Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00478309
Status:
COMPLETED
Last Update Posted:
2016-03-03
First Post:
2007-05-23
Brief Title:
Genetic Epidemiology Risk Assessment Program or Usual Care in Colorectal Cancer Screening for Healthy Participants
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Gene Environment Risk Assessment and CRC Screening
Status:
COMPLETED
Status Verified Date:
2016-03
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:
RATIONALE The Genetic Epidemiology and Risk Assessment program may be more effective than usual care in increasing the number of healthy participants who regularly receive screening for colorectal cancer
PURPOSE This randomized clinical trial is studying the Genetic Epidemiology and Risk Assessment program to see how well it works compared with usual care to increase colorectal cancer screening in healthy participants
PURPOSE This randomized clinical trial is studying the Genetic Epidemiology and Risk Assessment program to see how well it works compared with usual care to increase colorectal cancer screening in healthy participants
Detailed Description:
OBJECTIVES
Compare Genetic Epidemiology and Risk Assessment GERA feedback vs usual care UC in terms of colorectal cancer CRC screening utilization by healthy participants
Determine the impact of GERA feedback and UC on psychological distress in these participants
Compare GERA feedback vs UC in terms of intention to have CRC screening perceived CRC risk CRC knowledge salience and coherence of CRC screening and support for CRC screening in these participants
Identify factors that moderate the impact of GERA feedback on CRC screening utilization
OUTLINE This is a randomized study Participants are randomized to 1 of 2 screening arms
Arm I Participants receive standard primary care
Arm II Participants receive standard primary care followed by the Genetic Epidemiology and Risk Assessment GERA intervention Participants also participate in a discussion session regarding the GERA including the rationale behind methylenetetrahydrofolate reductase mutation detection and folate assessment and its relationship to colorectal cancer risk
All participants undergo a fecal occult blood test 3 weeks after the screening office visit
PROJECTED ACCRUAL A total of 1950 participants will be accrued for this study
Compare Genetic Epidemiology and Risk Assessment GERA feedback vs usual care UC in terms of colorectal cancer CRC screening utilization by healthy participants
Determine the impact of GERA feedback and UC on psychological distress in these participants
Compare GERA feedback vs UC in terms of intention to have CRC screening perceived CRC risk CRC knowledge salience and coherence of CRC screening and support for CRC screening in these participants
Identify factors that moderate the impact of GERA feedback on CRC screening utilization
OUTLINE This is a randomized study Participants are randomized to 1 of 2 screening arms
Arm I Participants receive standard primary care
Arm II Participants receive standard primary care followed by the Genetic Epidemiology and Risk Assessment GERA intervention Participants also participate in a discussion session regarding the GERA including the rationale behind methylenetetrahydrofolate reductase mutation detection and folate assessment and its relationship to colorectal cancer risk
All participants undergo a fecal occult blood test 3 weeks after the screening office visit
PROJECTED ACCRUAL A total of 1950 participants will be accrued for this study
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 |
|---|---|---|---|
| IRB06807 | OTHER | Fox Chase Cancer Center | None |