Know Cancer

or
forgot password

Attitudes Towards Prophylactic Colectomy in HNPCC Patients


N/A
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

Thank you

Trial Information

Attitudes Towards Prophylactic Colectomy in HNPCC Patients


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Family-Based, Time Perspective: Cross-Sectional

Outcome Measure:

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;

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Karen Hurley, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

04-127

NCT ID:

NCT00582452

Start Date:

November 2004

Completion Date:

December 2009

Related Keywords:

  • Colorectal Cancer
  • HNPCC
  • prophylactic colectomy
  • Colorectal Neoplasms
  • Colorectal Neoplasms, Hereditary Nonpolyposis

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021