A Pilot Study of "a Home-based and Group-based Tele-exercise Program for Breast Cancer Survivors: a Randomized Controlled Trial"
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hong Kong Baptist University
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Acceptability (qualitative)
Study Overview
Brief Summary
The research protocol outlines a pilot study for a home-based and group-based tele-exercise program designed for breast cancer survivors. The study is a randomized controlled trial (RCT) led by Dr. Yang Gao from Hong Kong Baptist University, with multiple other investigators from Kwong Wah Hospital and the university itself.
Breast cancer is identified as the most prevalent cancer among women globally and in Hong Kong. The document states that adjuvant therapies post-surgery, such as radiation and chemotherapy, can have both short-term and long-term side effects, which may affect the survivors' physical and mental health.
The study is based on evidence that physical activity levels often decrease after a breast cancer diagnosis and that exercise can mitigate the side effects of treatment, improving health and quality of life. The pilot aims to test the acceptability and feasibility of a 12-week tele-exercise program that combines psychological theories and behaviour change techniques, transitioning from supervised to unsupervised exercise to build sustainable exercise habits.
The study will enrol 24 patients, randomly assigning them to an intervention group or an active control group. The intervention group will receive 12 online training sessions plus 4 psychological counselling sessions, whereas the control group will receive educational essays on exercise and health.
The training sessions for the intervention group will include various exercises with increasing intensity and duration over the 4 weeks, monitored by a pulse oximeter to ensure exercises are done at the appropriate heart rate. The sessions will be led by qualified coaches, with Dr. Gao overseeing quality control.
Detailed Description
It is a prospective and pilot study of RCT. It will be a pilot to test the acceptability and feasibility of a two-armed tele-exercise RCT to mitigate symptoms and improve health for breast cancer survivors. In this study, outcome assessors and data analysts will be masked from the allocation results. The pilot will recruit 24 patients and randomly assign them to an intervention group (Group A) and an active control group (Group B). All participants in both groups will continue receiving usual care from the study hospital during the study period. Additionally, those in Group A (intervention) will receive the tele-exercise (12 home-based online training sessions + 4 psychological counselling sessions), while those in Group B (active control) will receive 4 essays on exercise and health. Outcome measurements will be repeatedly performed before and after the intervention.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 64 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Females aged 40-64 years old;
- •Within 6 weeks after completion of chemotherapy;
- •Without severe anemia;
- •Without cancer metastasis;
- •Able to read and communicate in Cantonese or Mandarin;
- •Smartphone users.
Exclusion Criteria
- •With any medical, physical and psychological conditions that may limit participation (e.g., uncontrolled severe cardiovascular disease, schizophrenia, severe neurological dysfunction, etc.).
Outcomes
Primary Outcomes
Acceptability (qualitative)
Time Frame: baseline, 13 weeks
Participants rated intervention regarding the aspects of satisfaction, enjoyment, perceptions of safety, difficulty, tolerability of treatment, adverse events by interviews.
Recruitment rate
Time Frame: baseline, 13 weeks
The proportion of eligible participants who are enrolled at baseline of the study.
Attendance rate
Time Frame: baseline, 13 weeks
The proportion of total sessions offered to participants to the actual number of sessions participants attended.
Compliance rate
Time Frame: baseline, 13 weeks
Participants' level of adherence to the content, frequency, duration, and coverage of the treatment as delivered by the research team. Assessed by percentage of participants who complied with intervention procedures.
Acceptability (quantitative)
Time Frame: baseline, 13 weeks
Participants rated intervention regarding the aspects of satisfaction, enjoyment, perceptions of safety, difficulty, tolerability of treatment, adverse events using a 5-Liker questionnaire, mean score was used to assess, and higher score indicates greater acceptability.
Retention rate
Time Frame: baseline, 13 weeks
The proportion of enrolled participants who are present throughout the full length of the treatment.
Secondary Outcomes
- Cardiorespiratory fitness(baseline, 13 weeks)
- Health-related quality of life(baseline, 13 weeks)
- Limb circumference and lymphedema(baseline, 13 weeks)
- muscle strength(baseline, 13 weeks)
- % body fat(baseline, 13 weeks)
- height(baseline, 13 weeks)
- balance(baseline, 13 weeks)
- skeletal muscle mass(baseline, 13 weeks)
- Shoulder joint range of motion (ROM) of affected side(baseline, 13 weeks)
- Physical activity level (min/week)(baseline, 13 weeks)
Investigators
Gao Yang
Associate Professor
Hong Kong Baptist University