- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02442583
Reducing Sedentary Behaviors Among Colorectal Cancer Survivors
February 24, 2017 updated by: Duke University
Reducing Sedentary Behaviors Among Colorectal Cancer Survivors: Cancer Survivorship Center Pilot Project
Interview colorectal cancer survivors and use this input to create a brochure intended to guide reduction of sedentary behaviors in this population.
Have colorectal cancer survivors review and comment on a draft of the brochure.
A third group of colorectal cancer survivors will wear an Actigraph activity monitor for one week, then receive feedback on their activity level with the brochure.
After one month this group will be surveyed by telephone regarding their use of the brochure, and their physical activity level.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27701
- Duke University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult
- Early (stage 1 or 2) colorectal cancer
- 6 months or greater post treatment
- Does not follow guidelines for physical activity
- Average at least 6 hours a day of sedentary behaviors
Exclusion Criteria:
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Arm 1: Phase 1, Step 1
In this part, 15 early stage colorectal cancer survivors will fill out surveys and have a recorded phone interview regarding their physical activity and sedentary behaviors, to inform the creation of a brochure about sedentary behaviors.
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No Intervention: Arm 2: Phase 1, Step 2
5 early stage colorectal cancer survivors will have recorded telephone interviews to provide feedback about the brochure.
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Experimental: Arm 3: Phase 2
15 early stage colorectal cancer survivors will complete a baseline survey about sedentary behaviors, then wear an Actigraph device and self-report their sedentary activities for one week.
They will receive feedback regarding their activity, and one month after receiving the feedback will participate in a phone survey regarding use of the brochure, physical activity and sedentary behaviors.
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This pilot will occur in two phases.
Phase 1 will occur in two steps.
In Step 1, we will conduct one-on-one telephone interviews with 15 early stage CRC (colorectal cancer) survivors to obtain their knowledge and insights about sedentary behaviors and ways to reduce them.
Their input will be used to help create a brochure on sedentary behaviors.
In Step 2, we will conduct one-on-one telephone interviews with 5 early stage CRC survivors to provide feedback about the brochure.
In Phase 2, we will recruit 15 CRC survivors.
After completing a baseline survey, they will be asked to both wear an ActiGraph and self-report their daily sedentary behaviors for one week.
They will receive tailored feedback as to their average weakly levels of sedentary behaviors and receive the brochure.
One month post-intervention, they will be asked to take part in telephone survey assessing sedentary behaviors, PA (physical activity), and use of brochure.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Feasibility of the print brochure, as measured by Likert scale.
Time Frame: Baseline
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Feasibility will be based in part on achieving higher (>5) on the Likert scale on topics such as usefulness, clarity, understanding how to use the materials.
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Baseline
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Change in number of minutes per day of light to strenuous physical activity.
Time Frame: Baseline and 1 month
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The means and variances of self-reported total minutes per day of light to strenuous physical activity will be computed and compared from the survey at baseline, to the survey at the 1 month time point.
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Baseline and 1 month
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Change in number of minutes per day of bouts of sedentary behaviors.
Time Frame: Baseline and 1 month
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The means and variances of self-reported total minutes per day of sedentary behaviors, will be computed and compared from the survey at baseline, to the survey at the 1 month time point.
Time per day will also be analyzed by type of activity.
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Baseline and 1 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Covariation between baseline use of an ActiGraph, and self-reporting of sedentary behaviors
Time Frame: Baseline and 1 week
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To assess the baseline reliability of self-report, we will calculate the Pearson product-moment correlation coefficient between the self-report measure (total time and by each activity reported) and ActiGraph based on daily repeated measures for one week.
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Baseline and 1 week
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
May 7, 2015
First Submitted That Met QC Criteria
May 8, 2015
First Posted (Estimate)
May 13, 2015
Study Record Updates
Last Update Posted (Actual)
February 27, 2017
Last Update Submitted That Met QC Criteria
February 24, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00060174
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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