Cervical CancerFMMNCT01372241
Faith Moves Mountains: An Appalachian Cervical Cancer Prevention Project
A study testing Lay health advisor visits and newsletter in people with Cervical Cancer, run by Nancy Schoenberg at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a faith-placed lay health advisor intervention is effective in increasing use of Pap smears among middle-aged and older Appalachian women. Read more about this study
- Who is it for?
- Ages 40 to 64 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Lay health advisor visits and newsletter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Aug 2009
- 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 40 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Outside of cervical cancer screening guidelines at the time of study initiation
- Able to provide informed consent
Who cannot join
- History of cervical cancer
- History of hysterectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Appalachian Cervical Cancer Prevention Project
The purpose of this study is to determine whether a faith-placed lay health advisor intervention is effective in increasing use of Pap smears among middle-aged and older Appalachian women.
Read the detailed description
Project development relied on principles of community based participatory research. Participants were recruited from faith institutions in four distressed Appalachian Kentucky counties. Investigators at the University of Kentucky worked closely with local staff who implemented study procedures in the field.
- Conditions
- Cervical Cancer
- Being tested
- Lay health advisor visits and newsletter
- Keywords
- Papanicolaou test, Cervical cancer screening, Randomized controlled trial, Faith-placed, Appalachia
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lay health advisor visits and newsletterBehavioural
The focus of the intervention was on reducing participants' self-identified barriers to obtaining Pap tests.
| Study group | Role | What they receive |
|---|---|---|
| Early Intervention | Experimental | This group served as the treatment group for analysis of the primary outcome. Receives: Behavioral: Lay health advisor visits and newsletter |
| Delayed Intervention | No intervention | This group served as a wait-list control group, eventually receiving the intervention after the treatment group completed the intervention and the primary outcomes were assessed for both groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants self-reporting receipt of Pap test
This measure is obtained at multiple timepoints during the study, but as the primary outcome it will be analyzed at the timepoint one month following the Early Intervention group's completion of the intervention.
Measured: One month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2011 (estimated)
- Study startDec 2005
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nancy Schoenberg
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Nancy Schoenberg, University of Kentucky
- Investigators
- Nancy Schoenberg, Ph.D., Principal investigator, University of KentuckyMark Dignan, Ph.D., Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01372241
- Sponsor's protocol ID
- R01CA108696
- Acronym
- FMM
- Status last verified
- Jun 2011
- First submitted
- 8 Jun 2011
- Last updated
- 21 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Schoenberg NE, Hatcher J, Dignan MB, Shelton B, Wright S, Dollarhide KF. Faith Moves Mountains: an Appalachian cervical cancer prevention program. Am J Health Behav. 2009 Nov-Dec;33(6):627-38. doi: 10.5993/ajhb.33.6.1.
PubMed 19320612Studts CR, Tarasenko YN, Schoenberg NE, Shelton BJ, Hatcher-Keller J, Dignan MB. A community-based randomized trial of a faith-placed intervention to reduce cervical cancer burden in Appalachia. Prev Med. 2012 Jun;54(6):408-14. doi: 10.1016/j.ypmed.2012.03.019. Epub 2012 Apr 3.
PubMed 22498022
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Appalachian Cervical Cancer Prevention Project
- ClinicalTrials.gov ID
- NCT01372241
- Acronym / sponsor ID
- FMM / R01CA108696
- Conditions
- Cervical Cancer
- Keywords
- Papanicolaou test, Cervical cancer screening, Randomized controlled trial, Faith-placed, Appalachia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- Nancy SchoenbergUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2005
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 13 Jun 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.
The purpose of this study is to determine whether a faith-placed lay health advisor intervention is effective in increasing use of Pap smears among middle-aged and older Appalachian women.
Detailed description
Project development relied on principles of community based participatory research. Participants were recruited from faith institutions in four distressed Appalachian Kentucky counties. Investigators at the University of Kentucky worked closely with local staff who implemented study procedures in the field.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Intervention | Experimental | Behavioral: Lay health advisor visits and newsletterThis group served as the treatment group for analysis of the primary outcome. |
| Delayed Intervention | No intervention | –This group served as a wait-list control group, eventually receiving the intervention after the treatment group completed the intervention and the primary outcomes were assessed for both groups. |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Outside of cervical cancer screening guidelines at the time of study initiation
- Able to provide informed consent
Key exclusion criteria (2 listed)
- History of cervical cancer
- History of hysterectomy
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 |
|---|---|---|
| Lay health advisor visits and newsletterThe focus of the intervention was on reducing participants' self-identified barriers to obtaining Pap tests. | Behavioural | Early Intervention |
Primary outcome
Proportion of participants self-reporting receipt of Pap test
Time frame: One month post-intervention
This measure is obtained at multiple timepoints during the study, but as the primary outcome it will be analyzed at the timepoint one month following the Early Intervention group's completion of the intervention.
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 21 Apr 2017.
- Background: PubMed 19320612Schoenberg NE, Hatcher J, Dignan MB, Shelton B, Wright S, Dollarhide KF. Faith Moves Mountains: an Appalachian cervical cancer prevention program. Am J Health Behav. 2009 Nov-Dec;33(6):627-38. doi: 10.5993/ajhb.33.6.1.
- Derived from this study: PubMed 22498022Studts CR, Tarasenko YN, Schoenberg NE, Shelton BJ, Hatcher-Keller J, Dignan MB. A community-based randomized trial of a faith-placed intervention to reduce cervical cancer burden in Appalachia. Prev Med. 2012 Jun;54(6):408-14. doi: 10.1016/j.ypmed.2012.03.019. Epub 2012 Apr 3.
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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.
Nancy Schoenberg, Ph.D. principal investigator
University of Kentucky
Mark Dignan, Ph.D. principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lay health advisor visits and newsletter in people with Cervical Cancer, run by Nancy Schoenberg 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 2 inclusion and 2 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 21 Apr 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?
Proportion of participants self-reporting receipt of Pap test (time frame: One month post-intervention). 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 NCT01372241, which also lists 2 linked publications.
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 21 Apr 2017.