Physical Activity Centers Empowerment

Colorectal Neoplasms Clinical Trial

— PACE  

Official title:

Physical Activity Intervention Co-created and Tested With African American Colorectal Cancer Survivors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06411756
• Other study ID #: LCCC2143AIM2
• Secondary ID: 1K23MD015719-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: September 1, 2025

Study information

• Verified date: May 2024
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: Cason E Whitcomb
• Phone: 919-966-3036
• Email: cason_whitcomb[@]med.unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Self-identifying as African American or Black

2. Age 18 years or older.

3. Histological diagnosis of goblet cell adenocarcinoma, adenosquamous carcinoma, and medullary carcinoma of colon/rectum.

4. Oncologist approval to participate

Exclusion Criteria:

1. Planning to be pregnant or become pregnant

2. Unable to provide informed consent

3. Does not own a smartphone with an active data plan or tablet (for Fitbit syncing)

4. No internet access (for viewing PACE video)

5. Contraindications to unsupervised PA, as determined by the PA readiness questionnaire

6. Not willing to be randomized.

7. Not willing to use Fitbit throughout the study.

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Behavioral:
• Narrative videos
Culturally targeted narrative videos will be sent via email.
• A Fitbit activity tracker
A Fitbit activity tracker is a wireless wearable device that monitors physical fitness activity.

Other:
• Daily text message
A daily adaptive step goal that will be sent via text message with a short positive message.
• Monthly Zoom meeting
Monthly Zoom meetings, led by the research team, to discuss physical activity with other study subjects.
• Website access
Access to Physical Activity Centers Empowerment (PACE) website.
• Printed materials
Printed materials from the American College of Sport's Medicine's "Moving through Cancer" campaign.

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

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility Reach- Recruitment	Feasibility Reach- Recruitment is measured by the number of participants screened, ineligible, eligible, enrolled and declined participation.	18 months
Primary	Feasibility Retention	Retention is measured by the frequency of enrolled participants continued study interventions	18 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Implementation of the video library	Implementation of the video library: The percentage of participants who watched study-related video content.	Up to 3 months
Primary	Implementation of using FITBIT	Implementation of using FITBIT: The percentage of days that participants wear the study-issued Fitbits.	Up to 3 months
Primary	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	Outcome expectations	Outcome expectations will be measured using the modified Multidimensional Outcome Expectations for Exercise Scale, which has an internal consistency of 0.82, 0.84, and 0.81 for physical, self-evaluative, and social outcomes. Differences in outcome expectation scores between the intervention and control arms will be analyzed.; This 5-point Likert scale contains 19 items with the outcome expectation score ranging from 19 to 95. A higher score indicates a higher expectation of doing physical activity for diverse health, cancer, social, and psychological outcomes.	Baseline, 3 months, 9 months
Secondary	Feasibility activity knowledge	Physical activity knowledge will be measured using a 5-point behavioral capacity Likert scale that assesses participants' knowledge about types, intensity, frequency, and skills of doing physical activity. The knowledge score ranges from 5 to 25. A higher score indicates a higher level of knowledge about doing appropriate physical activity. Differences in knowledge scores between the intervention and control arms will be analyzed.	Baseline, 3 months, 9 months
Secondary	Self-efficacy	Self-efficacy will be measured using a nine-item barrier self-efficacy scale and a four-item task self-efficacy scale to assess participants' confidence in overcoming barriers to physical activity and ability to do physical activity. The two self-efficacy scales have Cronbach's alpha of 0.96 and 0.89 among cancer patients, respectively. The total self-efficacy score ranges from The total self-efficacy score ranges from 13 to 65. A higher score indicates a higher level of confidence in overcoming barriers and doing physical activity. Differences in total self-efficacy scores between the intervention and control arms will be analyzed.	Baseline, 3 months, 9 months
Secondary	Physical activity engagement	Physical activity engagement is measured by a 6-point Likert scale that measures the habit strength for moderate-to-vigorous physical activity. The total habit score ranges from 17 to 102. A higher score indicates a greater engagement in physical activity. Differences in habit scores between the intervention and control arms will be analyzed.	Baseline, 3 months, 9 months
Secondary	Physical activity enjoyment	Enjoyment is measured by a short version of the Physical Activity Enjoyment Scale (4-item). The enjoyment score ranges from 4 to 20. A higher score indicates a higher level of enjoyment participants perceive from doing physical activity. Differences in enjoyment scores between the intervention and control arms will be analyzed.	Baseline, 3 months, 9 months
Secondary	Pain score	Pain will be measured using a 4-item 5-point Likert pain interference scale from the Patient-Reported Outcomes Measurement Information System (PROMIS) measures. The pain score ranges from 4 to 20. A higher score indicates a higher level of pain interfering with participants' activities. Differences in the pain score between intervention and control groups will be analyzed.	Baseline, 3 months, 9 months
Secondary	Fatigue score	Fatigue will be measured using a 4-item 5-point Likert fatigue scale from the PROMIS measures. The fatigue score ranges from 4 to 20. A higher score indicates a higher level of fatigue. Differences in the fatigue score between intervention and control groups will be analyzed.	Baseline, 3 months, 9 months
Secondary	Depression score	Depression will be measured using a 4-item 5-point Likert emotional distress scale from PROMIS measures. The depression score ranges from 4 to 20. A higher score indicates a higher level of depression. Differences in the depression score between intervention and control groups will be analyzed.	Baseline, 3 months, 9 months
Secondary	Bowel dysfunction score	Bowel dysfunction will be measured using a 5-point Likert scale from the PROMIS that measures gastrointestinal diarrhea and constipation. The bowel dysfunction score ranges from 15 to 75. A higher score indicates a higher gastrointestinal discomfort participants have. Differences in the score between intervention and control groups will be analyzed.	Baseline, 3 months, 9 months
Secondary	Sleep quality	Sleep quality will be measured using a 4-item 5-point Likert scale from the PROMIS measures. The sleep score ranges from 4 to 20. A higher score indicates a better sleep quality. Differences in the sleep score between intervention and control groups will be analyzed.	Baseline, 3 months, 9 months
Secondary	Neurotoxicity	Neurotoxicity will be measured using a 4-item 5-point Likert scale from the PROMIS measures. The neurotoxicity score ranges from 4 to 20. A higher score indicates greater neurotoxicity symptoms participants report. Differences in the neurotoxicity score between intervention and control groups will be analyzed.	Baseline, 3 months, 9 months
Secondary	Quality of life score	Quality of life score will be measured using the 36-item Short Form Health Survey. The quality of life score ranges from 0 to 100. The score for each item in the form ranges from 0 to 100 and the average scores of items representing general physical, mental, and social health are calculated, respectively. A higher score indicates better general physical, mental, or social health. Differences in the score between intervention and control groups will be analyzed.	Baseline, 3 months, 9 months
Secondary	Inflammation biomarkers level	Inflammation biomarkers, including IL-4, IL-10, IL-6, and TNF-a, will be measured by collecting participants' blood samples using the Dried Blood Spot card. The differences in inflammation biomarker levels between the intervention and control groups will be analyzed.	Baseline, 3 months, 9 months
Secondary	Dietary behaviors	Dietary behaviors are measured by the Rapid Eating Assessment for Participants (Shortened Version, 16 items). The diet score ranges from 1 to 46. A higher score indicates that the participant follows healthier dietary behaviors. Differences in diet scores between the intervention and control arms will be analyzed.	Baseline, 3 months, 9 months
Secondary	Comorbidities	Comorbidities will be measured using the Self-administered Comorbidity Questionnaire. Participants are asked to self-report whether they have or received treatment for 14 common health problems. The comorbidity score ranges from 0 to 28. Differences in comorbidity scores between the intervention and control arms will be analyzed.	Baseline, 3 months, 9 months

External Links

•   University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials