Graded Exercise Therapy and Cognitive Behavioral Therapy for Fatigue in Patients With Breast Cancer: Protocol for a Randomized Controlled Pilot Study.

Abstract

Fatigue is a common debilitating symptom of breast cancer (BC), and its treatment may result in a significant symptom burden and affect adherence to treatment. Graded exercise therapy (GET) and cognitive behavioral therapy (CBT) have separately been shown in previous studies to be beneficial for the management of cancer-related fatigue. This study's coprimary aims are to assess the feasibility and acceptability of combining GET and CBT for the treatment of fatigue in patients with BC in Singapore. The secondary aims are to generate preliminary efficacy estimates of the combination therapy. In this randomized controlled pilot study, a total of 100 female patients with BC, with a self-reported rating of at least moderate fatigue (One-Item Fatigue Scale score ≥4), will be recruited and randomized in a 1:1 ratio to undergo a combination of GET and CBT vs GET alone (standard of care). This will include a primary cohort of 90 patients with stage I to III BC who have completed surgery and adjuvant chemotherapy (if indicated), and an exploratory cohort of 10 patients with stage IV BC undergoing systemic therapy. Acceptability will be measured using the Client Satisfaction Questionnaire, including items on cultural sensitivity. Feasibility will be measured by participant uptake, adherence to sessions, and willingness to pay for therapy sessions. Efficacy will be assessed based on quantitative measures of fatigue, treatment adherence, quality of life, and physical and functional outcomes. Recruitment of participants commenced on July 14, 2025, and is projected to be completed by December 31, 2026. The primary completion date is expected to be April 30, 2027, and publication of the final results is expected by the end of 2027. This study will provide evidence on whether a combination of GET and CBT is feasible and acceptable for the treatment of fatigue in patients with BC in Singapore. It supports the refinement of evidence-based fatigue management guidelines and improvements in BC survivorship care.