A Tele-exercise Program for Breast Cancer Survivors

NCT06382441 | Completed

• 1 other identifier: KC/KE-23-0122/ER-4
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Behavior, Health

Keywords

tele-exercise; breast cancer survivors; randomized controlled trial

Outcome Measures

Primary Outcomes (6)

• Acceptability (quantitative)

  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.

  baseline, 13 weeks

• Acceptability (qualitative)

  Participants rated intervention regarding the aspects of satisfaction, enjoyment, perceptions of safety, difficulty, tolerability of treatment, adverse events by interviews.

  baseline, 13 weeks

• Recruitment rate

  The proportion of eligible participants who are enrolled at baseline of the study.

  baseline, 13 weeks

• Retention rate

  The proportion of enrolled participants who are present throughout the full length of the treatment.

  baseline, 13 weeks

• Attendance rate

  The proportion of total sessions offered to participants to the actual number of sessions participants attended.

  baseline, 13 weeks

• Compliance rate

  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.

  baseline, 13 weeks

Secondary Outcomes (10)

• Cardiorespiratory fitness

  baseline, 13 weeks

• muscle strength

  baseline, 13 weeks

• balance

  baseline, 13 weeks

• % body fat

  baseline, 13 weeks

• skeletal muscle mass

  baseline, 13 weeks

Study Arms (2)

Tele-excercise

EXPERIMENTAL

In Group A (intervention), the 12 participants will form 2 groups (6 participants per group) according to their individual exercise intensity levels determined prior to the intervention for each participant. Each group will receive online coach-supervised training sessions 3 times per week for 4 weeks (a total of 12 sessions), which will be delivered by a certified coach and an assistant (a student helper, major in sports and health). Each session will consist of warm-up, aerobic exercise, resistance exercise, stretching and cool-down, with exercise period progressively increasing from 30 minutes to 50 minutes and exercise intensity progressively increasing from low to moderate levels (Table 1). Lighter intensity may be adopted when there is a need (e.g., for those with severe conditions). Target heart rate during exercise will be monitored by a pulse oximeter. Cameras will be requested to be turned on all the time.

Behavioral: tele-exercise

Control

NO INTERVENTION

Participants in Group B (active control) will receive an essay on exercise and health every week for four weeks (a total of 4 essays). Proposed topics include: 1) beneficial effects of exercise and recommended exercise for breast cancer survivors; 2) WHO's recommendations for physical activity; 3) exercise intensity; 4) principles of exercise.

Interventions

tele-exercise BEHAVIORAL

It is a prospective and pilot study of RCT. It will be a pilot to test 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.

Tele-excercise

Eligibility Criteria

• Age: 40 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• With any medical, physical and psychological conditions that may limit participation (e.g., uncontrolled severe cardiovascular disease, schizophrenia, severe neurological dysfunction, etc.).

Sponsors & Collaborators

• Hong Kong Baptist University: lead

Study Sites (2)

Xiong Zhennan

Kowloon Tong, Kowloon, Hong Kong

Location

Yan SUN

Kowloon Tong, Kowloon, Hong Kong

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Oi Kwan CHUN

  Dept of Surgery, KWH

  STUDY DIRECTOR

• Wai Wun Sara FUNG

  Dept of Surgery, KWH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: April 24, 2024
• Study Start: November 1, 2023
• Primary Completion: May 31, 2024
• Study Completion: June 30, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2)