Clinical trial NCT06382441: A Tele-exercise Program for Breast Cancer Survivors
Official title: A Pilot Study of "a Home-based and Group-based Tele-exercise Program for Breast Cancer Survivors: a Randomized Controlled Trial"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior, Health
Keywords: tele-exercise
breast cancer survivors
randomized controlled trial
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 24
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.).

Primary outcomes:
measure: Acceptability (quantitative)
timeFrame: baseline, 13 weeks
measure: Acceptability (qualitative)
timeFrame: baseline, 13 weeks
measure: Recruitment rate
timeFrame: baseline, 13 weeks
measure: Retention rate
timeFrame: baseline, 13 weeks
measure: Attendance rate
timeFrame: baseline, 13 weeks
measure: Compliance rate
timeFrame: baseline, 13 weeks
Secondary outcomes:
measure: Cardiorespiratory fitness
timeFrame: baseline, 13 weeks
measure: muscle strength
timeFrame: baseline, 13 weeks
measure: balance
timeFrame: baseline, 13 weeks
measure: % body fat
timeFrame: baseline, 13 weeks
measure: skeletal muscle mass
timeFrame: baseline, 13 weeks
measure: height
timeFrame: baseline, 13 weeks
measure: Shoulder joint range of motion (ROM) of affected side
timeFrame: baseline, 13 weeks
measure: Limb circumference and lymphedema
timeFrame: baseline, 13 weeks
measure: Health-related quality of life
timeFrame: baseline, 13 weeks
measure: Physical activity level (min/week)
timeFrame: baseline, 13 weeks
Other outcomes:
Locations:
city: Kowloon Tong
country: Hong Kong
facility: Xiong Zhennan
state: Kowloon
city: Kowloon Tong
country: Hong Kong
facility: Yan SUN
state: Kowloon
Study officials:
affiliation: Dept of Surgery, KWH
name: Oi Kwan CHUN
role: STUDY_DIRECTOR
affiliation: Dept of Surgery, KWH
name: Wai Wun Sara FUNG
role: STUDY_DIRECTOR
References: