Behavior, HealthNCT06382441

A Tele-exercise Program for Breast Cancer Survivors

A study testing tele-exercise in people with Behavior, Health, run by Hong Kong Baptist University at 2 sites in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 40 to 64 years, women onlyHealthy volunteers can take part
Conditions the study is for: Behavior, Health
What is being tested?: tele-exercise
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 2 sitesHong Kong
Study dates: 1 Nov 2023to 30 Jun 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 64 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Hong Kong2 sites

Xiong Zhennan
Kowloon Tong, Kowloon
Yan SUN
Kowloon Tong, Kowloon

Other trials in Hong Kong

About this study

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

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.

Read the 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.

Conditions: Behavior, Health
Being tested: tele-exercise
Keywords: tele-exercise, breast cancer survivors, randomized controlled trial
Medical subject headings: Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

tele-exerciseBehavioural
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.

Study groups in NCT06382441
Study group	Role	What they receive
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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: baseline, 13 weeks
Recruitment rate
The proportion of eligible participants who are enrolled at baseline of the study.
Measured: baseline, 13 weeks
Retention rate
The proportion of enrolled participants who are present throughout the full length of the treatment.
Measured: baseline, 13 weeks
Attendance rate
The proportion of total sessions offered to participants to the actual number of sessions participants attended.
Measured: 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.
Measured: baseline, 13 weeks

Secondary outcomes (10)

Cardiorespiratory fitness
estimated by the 6-minute walk test, primary outcome of the main study
Measured: baseline, 13 weeks
muscle strength
upper extremity muscle strength by the hand grip test and lower extremity muscle strength by the timed stand test
Measured: baseline, 13 weeks
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.
Measured: baseline, 13 weeks
% body fat
A Body Composition Analyzer (InBody 270)
Measured: baseline, 13 weeks
skeletal muscle mass
A Body Composition Analyzer (InBody 270)
Measured: baseline, 13 weeks
height
Measured using a portable stadiometer
Measured: baseline, 13 weeks
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
Measured: baseline, 13 weeks
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.
Measured: baseline, 13 weeks
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.
Measured: baseline, 13 weeks
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.
Measured: baseline, 13 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 202330 Jun 2024

First posted24 Apr 2024
Study start1 Nov 2023
Primary completion31 May 2024
Study completion30 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Behavior, HealthStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Care provider, Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06382441
Sponsor's protocol ID: KC/KE-23-0122/ER-4
Status last verified: Oct 2024
First submitted: 5 Mar 2024
Last updated: 18 Oct 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Not yet recruiting
The AYA Oncology Self-care Movement
Acute Lymphobkastic Leukemia, Medication Adherence
Not yet recruitingPhase 1
Consciousness and Psilocybin Effects on Well-Being: The CoPEWell Study
Well-Being, Psychological, Psychedelic Experiences
Not yet recruiting
Building Resilience Through Anxiety Virtual Education in PICU Survivors
Critical Illness Recovery, Mental Health
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety

All Behavior, Health trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study of "a Home-based and Group-based Tele-exercise Program for Breast Cancer Survivors: a Randomized Controlled Trial"
ClinicalTrials.gov ID: NCT06382441
Acronym / sponsor ID: KC/KE-23-0122/ER-4
Conditions: Behavior, Health
Keywords: tele-exercise, breast cancer survivors, randomized controlled trial
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Hong Kong Baptist UniversityUniversity, hospital or other
Study start: 1 Nov 2023 (actual)
Primary completion: 31 May 2024 (actual)
Study completion: 30 Jun 2024 (actual)
First posted: 24 Apr 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Tele-excercise	Experimental	Behavioral: tele-exerciseIn 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.
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.

Who may qualify

Ages: 40 to 64 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
tele-exerciseIt 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.	Behavioural	Tele-excercise

Primary outcome

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.
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.
Retention rate
Time frame: baseline, 13 weeks
The proportion of enrolled participants who are present throughout the full length of the treatment.
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.

10 secondary outcomes

Cardiorespiratory fitness
Time frame: baseline, 13 weeks
muscle strength
Time frame: baseline, 13 weeks
balance
Time frame: baseline, 13 weeks
% body fat
Time frame: baseline, 13 weeks
skeletal muscle mass
Time frame: baseline, 13 weeks
height
Time frame: baseline, 13 weeks
Shoulder joint range of motion (ROM) of affected side
Time frame: baseline, 13 weeks
Limb circumference and lymphedema
Time frame: baseline, 13 weeks
Health-related quality of life
Time frame: baseline, 13 weeks
Physical activity level (min/week)
Time frame: baseline, 13 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
Individual participant dataSharing planned: No

Related trials for Behavior, Health

Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Not yet recruiting
The AYA Oncology Self-care Movement
Acute Lymphobkastic Leukemia, Medication Adherence
Not yet recruitingPhase 1
Consciousness and Psilocybin Effects on Well-Being: The CoPEWell Study
Well-Being, Psychological, Psychedelic Experiences
Not yet recruiting
Building Resilience Through Anxiety Virtual Education in PICU Survivors
Critical Illness Recovery, Mental Health
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Oi Kwan CHUN study director

Dept of Surgery, KWH

Wai Wun Sara FUNG study director

Dept of Surgery, KWH

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing tele-exercise in people with Behavior, Health, run by Hong Kong Baptist University at 2 sites in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability (quantitative) (time frame: baseline, 13 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06382441.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.