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Behavioural Intervention
Physical Activity Program for Colorectal Cancer (PACE Trial)
N/A
Waitlist Available
Led By Rachel Hirschey, Ph.D, RN
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histological diagnosis of goblet cell adenocarcinoma, adenosquamous carcinoma, and medullary carcinoma of colon/rectum
Age 18 years or older
Must not have
Not willing to be randomized
Unable to provide informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months to 9 months
Awards & highlights
Summary
This trial aims to see if a physical activity program called PACE can help African American individuals with colorectal cancer. The study will look at how well the program is reaching people, how effective it is
Who is the study for?
This trial is for African American individuals who have been diagnosed with colorectal cancer. It aims to test a new program designed to help them be more active.
What is being tested?
The study is testing the PACE program, which includes website access, monthly Zoom meetings, narrative videos, a Fitbit tracker, daily texts, and printed materials. Participants will be randomly placed into two groups to compare outcomes.
What are the potential side effects?
Since this trial focuses on physical activity support tools rather than medication or invasive procedures, side effects may include typical exercise-related issues such as muscle soreness or fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My diagnosis is a specific type of colon/rectum cancer.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not open to being randomly assigned to a treatment group.
Select...
I am unable to understand and agree to the study's details on my own.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months to 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months to 9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adaption of the study
Average weekly steps
Daily engagement in sedentary behaviors
+6 moreSecondary outcome measures
Bowel dysfunction score
Comorbidities
Depression score
+12 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Intervention ArmExperimental Treatment5 Interventions
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.
Group II: Control ArmExperimental Treatment2 Interventions
Subjects will receive access to the video library after the study period (after the 9-month assessment).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Printed materials
2006
Completed Phase 3
~90
Find a Location
Who is running the clinical trial?
National Institute on Minority Health and Health Disparities (NIMHD)NIH
395 Previous Clinical Trials
1,342,808 Total Patients Enrolled
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
354 Previous Clinical Trials
91,386 Total Patients Enrolled
Rachel Hirschey, Ph.D, RNPrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center
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