Exercise Therapy and Cognitive Behavioural Therapy for Fatigue in Female Cancer Patients in Singapore
Recruiting · NCT07116161 · Interventional (participants receive a specific treatment) · Lead sponsor: National Cancer Centre, Singapore
View the official record on ClinicalTrials.gov →Interventions studied
Experimental: Exercise Therapy (GET) plus Cognitive Behavioural Therapy (CBT)Graded Exercise Therapy Arm (GET)
What this trial is about
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.
Who can take part
Age range
21 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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)
- Reported fatigue (One-item fatigue scale score ≥ 4)
- Ability to read and communicate in English
- Willing to provide informed consent for the study participation
Exclusion criteria
- for both cohorts:
- 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
Where it is running
4 locations listed.
- National Cancer Centre, Singapore (NCCS) - Singapore, Singapore
- Singapore General Hospital - Singapore, Singapore
- NCCS Satellite Clinic @ Changi General Hospital - Singapore, Singapore
- NCCS Satellite Clinic @ Sengkang General Hospital - Singapore, Singapore