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Behavioural Intervention

Physical Activity Program for Colorectal Cancer (PACE Trial)

N/A

Recruiting

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

No Placebo-Only Group

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 below

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My diagnosis is a specific type of colon/rectum cancer.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not open to being randomly assigned to a treatment group.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months to 9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adaption of the study

Average weekly steps

Daily engagement in sedentary behaviors

+6 more

Secondary study objectives

Bowel dysfunction score

Comorbidities

Depression score

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

0 / 4Eligibility criteria met