Physical Activity Centers Empowerment

NCT ID: NCT06411756

Last Updated: 2026-01-06

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-14

Study Completion Date

2027-01-31

Brief Summary

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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

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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.

Conditions

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Colorectal Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

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.

Group Type OTHER

Narrative videos

Intervention Type BEHAVIORAL

Culturally targeted narrative videos will be sent via email.

A Fitbit activity tracker

Intervention Type BEHAVIORAL

A Fitbit activity tracker is a wireless wearable device that monitors physical fitness activity.

Daily text message

Intervention Type OTHER

A daily adaptive step goal that will be sent via text message with a short positive message.

Monthly Zoom meeting

Intervention Type OTHER

Monthly Zoom meetings, led by the research team, to discuss physical activity with other study subjects.

Website access

Intervention Type OTHER

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).

Group Type OTHER

A Fitbit activity tracker

Intervention Type BEHAVIORAL

A Fitbit activity tracker is a wireless wearable device that monitors physical fitness activity.

Printed materials

Intervention Type OTHER

Printed materials from the American College of Sport's Medicine's "Moving through Cancer" campaign.

Printed materials

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

A Fitbit activity tracker

A Fitbit activity tracker is a wireless wearable device that monitors physical fitness activity.

Intervention Type BEHAVIORAL

Daily text message

A daily adaptive step goal that will be sent via text message with a short positive message.

Intervention Type OTHER

Monthly Zoom meeting

Monthly Zoom meetings, led by the research team, to discuss physical activity with other study subjects.

Intervention Type OTHER

Website access

Access to Physical Activity Centers Empowerment (PACE) website.

Intervention Type OTHER

Printed materials

Printed materials from the American College of Sport's Medicine's "Moving through Cancer" campaign.

Intervention Type OTHER

Printed materials

Printed materials from the American College of Sports Medicine's "Moving through Cancer" campaign.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. self-identifying as AA of Black,
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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 41105939 (View on PubMed)

Related Links

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http://unclineberger.org/patientcare/clinical-trials/clinical-trials

University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Other Identifiers

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1K23MD015719-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

LCCC2143AIM2

Identifier Type: -

Identifier Source: org_study_id

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