Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06382441
Status:
COMPLETED
Last Update Posted:
2024-04-24
First Post:
2024-03-05
Brief Title:
A Tele-exercise Program for Breast Cancer Survivors
Sponsor:
Hong Kong Baptist University
Organization:
Hong Kong Baptist University
Study Overview
Official Title:
A Pilot Study of a Home-based and Group-based Tele-exercise Program for Breast Cancer Survivors a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None