Colorectal CancerNCT02442583
Reducing Sedentary Behaviors Among Colorectal Cancer Survivors
A study testing Brochure regarding sedentary behavior in people with Colorectal Cancer, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Brochure regarding sedentary behavior
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27701
About this study
Official title: 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.
- Conditions
- Colorectal Cancer
- Being tested
- Brochure regarding sedentary behavior
- Keywords
- colorectal cancer, survivor, exercise, physical activity, sedentary
- Medical subject headings
- Colorectal Neoplasms, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brochure regarding sedentary behaviorOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Phase 1, Step 1 | No intervention | 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 2: Phase 1, Step 2 | No intervention | 5 early stage colorectal cancer survivors will have recorded telephone interviews to provide feedback about the brochure. |
| Arm 3: Phase 2 | Experimental | 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. Receives: Other: Brochure regarding sedentary behavior |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and 1 month
Secondary outcomes (1)
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.
Measured: Baseline and 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isaac Lipkus, PhD, Principal investigator, Duke University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02442583
- Sponsor's protocol ID
- Pro00060174
- Status last verified
- Feb 2017
- First submitted
- 7 May 2015
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Sedentary Behaviors Among Colorectal Cancer Survivors: Cancer Survivorship Center Pilot Project
- ClinicalTrials.gov ID
- NCT02442583
- Acronym / sponsor ID
- Pro00060174
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, survivor, exercise, physical activity, sedentary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 13 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Phase 1, Step 1 | No intervention | –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 2: Phase 1, Step 2 | No intervention | –5 early stage colorectal cancer survivors will have recorded telephone interviews to provide feedback about the brochure. |
| Arm 3: Phase 2 | Experimental | Other: Brochure regarding sedentary behavior15 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brochure regarding sedentary behaviorThis 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. | Other | Arm 3: Phase 2 |
Primary outcome
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.
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.
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.
1 secondary outcome
Covariation between baseline use of an ActiGraph, and self-reporting of sedentary behaviors
Time frame: Baseline and 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isaac Lipkus, PhD principal investigator
Duke University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brochure regarding sedentary behavior in people with Colorectal Cancer, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the print brochure, as measured by Likert scale. (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2017.