Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00137683
Status:
WITHDRAWN
Last Update Posted:
2012-03-14
First Post:
2005-08-27
Brief Title:
Colorectal Cancer Control in Appalachian Churches
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Colorectal Cancer Control in Appalachian Churches
Status:
WITHDRAWN
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this project is to conduct a community-based intervention and evaluate the independent and combined effects of two intervention strategies on primary and secondary prevention of colorectal cancer CRC among members of rural Appalachian churches The sampling frame consists of all of the churches in a 7 county area of western West Virginia Eligible churches will have at least 180 active members will not share a common pastor and will have no CRC control activities Using a 2x2 experimental design churches will be divided into two separate clusters those with and without an existing parish nurse program Then churches from each cluster will be randomized to one of two conditions a natural helper or a control condition
Detailed Description:
The purpose of this project is to conduct a community-based intervention and evaluate the independent and combined effects of two intervention strategies on primary and secondary prevention of colorectal cancer CRC among members of rural Appalachian churches Many regions of Appalachia have high poverty low education and high unemployment Health disparities are great in this region and social and behavioral factors put many individuals at high risk for increased mortality from CRC
The sampling frame consists of all churches in a 7 county area of western West Virginia Eligible churches will have at least 180 active members will not share a common pastor and have no CRC control activities Using a 2x2 experimental design churches will be divided into two separate clusters those with and without an existing parish nurse program Then churches from each cluster will be randomized to one of two conditions a natural helper or control condition
Eligible church members will be adult males and females who are identified through member lists provided by the recruited churches Because the primary outcome variable is CRC screening at least half of the recruited church members must be age 50 and older report no history of CRC and have not recently completed CRC screening Interested members will be asked to complete an informed consent form detailing participation in either the intervention or control arm of the study The control group will be offered other health promotion interventions through the church and the CRC educational materials after data collection is completed
Data will be collected before and after the intervention activities Study participants will complete a paper and pencil survey at the church at each measurement point baseline follow-up The baseline survey will assess sociodemographics psychosocial information stage of change self-efficacy health beliefs barriers to change health behavior knowledge and practices involving diet physical activity and CRC screening The follow-up survey will assess body mass index dietary intake physical activity level and CRC screening by FOBT flexible sigmoidoscopy and colonoscopy
The primary hypothesis to be tested is that the combination of these two community-based intervention strategies will be most effective overall To evaluate the effectiveness of the intervention strategies the proportions in outcome measures between each intervention the combined intervention and control groups will be compared
The sampling frame consists of all churches in a 7 county area of western West Virginia Eligible churches will have at least 180 active members will not share a common pastor and have no CRC control activities Using a 2x2 experimental design churches will be divided into two separate clusters those with and without an existing parish nurse program Then churches from each cluster will be randomized to one of two conditions a natural helper or control condition
Eligible church members will be adult males and females who are identified through member lists provided by the recruited churches Because the primary outcome variable is CRC screening at least half of the recruited church members must be age 50 and older report no history of CRC and have not recently completed CRC screening Interested members will be asked to complete an informed consent form detailing participation in either the intervention or control arm of the study The control group will be offered other health promotion interventions through the church and the CRC educational materials after data collection is completed
Data will be collected before and after the intervention activities Study participants will complete a paper and pencil survey at the church at each measurement point baseline follow-up The baseline survey will assess sociodemographics psychosocial information stage of change self-efficacy health beliefs barriers to change health behavior knowledge and practices involving diet physical activity and CRC screening The follow-up survey will assess body mass index dietary intake physical activity level and CRC screening by FOBT flexible sigmoidoscopy and colonoscopy
The primary hypothesis to be tested is that the combination of these two community-based intervention strategies will be most effective overall To evaluate the effectiveness of the intervention strategies the proportions in outcome measures between each intervention the combined intervention and control groups will be compared
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U57CCU320638 | None | None | None |