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

December 9, 2009 updated by: Memorial Sloan Kettering Cancer Center

Attitudes Towards Prophylactic Colectomy in HNPCC Patients

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Family-Based
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Memorial Sloan Kettering Cancer Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Karen Hurley, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 28, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 04-127
  • NCI CA101511
  • CA109236

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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