Assessment of eligibility criteria in renal cell carcinoma trials evaluating systemic therapy.

OBJECTIVES: To characterise the restrictiveness of eligibility criteria in contemporary renal cell carcinoma (RCC) trials, using recommendations from the American Society of Clinical Oncology (ASCO)-Friends of Cancer Research (FCR) initiative. METHODS: vPhase I-III trials assessing systemic therapies in patients with RCC starting between 30 June 2012 and 30 June 2022 were identified. Eligibility criteria regarding brain metastases, prior or concurrent malignancies, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, and human immunodeficiency virus (HIV) infection were identified and stratified into three groups: exclusion, conditional inclusion, and not reported. Descriptive statistics were used to determine the frequency of eligibility criteria. Fisher's exact test or chi-square test were used to calculate their associations with certain trial characteristics. RESULTS: A total of 423 RCC trials were initially identified of which 112 (26.5%) had sufficient accessible information. Exclusion of patients with HIV infection, HBV/HCV infection, brain metastases, and prior or concurrent malignancies were reported in 74.1%, 53.6%, 33.0%, and 8.0% of trials, respectively. In the context of HIV and HBV/HCV infection, patients were largely excluded from trials evaluating immunotherapy (94.4% and 77.8%, respectively). In addition, brain metastases were excluded in trials assessing targeted therapy (36.4%), combined therapy (33.3%), and immunotherapy (22.2%). Exclusion of patients with prior or concurrent malignancies was less frequently reported, accounting for 9.1%, 8.3%, and 5.6% targeted therapy, combined therapy and immunotherapy trials, respectively. CONCLUSION: A substantial proportion of RCC trials utilise restrictive eligibility criteria, excluding patients with fairly prevalent comorbidities. Implementing the ASCO-FCR recommendations will ensure resulting data are more inclusive and aligned with patient populations in the real-world.

Implementation and evaluation of a remote geriatric assessment and intervention program in Brazil.

BACKGROUND: This study sought to determine the feasibility and acceptability of a remote geriatric assessment (GA) and implementation (GAIN) program in Brazil. The authors also explored the effect of this program on health-related quality of life (HR-QOL) outcomes 3 months after initiating treatment. METHODS: This is a longitudinal study enrolling older adults (65+ years), diagnosed with any type of solid tumor, scheduled to initiate chemotherapy in a networked Brazilian cancer center. The GA was performed through telehealth. We assessed the feasibility of the remote GA, acceptability to patients, and changes in patient-centered outcomes (HR-QOL, mood, function) from baseline to month 3. Linear mixed model analysis was done, adjusting for age, gender, race, income, and disease stage. RESULTS: Fifty-six patients completed all intended assessments. Notably, the threshold of feasibility was 70% and there was 92% complete adherence. Average age was 76 years old (SD = 7.2). Most patients were female (57%), married (59%), and had a college degree (46%). The most common diagnoses were gastrointestinal (39%) and gynecological cancers (18%); most were diagnosed at an advance disease stage (77%). A total of 32 patients were referred to a remote appointment and 86% followed this recommendation(s). Significant improvement in Functional Assessment of Cancer Therapy - General FACT-G (mean difference, 6.04; p < .001), Geriatric Depression Scale (mean difference, -0.86; p = .008), and instrumental activities of daily living ratio (mean difference, 0.17; p < .001) were found. CONCLUSION: Remote GAIN is feasible and acceptable to older adults with cancer receiving treatment in Brazil. The authors also found significant improvement in HR-QOL outcomes over time. Notably, this GAIN program could guide early detection of chemotherapy toxicity and improving patient-reported outcomes in low-resource environments.

Patients' Perceptions Regarding the Relevance of Items Contained in the Functional Assessment of Cancer Therapy Kidney Symptom Index-19.

BACKGROUND: There is a lack of consensus regarding the optimal method of assessing health-related quality of life (HR-QOL) among patients with metastatic renal cell carcinoma (mRCC). This study explored the perceived relevance of items that make up the Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19), as judged by patients with mRCC. METHODS: This was a multinational cross-sectional survey. Eligible patients responded to a questionnaire composed of 18 items that assessed the perceived relevance of each item in the FKSI-19 questionnaire. Open-ended questions assessed additional issues deemed relevant by patients. Responses were grouped as relevant (scores 2-5) or nonrelevant (score 1). Descriptive statistics were collated, and open-ended questions were analyzed and categorized into descriptive categories. Spearman correlation statistics were used to test the association between relevance and clinical characteristics. RESULTS: A total of 151 patients were included (gender: 78.1 M, 21.9F; median age: 64; treatment: 38.4 immunotherapy, 29.8 targeted therapy, 13.9 immuno-TKI combination therapy) in the study. The most relevant questions evaluated fatigue (77.5), lack of energy (72.2), and worry that their condition will get worse (71.5). Most patients rated blood in urine (15.2), fevers (16.6), and lack of appetite (23.2) as least relevant. Qualitative analysis of open-ended questions revealed several themes, including emotional and physical symptoms, ability to live independently, effectiveness of treatment, family, spirituality, and financial toxicity. CONCLUSION: There is a need to refine widely used HR-QOL measures that are employed among patients diagnosed with mRCC treated with contemporary therapies. Guidance was provided for the inclusion of more relevant items to patients' cancer journey.

Complementary Role of Circulating Tumor DNA Assessment and Tissue Genomic Profiling in Metastatic Renal Cell Carcinoma.

PURPOSE: The role of circulating cell-free tumor DNA (ctDNA) as an adjunct to tissue genomic profiling is poorly defined in metastatic renal cell carcinoma (mRCC). In this study, we aim to validate previous findings related to genomic alteration (GA) frequency in ctDNA and determine the concordance between ctDNA and tissue-based profiling in patients with mRCC. EXPERIMENTAL DESIGN: Results of 839 patients with mRCC who had ctDNA assessment with a Clinical Laboratory Improvement Amendments (CLIA)-certified ctDNA assay between November 2016 and December 2019 were collected. Tissue-based genomic profiling was collected when available and concordance analysis between blood- and tissue-based testing was performed. RESULTS: ctDNA was assessed in 839 patients (comprising 920 samples) with mRCC. GAs were detected in 661 samples (71.8%). Tissue-based GAs were assessed in 112 patients. Limiting our analyses to a common 73-/74-gene set and excluding samples with no ctDNA detected, a total of 228 mutations were found in tissue and blood. Mutations identified in tissue (34.7%; 42/121) were also identified via ctDNA, whereas 28.2% (42/149) of the mutations identified in liquid were also identified via tissue. Concordance between ctDNA and tissue-based profiling was inversely related to the time elapsed between these assays. CONCLUSIONS: This study confirms the feasibility of ctDNA profiling in the largest mRCC cohort to date, with ctDNA identifying multiple actionable alterations. It also demonstrates that ctDNA and tissue-based genomic profiling are complementary, with both platforms identifying unique alterations, and confirms that the frequency of unique alterations increases with greater temporal separation between tests.

Emotional problem-related distress screening and its prevalence by cancer type: Assessment by patients' characteristics and level of assistance requested.

OBJECTIVE: Emotional problem-related distress is a common issue faced by patients with cancer. However, patients suffering with this emotional burden do not typically seek assistance. This study sought to determine the prevalence of emotional problem-related distress by cancer type, and identify factors correlated with the level of assistance requested. METHODS: Using the SupportScreen®, patients were screened for emotional problem-related distress at their first or second visit to an NCI designated Comprehensive Cancer Center. General Linear Model was used to test the association between emotional problem-related distress and type of cancer, and the relationship between level of assistance requested and patients' characteristics. RESULTS: A total of 2,421 patients were included in this analysis. Patients were mostly female (62%), diagnosed with breast (24%), gynecological (16%) or gastrointestinal (15%) cancers. Highest levels of emotional problem-related distress were reported by patients diagnosed with lung, gynecological, breast and gastrointestinal cancers. Level of assistance requested were significantly associated with problem-related distress scores (p < 0.001), which were higher among patients with lower household incomes (p < 0.001) and Spanish as primary language (p = 0.001). CONCLUSION: Our study found an association between Level of assistance requested and emotional problem-related distress, which were heightened by lower income and Spanish-speaking. Intervention strategies should be considered to increase access to psychosocial support services.

Emotional Distress During the COVID-19 Pandemic: Psycho-Oncology Perspective.

Patients with cancer represent a vulnerable population and are at greater risk of developing serious complications as a result of a COVID-19 infection. In response, oncology societies around the world have proposed changes to their standards of care. These changes have helped guide health care providers in prioritizing clinical management of patients with cancer: identifying situations in which urgent intervention is needed and those that can be triaged until the risk of infection has lessened.

Assessment of distress and quality of life in rare cancers.

OBJECTIVE: Rare cancers are a heterogeneous group of conditions that can be associated with emotional and physical impairments. In view of the dearth of research in this area, we investigated the quality of life and prevalence of distress in a cohort of patients diagnosed with a rare cancer, classified by the RARECARE definition. METHODS: A cohort of rare cancer patients, treated in a Brazilian public cancer center, was assessed for distress (Distress Thermometer), anxiety/depression (Hospital Anxiety and Depression Scale), and quality of life (Functional Assessment of Cancer Therapy-General Version). Descriptive statistics were generated, and multivariate analyses were used to identify factors associated with distress, anxiety/depression, and quality of life. RESULTS: A total of 137 patients (52.6% male, mean age of 50 years; range 18-90) were identified. Nearly half (49.6%) of patients reported high levels of distress, with 19.7% endorsing anxiety and 15.3% depression. In multivariate analysis, demographic and clinical variables associated with worse psychosocial outcomes included younger age (P < 0.05), female gender (P < 0.01), advanced disease stage (P < 0.01), and engagement in active therapy (P < 0.05). CONCLUSIONS: Patients diagnosed with rare cancer reported poorer psychosocial outcomes and impaired quality of life when compared to the general population of cancer patients. Certain demographic groups (eg, women and younger patients) may benefit from targeted psychosocial interventions.

Associations between mental health and surgical outcomes among women undergoing mastectomy for cancer.

Following diagnosis of breast cancer, many women experience serious psychological distress, which can adversely affect their cancer care and outcomes. We conducted this study to examine the association between mental health conditions and hospital outcomes and costs among women undergoing mastectomy for invasive breast cancer. Using nationally representative data from the 2005 to 2008 Nationwide Inpatient Sample, we identified women aged ≥18 years with invasive breast cancer who underwent inpatient mastectomy (N = 40,202). Individuals with a psychiatric diagnosis (major depressive, posttraumatic stress, panic, adjustment, or generalized anxiety disorder) or substance abuse were compared with those without a mental health condition. Outcomes included risk of complications, prolonged hospitalization (>3 days), and direct costs of care. Multivariable logistic and linear regression analyses were performed to control for sociodemographic and clinical characteristics. Overall, 4.5% of patients had a mental health condition. Patients with substance abuse were more likely than those without to experience both complications (8.5% versus 4.8%; adjusted odds ratio [AOR] = 1.61 [1.30-2.00]) and prolonged hospitalization (26.4% versus 13.6%; AOR = 2.25 [1.95-2.59]), and to have higher average costs ($9,855 versus $9,128, p = 0.009). Presence of psychiatric diagnoses was also significantly associated with increased complications (5.9% versus 4.8%; AOR = 1.21 [1.10-1.34]), prolonged hospitalization (8.5% versus 4.8%; AOR = 1.40 [1.32-1.49]), and higher average costs ($9,723 versus $9,108, p < 0.001). Mental health conditions are associated with poorer outcomes and higher costs in breast cancer patients undergoing inpatient mastectomy. Greater efforts are needed to identify and manage these patients with psychiatric and substance use disorders during the perioperative period.

Characteristics of male attendees of health education interventions for Latinos.

Latino subgroups in the US often shoulder a greater burden of some common diseases, including cancer. The cultural norm of patriarchy in health-related decision-making has been found to be common among Latinos, and thus male members may be important in the adoption of health practices amongst family members. Demographic information was collected from 488 male attendees (20% of the total sample) as part of a larger randomized trial focused on promoting breast and cervical cancer screening among Latinas in which attendance was open to the entire community. The majority of male attendees were over the age of 40 (62%) and originally from Mexico (39%) or Puerto Rico (25%). Approximately half of attendees reported having no health coverage and living less than 5 years in the United States. Male attendees demonstrated significant increases in knowledge relevant to their group attendance. There were few significant differences between the characteristics of male attendees at a female focused cancer program (intervention) versus more general diabetes program (control). The current study describes characteristics of a group that may be influential in guiding health behaviors and decisions. This information extends our understanding of community participation in health interventions and will assist in the development of effective interventions in the Latino community.

Assessment of self-efficacy for caregiving: the critical role of self-care in caregiver stress and burden.

OBJECTIVE: Little attention has been given to assessing the importance of self-care and communication in the caregiving setting, especially caregiving for those who are terminally ill. The Caregiver Inventory (CGI), a measure of self-efficacy for caregiving that includes these two dimensions, was subjected to psychometric analyses. METHOD: One hundred and thirty-three primary caregivers completed the CGI; of those, 81 also completed the Perceived Stress Scale (PSS), Caregiver Burden Inventory (CBI), and a measure of caregiver tasks (ADLR-CG). Based on home visits, social workers also rated the caregiver tasks required (ADLR-SW). Exploratory Factor Analysis, as well as reliability and validity analyses were conducted. RESULTS: Fit indices in M + I (V. 5.1) indicated a four factors solution: Managing Medical Information (α = 0.64), Caring for Care Recipient (α = 0.78), Caring for Oneself (α = 0.88), and Managing Difficult Interactions/Emotions (α = 0.76). The CGI was highly negatively related to stress (PSS, r = -0.54, p = 0.001) and burden (CBI, p = -0.37, p = 0.001); ADLR-CG was related to burden (r = 0.43, p = 0.001) but not stress. In regression and relative importance analyses, Care of Oneself and Managing Difficult Interactions/Emotions emerged as equal in terms of having the strongest and most robust negative relationships with stress and burden. SIGNIFICANCE OF RESULTS: Results suggest that the CGI is a reliable and valid measure of self-efficacy for caregiving, and indicate the importance of self-efficacy for self-care and for managing difficult communication in successfully navigating the demands of caregiving for terminally ill persons.