Physical Activity Centers Empowerment

NCT06411756 | Active Not Recruiting DMC

• 2 other identifiers: LCCC2143AIM21K23MD015719-01
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Neoplasms

Keywords

Physical activity; Colorectal Neoplasms; Health Equity; Black or African American

Outcome Measures

Primary Outcomes (9)

• Feasibility Reach- Recruitment

  Feasibility Reach- Recruitment is measured by the number of participants screened, ineligible, eligible, enrolled and declined participation.

  18 months

• Feasibility Retention

  Retention is measured by the frequency of enrolled participants continued study interventions

  18 months

• Average weekly steps

  Average weekly steps and the frequency of participants achieving daily step goals. Daily steps are collected via Fitbit Inspire activity tracker. Differences in daily steps and the frequency of meeting daily step goals between the intervention and control arms.

  3 months

• Weekly participation in mild, moderate, and vigorous exercise

  Weekly participation in mild, moderate, and vigorous exercise is time spent on physical activity each week is measured subjectively using the Godin Leisure-time Exercise Questionnaire (GLTEQ) and objectively by the Fitbit Inspire activity tracker. The GLTEQ asks participants to self-report how many times they do strenuous, moderate, and mild or light exercise each week and the average duration of exercise. The intervention effectiveness is operationalized by the differences in minutes of doing mild, moderate, and vigorous physical activity between the intervention and control arms.

  3 months

• Daily engagement in sedentary behaviors

  Daily engagement in sedentary behaviors will be measured as time spent on sedentary behaviors per day is measured subjectively by a 10-option Likert scale called the Sedentary Behavior Questionnaire. Participants are asked to select one of the following options: none,\<=15 minutes, 30 minutes,1 hour,2 hours,3 hours, 4 hours, 5 hours, and 6 hours or more" to estimate the time they spend doing each sedentary behavior on a typical week and a typical weekend day. The behaviors include watching television, playing computer or video games, sitting and listening to music on the radio, tapes, or CDs, sitting and talking on the phone, doing paperwork or computer work, sitting and reading a book or magazine, playing a musical instrument, doing artwork or crafts, and sitting and driving a car, bus or train. The total daily sedentary score ranges from 0 to 81. Daily sedentary time is also recorded objectively by the Fitbit Inspire activity tracker.

  3 months

• Adaption of the study

  Adaption of the study will be measured by the percentage of contacted individuals who meet study criteria to participate in the study.

  Up to 18 months

• Implementation of the video library

  Implementation of the video library: The percentage of participants who watched study-related video content.

  Up to 3 months

• Implementation of using FITBIT

  Implementation of using FITBIT: The percentage of days that participants wear the study-issued Fitbits.

  Up to 3 months

• The differences between intervention and control arms

  The Maintenance will be measured as the differences in intervention effects between intervention and control arms groups 6 months post-intervention (9 months post-baseline).

  3 months to 9 months

Secondary Outcomes (15)

• Outcome expectations

  Baseline, 3 months, 9 months

• Feasibility activity knowledge

  Baseline, 3 months, 9 months

• Self-efficacy

  Baseline, 3 months, 9 months

• Physical activity engagement

  Baseline, 3 months, 9 months

• Physical activity enjoyment

  Baseline, 3 months, 9 months

Study Arms (2)

Intervention Arm

OTHER

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.

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

Control Arm

OTHER

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

Behavioral: A Fitbit activity tracker; Other: Printed materials; Behavioral: Printed materials

Interventions

Narrative videos BEHAVIORAL

Culturally targeted narrative videos will be sent via email.

Intervention Arm

A Fitbit activity tracker BEHAVIORAL

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

Control Arm; Intervention Arm

Website access OTHER

Access to Physical Activity Centers Empowerment (PACE) website.

Intervention Arm

Printed materials OTHER

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

Control Arm

Daily text message OTHER

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

Intervention Arm

Monthly Zoom meeting OTHER

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

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• self-identifying as AA of Black,
• diagnosis of CRC,
• scheduled to receive chemotherapy,
• age 18 years or older,
• no contraindications to unsupervised PA as determined by the PA readiness questionnaire,
• oncologist approval to participate, and
• a smartphone for Fitbit syncing.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (1)

• 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.

  PMID: 41105939 DERIVED

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Colorectal Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Behavior

Study Officials

• Rachel Hirschey, Ph.D, RN

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 13, 2024
• Study Start: August 14, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

US (1)