Exercise plus cognitive behavioural therapy for fatigue in women treated for breast cancer in Singapore

Pilot Study of Exercise Therapy and Cognitive Behavioural Therapy for Fatigue in Female Cancer Patients in Singapore

This program tests whether graded exercise combined with cognitive behavioural therapy can reduce fatigue and help women with breast cancer stay on their treatment plans.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 21 Years and up
• Sex: Female
• Sponsor: National Cancer Centre, Singapore (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 4 sites (Singapore and 3 other locations)
• Trial ID: NCT07116161 on ClinicalTrials.gov

What this trial studies

This is a randomized, controlled pilot intervention enrolling 100 women across National Cancer Centre Singapore, Singapore General Hospital and NCCS satellite clinics to test graded exercise therapy with or without added cognitive behavioural therapy. Ninety participants form the primary cohort (stage I–III who have completed surgery and adjuvant chemotherapy if indicated) and ten form an exploratory cohort (stage IV on systemic therapy). Participants are screened using routine referrals, the distress thermometer, and a one-item fatigue scale (score ≥4) and provide informed consent before randomization. Primary outcomes include acceptability, feasibility, fatigue levels, and treatment adherence over the study period.

Who should consider this trial

Good fit: Ideal candidates are English-speaking women aged 21 or older with stage I–III breast cancer who have completed surgery (and adjuvant chemotherapy if indicated) and report significant fatigue (one-item fatigue score ≥4).

Not a fit: Patients who are pregnant or lactating, medically unable to undertake graded exercise, do not report significant fatigue, or cannot attend in-person visits or communicate in English are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, combining graded exercise and CBT could meaningfully reduce cancer-related fatigue and improve adherence to breast cancer treatments and daily functioning.

How similar studies have performed: Prior trials have shown that exercise programs and cognitive behavioural therapy can each reduce cancer-related fatigue, though combining them in this specific Singapore clinical setting is being tested here.

Eligibility criteria

Inclusion Criteria:

Primary cohort (N=90):

1. Female
2. ≥21 years of age
3. Stage I-III breast cancer regardless of hormone receptor status or human epidermal growth factor receptor 2 (HER2) status
4. Completed surgery
5. Completed adjuvant chemotherapy, if indicated
6. Reported fatigue (One-item fatigue scale score ≥ 4)
7. Ability to read and communicate in English
8. Willing to provide informed consent for the study participation

Exploratory cohort (N=10):

1. Female
2. ≥21 years of age
3. Stage IV breast cancer regardless of hormone receptor status or human epidermal growth factor receptor 2 (HER2) status
4. Completed surgery
5. Currently receiving systemic therapy (e.g. endocrine therapy, chemotherapy, targeted therapy or immunotherapy)
6. Reported fatigue (One-item fatigue scale score ≥ 4)
7. Ability to read and communicate in English
8. Willing to provide informed consent for the study participation

Exclusion Criteria for both cohorts:

1. Pregnant or lactating
2. Presence of dementia or major psychiatric disease
3. Deemed medically unsuitable by medical team for low to moderate intensity exercise
4. Unable or unwilling for tele-counselling sessions
5. Uncontrolled pain or undiagnosed pain
6. Low blood counts: Hb \<8.0, Platelet \<50K, ANC \<1
7. Electrolyte imbalances: K \<3.0, Na \<130
8. Cardiovascular diseases, including but not limited to: LVEF \<35%, uncontrolled arrhythmias, severe coronary artery disease, severe valvular heart disease, uncontrolled hypertension etc. not cleared by a cardiologist
9. Active infection
10. Currently engaged in moderate to vigorous physical activity

Where this trial is running

Singapore and 3 other locations

• National Cancer Centre, Singapore (NCCS) — Singapore, Singapore (RECRUITING)
• Singapore General Hospital — Singapore, Singapore (RECRUITING)
• NCCS Satellite Clinic @ Changi General Hospital — Singapore, Singapore (RECRUITING)
• NCCS Satellite Clinic @ Sengkang General Hospital — Singapore, Singapore (RECRUITING)

Study contacts

• Principal investigator: Dr Ryan Shea YC TAN, MBBS, MRCP(UK), MMed — National Cancer Centre, Singapore
• Study coordinator: Dr Ryan Shea YC TAN, MBBS, MRCP(UK), MMed

Conditions: Fatigue, Breast Cancer Female, Exercise Therapy, Cognitive Behavioural Therapy