Colorectal CancerACTSNCT01139242
Increasing Colorectal Cancer Screening in Urban African American Communities Via Churches
A study testing Body & Soul nutritional intervention and Experimental: newsletters and peer counseling in people with Colorectal Cancer, run by University of North Carolina, Chapel Hill.
Trial summary
This is an intervention study to increase colorectal cancer screening and physical activity in members of African-American churches who are 50 years old and older. The control arm receives the Body \& Soul program, a program to increase fruit and vegetable intake. Read more about this study
- Who is it for?
- Ages 50 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Body & Soul nutritional intervention and Experimental: newsletters and peer counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 955 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to May 2010
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Members of African-American churches who are at least 50 years old.
Who cannot join
- Non-members of African-American churches; members who are under 50 years of age.
About this study
Official title: Increasing CRC Screening in Urban African American Communities Via Churches
This is an intervention study to increase colorectal cancer screening and physical activity in members of African-American churches who are 50 years old and older. The control arm receives the Body \& Soul program, a program to increase fruit and vegetable intake. The investigators hypothesize that those receiving the intervention, which includes four tailored newsletters and peer counseling, will be more likely to be screened if not up-to-date, and more likely to increase physical activity if screening was up-to-date at baseline, than controls.
- Conditions
- Colorectal Cancer
- Being tested
- Body & Soul nutritional intervention, Experimental: newsletters and peer counseling
- Keywords
- CRC screening status, physical activity level, fruit and vegetable consumption, Early Detection of Cancer, Colorectal Cancer (CRC) screening status
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body & Soul nutritional interventionBehavioural
Pastoral and peer counseling, and church activities/menus to promote increased fruit and vegetable consumption among church members.
Experimental: newsletters and peer counselingBehavioural
Four tailored newsletters and peer counseling calls to promote CRC screening in church members who are out-of-date with screening. Four tailored newsletters and peer counseling calls to others to increase physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Body & Soul nutritional intervention | Other | This is a standardized intervention to increase fruit and vegetable consumption among church members through pastoral and peer counseling and church activities/menus. Receives: Behavioral: Body & Soul nutritional intervention |
| Newsletters/peer counseling | Experimental | Four tailored newsletters and peer counseling calls to promote CRC screening among church members out-of-date according to screening guidelines. For those up-to-date, promotion is of increased physical activity. Receives: Behavioral: Experimental: newsletters and peer counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Higher incidence of CRC screening, if needed, among experimental participants.
Among church members who were out-of-date for CRC screening at baseline, a higher percentage of experimental participants will have been screened at the time of follow-up.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2010 (estimated)
- Study startFeb 2008
- Primary completionAug 2009
- Study completionMay 2010
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 University of North Carolina, Chapel HillThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 955 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Marci K Campbell, PhD, Principal investigator, UNC - Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01139242
- Sponsor's protocol ID
- 05-1271
- Other IDs
- U48DP000059-02S1
- Acronym
- ACTS
- Status last verified
- Jun 2010
- First submitted
- 4 Jun 2010
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing CRC Screening in Urban African American Communities Via Churches
- ClinicalTrials.gov ID
- NCT01139242
- Acronym / sponsor ID
- ACTS / 05-1271
- Conditions
- Colorectal Cancer
- Keywords
- CRC screening status, physical activity level, fruit and vegetable consumption, Early Detection of Cancer, Colorectal Cancer (CRC) screening status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 955 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Feb 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 8 Jun 2010 (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.
This is an intervention study to increase colorectal cancer screening and physical activity in members of African-American churches who are 50 years old and older. The control arm receives the Body \& Soul program, a program to increase fruit and vegetable intake. The investigators hypothesize that those receiving the intervention, which includes four tailored newsletters and peer counseling, will be more likely to be screened if not up-to-date, and more likely to increase physical activity if screening was up-to-date at baseline, than controls.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Body & Soul nutritional intervention | Other | Behavioral: Body & Soul nutritional interventionThis is a standardized intervention to increase fruit and vegetable consumption among church members through pastoral and peer counseling and church activities/menus. |
| Newsletters/peer counseling | Experimental | Behavioral: Experimental: newsletters and peer counselingFour tailored newsletters and peer counseling calls to promote CRC screening among church members out-of-date according to screening guidelines. For those up-to-date, promotion is of increased physical activity. |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Members of African-American churches who are at least 50 years old.
Key exclusion criteria (1 listed)
- Non-members of African-American churches; members who are under 50 years of age.
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 |
|---|---|---|
| Body & Soul nutritional interventionPastoral and peer counseling, and church activities/menus to promote increased fruit and vegetable consumption among church members. | Behavioural | Body & Soul nutritional intervention |
| Experimental: newsletters and peer counselingFour tailored newsletters and peer counseling calls to promote CRC screening in church members who are out-of-date with screening. Four tailored newsletters and peer counseling calls to others to increase physical activity. | Behavioural | Newsletters/peer counseling |
Primary outcome
Higher incidence of CRC screening, if needed, among experimental participants.
Time frame: One year
Among church members who were out-of-date for CRC screening at baseline, a higher percentage of experimental participants will have been screened at the time of follow-up.
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 26 Feb 2024.
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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.
Marci K Campbell, PhD principal investigator
UNC - Chapel Hill
Questions about this trial
What is this clinical trial studying?
A study testing Body & Soul nutritional intervention and Experimental: newsletters and peer counseling in people with Colorectal Cancer, run by University of North Carolina, Chapel Hill.
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 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 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Higher incidence of CRC screening, if needed, among experimental participants. (time frame: One year). 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 26 Feb 2024.