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

The purpose of this research study is to investigate the acceptability, feasibility, and effectiveness of exercise therapy and cognitive behavioral therapy (CBT) in improving fatigue levels and breast cancer treatment adherence in breast cancer patients.

ClinicalTrials.gov IDNCT07116161

PhaseNA

Enrollment100

SponsorNational Cancer Centre, Singapore

Age21 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Fatigue, Breast Cancer Female

About this study

Interventions

Other: Graded Exercise Therapy Arm (GET) — Consists of a self-supervised individualized exercise prescription by the rehabilitation professional consisting of aerobic (e.g. brisk walking / cycling) and resistance training exercises, customized by patient preference.
Other: Experimental: Exercise Therapy (GET) plus Cognitive Behavioural Therapy (CBT) — Consists of four major components adapted from previous studies,13,15,16 and delivered by qualified and trained study psychologists. First, the ABCD model of cognitive behavioural therapy (A: activating events, B: beliefs, C: consequences, D: Dispute) will be taught and applied to identify negative, unhelpful beliefs and the emotional, behavioural and physical consequences of those beliefs. Second, patients were taught behavioural strategies to manage fatigue (e.g. sleep hygiene, activity scheduling). Lastly, participants will be guided to reformulate dysfunctional cognitions regarding fatigue, improve coping strategies in relation to significant others (e.g. family, friends) and set goals.

Primary outcomes

Client Satisfaction with Exercise Therapy and Cognitive Behavioural Therapy (CBT) (Up to 12 months post-enrolment.)
Perceived Cultural Sensitivity of the Intervention (Up to 12 months post-enrolment.)
Uptake and Adherence to Exercise Therapy and Cognitive Behavioural Therapy (CBT) (3 Months post-enrolment.)
Willingness to Pay for Therapy Sessions (3 Months post-enrolment.)

Eligibility information

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

Study locations

National Cancer Centre, Singapore (NCCS), Singapore, 168583 Singapore
Singapore General Hospital, Singapore, 169608 Singapore
NCCS Satellite Clinic @ Changi General Hospital, Singapore, 529889 Singapore
NCCS Satellite Clinic @ Sengkang General Hospital, Singapore, 544886 Singapore

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.