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| ID | Type | Description | Link |
|---|---|---|---|
| IRB#06807 | Other Identifier | Fox Chase Cancer Center |
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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.
OBJECTIVES:
OUTLINE: This is a randomized study. Participants are randomized to 1 of 2 screening arms.
All participants undergo a fecal occult blood test 3 weeks after the screening office visit.
PROJECTED ACCRUAL: A total of 1,950 participants will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | No Intervention | Participants receive standard primary care. | |
| Arm II | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| counseling intervention | Other |
| ||
| educational intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Genetic Epidemiology and Risk Assessment (GERA) feedback vs usual care (UC) in terms of colorectal cancer (CRC) screening utilization | At study completion | |
| Impact of GERA feedback and UC on psychological distress | At study completion | |
| Comparison of 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 | At study completion | |
| Factors that moderate the impact of GERA feedback on CRC screening utilization | At study completion |
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DISEASE CHARACTERISTICS:
Healthy participants meeting the following criteria:
Nonadherent with standard CRC screening recommendations at the time of their index office visit
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| David Weinberg, MD, MSC | Fox Chase Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fox Chase Cancer Center - Philadelphia | Philadelphia | Pennsylvania | 19111-2497 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20828635 | Result | Myers RE, Manne SL, Wilfond B, Sifri R, Ziring B, Wolf TA, Cocroft J, Ueland A, Petrich A, Swan H, DiCarlo M, Weinberg DS. A randomized trial of genetic and environmental risk assessment (GERA) for colorectal cancer risk in primary care: trial design and baseline findings. Contemp Clin Trials. 2011 Jan;32(1):25-31. doi: 10.1016/j.cct.2010.08.013. Epub 2010 Sep 7. |
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|
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| D018479 | Early Intervention, Educational |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D002662 | Child Health Services |
| D011314 | Preventive Health Services |
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