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New treatment option for Fatigue
Official title Exercise Therapy and Cognitive Behavioural Therapy for Fatigue in Female Cancer Patients in Singapore
ClinicalTrials.gov ID: NCT07116161
What this study is testing
- What it's testing
- 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.
- Time commitment: about 12 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older, women only
You may be able to join 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Singapore, Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore, Singapore. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.