Colon Cancer ScreeningNCT01411826
Online Programs to Promote Colon Cancer Screening
A study testing Information + Narratives + Support Group and Information Only in people with Colon Cancer Screening, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
To evaluate online peer support and colorectal cancer screening behavior among individuals who are not currently meeting colorectal cancer screening guidelines. This is a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer Screening
- What is being tested?
- Information + Narratives + Support Group and Information Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to May 2012
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 50-75
- Not currently meeting colorectal cancer screening guidelines
- No previous colorectal cancer.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
To evaluate online peer support and colorectal cancer screening behavior among individuals who are not currently meeting colorectal cancer screening guidelines. This is a randomized controlled trial.
Read the detailed description
Participants in the control group will view standard online information about colon cancer screening. Participants in the intervention group will view the same information and also will be invited to sign on to the online website and interact with peer supporters at their convenience. They will have 6 months to communicate with peer supporters. Peer supporters are encouraged to address comments and concerns of the study participants.
About 300 study participants, majority white, female. Inclusion criteria: age 50-75, not currently meeting colorectal cancer screening guidelines, no previous colorectal cancer.
The study will also include 15 previously identified peer supporters.
Recruitment: Administrators of the SparkPeople.com weight loss community will send study recruitment emails to members at least 50 years of age. Interested individuals will pass an eligibility screening and provide informed consent.
- Conditions
- Colon Cancer Screening
- Being tested
- Information + Narratives + Support Group, Information Only
- Keywords
- Colon cancer screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information + Narratives + Support GroupBehavioural
Information from CDC website Narratives about CRCS written by others Peer social support among study participants
Information OnlyBehavioural
Information from CDC website on colon cancer screening.
| Study group | Role | What they receive |
|---|---|---|
| Information | Active comparator | Not described Receives: Behavioral: Information Only |
| Information + Narratives + Support group | Experimental | Not described Receives: Behavioral: Information + Narratives + Support Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Feasibility of recruitment, randomization, intervention delivery, retention, and assessment of colon cancer screening status
Measured: 6 months
Secondary outcomes (1)
Colon cancer screening attitudes
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon Cancer ScreeningStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Hwang, MD, The University of Texas Health Science Center, Houston
- Investigators
- Kevin Hwang, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01411826
- Sponsor's protocol ID
- HSC-MS-11-0305
- Status last verified
- Nov 2012
- First submitted
- 4 Aug 2011
- Last updated
- 8 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Hwang KO, Ottenbacher AJ, Graham AL, Thomas EJ, Street RL Jr, Vernon SW. Online narratives and peer support for colorectal cancer screening: a pilot randomized trial. Am J Prev Med. 2013 Jul;45(1):98-107. doi: 10.1016/j.amepre.2013.02.024.
PubMed 23790994
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Programs to Promote Colon Cancer Screening
- ClinicalTrials.gov ID
- NCT01411826
- Acronym / sponsor ID
- HSC-MS-11-0305
- Conditions
- Colon Cancer Screening
- Keywords
- Colon cancer screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 8 Aug 2011 (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.
To evaluate online peer support and colorectal cancer screening behavior among individuals who are not currently meeting colorectal cancer screening guidelines. This is a randomized controlled trial.
Detailed description
Participants in the control group will view standard online information about colon cancer screening. Participants in the intervention group will view the same information and also will be invited to sign on to the online website and interact with peer supporters at their convenience. They will have 6 months to communicate with peer supporters. Peer supporters are encouraged to address comments and concerns of the study participants.
About 300 study participants, majority white, female. Inclusion criteria: age 50-75, not currently meeting colorectal cancer screening guidelines, no previous colorectal cancer.
The study will also include 15 previously identified peer supporters.
Recruitment: Administrators of the SparkPeople.com weight loss community will send study recruitment emails to members at least 50 years of age. Interested individuals will pass an eligibility screening and provide informed consent.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Information | Active comparator | Behavioral: Information Only |
| Information + Narratives + Support group | Experimental | Behavioral: Information + Narratives + Support Group |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 50-75
- Not currently meeting colorectal cancer screening guidelines
- No previous colorectal cancer.
Key exclusion criteria (0 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 |
|---|---|---|
| Information + Narratives + Support GroupInformation from CDC website Narratives about CRCS written by others Peer social support among study participants | Behavioural | Information + Narratives + Support group |
| Information OnlyInformation from CDC website on colon cancer screening. | Behavioural | Information |
Primary outcome
Feasibility
Time frame: 6 months
Feasibility of recruitment, randomization, intervention delivery, retention, and assessment of colon cancer screening status
1 secondary outcome
Colon cancer screening attitudes
Time frame: 6 months
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 8 Nov 2012.
- Derived from this study: PubMed 23790994Hwang KO, Ottenbacher AJ, Graham AL, Thomas EJ, Street RL Jr, Vernon SW. Online narratives and peer support for colorectal cancer screening: a pilot randomized trial. Am J Prev Med. 2013 Jul;45(1):98-107. doi: 10.1016/j.amepre.2013.02.024.
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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.
Kevin Hwang, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information + Narratives + Support Group and Information Only in people with Colon Cancer Screening, run by The University of Texas Health Science Center, Houston 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 3 inclusion and 0 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 8 Nov 2012. 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 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01411826, which also lists 1 linked publication.
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 8 Nov 2012.