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

NCT07116161 | Recruiting DMC

• 1 other identifier: 2025-0016
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Fatigue; Breast Cancer Female

Keywords

Exercise Therapy; Cognitive Behavioural Therapy

Outcome Measures

Primary Outcomes (4)

• Client Satisfaction with Exercise Therapy and Cognitive Behavioural Therapy (CBT)

  Measured using a 8-item Client Satisfaction Questionnaire. Each item is rated on a 4-point scale, with higher scores indicating greater satisfaction.

  Up to 12 months post-enrolment.

• Perceived Cultural Sensitivity of the Intervention

  Measured using 4 items adapted from the Cultural Sensitivity Assessment Tool. Each item is rated on a 4 point-scale (1 = Strongly Disagree, 4 = Strongly Agree) with higher scores indicating greater cultural sensitivity.

  Up to 12 months post-enrolment.

• Uptake and Adherence to Exercise Therapy and Cognitive Behavioural Therapy (CBT)

  Measured using the percentage of randomized patients who attended at least one session of their allocated intervention and the percentage of randomized patients who completed their allocated interventions.

  3 Months post-enrolment.

• Willingness to Pay for Therapy Sessions

  * Measured using a 10-item custom survey based on a step-wise price-point method ($130, $100, $75, $50, $30 per session) to reflect a range of rates covering private and subsidized rates of different tiers. * Participants respond with binary Yes/No options, followed by questions assessing willingness to participate if costs are covered by Medisave. * This allows estimation of maximum willingness to pay under both cash and insurance-covered scenarios.

  3 Months post-enrolment.

Secondary Outcomes (7)

• Preliminary Effectiveness (Fatigue)

  Up to 12 months post-enrolment.

• Adherence to Breast Cancer Treatments

  Up to 12 months post-enrolment.

• Quality of Life (QoL)

  Up to 12 months post-enrolment.

• Godin-Shephard Leisure-Time Physical Activity Questionnaire (GLTPAQ)

  Up to 12 months post-enrolment.

• 6-Minute Walk Test (6MWT)

  Up to 12 months post-enrolment.

Study Arms (2)

Graded Exercise Therapy Arm (GET)

EXPERIMENTAL

Other: Graded Exercise Therapy Arm (GET)

Exercise Therapy (GET) plus Cognitive Behavioural Therapy (CBT)

EXPERIMENTAL

Other: Experimental: Exercise Therapy (GET) plus Cognitive Behavioural Therapy (CBT)

Interventions

Graded Exercise Therapy Arm (GET) OTHER

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.

Graded Exercise Therapy Arm (GET)

Experimental: Exercise Therapy (GET) plus Cognitive Behavioural Therapy (CBT) OTHER

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.

Exercise Therapy (GET) plus Cognitive Behavioural Therapy (CBT)

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary cohort (N=90):
• Female
• ≥21 years of age
• Stage I-III breast cancer regardless of hormone receptor status or human epidermal growth factor receptor 2 (HER2) status
• Completed surgery
• Completed adjuvant chemotherapy, if indicated
• Reported fatigue (One-item fatigue scale score ≥ 4)
• Ability to read and communicate in English
• Willing to provide informed consent for the study participation
• Exploratory cohort (N=10):
• Female
• ≥21 years of age
• Stage IV breast cancer regardless of hormone receptor status or human epidermal growth factor receptor 2 (HER2) status
• Completed surgery
• Currently receiving systemic therapy (e.g. endocrine therapy, chemotherapy, targeted therapy or immunotherapy)

You may not qualify if:

• Pregnant or lactating
• Presence of dementia or major psychiatric disease
• Deemed medically unsuitable by medical team for low to moderate intensity exercise
• Unable or unwilling for tele-counselling sessions
• Uncontrolled pain or undiagnosed pain
• Low blood counts: Hb \<8.0, Platelet \<50K, ANC \<1
• Electrolyte imbalances: K \<3.0, Na \<130
• 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
• Active infection
• Currently engaged in moderate to vigorous physical activity

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead
• Singapore Cancer Society: collaborator
• Singapore General Hospital: collaborator

Study Sites (4)

National Cancer Centre, Singapore (NCCS)

Singapore, 168583, Singapore

RECRUITING

Singapore General Hospital

Singapore, 169608, Singapore

RECRUITING

NCCS Satellite Clinic @ Changi General Hospital

Singapore, 529889, Singapore

RECRUITING

NCCS Satellite Clinic @ Sengkang General Hospital

Singapore, 544886, Singapore

RECRUITING

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr Ryan Shea YC TAN, MBBS, MRCP(UK), MMed

  National Cancer Centre, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Ryan Shea YC TAN, MBBS, MRCP(UK), MMed

CONTACT

+65 63065771; ryan.shea.tan.y.c@singhealth.com.sg

Michelle Chow

CONTACT

michelle.chow.t.n@nccs.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: August 11, 2025
• Study Start: July 14, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

SG (4)