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Reducing Sedentary Behaviors Among Colorectal Cancer Survivors

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brochure regarding sedentary behavior
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring colorectal cancer, survivor, exercise, physical activity, sedentary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

-

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

No Intervention

Experimental

Arm Label

Arm 1: Phase 1, Step 1

Arm 2: Phase 1, Step 2

Arm 3: Phase 2

Arm Description

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.

5 early stage colorectal cancer survivors will have recorded telephone interviews to provide feedback about the brochure.

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.

Outcomes

Primary Outcome Measures

Feasibility of the print brochure, as measured by Likert scale.
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.
Change in number of minutes per day of light to strenuous physical activity.
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.
Change in number of minutes per day of bouts of sedentary behaviors.
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.

Secondary Outcome Measures

Covariation between baseline use of an ActiGraph, and self-reporting of sedentary behaviors
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.

Full Information

First Posted
May 7, 2015
Last Updated
February 24, 2017
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT02442583
Brief Title
Reducing Sedentary Behaviors Among Colorectal Cancer Survivors
Official Title
Reducing Sedentary Behaviors Among Colorectal Cancer Survivors: Cancer Survivorship Center Pilot Project
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colorectal cancer, survivor, exercise, physical activity, sedentary

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Phase 1, Step 1
Arm Type
No Intervention
Arm Description
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.
Arm Title
Arm 2: Phase 1, Step 2
Arm Type
No Intervention
Arm Description
5 early stage colorectal cancer survivors will have recorded telephone interviews to provide feedback about the brochure.
Arm Title
Arm 3: Phase 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Brochure regarding sedentary behavior
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of the print brochure, as measured by Likert scale.
Description
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.
Time Frame
Baseline
Title
Change in number of minutes per day of light to strenuous physical activity.
Description
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.
Time Frame
Baseline and 1 month
Title
Change in number of minutes per day of bouts of sedentary behaviors.
Description
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.
Time Frame
Baseline and 1 month
Secondary Outcome Measure Information:
Title
Covariation between baseline use of an ActiGraph, and self-reporting of sedentary behaviors
Description
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.
Time Frame
Baseline and 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isaac Lipkus, PhD
Organizational Affiliation
Duke University School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27701
Country
United States

12. IPD Sharing Statement

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Reducing Sedentary Behaviors Among Colorectal Cancer Survivors

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