Transition From Research to Disclosure in Human Genetics
The goal of this study is to design a means of providing research families, from diverse geographical locations, the chance to receive genetic testing after having been educated by video, and meetings or telephone conversations with a genetic counselor/study professional.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Transition From Research to Disclosure in Human Genetics|
- Number of Participants Received Pre-test Genetic Counseling [ Time Frame: 10 Years ] [ Designated as safety issue: No ]
- Number of participants completing genetic testing for p53 [ Time Frame: Baseline to time of follow-up (2 weeks, 6, and 12 months) ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Optional small sample of blood (about 6 tablespoons) for genetic testing for p53 following pre-test genetic counseling.
|Study Start Date:||May 1999|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
|Pre-Test Genetic Counseling + Genetic Sample||
Behavioral: Genetic Counseling
Genetic counseling conducted in person, by telephone with an M. D. Anderson Genetic Counselor, or with a local Genetic Counselor in conference with the M. D. Anderson Genetic Counselor.
Participants will receive pre-test genetic counseling in one of three ways: (1) in person at MD Anderson; (2) by telephone with an MD Anderson Genetic Counselor/study professional; (3) with a local Genetic Counselor in conference with the MD Anderson Genetic Counselor/study professional. After receiving pre-test genetic counseling, participants will be given the opportunity to schedule a submission of a small sample of blood (about 6 tablespoons) for genetic testing for p53.
Participants who submit a sample will be required to see a genetic counselor/study professional to receive the results of the genetic test. Genetic counseling may take place at MD Anderson at no cost. Participants may wish to have counseling close to their home, though they then are responsible for the cost of the counseling. If, after talking to the counselor/study professional, the participant wants to know the results of the test, he or she will be told. A participant will be given more counseling and advice on what other care might be needed and what other actions they should take.
If you have a child under the age of 27, you will fill out survey that will ask about how you would feel about your child taking part in genetic testing. This survey will take about 15-20 minutes to complete.
You will either fill out this survey over the telephone or it will be mailed to you. If it is by mail, you will be given a self-addressed stamped envelope to send the survey back to the study staff.
Participants who decide to know the test results will schedule a telephone conversation with the genetic counselor/study professional within 2-3 months. This will include more counseling, with additional follow-up as needed.
The test results and the survey will be kept private. Names will not be used in computer records.
This is an investigational study. About 800 people will be offered genetic testing. This study is being performed only at MD Anderson.
|Contact: Louise C. Strong, MD||713-792-7555|
|United States, Texas|
|U.T.M.D. Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Louise C. Strong, MD|
|Principal Investigator:||Louise C. Strong, MD||M.D. Anderson Cancer Center|