistent with the mission statement of the hospital the researcher wanted this service to be more accessible and equitable by addressing language differences for our non english speaking end-users. Hence, the study aimed to document validity and reliability of translated Tagalog and Ilokano versions of the FACT-G questionnaire for use in patients catered upon by the Baguio General Hospital and Medical Center (BGHMC). Methods: Psychometric evaluation of the above tools was done involving 384 adult cancer patients of BGHMC. Data management and analysis using SPSS software was used to evaluate reliability, face validity, content validity, and construct validity. An addition of cognitive interviews was done with end-users and subsequent thematic analysis aimed to improve questionnaire quality. Results: Both the Tagalog and Ilokano questionnaires had indices above the set value for reliability measured as Chronbach’s alpha of 0.968 and 0.974, content validity indices of 0.95 and 0.95, and face validity indices of 0.98 and 0.98, respectively. Construct validity was established through an exploratory factor analysis comprised of a principal components analysis and Varimax factor rotation with Kaiser normalization. Conclusions: The Tagalog and Ilokano questionnaires are reliable and valid tools for use of approximation of HRQOL of cancer patients catered by the BGHMC. With the results of the validation study it is recommended to incorporate the use of these translated questionnaires to the day to day health service provision to approximate the health-related quality of life of cancer patients. These can also be used as measures to evaluate interventions and policies that are directed towards cancer patients catered in Northern Luzon. To better these questionnaires the revised questionnaires includes the omission of the 7th item in the scale of general social and family well-being to minimize disruptions in rapport due to nature of the question. Another is the reversion of the 2nd item in the scale of general emotional well-being so that it would have the same direction on the approximation of HRQOL with the other items in the scale.

0827 Effect of virtual cognitive behavioral therapy for insomnia on perceived cognitive functioning among cancer survivors

Abstract Introduction Comorbid insomnia and perceived cognitive impairments (PCI) affect up to 26% of individuals diagnosed with cancer. Given the association between sleep and cognition, and the lack of interventions to improve PCI, the present study examined the impact of cognitive behavioral therapy for insomnia (CBT-I) on PCI among cancer survivors with insomnia disorder and cognitive complaints (clinicaltrials.gov:NCT04026048). Methods Cancer survivors (N=122) with insomnia and PCI were randomized to 7 weekly virtual CBT-I treatment sessions (n=56) or waitlist control (WLC: n=66). Participants completed the Insomnia Severity Index and the Functional Assessment of Cancer Therapy – Cognitive Function upon entering the study (baseline; T0), and then again at 4 (T1), and 8 (T2) weeks. A series of 2 (treatment group: CBT-I and WLC) by 3 (time: T0, T1, T2) mixed ANOVAs were performed to assess changes in insomnia symptoms, PCI, perceived cognitive abilities (PCA), and impact of cognitive function on quality of life (QOL). Results Participants were, on average, aged 60 years, had 16 years of education, and 79% were female. Breast cancer was the most reported cancer type (46%). No significant differences were observed between groups at T0 for demographic or clinical variables (p&amp;gt;.05). There was a significant group by time interaction for insomnia [p=&amp;lt;.001, partial eta squared (pes)=.36]. Individuals randomized to CBT-I reported significant decreases in insomnia symptoms post treatment compared to WLC (CBT-I: -11.5; WLC: -2.7). Significant interactions were also observed for PCI (p=&amp;lt;.001, pes=.11), PCA (p=&amp;lt;.001, pes=.16), and impact on QOL (p=&amp;lt;.001, pes=.15). Participants randomized to CBT-I reported significantly less PCI (CBT-I: 14.7; WLC: 4.1), better PCA (CBT-I: 5.8; WLC: 1.1), and less impact on QOL (CBT-I: 4.9; WLC: 1.1) than participants in the WLC. Conclusion In addition to improving insomnia, CBT-I significantly improve perceived cognitive functioning and quality of life among cancer survivors. Further research is needed to understand the mechanisms underlying improvements in cognition following CBT-I. Support (if any) Dr. Sheila Garland is supported by a Canadian Cancer Society Emerging Scholar Award (Survivorship) (grant #707146). This project was funded through a grant from the Canadian Institutes of Health Research (CIHR) (grant number: PJT 162428) and the Beatrice Hunter Cancer Research Institute.

Preservation of Erectile and Ejaculatory Functions After Tetramodal Bladder-Sparing Therapy Incorporating Consolidative Partial Cystectomy Against Muscle Invasive Bladder Cancer.

To cross-sectionally assess erectile and ejaculatory functions after tetramodal bladder-sparing therapy consisting of transurethral resection, chemoradiotherapy, and consolidative partial cystectomy in patients with muscle invasive bladder cancer. Among 72 enrolled male patients who underwent tetramodal bladder-sparing therapy from 2006 to 2019, 42 who visited the outpatient clinic from February to October 2020 received questionnaires. Erectile function, ejaculatory function, and quality of life were assessed using the International Index of Erectile Function short form, the Male Sexual Health Questionnaire Ejaculatory Dysfunction short form, and the Functional Assessment of Cancer Therapy. Among the 42 patients, 9 were excluded because of incomplete responses and 33 were eligible for analyses. The median (range) age at survey and the time from treatment completion to responding to the questionnaires was 70 (50-87) years and 4.2 (0.4-14.0) years, respectively. The median International Index of Erectile Function short form-5 score was 11 (5-25), and 3 (9.1%) and 9 (27.3%) patients had no and mild erectile dysfunction, respectively. The Male Sexual Health Questionnaire Ejaculatory Dysfunction short form results showed that 23 (69.7%) patients responded that they could ejaculate. Patients with higher Male Sexual Health Questionnaire Ejaculatory Dysfunction short form scores had better erectile function and quality of life than those with lower Male Sexual Health Questionnaire Ejaculatory Dysfunction short form scores. Preservation of erectile and ejaculatory functions was demonstrated in muscle invasive bladder cancer patients treated with tetramodal bladder-sparing therapy. In addition to lower urinary tract function, preservation of male sexual function, especially ejaculatory function, in bladder-sparing therapy can be an advantage over radical cystectomy.

Supportive care among head and neck cancer patients: An initial validation of the Dutch version of the Performance Status Scale for Head and Neck Cancer (D-PSS-HN).

Acute and late toxicities in patients treated with (chemo)radiotherapy for head and neck cancer (HNC) is common and can negatively impact quality of life and performance. Performance status instruments measure the functional ability to perform daily life activities and are important tools in the oncologic population. Since Dutch performance status scales for the HNC population are lacking, we conducted this study to translate the Performance Status Scale for Head and Neck Cancer Patients (PSS-HN) into Dutch (D-PSS-HN) and to validate this version. The D-PSS-HN was translated into Dutch according to the internationally described cross-cultural adaptation process. It was administered to HNC patients and together with the Functional Oral Intake Scale completed by a speech and language pathologist at five different time points during the first 5 weeks of (chemo)radiotherapy. Patients were asked each time to complete the Functional Assessment of Cancer Therapy and the Swallowing Quality of Life Questionnaire. Pearson correlation coefficients were used to calculate convergent and discriminant validity and the evolution of D-PSS-HN scores was assessed by means of linear mixed models. A total of 35 patients were recruited and > 98% of the clinician-rated scales were completed. Convergent and discriminant validity were demonstrated, with all correlations rs between 0.467 and 0.819, and between 0.132 and 0.256, respectively. The subscales of the D-PSS-HN are sensitive to detect changes through time. The D-PSS-HN is a valid and reliable instrument to assess performance status in patients with HNC treated with (chemo)radiotherapy. It is a useful tool to measure HNC patients' current diet level and functional abilities to perform daily life activities. What is already known on the subject Acute and late toxicities in patients treated with (chemo)radiotherapy for HNC are common and can negatively impact quality of life and performance. Performance status instruments measure the functional ability to perform daily life activities and are important tools in the oncologic population. However, Dutch performance status scales for the HNC population are lacking. Therefore, we translated the Performance Status Scale for Head and Neck Cancer Patients (PSS-HN) into Dutch (D-PSS-HN) and validated this version. What this paper adds to existing knowledge We translated the PSS-HN and demonstrated its convergent and discriminant validity. The subscales of the D-PSS-HN are sensitive to detect changes through time. What are the potential or actual clinical implications of this work? The D-PSS-HN is a useful tool to measure HNC patients' functional abilities to perform daily life activities. The tool can easily be used in clinical settings: since data collection duration is very short, this facilitates clinical (and research-related) implementation of the scale. Patients' individual needs could be identified by using the D-PSS-HN, resulting in more appropriate approaches and (early) referrals if needed. Interdisciplinary communication could be facilitated.

Psychometric properties of the Functional Assessment of Cancer Therapy, prostate version (FACT-P), in Mexican patients

Psychometric properties of the Functional Assessment of Cancer Therapy, prostate version (FACT-P), in Mexican patients