A Flexible Individualised ExeRcise programme for cancer patients during ChEmotherapy (FIERCE): Protocol for a randomised controlled feasibility trial
Exercise is an important tool which has been shown to help patients manage many of the side effects of their cancer treatment, reduce toxicities, and improve prognosis. The benefits of exercise have been well documented, however, performing regular exercise during treatment remains a challenge for most patients. The Flexible Individualised ExeRcise programme for cancer patients during ChEmotherapy (FIERCE) is an exercise programme that has been co-designed by healthcare professionals and people with a personal lived experience of chemotherapy. The primary aim of this study is to examine the feasibility of delivering the FIERCE programme for cancer patients during chemotherapy. The FIERCE study is a randomised controlled feasibility trial which will include 50 participants who are scheduled to receive chemotherapy for the treatment of breast, colorectal, or ovarian cancer. Participants will be randomly allocated to Group 1: FIERCE programme, or Group 2: Self-managed pedometer programme in a 2:1 ratio. Participants will be enrolled in the study for the duration of their chemotherapy treatment. The primary outcome of feasibility will be measured using a mixed-methods approach. Secondary outcomes of cardiorespiratory fitness, muscular strength, skeletal muscle mass, physical function, fatigue, and quality of life will be measured at baseline (T0) and post-intervention (T1). The FIERCE feasibility study aims to explore if a flexible, individualised exercise programme will support individuals to be active during chemotherapy treatment. If proven to be feasible, a large-scale randomised controlled trial will be undertaken focusing on the efficacy of the FIERCE programme on different health outcomes. The study is registered with ClinicalTrials.gov, registration number: NCT06280885.