Attitudes Towards Prophylactic Colectomy in Hereditary Non-polyposis Colorectal Cancer (HNPCC) Patients

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00582452
First received: December 21, 2007
Last updated: December 9, 2009
Last verified: December 2009
  Purpose

The purpose of this study is to learn more about individual's with a family history of colon cancer and the process by which they may decide to undergo or not undergo prophylactic colectomy. This is a surgery to remove the colon in order to reduce risk of cancer (or of getting cancer again).


Condition Intervention
Colorectal Cancer
Other: Telephone survey

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Cross-Sectional
Official Title: Attitudes Towards Prophylactic Colectomy in HNPCC Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To assess levels of intention in prophylactic colectomy among individuals at increased familial risk of colorectal cancer and to identify distinctive decision types based on profiles of perceived pros and cons of prophylactic colectomy; [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: November 2004
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
2
Affected patients who are at high risk for metachronous colorectal tumors due to mutation status.
Other: Telephone survey
Telephone survey
1
Unaffected patients who are at high risk for developing colon cancer based on family history and/or mutation status.
Other: Telephone survey
Telephone survey

Detailed Description:

Hereditary non-polyposis colorectal cancer (HNPCC) is associated with up to an 80% lifetime risk of developing colorectal cancer and a 40-50% chance of a metachronous tumor after partial colectomy for the disease. For these patients, prophylactic colectomy has been proposed as a potential risk management alternative to a lifetime of intensive surveillance by colonoscopy. The highly personal nature of such risk management decisions has been recognized in the development of individualized genetic counseling services. However, prior psychosocial research in this area has tended to use linear statistical techniques in which clinically important details are lost in an overly broad, one size-fits-all model that is difficult to apply in a one-to-one counseling session. We propose an innovative approach based on the Cognitive-Social Health Information Processing (C-SHIP) model in which we will explore how attitudes towards prophylactic colectomy are organized into meaningful patterns or types that can translate readily into tailored counseling recommendations. Specific aims of this study are: 1)to assess levels of intention in prophylactic colectomy among HNPCC patients; 2)To identify distinctive decision types based on profiles of perceived pros and cons of prophylactic colectomy; and 3) To explore the pattern of relations between decision types and counseling-related outcomes (level of intention in colectomy, cancer-specific anxiety, and colonoscopy adherence). We will conduct a one-time cross-sectional telephone survey of 320 HNPCC patients (defined as either carriers of a mutated mismatch repair gene associated with HNPCC or those with a personal/family history meeting published criteria for HNPCC). Using cluster analysis we will create a taxonomy of decision types. Prior research leads us to expect at least three types: Disengaged, Risk-Focused, and Ambivalent. We hypothesize that each type will have a different pattern of relations with the outcome variables (e.g., Risk-focused types will show higher level of intention regarding surgery, high anxiety, low avoidance, and high colonoscopy adherence, whereas Ambivalent types will show higher level of intention regarding surgery, high anxiety, high avoidance, and low colonoscopy adherence). Understanding these patterns will enhance the ability of physicians, genetic counselors, and other providers to help their patients make well informed, thoughtful decisions about the preventive strategy that will best protect their health, emotional well-being, and quality of life.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Unaffected patients who are at high risk for developing colon cancer based on family history and/or mutation status, and affected patients who are at high risk for metachronous colorectal tumors due to mutation status.

Criteria

Inclusion Criteria:

  • are from a family that has a known mismatch repair mutation; or
  • meet Amsterdam I or Amsterdam II criteria that spell out the family and personal cancer history characteristics associated with HNPCC
  • are considered at sufficiently high risk by their CRC specialty physician that prophylactic colectomy may be presented as an option (excluding FAP).

Amsterdam I Criteria

  1. At least three relatives with a colorectal cancer and the following criteria:

    • One should be a first degree relative of the other two
    • At least two successive generations should be affected
    • At least one colorectal cancer should be diagnosed before the age of 50
    • Familial Adenomatous Polyposis (FAP) should be excluded in the colorectal cancer case(s), if any

    Amsterdam II Criteria (also known as Revised Amsterdam Criteria

  2. At least three relatives with an HNPCC-associated cancer (colorectal cancer, cancer of the endometrium, small bowel, ureter, or renal pelvis) *:

    • One should be a first degree relative of the other two
    • At least two successive generations should be affected
    • At least one relative should be diagnosed before age 50
    • FAP should be excluded in the colorectal cancer case(s), if any *NOTE: ovarian cancer will also be considered an HNPCCassociated cancer as per Lynch et al (NEJM 2003)

Exclusion Criteria:

  • non-English speaking
  • under the age of 18
  • are unable to give meaningful informed consent due to physical, psychiatric or cognitive disability
  • are from a family affected by FAP
  • have already undergone subtotal colectomy or total proctocolectomy
  • are in active treatment and/or less than six months post-surgery for cancer.
  • Have undergone genetic counseling and testing for HNPCC at MSKCC
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00582452

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Karen Hurley, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Karen Hurley, PhD, Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00582452     History of Changes
Other Study ID Numbers: 04-127, NCI CA101511, CA109236
Study First Received: December 21, 2007
Last Updated: December 9, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
HNPCC
prophylactic colectomy

Additional relevant MeSH terms:
Colorectal Neoplasms
Colorectal Neoplasms, Hereditary Nonpolyposis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 22, 2014