Currently submitted to: JMIR Research Protocols
Date Submitted: Jan 21, 2026
Open Peer Review Period: Jan 22, 2026 - Mar 19, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Graded Exercise Therapy and Cognitive Behavioral Therapy for fatigue in breast cancer patients (GET-CBT): protocol for a randomized controlled pilot study
ABSTRACT
Background:
Fatigue is a common debilitating symptom of breast cancer, and its treatment may result in 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 (CRF).
Objective:
This study aims to assess the feasibility, acceptability and potential efficacy of combining GET and CBT for treatment of fatigue in breast cancer patients on treatment in Singapore.
Methods:
In this randomized controlled pilot study, a total of 100 female breast cancer patients, with 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 versus GET alone (standard of care). This will include a primary cohort of 90 patients with Stage I to III breast cancer who have completed surgery and adjuvant chemotherapy (if indicated), and an exploratory cohort of 10 patients with Stage IV breast cancer undergoing systemic therapy. Acceptability is measured using client satisfaction questionnaire including items on cultural sensitivity. Feasibility is measured by participant uptake, adherence to sessions and willingness to pay for therapy sessions. Efficacy is assessed based on quantitative measures of fatigue, quality of life, and physical and functional outcomes.
Results:
The recruitment of participants commenced on 14 July 2025 and is projected to be completed by 31 July 2026. Potential extension to this project would be the subsequent expansion of the current exploratory cohort of patients with metastatic breast cancer.
Conclusions:
The present study compares the use of a combination of GET and CBT against GET alone for management of fatigue in breast cancer survivors, applied to the Singaporean context. The primary aim is to establish feasibility and acceptability of GET and CBT interventions in the local context, with a secondary aim of evaluating efficacy in terms of fatigue, quality of life and functional outcomes. Clinical Trial: ClinicalTrials.gov ID: NCT07116161
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