TOward a comPrehensive supportive Care intervention for Older men with metastatic Prostate cancer (TOPCOP3): A pilot randomized controlled trial and process evaluation.

INTRODUCTION: Current management of metastatic prostate cancer (mPC) includes androgen receptor axis-targeted therapy (ARATs), which is associated with substantial toxicity in older adults. Geriatric assessment and management and remote symptom monitoring have been shown to reduce toxicity and improve quality of life in patients undergoing chemotherapy, but their efficacy in patients being treated with ARATs has not been explored. The purpose of this study is to examine whether these interventions, alone or in combination, can improve treatment tolerability and quality of life (QOL) for older adults with metastatic prostate cancer on ARATs. MATERIALS AND METHODS: TOPCOP3 is a multi-centre, factorial pilot clinical trial coupled with an embedded process evaluation. The study includes four treatment arms: geriatric assessment and management (GA + M); remote symptom monitoring (RSM); geriatric assessment and management plus remote symptom monitoring; and usual care and will be followed for six months. The aim is to recruit 168 patients between two cancer centres in Toronto, Canada. Eligible participants will be randomized equally via REDCap. Participants in all arms will complete a comprehensive baseline assessment upon enrollment following the Geriatric Core dataset, as well as follow-up assessments at 1.5, 3, 4.5, and 6 months. The co-primary outcomes will be grade 3-5 toxicity and QOL. Toxicities will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. QOL will be measured by patient self-reporting using the EuroQol 5 dimensions of health questionnaire. Secondary outcomes include fatigue, insomnia, and depression. Finally, four process evaluation outcomes will also be observed, namely feasibility, fidelity, and acceptability, along with implementation barriers and facilitators. DISCUSSION: Data will be collected to observe the effects of GA + M and RSM on QOL and toxicities experienced by older adults receiving ARATs for metastatic prostate cancer. Data will also be collected to help the design and conduct of a definitive multicentre phase III randomized controlled trial. This study will extend supportive care interventions for older adults with cancer into new areas and inform the design of larger trials. TRIAL REGISTRATION: The trial is registered at clinicaltrials.gov (registration number: NCT05582772).

Exploring the Needs of Adults Living With Type 1 or Type 2 Diabetes Distress Using the Problem Areas in Diabetes 5 Tool.

OBJECTIVES: This study investigated the feasibility and acceptability of implementing a screening tool as a part of routine care and the subsequent screening experiences of patients and clinicians. Additionally, potential sources of diabetes distress (DD) were identified in this clinical population. METHODS: Our investigation was a cross-sectional, mixed-methods, convenience sample of 203 patients living with type 1 or type 2 diabetes from 2 Canadian tertiary hospital-based clinics. The Problem Areas in Diabetes 5 (PAID5) scale was used to assess DD. Structured telephone interviews of patients with high DD scores and care provider focus group transcriptions were analyzed using a deductive thematic content analysis. RESULTS: The prevalence of DD was 45%. Lack of medication coverage (p=0.02) and presence of neuropathy (p=0.04) were approximately 5- and 2-fold more likely to be predictors of high DD, respectively. Patient interviews identified DD screening as an opportunity to share and feel supported but demonstrated their fear of discussing mental health concerns. Patients found discussion about mental health helpful and often did not require a referral to a mental health specialist. Staff focus groups discussed screening as a feasible tool, but also acknowledged barriers and knowledge gaps that preclude DD screening integration in routine clinical practice. Specialized training for clinicians may help increase confidence and improve uptake of DD screening into routine clinical practice. CONCLUSIONS: The prevalence of DD in outpatient care settings is high. Findings suggest that integrating the PAID5 screening tool into regular clinical practice is feasible by patients and care providers.