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Trial Title:
Physical Activity Centers Empowerment
NCT ID:
NCT06411756
Condition:
Colorectal Neoplasms
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
Physical activity
Colorectal Neoplasms
Health Equity
Black or African American
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Narrative videos
Description:
Culturally targeted narrative videos will be sent via email.
Arm group label:
Intervention Arm
Intervention type:
Behavioral
Intervention name:
A Fitbit activity tracker
Description:
A Fitbit activity tracker is a wireless wearable device that monitors physical fitness
activity.
Arm group label:
Control Arm
Arm group label:
Intervention Arm
Intervention type:
Other
Intervention name:
Daily text message
Description:
A daily adaptive step goal that will be sent via text message with a short positive
message.
Arm group label:
Intervention Arm
Intervention type:
Other
Intervention name:
Monthly Zoom meeting
Description:
Monthly Zoom meetings, led by the research team, to discuss physical activity with other
study subjects.
Arm group label:
Intervention Arm
Intervention type:
Other
Intervention name:
Website access
Description:
Access to Physical Activity Centers Empowerment (PACE) website.
Arm group label:
Intervention Arm
Intervention type:
Other
Intervention name:
Printed materials
Description:
Printed materials from the American College of Sport's Medicine's "Moving through Cancer"
campaign.
Arm group label:
Control Arm
Intervention type:
Behavioral
Intervention name:
Printed materials
Description:
Printed materials from the American College of Sports Medicine's "Moving through Cancer"
campaign.
Arm group label:
Control Arm
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Self-identifying as African American or Black
2. Age 18 years or older.
3. Histological diagnosis of goblet cell adenocarcinoma, adenosquamous carcinoma, and
medullary carcinoma of colon/rectum.
4. Oncologist approval to participate
Exclusion Criteria:
1. Planning to be pregnant or become pregnant
2. Unable to provide informed consent
3. Does not own a smartphone with an active data plan or tablet (for Fitbit syncing)
4. No internet access (for viewing PACE video)
5. Contraindications to unsupervised PA, as determined by the PA readiness
questionnaire
6. Not willing to be randomized.
7. Not willing to use Fitbit throughout the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of North Carolina at Chapel Hill
Address:
City:
Chapel Hill
Zip:
27514
Country:
United States
Contact:
Last name:
Jingle Xu, MS
Investigator:
Last name:
Rachel Hirschey, PhD RN
Email:
Principal Investigator
Start date:
December 20, 2024
Completion date:
January 31, 2027
Lead sponsor:
Agency:
UNC Lineberger Comprehensive Cancer Center
Agency class:
Other
Collaborator:
Agency:
National Institute on Minority Health and Health Disparities (NIMHD)
Agency class:
NIH
Source:
UNC Lineberger Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06411756
http://unclineberger.org/patientcare/clinical-trials/clinical-trials
