Lung CancerNCT01373320
Faith Moves Mountains: A Community Based Participatory Research (CBPR) Appalachian Wellness & Cancer Prevention Program
A study testing Lay health advisor interactions in people with Lung Cancer and Cervical Cancer, run by Nancy Schoenberg at 1 site in United States.
Trial summary
The study purpose is to evaluate the effectiveness of a set of culturally appropriate, faith-placed lay health advisor interventions aimed at facilitating smoking cessation and increasing cancer screening among Appalachian participants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Cervical Cancer, Breast Cancer
- What is being tested?
- Lay health advisor interactions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,415 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Nov 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For smoking cessation: age 18 or older; current cigarette smoker; able to provide informed consent
- For cervical cancer screening: female; age 18 or older AND outside of screening guidelines; able to provide informed consent
- For breast cancer screening: female; age 40 or older AND outside of screening guidelines; able to provide informed consent
- For colorectal cancer screening: age 40 or older AND outside of screening guidelines; able to provide informed consent
Who cannot join
- For smoking cessation: None
- For cervical cancer screening: History of cervical cancer; history of hysterectomy
- For breast cancer screening: History of breast cancer
- For colorectal cancer screening: History of colorectal cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Faith Moves Mountains: A CBPR Appalachian Wellness & Cancer Prevention Program
The study purpose is to evaluate the effectiveness of a set of culturally appropriate, faith-placed lay health advisor interventions aimed at facilitating smoking cessation and increasing cancer screening among Appalachian participants.
Read the detailed description
The developmental phase of this project incorporated community based participatory research (CBPR) principles to identify the needs and preferences of community members with regard to cancer prevention. In the intervention phase, this group-randomized trial administers and evaluates a set of culturally appropriate interventions aimed at facilitating smoking cessation and increasing cancer screening among participants in 6 distressed Appalachian counties. Faith institutions are recruited and randomized to treatment or wait-list control conditions, and participants are recruited and enrolled within those institutions. Participants select one or more targeted health behaviors from a menu including smoking cessation, colorectal cancer screening, cervical cancer screening, and breast cancer screening, and subsequently receive the intervention(s) aimed at their selected health behaviors.
- Conditions
- Lung Cancer, Cervical Cancer, Breast Cancer, Colorectal Cancer
- Being tested
- Lay health advisor interactions
- Keywords
- Smoking cessation, Cancer screening, Appalachia, Group-randomized trial, Faith-placed
- Medical subject headings
- Lung Neoplasms, Uterine Cervical Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lay health advisor interactionsBehavioural
For smoking cessation: Cooper-Clayton group sessions plus motivational interviewing, both delivered by local lay health advisor.
For all cancer screenings: lay health advisor home visits incorporating motivational interviewing and focused on decreasing participant-identified barriers to screening.
| Study group | Role | What they receive |
|---|---|---|
| Early Intervention | Experimental | Participants in this group are nested in churches which were randomly assigned to the treatment group. Receives: Behavioral: Lay health advisor interactions |
| Delayed Intervention | No intervention | Participants in this group are nested in churches which were randomly assigned to the wait-list control group. They receive an educational luncheon focused on stress reduction during the intervention window for the Early Intervention group, and subsequently receive the intervention(s) for their selected target health behaviors at a later date. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants reporting the health behavior of interest (depending on which intervention component(s) were selected)
For smoking cessation: Self-reported smoking status. For cancer screenings: Self-reported receipt of cervical, breast, and/or colorectal cancer screening. This assessment occurs after the Early Treatment group has completed the intervention.
Measured: Assessed approximately 4 months after baseline
Secondary outcomes (3)
Change in stage of readiness to change the selected health behavior(s) from baseline
Measured using reliable and valid instruments which were pretested in focus groups comprised of members of the target population. Positive change (i.e., increasing stage of readiness) from baseline to post-test will be coded as "1," while negative or no change will be coded "0." This assessment occurs after the Early Treatment group has completed the intervention.
Measured: Assessed approximately 4 months after baseline
Number of visits completed
This process measure will reflect the number of visits/classes attended by participants, as a means of assessing participation rate and feasibility.
Measured: Approximately 4 months after baseline
Retention (i.e., number of participants who complete all planned assessment timepoints)
Retention numbers will be assessed as a process measure outcome. Participants who complete all study assessment timepoints will be coded as "1," while participants who drop out will be coded "0." Number/percentage of participants who remained enrolled and complete all study procedures and assessments will be used as an indicator of feasibility in the community setting.
Measured: Approximately one year after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2011 (estimated)
- Study startMar 2010
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung 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
- 1,415 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nancy Schoenberg
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor-investigator, Nancy Schoenberg, University of Kentucky
- Investigators
- Nancy Schoenberg, Ph.D., Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373320
- Sponsor's protocol ID
- R24MD002757
- Other IDs
- R24MD002757
- Status last verified
- Oct 2013
- First submitted
- 10 Jun 2011
- Last updated
- 23 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faith Moves Mountains: A CBPR Appalachian Wellness & Cancer Prevention Program
- ClinicalTrials.gov ID
- NCT01373320
- Acronym / sponsor ID
- R24MD002757
- Conditions
- Lung Cancer, Cervical Cancer, Breast Cancer, Colorectal Cancer
- Keywords
- Smoking cessation, Cancer screening, Appalachia, Group-randomized trial, Faith-placed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,415 participants (actual)
- Lead sponsor
- Nancy SchoenbergUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Mar 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 14 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 study purpose is to evaluate the effectiveness of a set of culturally appropriate, faith-placed lay health advisor interventions aimed at facilitating smoking cessation and increasing cancer screening among Appalachian participants.
Detailed description
The developmental phase of this project incorporated community based participatory research (CBPR) principles to identify the needs and preferences of community members with regard to cancer prevention. In the intervention phase, this group-randomized trial administers and evaluates a set of culturally appropriate interventions aimed at facilitating smoking cessation and increasing cancer screening among participants in 6 distressed Appalachian counties. Faith institutions are recruited and randomized to treatment or wait-list control conditions, and participants are recruited and enrolled within those institutions. Participants select one or more targeted health behaviors from a menu including smoking cessation, colorectal cancer screening, cervical cancer screening, and breast cancer screening, and subsequently receive the intervention(s) aimed at their selected health behaviors.
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 interactionsParticipants in this group are nested in churches which were randomly assigned to the treatment group. |
| Delayed Intervention | No intervention | –Participants in this group are nested in churches which were randomly assigned to the wait-list control group. They receive an educational luncheon focused on stress reduction during the intervention window for the Early Intervention group, and subsequently receive the intervention(s) for their selected target health behaviors at a later date. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- For smoking cessation: age 18 or older; current cigarette smoker; able to provide informed consent
- For cervical cancer screening: female; age 18 or older AND outside of screening guidelines; able to provide informed consent
- For breast cancer screening: female; age 40 or older AND outside of screening guidelines; able to provide informed consent
- For colorectal cancer screening: age 40 or older AND outside of screening guidelines; able to provide informed consent
Key exclusion criteria (4 listed)
- For smoking cessation: None
- For cervical cancer screening: History of cervical cancer; history of hysterectomy
- For breast cancer screening: History of breast cancer
- For colorectal cancer screening: History of colorectal cancer
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 interactionsFor smoking cessation: Cooper-Clayton group sessions plus motivational interviewing, both delivered by local lay health advisor. For all cancer screenings: lay health advisor home visits incorporating motivational interviewing and focused on decreasing participant-identified barriers to screening. | Behavioural | Early Intervention |
Primary outcome
Proportion of participants reporting the health behavior of interest (depending on which intervention component(s) were selected)
Time frame: Assessed approximately 4 months after baseline
For smoking cessation: Self-reported smoking status. For cancer screenings: Self-reported receipt of cervical, breast, and/or colorectal cancer screening. This assessment occurs after the Early Treatment group has completed the intervention.
3 secondary outcomes
Change in stage of readiness to change the selected health behavior(s) from baseline
Time frame: Assessed approximately 4 months after baseline
Number of visits completed
Time frame: Approximately 4 months after baseline
Retention (i.e., number of participants who complete all planned assessment timepoints)
Time frame: Approximately one year after baseline
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 23 Oct 2013.
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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
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 interactions in people with Lung Cancer and 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 4 inclusion and 4 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 23 Oct 2013. 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 reporting the health behavior of interest (depending on which intervention component(s) were selected) (time frame: Assessed approximately 4 months after baseline). 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 23 Oct 2013.