Abstract
BACKGROUND: Cancer can impact the way older adults and their care partners engage in their occupations. As an expert in the field of occupations, the occupational therapist is able to assess and support both a person with cancer and (if applicable) their care partners, with regard to occupational disruptions. The primary objective of this study is to assess the effect of occupational therapy (OT) on quality of life (QoL) in older adults with cancer. The study's secondary objectives are to (i) describe changes over time in occupational performance and satisfaction scores in older adults with cancer receiving (or not) OT and (if applicable) for their care partners, (ii) assess the effect of OT sessions on QoL and adverse events in older adults with cancer and in their care partners, and (iii) describe the OT sessions' content and procedures. METHODS: OCEAN-OT is a multicentre, pragmatic, three-arm, parallel-group, open-label, assessor-blinded, superiority randomized controlled trial. The inclusion criteria are age 70 or over, a diagnosis of colorectal, breast, prostate or lung cancer, treatment with curative intent, and residence at-home. The first control group will receive usual care. A second control group will receive usual care and a priority-setting interview called the Canadian Occupation Performance Measure (COPM) at baseline and at 3 and 6 months. The intervention group will receive usual care, the COPM, and a three-month program of home OT sessions. QoL will be assessed by administering the 30-item European Organisation for Research and Treatment of Cancer Quality of Life Group Core Questionnaire at baseline and at 3 and 6 months (for patients) and the Zarit Burden Interview (for care partners). DISCUSSION: There are few published, evidence-based studies of rehabilitation in older adults with cancer, and the available data are related to exercise and physical health, rather than occupations. The future trial results might have implications for health policies and might be crucial for maintaining quality of life for older adults with cancer and for their care partners. TRIAL REGISTRATION: The study protocol has been approved by an investigational review board (reference: 2023-A00925-40) and registered at ClinicalTrials.gov (NCT05878782).