Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06248918
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-18
First Post:
2024-01-31
Brief Title:
Nurse-led Physical Activity Program Among Breast Cancer Survivors
Sponsor:
Istanbul Medipol University Hospital
Organization:
Istanbul Medipol University Hospital
Study Overview
Official Title:
The Effects of a Nurse-led Using Wearable Technology Physical Activity Program on Health-Related Quality of Life and Physical Activity Level Among Breast Cancer Survivors
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
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:
WATSOCPAP
Brief Summary:
A nurse-led physical activity program including an individualized exercise program using wearable technology and health coaching based on Social Cognitive Theory will be implemented for women surviving cancer The impact of the nurse-led physical activity program on physical activity level health-related quality of life and cognitive factors self regulation outcome expectation self efficacy perceived social support perceived environment will be evaluated in the study
Detailed Description:
This study protocol describes a randomized controlled trial with parallel group design Participants will be Breast cancer survivors who aged 18-65 have finished active treatment surgery chemotherapy andor radiotherapy in the previous 5 years no evidence of recurrence and contraindications and are completing less than 150-minutes of Moderate-Vigorous intensity Physical Activity MVPA per week Participants will be randomly assigned to the intervention and control group
Wearable Technology using Social Cognitive Theory based physical activity program WATSOCPAP created for the Intervention Group includes 3 different intervention components 1 Supervised and individualized exercise plan 2 Physical activity monitoring with activity tracker 3 Nurse-led physical activity coaching program Participants will be administered strengthening and aerobic exercise program structured and individualized according to the persons individual capacity and needs under the supervision of a physiotherapist The activity tracker will provide real-time activity information about daily steps time spent with MVPA minutesday and sedentary time The nurse-led physical activity coaching program was planned according to the Social Cognitive Theory SCT components such as self-regulation outcome expectation social support and perceived environment WATSOCPAP is a 12-week program that includes text messages face-to-face and online interviews The first intervention in this group will begin with a 60-minute face-to-face individual training After the first interview text messages will be made according to the Social Cognitive Theory SCT components per weeks Control group will receive standard care Follow-up questionnaires will be applied by repeating the post-test at the 24th week In the intervention and control groups post-test will be applied 12 weeks after the pre-test and follow-up questionnaires will be applied 24 weeks after the pre-test
Wearable Technology using Social Cognitive Theory based physical activity program WATSOCPAP created for the Intervention Group includes 3 different intervention components 1 Supervised and individualized exercise plan 2 Physical activity monitoring with activity tracker 3 Nurse-led physical activity coaching program Participants will be administered strengthening and aerobic exercise program structured and individualized according to the persons individual capacity and needs under the supervision of a physiotherapist The activity tracker will provide real-time activity information about daily steps time spent with MVPA minutesday and sedentary time The nurse-led physical activity coaching program was planned according to the Social Cognitive Theory SCT components such as self-regulation outcome expectation social support and perceived environment WATSOCPAP is a 12-week program that includes text messages face-to-face and online interviews The first intervention in this group will begin with a 60-minute face-to-face individual training After the first interview text messages will be made according to the Social Cognitive Theory SCT components per weeks Control group will receive standard care Follow-up questionnaires will be applied by repeating the post-test at the 24th week In the intervention and control groups post-test will be applied 12 weeks after the pre-test and follow-up questionnaires will be applied 24 weeks after the pre-test
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