Reducing Sedentary Behaviors Among Colorectal Cancer Survivors

Colorectal Cancer Clinical Trial

Official title:

Reducing Sedentary Behaviors Among Colorectal Cancer Survivors: Cancer Survivorship Center Pilot Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02442583
• Other study ID #: Pro00060174
• Status: Completed
• Phase: N/A
• First received: May 7, 2015
• Last updated: February 24, 2017
• Start date: May 2015
• Est. completion date: December 2015

Study information

• Verified date: February 2017
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Brochure regarding sedentary behavior
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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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.	Baseline and 1 month
Primary	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.	Baseline and 1 month
Secondary	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.	Baseline and 1 week