Effect of a postoperative home-based exercise and self-management programme on physical function in people with lung cancer (CAPACITY): protocol for a randomised controlled trial.

ABSTRACT

INTRODUCTION: Exercise is important in the postoperative management of lung cancer, yet no strong evidence exists for delivery of home-based programmes. Our feasibility (phase I) study established feasibility of a home-based exercise and self-management programme (the programme) delivered postoperatively. This efficacy (phase II) study aims to determine whether the programme, compared with usual care, is effective in improving physical function (primary outcome) in patients after lung cancer surgery. METHODS AND ANALYSIS: This will be a prospective, multisite, two-arm parallel 11, randomised controlled superiority trial with assessors blinded to group allocation. 112 participants scheduled for surgery for lung cancer will be recruited and randomised to usual care (no exercise programme) or, usual care plus the 12-week programme. The primary outcome is physical function measured with the EORTC QLQ c30 questionnaire. Secondary outcomes include health-related quality of life (HRQoL); exercise capacity; muscle strength; physical activity levels and patient reported outcomes. HRQoL and patient-reported outcomes will be measured to 12 months, and survival to 5 years. In a substudy, patient experience interviews will be conducted in a subgroup of intervention participants. ETHICS AND DISSEMINATION Ethics approval was gained from all sites. Results will be submitted for publications in peer-reviewed journals. TRIAL REGISTRATION NUMBER ACTRN12617001283369.