Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2026-03-17 @ 4:23 PM
Study NCT ID:
NCT06658912
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-14
First Post:
2024-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Planning Grant for TOPS for Breast Cancer Survivors
Sponsor:
Duke University
Organization:
Study Overview
Official Title:
Planning Grant for Take Off Pounds Sensibly (TOPS) Classes for Breast Cancer Survivors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-04
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 purpose of this study is to help make a community led weight loss program known as Take Off Pounds Sensibly (TOPS) more relevant for breast cancer survivors.
This study is made up to two parts. The first part includes using focus groups to review current materials that the investigators plan to use in upcoming TOPS classes and provide feedback. Focus groups will be made up of women who are breast cancer survivors.
The second part includes taking the feedback received from these focus groups and use this feedback to tailor TOPS classes for breast cancer survivors.
This ClinicalTrials.gov record is specific to the second part of the study.
This study is made up to two parts. The first part includes using focus groups to review current materials that the investigators plan to use in upcoming TOPS classes and provide feedback. Focus groups will be made up of women who are breast cancer survivors.
The second part includes taking the feedback received from these focus groups and use this feedback to tailor TOPS classes for breast cancer survivors.
This ClinicalTrials.gov record is specific to the second part of the study.
Detailed Description:
The purpose of this study is to help make a community led weight loss program known as Take Off Pounds Sensibly (TOPS) more relevant for breast cancer survivors.
This study is made up to two parts. The first part includes using focus groups to review current materials that the investigators plan to use in upcoming TOPS classes and have the groups provide feedback. Focus groups will be made up of breast cancer survivors that have recruited from local support group chapters. The goal is to recruit approximately 25 people to take part in these focus groups. Meetings of focus groups will be conducted remotely through Zoom and will be recorded. A meeting of the focus group will last anywhere from 60-90 minutes.
The information gathered from these groups will be used to improve the materials which lead to part two of the study.
The second part includes using these materials in TOPS classes that are tailored for breast cancer survivors and determining if the TOPS classes are effective on those who attend the classes. Effectiveness of the class will be determined by the weight loss of the participant and an impact on their heart health.
For the first 6 months, participants will attend dietician-led TOPS sessions conducted virtually through Zoom. Participants' weight will be measured as instructed using a Bluetooth scale that will send their weight measurements back to the team. Participants will also measure their blood pressure through a Bluetooth device provided by the study team.
After 6 months, participants will be asked to join a TOPS chapter in their community. The study team will help them local a chapter that is convenient for them. They must attend these classes for another 6 months. Total time in this portion of the study will be approximately 12 months.
While on study, in addition to measuring their weight and blood pressure via the Bluetooth devices, the study team asks that participants also have their blood collected. Participants will have to go to their local LabCorp facility to have blood drawn at baseline visit, 3 months, 6 months, and 12 months. Participants will also be asked to complete surveys via their email. Surveys will ask about participant's current medications and ask them to score their overall health at that time.
This ClinicalTrials.gov record is specific to the second part of the study.
This study is made up to two parts. The first part includes using focus groups to review current materials that the investigators plan to use in upcoming TOPS classes and have the groups provide feedback. Focus groups will be made up of breast cancer survivors that have recruited from local support group chapters. The goal is to recruit approximately 25 people to take part in these focus groups. Meetings of focus groups will be conducted remotely through Zoom and will be recorded. A meeting of the focus group will last anywhere from 60-90 minutes.
The information gathered from these groups will be used to improve the materials which lead to part two of the study.
The second part includes using these materials in TOPS classes that are tailored for breast cancer survivors and determining if the TOPS classes are effective on those who attend the classes. Effectiveness of the class will be determined by the weight loss of the participant and an impact on their heart health.
For the first 6 months, participants will attend dietician-led TOPS sessions conducted virtually through Zoom. Participants' weight will be measured as instructed using a Bluetooth scale that will send their weight measurements back to the team. Participants will also measure their blood pressure through a Bluetooth device provided by the study team.
After 6 months, participants will be asked to join a TOPS chapter in their community. The study team will help them local a chapter that is convenient for them. They must attend these classes for another 6 months. Total time in this portion of the study will be approximately 12 months.
While on study, in addition to measuring their weight and blood pressure via the Bluetooth devices, the study team asks that participants also have their blood collected. Participants will have to go to their local LabCorp facility to have blood drawn at baseline visit, 3 months, 6 months, and 12 months. Participants will also be asked to complete surveys via their email. Surveys will ask about participant's current medications and ask them to score their overall health at that time.
This ClinicalTrials.gov record is specific to the second part of the study.
Study Oversight
Has Oversight DMC:
True
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?: