Exercise Therapy and Cognitive Behavioural Therapy for Fatigue in Female Cancer Patients in Singapore
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21+
SponsorNational Cancer Centre, Singapore
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Graded Exercise Therapy Arm (GET)
Other interventionConsists 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.
Experimental: Exercise Therapy (GET) plus Cognitive Behavioural Therapy (CBT)
Other interventionConsists 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Graded Exercise Therapy Arm (GET)Experimental treatment 1 intervention
Group B: Exercise Therapy (GET) plus Cognitive Behavioural Therapy (CBT)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 12 months post-enrolment.2
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.
Time frame
Up to 12 months post-enrolment.3
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.
Time frame
3 Months post-enrolment.4
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.
Time frame
3 Months post-enrolment.Secondary outcomes
1
Preliminary Effectiveness (Fatigue)
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) subscale evaluates changes in self-reported fatigue levels, a key symptom among breast cancer survivors. FACIT-F scores range from 0 to 52, with higher scores indicating less fatigue.
Time frame
Up to 12 months post-enrolment.2
Adherence to Breast Cancer Treatments
5-item medication adherence survey adapted from prior studies measuring adherence to prescribed medications over the past 3 months. The primary measure item asks how often participants took their medication as prescribed over the past 3 months. Nonadherence is defined as 75% of the time or less. Additional items assess frequency of forgetting or intentionally skipping medications, with nonadherence defined as once per week or more. Two items address medication switching and discontinuation. Participants who skipped medications only due to switching between tamoxifen and aromatase inhibitors (AIs) will be considered adherent, while those who discontinued tamoxifen or an AI will be asked to provide reasons.
Time frame
Up to 12 months post-enrolment.3
Quality of Life (QoL)
Functional Assessment of Cancer Therapy - General (FACT-G), assesses quality of life. FACT-G scores range from 0-108 with higher scores indicating better quality of life.
Time frame
Up to 12 months post-enrolment.4
Godin-Shephard Leisure-Time Physical Activity Questionnaire (GLTPAQ)
Captures the frequency and intensity of participants' physical activity during their free time. GLTPAQ scores are calculated based on frequency and intensity of weekly leisure activity. A score of 24 or more indicates active, a score of 23 or less indicates insufficient activity.
Time frame
Up to 12 months post-enrolment.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
National Cancer Centre, Singapore
Lead sponsor
Singapore Cancer Society
Collaborator
Singapore General Hospital
Collaborator
Source ClinicalTrials.gov