HNPCCNCT00341575
Psychosocial Aspects of Genetic Testing for Hereditary Nonpolyposis Colon Cancer
An observational study of HNPCC and Hereditary Nonpolyposis Colon Cancer, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial summary
This study, conducted by NHGRI and the M.D. Anderson Cancer Center in Houston, Texas, will develop statistical approaches for modeling family social structure and apply these models to explore the role of family social structure in participation in genetic testing and counseling, disclosure of test results and… Read more about this study
- Who is it for?
- Ages 18 to 82 years
- Conditions the study is for
- HNPCC, Hereditary Nonpolyposis Colon Cancer
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2005to 2 Aug 2010
- 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 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed consent
- Ability to speak, read, and write English
- Diagnosis of adenocarcinoma of the colon or rectum (CRC) patients who test positive for HNPCC mutations, or adult FDR of HNPCC mutation carriers, or spouses of CRC patient or FDR of HNPCC mutation carriers.
Who cannot join
- Presence of current major psychiatric disorder as defined by the
- DSM-IV, 2) age less than 18 years.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Human Genome Research Institute (NHGRI), 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Psychosocial Aspects of Genetic Testing for HNPCC
This study, conducted by NHGRI and the M.D. Anderson Cancer Center in Houston, Texas, will develop statistical approaches for modeling family social structure and apply these models to explore the role of family social structure in participation in genetic testing and counseling, disclosure of test results and adjustment to risk status. With recent genetic advances and the ability to test for hereditary illnesses, methods that provide an understanding of the family social structure and how that structure affects the dissemination of genetic risk information are increasingly important.
The data for this study were collected by the M.D. Anderson Cancer Center as part of a study on family communication and family functioning with regard to genetic testing for hereditary nonpolyposis colon cancer (HNPCC). Relatives of people with HNPCC are more likely than the general population to get colon cancer and other types of cancer if they have inherited the gene alteration (mutation) that predisposes to the disease. This alteration can be passed on from a parent to some or all of his or her children.
Read more
In the M.D. Anderson Cancer Center study, telephone interviews were conducted with 80 adult members of 16 extended families with a known gene alteration predisposing for HNPCC. These participants included people who had been diagnosed with an HNPCC syndrome cancer, their unaffected family members who were at risk of carrying a gene mutation for HNPCC, and their spouses. Participants were interviewed about their feelings, moods, coping style, and relationships with their spouse, relatives, and friends, about their willingness to have genetic testing, and about their feelings and beliefs about colon cancer, cancer screening and genetic testing and counseling. Some participants were asked about their family communication style and how the family coped with the idea of genetic testing and with the results, if testing was done.
The information obtained from the current study may help facilitate family participation, communication and psychological adjustment regarding risk information about genetic diseases.
Read the detailed description
The current research has two objectives: (1) development of statistical methods for modeling family systems, and (2) characterization of the psychosocial and relational aspects of families with a known mutation for hereditary nonpolyposis colon cancer (HNPCC). This work focuses on the family, and the family's social structure, as the unit of study. Data were collected between 8/1999 and 6/2002 at the University of Texas MD Anderson Cancer Center (UTMDACC) as part of a qualitative study of family communication and family functioning with regard to HNPCC genetic testing. Semi-structured telephone interviews were conducted with 80 adult members of 16 extended families with a known HNPCC-predisposing mutation. Family members included those who had been diagnosed with a HNPCC syndrome cancer, unaffected individuals who are at risk of carrying a mutation, and their spouses. The semistructured interview guide was designed to define family network members and to measure the social relations within each respondent's familial network. Social network data were collected describing the support, communicative, and affective relationships between respondents' and members of their family. Both positive (e.g. closeness) and negative (e.g. conflict) relationships were measured. Communication relations specific to disclosure of mutation status, cancer risk, participation in genetic testing and counseling efforts and surveillance practices were obtained. In addition to relational measurements, demographic, health-related (e.g. previous cancer diagnoses, adherence to surveillance regimens), psychosocial (e.g. distress, coping) and behavioral (e.g. participation in genetic testing) measures were obtained. The measurement methodology involved the use of interdependent ego-centered networks. The respondents, or egos, defined those persons (alters) who they perceived to be members of their family. Each respondent was then interviewed to obtain relational measurements (e.g. social support, communication) for each of their alters. Respondents who were members of the same family may name each other as family members and also may have alters in common. This interdependency based on overlapping family membership needs to be accounted for in the statistical approaches used to analyze the data. The primary goal of the current project is to develop and refine statistical models for interdependent ego-centered networks. The developed models will then be used to investigate the role of the familial social structure in communications about genetic testing and counseling, disclosure of mutation status, participation in genetic testing and counseling efforts, and adjustment to risk status.
- Conditions
- HNPCC, Hereditary Nonpolyposis Colon Cancer
- Keywords
- Family Systems, Communication, Information Diffusion, Social Networks, Family Dynamics
- Medical subject headings
- Colorectal Neoplasms, Hereditary Nonpolyposis, Communication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start28 Sep 2005
- Study completion2 Aug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HNPCCStudies of the same condition, open and under way.
- 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
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00341575
- Sponsor's protocol ID
- 999905249
- Other IDs
- 05-HG-N249
- Status last verified
- 2 Aug 2010
- First submitted
- 19 Jun 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Burke W, Daly M, Garber J, Botkin J, Kahn MJ, Lynch P, McTiernan A, Offit K, Perlman J, Petersen G, Thomson E, Varricchio C. Recommendations for follow-up care of individuals with an inherited predisposition to cancer. II. BRCA1 and BRCA2. Cancer Genetics Studies Consortium. JAMA. 1997 Mar 26;277(12):997-1003.
PubMed 9091675Claes E, Denayer L, Evers-Kiebooms G, Boogaerts A, Philippe K, Tejpar S, Devriendt K, Legius E. Predictive testing for hereditary nonpolyposis colorectal cancer: subjective perception regarding colorectal and endometrial cancer, distress, and health-related behavior at one year post-test. Genet Test. 2005 Spring;9(1):54-65. doi: 10.1089/gte.2005.9.54.
PubMed 15857188Claes E, Denayer L, Evers-Kiebooms G, Boogaerts A, Legius E. Predictive testing for hereditary non-polyposis colorectal cancer: motivation, illness representations and short-term psychological impact. Patient Educ Couns. 2004 Nov;55(2):265-74. doi: 10.1016/j.pec.2003.11.002.
PubMed 15530764
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Aspects of Genetic Testing for HNPCC
- ClinicalTrials.gov ID
- NCT00341575
- Acronym / sponsor ID
- 999905249
- Conditions
- HNPCC, Hereditary Nonpolyposis Colon Cancer
- Keywords
- Family Systems, Communication, Information Diffusion, Social Networks, Family Dynamics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 28 Sep 2005
- Study completion
- 2 Aug 2010
- First posted
- 21 Jun 2006 (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.
This study, conducted by NHGRI and the M.D. Anderson Cancer Center in Houston, Texas, will develop statistical approaches for modeling family social structure and apply these models to explore the role of family social structure in participation in genetic testing and counseling, disclosure of test results and adjustment to risk status. With recent genetic advances and the ability to test for hereditary illnesses, methods that provide an understanding of the family social structure and how that structure affects the dissemination of genetic risk information are increasingly important.
The data for this study were collected by the M.D. Anderson Cancer Center as part of a study on family communication and family functioning with regard to genetic testing for hereditary nonpolyposis colon cancer (HNPCC). Relatives of people with HNPCC are more likely than the general population to get colon cancer and other types of cancer if they have inherited the gene alteration (mutation) that predisposes to the disease. This alteration can be passed on from a parent to some or all of his or her children.
In the M.D. Anderson Cancer Center study, telephone interviews were conducted with 80 adult members of 16 extended families with a known gene alteration predisposing for HNPCC. These participants included people who had been diagnosed with an HNPCC syndrome cancer, their unaffected family members who were at risk of carrying a gene mutation for HNPCC, and their spouses. Participants were interviewed about their feelings, moods, coping style, and relationships with their spouse, relatives, and friends, about their willingness to have genetic testing, and about their feelings and beliefs about colon cancer, cancer screening and genetic testing and counseling. Some participants were asked about their family communication style and how the family coped with the idea of genetic testing and with the results, if testing was done.
The information obtained from the current study may help facilitate family participation, communication and psychological adjustment regarding risk information about genetic diseases.
Detailed description
The current research has two objectives: (1) development of statistical methods for modeling family systems, and (2) characterization of the psychosocial and relational aspects of families with a known mutation for hereditary nonpolyposis colon cancer (HNPCC). This work focuses on the family, and the family's social structure, as the unit of study. Data were collected between 8/1999 and 6/2002 at the University of Texas MD Anderson Cancer Center (UTMDACC) as part of a qualitative study of family communication and family functioning with regard to HNPCC genetic testing. Semi-structured telephone interviews were conducted with 80 adult members of 16 extended families with a known HNPCC-predisposing mutation. Family members included those who had been diagnosed with a HNPCC syndrome cancer, unaffected individuals who are at risk of carrying a mutation, and their spouses. The semistructured interview guide was designed to define family network members and to measure the social relations within each respondent's familial network. Social network data were collected describing the support, communicative, and affective relationships between respondents' and members of their family. Both positive (e.g. closeness) and negative (e.g. conflict) relationships were measured. Communication relations specific to disclosure of mutation status, cancer risk, participation in genetic testing and counseling efforts and surveillance practices were obtained. In addition to relational measurements, demographic, health-related (e.g. previous cancer diagnoses, adherence to surveillance regimens), psychosocial (e.g. distress, coping) and behavioral (e.g. participation in genetic testing) measures were obtained. The measurement methodology involved the use of interdependent ego-centered networks. The respondents, or egos, defined those persons (alters) who they perceived to be members of their family. Each respondent was then interviewed to obtain relational measurements (e.g. social support, communication) for each of their alters. Respondents who were members of the same family may name each other as family members and also may have alters in common. This interdependency based on overlapping family membership needs to be accounted for in the statistical approaches used to analyze the data. The primary goal of the current project is to develop and refine statistical models for interdependent ego-centered networks. The developed models will then be used to investigate the role of the familial social structure in communications about genetic testing and counseling, disclosure of mutation status, participation in genetic testing and counseling efforts, and adjustment to risk status.
Study design
Who may qualify
- Ages
- 18 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed consent
- Ability to speak, read, and write English
- Diagnosis of adenocarcinoma of the colon or rectum (CRC) patients who test positive for HNPCC mutations, or adult FDR of HNPCC mutation carriers, or spouses of CRC patient or FDR of HNPCC mutation carriers.
Key exclusion criteria (2 listed)
- Presence of current major psychiatric disorder as defined by the
- DSM-IV, 2) age less than 18 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 2 Jul 2017.
- Background: PubMed 9091675Burke W, Daly M, Garber J, Botkin J, Kahn MJ, Lynch P, McTiernan A, Offit K, Perlman J, Petersen G, Thomson E, Varricchio C. Recommendations for follow-up care of individuals with an inherited predisposition to cancer. II. BRCA1 and BRCA2. Cancer Genetics Studies Consortium. JAMA. 1997 Mar 26;277(12):997-1003.
- Background: PubMed 15857188Claes E, Denayer L, Evers-Kiebooms G, Boogaerts A, Philippe K, Tejpar S, Devriendt K, Legius E. Predictive testing for hereditary nonpolyposis colorectal cancer: subjective perception regarding colorectal and endometrial cancer, distress, and health-related behavior at one year post-test. Genet Test. 2005 Spring;9(1):54-65. doi: 10.1089/gte.2005.9.54.
- Background: PubMed 15530764Claes E, Denayer L, Evers-Kiebooms G, Boogaerts A, Legius E. Predictive testing for hereditary non-polyposis colorectal cancer: motivation, illness representations and short-term psychological impact. Patient Educ Couns. 2004 Nov;55(2):265-74. doi: 10.1016/j.pec.2003.11.002.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 HNPCC and Hereditary Nonpolyposis Colon Cancer, run by National Human Genome Research Institute (NHGRI) 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 3 inclusion and 2 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 2 Jul 2017. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00341575, which also lists 3 linked publications.
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 2 Jul 2017.