Colorectal CancerNCT00582452
Attitudes Towards Prophylactic Colectomy in Hereditary Non-polyposis Colorectal Cancer (HNPCC) Patients
An observational study of Colorectal Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Telephone survey
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
- At least three relatives with a colorectal cancer and the following criteria:
- One should be a first degree relative of the other two
Show all 15Show fewer
- 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
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: 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).
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Telephone survey
- Keywords
- HNPCC, prophylactic colectomy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone surveyOther
Telephone survey
| Study group | Role | What they receive |
|---|---|---|
| 2 | Affected patients who are at high risk for metachronous colorectal tumors due to mutation status. Receives: Other: Telephone survey | |
| 1 | Unaffected patients who are at high risk for developing colon cancer based on family history and/or mutation status. Receives: Other: Telephone survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2007 (estimated)
- Study startNov 2004
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Karen Hurley, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00582452
- Sponsor's protocol ID
- 04-127
- Other IDs
- NCI CA101511, CA109236
- Status last verified
- Dec 2009
- First submitted
- 21 Dec 2007
- Last updated
- 10 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attitudes Towards Prophylactic Colectomy in HNPCC Patients
- ClinicalTrials.gov ID
- NCT00582452
- Acronym / sponsor ID
- 04-127
- Conditions
- Colorectal Cancer
- Keywords
- HNPCC, prophylactic colectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2004
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 28 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | – | Other: Telephone surveyAffected patients who are at high risk for metachronous colorectal tumors due to mutation status. |
| 1 | – | Other: Telephone surveyUnaffected patients who are at high risk for developing colon cancer based on family history and/or mutation status. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (15 listed)
- 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
- At least three relatives with a colorectal cancer and the following criteria:
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone surveyTelephone survey | Other | 1, 2 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2009.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Hurley, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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; (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2009.