Short-term integrated rehabilitation for people with newly diagnosed thoracic cancer: a multi-centre randomized controlled feasibility trial

Bayly, Joanne; Fettes, Lucy; Douglas, Eleanor; Douglas, Eleanor; Teixiera, Maria J; Peat, Nicola; Tunnard, India; Patel, Vishit; Gao, Wei; Wilcock, Andrew; Higginson, Irene J; Maddocks, Matthew

Abstract

© The Author(s) 2019. Objectives: The main objective of this study is to determine the feasibility of recruiting and retaining patients recently diagnosed with thoracic cancer to a trial of short-term integrated rehabilitation; evaluate uptake of theoretically informed components targeting physical function, symptom self-management and participation; estimate sample size requirements for an efficacy trial. Design: Parallel group randomized controlled feasibility trial. Setting: Three U.K. hospitals. Participants: Patients ⩽eight weeks of thoracic cancer diagnosis, Eastern Cooperative Oncology Group Performance Status 0–3, any cancer stage and treatment plan. Interventions: Participants randomly allocated (1:1) to short-term integrated rehabilitation and standard care or standard care alone over 30 days. Main measures: Primary: participant recruitment and retention, targeting ⩾30% of eligible patients enrolling and ⩾50% of participants reporting outcomes at 30 days. Secondary: intervention fidelity; missing data and performance of outcome measures for self-efficacy, symptoms, physical activity and health-related quality of life. Results: Of 159 eligible patients approached, 54 (34%) were recruited. A total of 44 (82%) and 39 (72%) participants reported outcomes at 30 and 60 days, respectively. Intervention fidelity was high. Rehabilitation was delivered across 3 (1–3) sessions over 32 (22–45) days (median (range)). Changes in clinical outcomes were modest but most apparent at 60 days for health-related quality of life: Functional Assessment of Cancer Therapy Lung Cancer score median (interquartile range) change 9.7 (−12.0 to 16.0) rehabilitation versus 2.3 (−15.0 to 14.5) standard care. Conclusion: A trial to examine efficacy of short-term integrated rehabilitation for people newly diagnosed with thoracic cancer is feasible. A sample of 336 participants could detect a meaningful effect on health-related quality of life as the primary outcome.

Citation

Bayly, J., Fettes, L., Douglas, E., Douglas, E., Teixiera, M. J., Peat, N., Tunnard, I., Patel, V., Gao, W., Wilcock, A., Higginson, I. J., & Maddocks, M. (2020). Short-term integrated rehabilitation for people with newly diagnosed thoracic cancer: a multi-centre randomized controlled feasibility trial. Clinical Rehabilitation, 34(2), 205-219. https://doi.org/10.1177/0269215519888794

• Journal Article Type: Article
• Acceptance Date: Oct 20, 2019
• Online Publication Date: Dec 2, 2019
• Publication Date: 2020-02
• Deposit Date: Dec 3, 2019
• Publicly Available Date: Dec 5, 2019
• Journal: Clinical Rehabilitation
• Print ISSN: 0269-2155
• Electronic ISSN: 1477-0873
• Publisher: SAGE Publications
• Peer Reviewed: Peer Reviewed
• Volume: 34
• Issue: 2
• Pages: 205-219
• DOI: https://doi.org/10.1177/0269215519888794
• Public URL: https://nottingham-repository.worktribe.com/output/3467057
• Publisher URL: https://journals.sagepub.com/doi/10.1177/0269215519888794