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Colorectal CancerPhase 2/3NCT00137683

Colorectal Cancer Control in Appalachian Churches

A Phase 2/3 study testing one-on-one education, group education, small media in people with Colorectal Cancer, run by Centers for Disease Control and Prevention at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this project is to conduct a community-based intervention and evaluate the independent and combined effects of two intervention strategies on primary and secondary prevention of colorectal cancer (CRC) among members of rural Appalachian churches. Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Colorectal Cancer
What is being tested?
one-on-one education, group education, small media
How many people
0 participants
Where
1 siteUnited States
Study dates
Sep 2001to Mar 2005
Phase
Phase 2/3
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Members of church congregations in the Ohio River Valley of West Virginia

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • West Virginia University

    Morgantown, West Virginia, 26506

Other trials in United States

About this study

The purpose of this project is to conduct a community-based intervention and evaluate the independent and combined effects of two intervention strategies on primary and secondary prevention of colorectal cancer (CRC) among members of rural Appalachian churches. The sampling frame consists of all of the churches in a 7 county area of western West Virginia. Eligible churches will have at least 180 active members, will not share a common pastor, and will have no CRC control activities. Using a 2x2 experimental design, churches will be divided into two separate clusters, those with and without an existing parish nurse program. Then churches from each cluster will be randomized to one of two conditions, a natural helper or a control condition.

Read the detailed description

The purpose of this project is to conduct a community-based intervention and evaluate the independent and combined effects of two intervention strategies on primary and secondary prevention of colorectal cancer (CRC) among members of rural Appalachian churches. Many regions of Appalachia have high poverty, low education, and high unemployment. Health disparities are great in this region and social and behavioral factors put many individuals at high risk for increased mortality from CRC.

The sampling frame consists of all churches in a 7 county area of western West Virginia. Eligible churches will have at least 180 active members, will not share a common pastor, and have no CRC control activities. Using a 2x2 experimental design, churches will be divided into two separate clusters, those with and without an existing parish nurse program. Then churches from each cluster will be randomized to one of two conditions, a natural helper or control condition.

Eligible church members will be adult males and females who are identified through member lists provided by the recruited churches. Because the primary outcome variable is CRC screening, at least half of the recruited church members must be age 50 and older, report no history of CRC, and have not recently completed CRC screening. Interested members will be asked to complete an informed consent form detailing participation in either the intervention or control arm of the study. The control group will be offered other health promotion interventions through the church and the CRC educational materials after data collection is completed.

Data will be collected before and after the intervention activities. Study participants will complete a paper and pencil survey at the church at each measurement point (baseline, follow-up). The baseline survey will assess sociodemographics, psychosocial information, stage of change, self-efficacy, health beliefs, barriers to change, health behavior knowledge and practices involving diet, physical activity, and CRC screening. The follow-up survey will assess body mass index, dietary intake, physical activity level, and CRC screening by FOBT, flexible sigmoidoscopy, and colonoscopy.

The primary hypothesis to be tested is that the combination of these two community-based intervention strategies will be most effective overall. To evaluate the effectiveness of the intervention strategies, the proportions in outcome measures between each intervention, the combined intervention, and control groups will be compared.

Being tested
one-on-one education, group education, small media
Keywords
screening, prevention, community health education
Medical subject headings
Colorectal Neoplasms, Health Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • one-on-one education, group education, small mediaBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. colorectal cancer screening

Secondary outcomes (3)
  1. physical activity

  2. diet

  3. knowledge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2005 (estimated)
  2. Study startSep 2001
  3. Study completionMar 2005

Resources

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 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00137683
Sponsor's protocol ID
CDC-NCCDPHP-9998
Other IDs
U57/CCU320638
Status last verified
Mar 2012
First submitted
27 Aug 2005
Last updated
14 Mar 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing one-on-one education, group education, small media in people with Colorectal Cancer, run by Centers for Disease Control and Prevention 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 1 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: withdrawn, as of the sponsor's last update on 14 Mar 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

colorectal cancer screening. 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 14 Mar 2012.

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