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

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

    • North Carolina
      • Durham, North Carolina, United States, 27701
        • Duke University Medical Center

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:

-

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
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of the print brochure, as measured by Likert scale.
Time Frame: Baseline
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.
Baseline
Change in number of minutes per day of light to strenuous physical activity.
Time Frame: Baseline and 1 month
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.
Baseline and 1 month
Change in number of minutes per day of bouts of sedentary behaviors.
Time Frame: Baseline and 1 month
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.
Baseline and 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Covariation between baseline use of an ActiGraph, and self-reporting of sedentary behaviors
Time Frame: Baseline and 1 week
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.
Baseline and 1 week

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

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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