NCT01373320

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,415

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
Completed

Started Mar 2010

Typical duration for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 14, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

October 23, 2013

Status Verified

October 1, 2013

Enrollment Period

2.7 years

First QC Date

June 10, 2011

Last Update Submit

October 21, 2013

Conditions

Lung CancerCervical CancerBreast CancerColorectal Cancer

Keywords

Smoking cessationCancer screeningAppalachiaGroup-randomized trialFaith-placed

Outcome Measures

Primary Outcomes (1)

  • 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.

    Assessed approximately 4 months after baseline

Secondary Outcomes (3)

  • Change in stage of readiness to change the selected health behavior(s) from baseline

    Assessed approximately 4 months after baseline

  • Number of visits completed

    Approximately 4 months after baseline

  • Retention (i.e., number of participants who complete all planned assessment timepoints)

    Approximately one year after baseline

Study Arms (2)

Early Intervention

EXPERIMENTAL

Participants in this group are nested in churches which were randomly assigned to the treatment group.

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.

Interventions

Lay health advisor interactionsBEHAVIORAL

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.

Early Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faith Moves Mountains

Whitesburg, Kentucky, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsUterine Cervical NeoplasmsBreast NeoplasmsColorectal NeoplasmsSmoking Cessation

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesHealth BehaviorBehavior

Study Officials

  • Nancy Schoenberg, Ph.D.

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor/PI

Study Record Dates

First Submitted

June 10, 2011

First Posted

June 14, 2011

Study Start

March 1, 2010

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

October 23, 2013

Record last verified: 2013-10

Locations

US(1)