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).

Co-design for stroke intervention development: Results of a scoping review.

BACKGROUND: Co-design methodology seeks to actively engage end-users in developing interventions. It is increasingly used to design stroke interventions; however, limited guidance exists, particularly with/for individuals with stroke who have diverse cognitive, physical and functional abilities. Thus, we describe 1) the extent of existing research that has used co-design for stroke intervention development and 2) how co-design has been used to develop stroke interventions among studies that explicitly used co-design, including the rationale, types of co-designed stroke interventions, participants involved, research methodologies/approaches, methods of incorporating end-users in the research, co-design limitations, challenges and potential strategies reported by researchers. MATERIALS AND METHODS: A scoping review informed by Joanna Briggs Institute and Arksey & O'Malley methodology was conducted by searching nine databases on December 21, 2022, to locate English-language literature that used co-design to develop a stroke intervention. Additional data sources were identified through a hand search. Data sources were de-duplicated, and two research team members reviewed their titles, abstracts and full text to ensure they met the inclusion criteria. Data relating to the research objectives were extracted, analyzed, and reported numerically and descriptively. RESULTS: Data sources used co-design for stroke intervention development with (n = 89) and without (n = 139) explicitly using the term 'co-design.' Among studies explicitly using co-design, it was commonly used to understand end-user needs and generate new ideas. Many co-designed interventions were technology-based (65%), and 48% were for physical rehabilitation or activity-based. Co-design was commonly conducted with multiple participants (82%; e.g., individuals with stroke, family members/caregivers and clinicians) and used various methods to engage end-users, including focus groups and workshops. Limitations, challenges and potential strategies for recruitment, participant-engagement, contextual and logistical and ethics of co-designed interventions were described. CONCLUSIONS: Given the increasing popularity of co-design as a methodology for developing stroke interventions internationally, these findings can inform future co-designed studies.