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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: ryan.shea.tan.y.c@singhealth.com.sg
• Phone: +65 63065771

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.