Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
21 participants
INTERVENTIONAL
2024-08-14
2027-01-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention Arm
Subjects will receive access to the video library, a Fitbit, a daily adaptive step goal that will be sent via text message with a short positive message; and monthly Zoom meetings, led by the research team, to discuss physical activity with other study subjects.
Narrative videos
Culturally targeted narrative videos will be sent via email.
A Fitbit activity tracker
A Fitbit activity tracker is a wireless wearable device that monitors physical fitness activity.
Daily text message
A daily adaptive step goal that will be sent via text message with a short positive message.
Monthly Zoom meeting
Monthly Zoom meetings, led by the research team, to discuss physical activity with other study subjects.
Website access
Access to Physical Activity Centers Empowerment (PACE) website.
Control Arm
Subjects will receive access to the video library after the study period (after the 9-month assessment).
A Fitbit activity tracker
A Fitbit activity tracker is a wireless wearable device that monitors physical fitness activity.
Printed materials
Printed materials from the American College of Sport's Medicine's "Moving through Cancer" campaign.
Printed materials
Printed materials from the American College of Sports Medicine's "Moving through Cancer" campaign.
Interventions
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Narrative videos
Culturally targeted narrative videos will be sent via email.
A Fitbit activity tracker
A Fitbit activity tracker is a wireless wearable device that monitors physical fitness activity.
Daily text message
A daily adaptive step goal that will be sent via text message with a short positive message.
Monthly Zoom meeting
Monthly Zoom meetings, led by the research team, to discuss physical activity with other study subjects.
Website access
Access to Physical Activity Centers Empowerment (PACE) website.
Printed materials
Printed materials from the American College of Sport's Medicine's "Moving through Cancer" campaign.
Printed materials
Printed materials from the American College of Sports Medicine's "Moving through Cancer" campaign.
Eligibility Criteria
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Inclusion Criteria
2. diagnosis of CRC,
3. scheduled to receive chemotherapy,
4. age 18 years or older,
5. no contraindications to unsupervised PA as determined by the PA readiness questionnaire,
6. oncologist approval to participate, and
7. a smartphone for Fitbit syncing.
18 Years
ALL
No
Sponsors
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National Institute on Minority Health and Health Disparities (NIMHD)
NIH
UNC Lineberger Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Rachel Hirschey, Ph.D, RN
Role: PRINCIPAL_INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
Locations
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Countries
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References
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Hirschey R, Xu J, Woodard N, Duggins P, Lea DF, Milner JL, Coleman K Jr, Bryant AL, Sanoff HK, Triglianos T, Zou B, Burse NR, Hoover RL, Leeman J, Wheeler SB, Battaglini CL, Valle CG. Community-Engaged Approach to Increase Physical Activity Among Black Individuals With Colorectal Cancer: Protocol for a Feasibility Randomized Controlled Trial of the Physical Activity Centers Empowerment Study. JMIR Res Protoc. 2025 Oct 17;14:e65804. doi: 10.2196/65804.
Related Links
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University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials
Other Identifiers
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LCCC2143AIM2
Identifier Type: -
Identifier Source: org_study_id
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