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Colorectal NeoplasmsPACENCT06411756

Physical Activity Centers Empowerment

A study testing Narrative videos, A Fitbit activity tracker and Daily text message in people with Colorectal Neoplasms, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Neoplasms
What is being tested?
Narrative videos, A Fitbit activity tracker and Daily text message
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
14 Aug 2024to 18 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Narrative videos, A Fitbit activity tracker, Daily text message, Monthly Zoom meeting, Website access
Keywords
Physical activity, Colorectal Neoplasms, Health Equity, Black or African American
Medical subject headings
Colorectal Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Narrative videosBehavioural

    Culturally targeted narrative videos will be sent via email.

  • A Fitbit activity trackerBehavioural

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

  • Daily text messageOther

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

  • Monthly Zoom meetingOther

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

  • Website accessOther

    Access to Physical Activity Centers Empowerment (PACE) website.

  • Printed materialsOther

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

  • Printed materialsBehavioural

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

Study groups in NCT06411756
Study groupRoleWhat they receive
Intervention ArmOtherSubjects 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.
Receives: Behavioral: Narrative videos; Behavioral: A Fitbit activity tracker; Other: Daily text message; Other: Monthly Zoom meeting; Other: Website access
Control ArmOtherSubjects will receive access to the video library after the study period (after the 9-month assessment).
Receives: Behavioral: A Fitbit activity tracker; Other: Printed materials; Behavioral: Printed materials

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility Reach- Recruitment

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

    Measured: 18 months

  2. Feasibility Retention

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

    Measured: 18 months

  3. 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.

    Measured: 3 months

  4. 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.

    Measured: 3 months

  5. 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.

    Measured: 3 months

  6. 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.

    Measured: Up to 18 months

  7. Implementation of the video library

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

    Measured: Up to 3 months

  8. Implementation of using FITBIT

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

    Measured: Up to 3 months

  9. 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).

    Measured: 3 months to 9 months

Secondary outcomes (15)

  1. 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.

    Measured: Baseline, 3 months, 9 months

  2. 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.

    Measured: Baseline, 3 months, 9 months

  3. 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.

    Measured: Baseline, 3 months, 9 months

  4. 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.

    Measured: Baseline, 3 months, 9 months

  5. 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.

    Measured: Baseline, 3 months, 9 months

  6. 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.

    Measured: Baseline, 3 months, 9 months

  7. 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.

    Measured: Baseline, 3 months, 9 months

  8. 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.

    Measured: Baseline, 3 months, 9 months

  9. 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.

    Measured: Baseline, 3 months, 9 months

  10. 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.

    Measured: Baseline, 3 months, 9 months

  11. 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.

    Measured: Baseline, 3 months, 9 months

  12. 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.

    Measured: Baseline, 3 months, 9 months

  13. Inflammation biomarkers level

    Inflammation biomarkers, including IL-4, IL-10, IL-6, and TNF-α, 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.

    Measured: Baseline, 3 months, 9 months

  14. 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.

    Measured: Baseline, 3 months, 9 months

  15. 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.

    Measured: Baseline, 3 months, 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2024
  2. Study start14 Aug 2024
  3. Primary completion18 May 2026
  4. Study completion18 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06411756
Sponsor's protocol ID
LCCC2143AIM2
Other IDs
1K23MD015719-01
Acronym
PACE
Status last verified
Jul 2026
First submitted
6 May 2024
Last updated
8 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 41105939

Questions about this trial

What is this clinical trial studying?

A study testing Narrative videos, A Fitbit activity tracker and Daily text message in people with Colorectal Neoplasms, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility Reach- Recruitment (time frame: 18 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06411756, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.

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