Community engaged approach to increase physical activity among Black individuals with colorectal cancer: Design of the Physical Activity Centers Empowerment (PACE) feasibility randomized controlled trial (Preprint)

Author:

Hirschey RachelORCID,Xu JingleORCID,Woodard NathanielORCID,Duggins Paulette,Lea Deirdre F.,Milner John L,Coleman Jr Karia,Bryant Ashley Leak,Sanoff Hanna K,Triglianos Tammy,Zou Baiming,Burse Natasha Renee,Hoover Rebecca L,Leeman Jennifer,Wheeler Stephanie B,Battaglini Claudio L,Valle Carmina GORCID

Abstract

BACKGROUND

Black individuals are more likely to die from colorectal cancer (CRC) and experience more treatment-related side effects compared to White individuals. Physical activity (PA) participation has been associated with decreased side effects, improved CRC treatment completion rates and responses, and survival. However, Black CRC survivors are 60% less likely to participate in PA than White survivors. The Physical Activity Centers Empowerment (PACE) study is testing an intervention specifically designed to increase PA among Black individuals diagnosed with CRC.

OBJECTIVE

This paper outlines the protocol for a randomized controlled trial (RCT). The study aims to test the feasibility of PACE; using the RE-AIM framework, reach, effectiveness, adoption, implementation, and maintenance will be measured.

METHODS

The PACE study was developed in partnership with a community advisory board consisting of Black cancer advocates and survivors. The study aims to recruit seventy-two participants over 18 years old who have been diagnosed with CRC from North Carolina. These participants will be randomized in a 1:1 ratio to an intervention or control group. During the 12-week intervention, all participants will receive a wearable activity tracker and informational materials from the American College of Sports Medicine's “Moving through Cancer” program. The intervention group will also receive additional PACE theory-guided intervention components, including personalized daily adaptive step goals, access to the PACE video library, and optional video chat meetings for PA support. Data will be collected at three points - baseline, post-intervention (3 months), and six months post-intervention (9 months). Using the RE-AIM framework, the study aims to evaluate the intervention's reach, effectiveness, acceptability, implementation, and maintenance.

RESULTS

The National Institute on Minority Health and Health Disparities funded this study in 2021. Study enrollment began in August 2024 and is anticipated to conclude in December 2024.

CONCLUSIONS

This study will advance our understanding of effective behavioral strategies to increase PA participation and help advance the utilization of PA as a form of complementary cancer treatment, with the aim of improving health outcomes for Black CRC survivors.

CLINICALTRIAL

This trial is registered on clinical.trials.gov (NCT06411756).

Publisher

JMIR Publications Inc.

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