These adverse effects can seriously impact patients’ quality of life and may even lead them to discontinue treatment prematurely. Geriatric assessment (GA) is a comprehensive evaluation that aims to assess older adults’ functional capacity, physical well-being, cognitive and emotional health, as well as their social and environmental situation. GA combined with management (GA+M) includes a customized management plan targeting issues identified in the GA and can be delivered by specialized teams or frontline clinicians (following tailored recommendations). Remote symptom monitoring (RSM) involves regular (typically ranging from once daily to once weekly) symptom assessment questionnaires along with a follow-up by a nurse when moderate or severe symptoms are reported. Studies have shown that interventions like GA+M and RSM can be successful in reducing treatment side effects, improving quality of life, and decreasing unplanned hospital visits among older adults undergoing chemotherapy (1-4). However, it is unclear whether these benefits extend to older men with mPC receiving ARATs.
The TOPCOP3 study presents a comprehensive approach that evaluates 2 supportive care interventions for older men with mPC. It employs a multi-center, pilot factorial randomized controlled trial (RCT) design along with an embedded process evaluation, which is crucial for understanding the complexities of such interventions. The study aims to enroll 168 participants across several academic cancer centers, utilizing a recruitment strategy that involves patient-clinician discussions, clinic screening, and enlisting the help of the drug reimbursement pharmacy team. Participants will be centrally randomized in a 1:1:1:1 fashion to one of 4 arms; GA+M, RSM, GA+M, and RSM combined, or usual care. Participants will receive their assigned intervention for a duration of six months. Follow-up assessments at regular intervals, combined with qualitative interviews, enhance the study's depth and insight into participant experiences. This balances participant burden and resources with a timeframe that is sufficient to observe clinical and implementation outcomes. The study emphasizes participant adherence and retention through various strategies, including honoraria, study newsletters, and personalized communications. Throughout the study, patient partners are actively involved, providing valuable input on the study process and outcomes. Co-primary outcomes include toxicity and quality of life (QOL). Secondary outcomes encompass a wide range of parameters, such as treatment discontinuation, symptom severity, functional decline, and healthcare utilization, providing a comprehensive evaluation of intervention effectiveness.
The trial represents the first attempt to evaluate these two promising interventions, either alone or combined, to improve treatment tolerability and quality of life in older men with mPC undergoing ARAT therapy. The findings from this study have the potential to inform future larger-scale trials and improve the care and outcomes of older men with mPC.
Written by: Soha Abdallah,1 Kian Godhwani,1 Ferozah Nasiri,1 Shabbir M.H. Alibhai1, 2
- Department of Medicine, University Health Network, Toronto, Ontario, Canada.
- Department of Supportive Care, Princess Margaret Hospital Cancer Centre, Toronto, Ontario, Canada.
- Lund CM, Vistisen KK, Olsen AP, Bardal P, Schultz M, Dolin TG, et al. The effect of geriatric intervention in frail older patients receiving chemotherapy for colorectal cancer: a randomised trial (GERICO). Br J Cancer. 2021;124(12):1949-58.
- Li D., Sun C-L., Kim H., Chung V., Koczywas M., Fakih M., et al. Geriatric assessment-driven intervention (GAIN) on chemotherapy toxicity in older adults with cancer: A randomized controlled trial. J Clin Oncol. 2020;38:abstract 12010.
- Absolom K, Warrington L, Hudson E, Hewison J, Morris C, Holch P, et al. Phase III Randomized Controlled Trial of eRAPID: eHealth Intervention During Chemotherapy. J Clin Oncol. 2021;39(7):734-47.
- Maguire R, McCann L, Kotronoulas G, Kearney N, Ream E, Armes J, et al. Real time remote symptom monitoring during chemotherapy for cancer: European multicentre randomised controlled trial (eSMART). BMJ. 2021;374:n1647.