Multi-Organ Screening Recommendations in Hereditary Non-Polyposis Colorectal Cancer (HNPCC) Patients - Full Text View

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI)
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00582296

Purpose

The purpose of this study is to examine how people with a family history of colon cancer and other related cancers respond to recommendations for cancer screening after genetic counseling. The purpose of your participation would be to (1) help us learn more about whether people with a personal and/or family history of colorectal cancer and other cancers follow cancer screening recommendations, and (2) to determine the effect of these screening recommendations on your quality of life.

Condition	Intervention
Hereditary Nonpolyposis Colorectal Cancer Colon Cancer	Behavioral: questionnaires, telephone interview, optional tube of blood drawn Behavioral: questionnaires, telephone interview and optional tub of blood drawn

Genetics Home Reference related topics: Lynch syndrome

MedlinePlus related topics: Cancer Colorectal Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Adherence to Comprehensive, Multi-Organ Screening Recommendations in Hereditary Non-Polyposis Colorectal Cancer (HNPCC) Patients

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

To assess adherence to comprehensive, multi-organ screening and risk-reducing behavior recommendations in HNPCC patients. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate predictive factors for adherence to comprehensive, multi-organ screening and risk-reducing behavior recommendations. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	145
Study Start Date:	December 2004
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 multi-organ follow-up	Behavioral: questionnaires, telephone interview, optional tube of blood drawn Initial CGS Visit (All Prospective Participants)Clinical assessment (screening, family & personal history of CA, surgeries) 6 Month Follow-Up Phone Interview (Prospective) Yearly Follow-Up Questionnaire (prospective and retrospective) Retrospective Initial Interview
2 control follow-up	Behavioral: questionnaires, telephone interview and optional tub of blood drawn Initial CGS Visit (All Prospective Participants)Clinical assessment (screening, family & personal history of CA, surgeries) 6 Month Follow-Up Phone Interview (Prospective) Yearly Follow-Up Questionnaire (prospective and retrospective) Retrospective Initial Interview

Detailed Description:

Hereditary nonpolyposis colorectal cancer (HNPCC; also known as Lynch syndrome), is a familial cancer syndrome involving a constellation of organs at risk, including the colon, stomach, ovaries, uterus, small intestine, ureter, and kidneys (Watson & Lynch, 1993). Risk reduction recommendations for HNPCC patients typically involve a complex combination of intensive surveillance of multiple organs, and possibly risk reducing surgery as well. This longitudinal study will focus on patterns of adherence with comprehensive, multi-organ screening guidelines in HNPCC patients. A few studies have shown adherence to colonoscopy in HNPCC patients is suboptimal, and less is known about screening beliefs and behaviors across the spectrum of other HNPCC related cancers. Indeed, most psychosocial research on screening adherence in general focuses on one screening test (e.g., colonoscopy) or one cancer site (e.g., ovarian) at a time, which does not reflect the patient's perspective of receiving multiple recommendations. We propose an innovative strategy to assess patterns of adherence (e.g., full adherence, selective adherence, non-adherence) with the full set of risk reduction recommendations given to patients who undergo genetic counseling/testing at MSKCC for HNPCC. In addition, the impact of HNPCC on individual patients' lives is quite large in that the complex decisional and behavioral requirements for risk reduction must be carried out in the context of concerns about personal risk, and of multiple experiences of illness and loss within the family. Therefore, we will compare adherence and quality of life ratings in high-risk patients recommended to follow comprehensive, multi-organ screening guidelines with that of patients who, after genetic counseling/testing for HNPCC, are recommended to follow limited, less intensive screening for colorectal (CRC) cancer only.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients seeking genetic counseling with or without genetic testing for colorectal cancer risk and/or suspected HNPCC will be recruited and offered enrollment during their first counseling visit at the Clinical Genetics Service at MSKCC

Criteria

Inclusion Criteria:

A patient will be eligible for enrollment if he/she is self-referred or physician-referred for genetic counseling at Memorial Sloan-Kettering Cancer Center's (MSKCC) Clinical Genetics Service due to a concern about increased risk for colon cancer or;
An individual who presents for genetic counseling at MSKCC's Clinical Genetics Service after undergoing genetic testing at an outside institution with a documented mutation in any gene associated with HNPCC or;
An individual who in the context of genetic counseling has received stricter colorectal and/or gynecologic screening recommendations than that of the general population regardless of genetic test results.

Exclusion Criteria:

Patients will be excluded from this study if: he/she has physical, cognitive or psychiatric conditions that interfere with ability to give meaningful informed consent; he/she cannot read, write or communicate in English; he/she is less than 18 years of age; he/she has received a diagnosis of FAP.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00582296

Contacts

Contact: Karen Hurely, PhD	646-888-0038	hurleyk@mskcc.org
Contact: Kenneth Offit, MD	212-434-5149	offitk@mskcc.org

Locations

United States, New York
Memorial Sloan Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Karen Hurely, PhD 646-888-0038 hurleyk@mskcc.org
Contact: Kenneth Offit, MD 212-434-5149 offitk@mskcc.org
Principal Investigator: Karen Hurley, PhD

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Karen Hurley, PhD

Memorial Sloan-Kettering Cancer Center

More Information

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Karen Hurley, Ph.D )
Study ID Numbers:	04-144
Study First Received:	December 21, 2007
Last Updated:	November 1, 2008
ClinicalTrials.gov Identifier:	NCT00582296
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Lynch syndrome

Study placed in the following topic categories:

Metabolic Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Hereditary nonpolyposis colon cancer
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Digestive System Diseases

Neoplastic Syndromes, Hereditary
Colorectal Neoplasms, Hereditary Nonpolyposis
Genetic Diseases, Inborn
Colorectal cancer, hereditary nonpolyposis, type 1
Gastrointestinal Neoplasms
Metabolic disorder
Colonic Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
DNA Repair-Deficiency Disorders

ClinicalTrials.gov processed this record on January 16, 2009