Clinical trial NCT06411756: Physical Activity Centers Empowerment
Official title: Physical Activity Intervention Co-created and Tested With African American Colorectal Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Neoplasms
Keywords: Physical activity
Colorectal Neoplasms
Health Equity
Black or African American
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-05-13
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility Reach- Recruitment
timeFrame: 18 months
measure: Feasibility Retention
timeFrame: 18 months
measure: Average weekly steps
timeFrame: 3 months
measure: Weekly participation in mild, moderate, and vigorous exercise
timeFrame: 3 months
measure: Daily engagement in sedentary behaviors
timeFrame: 3 months
measure: Adaption of the study
timeFrame: Up to 18 months
measure: Implementation of the video library
timeFrame: Up to 3 months
measure: Implementation of using FITBIT
timeFrame: Up to 3 months
measure: The differences between intervention and control arms
timeFrame: 3 months to 9 months
Secondary outcomes:
measure: Outcome expectations
timeFrame: Baseline, 3 months, 9 months
measure: Feasibility activity knowledge
timeFrame: Baseline, 3 months, 9 months
measure: Self-efficacy
timeFrame: Baseline, 3 months, 9 months
measure: Physical activity engagement
timeFrame: Baseline, 3 months, 9 months
measure: Physical activity enjoyment
timeFrame: Baseline, 3 months, 9 months
measure: Pain score
timeFrame: Baseline, 3 months, 9 months
measure: Fatigue score
timeFrame: Baseline, 3 months, 9 months
measure: Depression score
timeFrame: Baseline, 3 months, 9 months
measure: Bowel dysfunction score
timeFrame: Baseline, 3 months, 9 months
measure: Sleep quality
timeFrame: Baseline, 3 months, 9 months
measure: Neurotoxicity
timeFrame: Baseline, 3 months, 9 months
measure: Quality of life score
timeFrame: Baseline, 3 months, 9 months
measure: Inflammation biomarkers level
timeFrame: Baseline, 3 months, 9 months
measure: Dietary behaviors
timeFrame: Baseline, 3 months, 9 months
measure: Comorbidities
timeFrame: Baseline, 3 months, 9 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Rachel Hirschey, Ph.D, RN
role: PRINCIPAL_INVESTIGATOR
References: