protocolSection identificationModule nctId: NCT06382441, orgStudyIdInfo id: KC/KE-23-0122/ER-4, briefTitle: A Tele-exercise Program for Breast Cancer Survivors, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Hong Kong Baptist University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Behavior, Health, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ACTUAL, armsInterventionsModule interventions name: tele-exercise, outcomesModule primaryOutcomes measure: Acceptability (quantitative), primaryOutcomes measure: Acceptability (qualitative), primaryOutcomes measure: Recruitment rate, primaryOutcomes measure: Retention rate, primaryOutcomes measure: Attendance rate, primaryOutcomes measure: Compliance rate, secondaryOutcomes measure: Cardiorespiratory fitness, secondaryOutcomes measure: muscle strength, secondaryOutcomes measure: balance, secondaryOutcomes measure: % body fat, secondaryOutcomes measure: skeletal muscle mass, secondaryOutcomes measure: height, secondaryOutcomes measure: Shoulder joint range of motion (ROM) of affected side, secondaryOutcomes measure: Limb circumference and lymphedema, secondaryOutcomes measure: Health-related quality of life, secondaryOutcomes measure: Physical activity level (min/week), eligibilityModule sex: FEMALE, minimumAge: 40 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: Xiong Zhennan, city: Kowloon Tong, state: Kowloon, country: Hong Kong, geoPoint lat: 22.33312, lon: 114.17969, locations facility: Yan SUN, city: Kowloon Tong, state: Kowloon, country: Hong Kong, geoPoint lat: 22.33312, lon: 114.17969, hasResults: False