Reducing Sedentary Behaviors Among Colorectal Cancer Survivors
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable colorectal-cancer
Started May 2015
Shorter than P25 for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 7, 2015
CompletedFirst Posted
Study publicly available on registry
May 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFebruary 27, 2017
February 1, 2017
7 months
May 7, 2015
February 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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 Outcomes (1)
Covariation between baseline use of an ActiGraph, and self-reporting of sedentary behaviors
Baseline and 1 week
Study Arms (3)
Arm 1: Phase 1, Step 1
NO INTERVENTIONIn 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 2: Phase 1, Step 2
NO INTERVENTION5 early stage colorectal cancer survivors will have recorded telephone interviews to provide feedback about the brochure.
Arm 3: Phase 2
EXPERIMENTAL15 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Adult
- Early (stage 1 or 2) colorectal cancer
- months or greater post treatment
- Does not follow guidelines for physical activity
- Average at least 6 hours a day of sedentary behaviors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (1)
Duke University Medical Center
Durham, North Carolina, 27701, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Isaac Lipkus, PhD
Duke University School of Nursing
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2015
First Posted
May 13, 2015
Study Start
May 1, 2015
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
February 27, 2017
Record last verified: 2017-02