Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT06411756
Status:
RECRUITING
Last Update Posted:
2025-02-11
First Post:
2024-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Physical Activity Centers Empowerment
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Physical Activity Intervention Co-created and Tested With African American Colorectal Cancer Survivors
Status:
RECRUITING
Status Verified Date:
2025-02
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:
PACE
Brief Summary:
This research study tests the feasibility of the Physical Activity Centers Empowerment (PACE) physical activity intervention for African American individuals diagnosed with colorectal cancer.
Feasibility will be measured as intervention reach, effectiveness, adoption, implementation, and maintenance. Seventy-two subjects will be recruited to conduct a pilot two-group, randomized repeated measures study.
Feasibility will be measured as intervention reach, effectiveness, adoption, implementation, and maintenance. Seventy-two subjects will be recruited to conduct a pilot two-group, randomized repeated measures study.
Detailed Description:
The purpose of this research is to improve the quality of life for underserved cancer survivors by increasing physical activity. A physical activity intervention will be tested for feasibility with African American cancer survivors. The project will serve as a foundation for intervening with other underserved cancer survivors.
Feasibility will be measured as intervention Reach, Effectiveness, Adoption, Implementation, and Maintenance, following the RE-AIM framework. Survey and biomarker data will be collected at baseline, 3 and 9 months later. These time points will facilitate exploration of changes pre- and post-intervention, and to determine if effects are maintained 6 months after completing the intervention. Our primary hypothesis is that the intervention will be feasible to deliver.
Feasibility will be measured as intervention Reach, Effectiveness, Adoption, Implementation, and Maintenance, following the RE-AIM framework. Survey and biomarker data will be collected at baseline, 3 and 9 months later. These time points will facilitate exploration of changes pre- and post-intervention, and to determine if effects are maintained 6 months after completing the intervention. Our primary hypothesis is that the intervention will be feasible to deliver.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1K23MD015719-01 | NIH | None | https://reporter.nih.gov/quic… | View |