Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT01373320
Status:
COMPLETED
Last Update Posted:
2013-10-23
First Post:
2011-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Faith Moves Mountains: A Community Based Participatory Research (CBPR) Appalachian Wellness & Cancer Prevention Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1415}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-21', 'studyFirstSubmitDate': '2011-06-10', 'studyFirstSubmitQcDate': '2011-06-13', 'lastUpdatePostDateStruct': {'date': '2013-10-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants reporting the health behavior of interest (depending on which intervention component(s) were selected)', 'timeFrame': 'Assessed approximately 4 months after baseline', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in stage of readiness to change the selected health behavior(s) from baseline', 'timeFrame': 'Assessed approximately 4 months after baseline', 'description': '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.'}, {'measure': 'Number of visits completed', 'timeFrame': 'Approximately 4 months after baseline', 'description': 'This process measure will reflect the number of visits/classes attended by participants, as a means of assessing participation rate and feasibility.'}, {'measure': 'Retention (i.e., number of participants who complete all planned assessment timepoints)', 'timeFrame': 'Approximately one year after baseline', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Smoking cessation', 'Cancer screening', 'Appalachia', 'Group-randomized trial', 'Faith-placed'], 'conditions': ['Lung Cancer', 'Cervical Cancer', 'Breast Cancer', 'Colorectal Cancer']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For smoking cessation: age 18 or older; current cigarette smoker; able to provide informed consent\n* For cervical cancer screening: female; age 18 or older AND outside of screening guidelines; able to provide informed consent\n* For breast cancer screening: female; age 40 or older AND outside of screening guidelines; able to provide informed consent\n* For colorectal cancer screening: age 40 or older AND outside of screening guidelines; able to provide informed consent\n\nExclusion Criteria:\n\n* For smoking cessation: None\n* For cervical cancer screening: History of cervical cancer; history of hysterectomy\n* For breast cancer screening: History of breast cancer\n* For colorectal cancer screening: History of colorectal cancer'}, 'identificationModule': {'nctId': 'NCT01373320', 'briefTitle': 'Faith Moves Mountains: A Community Based Participatory Research (CBPR) Appalachian Wellness & Cancer Prevention Program', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Faith Moves Mountains: A CBPR Appalachian Wellness & Cancer Prevention Program', 'orgStudyIdInfo': {'id': 'R24MD002757', 'link': 'https://reporter.nih.gov/quickSearch/R24MD002757', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R24MD002757', 'link': 'https://reporter.nih.gov/quickSearch/R24MD002757', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early Intervention', 'description': 'Participants in this group are nested in churches which were randomly assigned to the treatment group.', 'interventionNames': ['Behavioral: Lay health advisor interactions']}, {'type': 'NO_INTERVENTION', 'label': 'Delayed Intervention', 'description': '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': [{'name': 'Lay health advisor interactions', 'type': 'BEHAVIORAL', 'description': 'For smoking cessation: Cooper-Clayton group sessions plus motivational interviewing, both delivered by local lay health advisor.\n\nFor all cancer screenings: lay health advisor home visits incorporating motivational interviewing and focused on decreasing participant-identified barriers to screening.', 'armGroupLabels': ['Early Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Whitesburg', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Faith Moves Mountains', 'geoPoint': {'lat': 37.11843, 'lon': -82.82683}}], 'overallOfficials': [{'name': 'Nancy Schoenberg, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nancy Schoenberg', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Sponsor/PI', 'investigatorFullName': 'Nancy Schoenberg', 'investigatorAffiliation': 'University of Kentucky'}}}}