A Tele-exercise Program for Breast Cancer Survivors

Behavior, Health Clinical Trial

Official title:

A Pilot Study of "a Home-based and Group-based Tele-exercise Program for Breast Cancer Survivors: a Randomized Controlled Trial"

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06382441
• Other study ID #: KC/KE-23-0122/ER-4
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: April 2024
• Source: Hong Kong Baptist University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 64 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Behavior, Health
• Breast Neoplasms

Intervention

Behavioral:
• tele-exercise
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.

Locations

Country	Name	City	State
Hong Kong	Xiong Zhennan	Kowloon Tong	Kowloon
Hong Kong	Yan SUN	Kowloon Tong	Kowloon

Sponsors (1)

Lead Sponsor	Collaborator
Hong Kong Baptist University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Recruitment rate	The proportion of eligible participants who are enrolled at baseline of the study.	baseline, 13 weeks
Primary	Retention rate	The proportion of enrolled participants who are present throughout the full length of the treatment.	baseline, 13 weeks
Primary	Attendance rate	The proportion of total sessions offered to participants to the actual number of sessions participants attended.	baseline, 13 weeks
Primary	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	Cardiorespiratory fitness	estimated by the 6-minute walk test, primary outcome of the main study	baseline, 13 weeks
Secondary	muscle strength	upper extremity muscle strength by the hand grip test and lower extremity muscle strength by the timed stand test	baseline, 13 weeks
Secondary	balance	Assessed using the Single Leg Stance Test. It is used to assess static postural and balance control and widely used in clinical settings to monitor neurological and musculoskeletal conditions.	baseline, 13 weeks
Secondary	% body fat	A Body Composition Analyzer (InBody 270)	baseline, 13 weeks
Secondary	skeletal muscle mass	A Body Composition Analyzer (InBody 270)	baseline, 13 weeks
Secondary	height	Measured using a portable stadiometer	baseline, 13 weeks
Secondary	Shoulder joint range of motion (ROM) of affected side	An arm goniometer will be used to measure shoulder joint ROM in forward flexion, internal rotation, external rotation, and abduction, following the Struyf and Meeus' recommendations to conduct the goniometric shoulder joint ROM measurements	baseline, 13 weeks
Secondary	Limb circumference and lymphedema	Arm circumference will be measured with a non-stretch tape at styloid and every 10 cm intervals from the ulnar styloid up to 40 cm distally 19. D Lymphedema will be defined as a more than 2 cm between-arm difference in arm circumference at any measurement point.	baseline, 13 weeks
Secondary	Health-related quality of life	Functional Assessment of Cancer Therapy - Breast (FACT-B) will be used. The total score of FACT-B ranged from 0 t o148. The higher the score, the better the quality of life.	baseline, 13 weeks
Secondary	Physical activity level (min/week)	International physical activity questionnaire (short version) was used to calculate physical activity level (min/week), higher scores mean a greater physical acitivity level.	baseline, 13 weeks