Oncology · Medical Literature
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.
Clinical relevance
Is a combined graded exercise therapy (GET) plus cognitive behavioral therapy (CBT) intervention feasible, acceptable, and potentially efficacious for the management of cancer-related fatigue in female patients with breast cancer in Singapore? __SNAPSHOT__ {"studyDesign":"Randomized controlled pilot study (study protocol publication; no efficacy results reported)","setting":"Singapore; institution type not reported in abstract","sampleSize":"Planned n=100 (intervention: 50, control: 50); primary cohort n=90 (stage I–III), exploratory cohort n=10 (stage IV)","population":"Female patients with breast cancer reporting at least moderate fatigue (One-Item Fatigue Scale score ≥4); primary cohort: stage I–III BC having completed surgery and adjuvant chemotherapy (if indicated); exploratory cohort: stage IV BC receiving systemic therapy","intervention":"Combined graded exercise therapy (GET) + cognitive behavioral therapy (CBT)","comparator":"GET alone (described as standard of care)","primaryOutcome":"Co-primary outcomes: (1) feasibility and (2) acceptability of the combined GET+CBT intervention; acceptability measured using the Client Satisfaction Questionnaire (full description truncated in abstract). Secondary aims: preliminary efficacy estimates of the combination therapy (specific efficacy outcomes not fully reported in available abstract).","followUp":"Not reported in available abstract","fundingSource":"Not reported in available abstract"}
Key findings
This is a protocol publication. No outcome data, effect sizes, p-values, confidence intervals, or NNT/NNH values are reported. The manuscript describes the planned methodology for a randomized controlled pilot study. No interim or preliminary efficacy results are available from this abstract. Any future efficacy estimates generated will be preliminary and hypothesis-generating given the pilot design.
Practice implications
This paper establishes the rationale and design of a pilot RCT examining whether adding CBT to GET (standard of care) is feasible and acceptable for breast cancer-related fatigue in a Singaporean population. It does not establish efficacy, safety, or clinical superiority of the combined approach. The study population is restricted to female patients with BC who report at least moderate fatigue (One-Item Fatigue Scale ≥4), limiting applicability to males and those with mild or no fatigue. The primary cohort (stage I–III, post-surgery and post-adjuvant chemotherapy) reflects a common survivorship context, while the stage IV exploratory cohort (n=10) is far too small to support any inference. Generalizability beyond Singapore's healthcare system and patient demographics is uncertain. The choice of GET alone as 'standard of care' may not reflect practice in all settings, where neither GET nor CBT is routinely structured or resourced. This is a pre-results protocol; no practice guidance can be drawn from this publication alone. Only the abstract was available for review, which further limits assessment of methodological rigor, randomization procedures, blinding strategy, statistical analysis plan, and outcome instrument validation details. __LIMITATIONS__ Protocol-only publication: no outcome data available; all findings are anticipated, not observed.,Small planned sample size (n=100 total) powered for feasibility, not efficacy; pilot studies are intrinsically underpowered to detect clinically meaningful differences in fatigue outcomes.,The exploratory stage IV cohort (n=10) is too small for any sub-group inference and results should be considered descriptive only.,Single-country, single-setting design (Singapore) limits external generalizability to other ethnic populations, healthcare systems, and resource environments.,Restriction to female patients with BC excludes males and non-BC cancer types, limiting breadth of applicability.,Comparator arm (GET alone as 'standard of care') may not reflect routine clinical practice globally, potentially limiting interpretability of results.,Blinding strategy, method of randomization, allocation concealment, and specific secondary efficacy endpoints are not fully described in the available abstract.,Follow-up duration not reported; cancer-related fatigue trajectories beyond the intervention window cannot be assessed.,Funding source not disclosed; potential conflicts of interest cannot be evaluated.,Only the abstract was available for review; full protocol details, including statistical analysis plan, power calculations for feasibility thresholds, and data safety monitoring provisions, could not be assessed. __BOTTOM_LINE_CATEGORY__ not_ready_for_clinical_application __BOTTOM_LINE__ This is a published protocol for a pilot RCT evaluating the feasibility and acceptability of combining GET and CBT for cancer-related fatigue in breast cancer patients in Singapore; no efficacy data are yet available. Clinicians should note that both CBT and exercise independently carry guideline-level support for cancer-related fatigue management, but the additive value of combining them in this population remains unproven. This study should be followed for its feasibility results, which will inform the design of a definitive powered efficacy trial.