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Completed

NCT Number: NCT01373320

Faith Moves Mountains: A Community Based Participatory Research (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.

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Key information

Conditions

Lung Cancer Behavior Breast Cancer Breast Diseases Breast Neoplasms Cervical Cancer Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Health Behavior Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Smoking Cessation Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faith Moves Mountains

Whitesburg, Kentucky, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Lay health advisor interactions

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: Assessed approximately 4 months after 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.

  2. Number of visits completed

    Time frame: Approximately 4 months after baseline

    This process measure will reflect the number of visits/classes attended by participants, as a means of assessing participation rate and feasibility.

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

    Time frame: Approximately one year after baseline

    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.

Sponsors and collaborators

Lead sponsor

Nancy Schoenberg

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Faith Moves Mountains: A CBPR Appalachian Wellness & Cancer Prevention Program

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 14, 2011
Registry last updated
Oct 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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