Physical Activity Centers Empowerment (PACE)

UNC Lineberger Comprehensive Cancer Center

Status: Active, not recruiting

Conditions: Colorectal Neoplasms

Treatments: Behavioral: Narrative videos; Other: Daily text message; Behavioral: Printed materials; Behavioral: A Fitbit activity tracker; Other: Monthly Zoom meeting; Other: Website access

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06411756

1K23MD015719-01 (U.S. NIH Grant/Contract)

LCCC2143AIM2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Intervention Arm

Other group

Description:

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.

Treatment:

Other: Website access

Other: Monthly Zoom meeting

Behavioral: A Fitbit activity tracker

Other: Daily text message

Behavioral: Narrative videos

Control Arm

Other group

Description:

Subjects will receive access to the video library after the study period (after the 9-month assessment).

Treatment:

Behavioral: Printed materials

Behavioral: A Fitbit activity tracker

Behavioral: Printed materials