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Behavioral Intervention
Genetic Testing and Counseling for Hereditary Cancer
N/A
Recruiting
Led By Jose Rauh-Hain, MD,MPH
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Can provide proof of deleterious/suspected deleterious HBOC or LS variant present in a first degree relative (biological mother or father, biological child, or full sibling)
18 years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
Study Summary
This trial will look at whether providing family members with education or other help increases genetic testing rates in families affected by hereditary cancer.
Who is the study for?
This trial is for adults in the U.S. who speak English or Spanish, have internet access, and a known genetic mutation linked to certain cancers (like BRCA1/2 or Lynch Syndrome) in their family. They should have at least one relative also at risk but can't join if they've already been tested negative for these mutations or don't have any relatives who could be affected.Check my eligibility
What is being tested?
The study tests an intervention called IGNITE-TX which includes a web platform and personal navigators to increase genetic testing rates among families with hereditary cancer syndromes. It compares the effectiveness of this approach with free genetic counseling and testing services.See study design
What are the potential side effects?
Since this trial involves genetic testing and counseling rather than medication, traditional side effects are not expected. However, participants may experience emotional or psychological impacts from learning about their genetic risks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can show that a close family member has a harmful gene variant linked to cancer.
Select...
I am 18 years old or older.
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I have a harmful mutation in BRCA1/2 or genes related to Lynch syndrome.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measure enrollment of probands and at-risk relatives over a 6-month period
Measure response rate to baseline and follow-up surveys by probands and at-risk relatives
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Group 4 (IGNITE-TX and free genetic testing and counseling group)Experimental Treatment3 Interventions
Relatives randomized to this arm will receive a family letter after enrollment and baseline survey with their personal access codes (not to be shared) to the IGNITE-TX "Hub" (access online educational material through a platform) and information to contact the tele genetics company. This arm will receive both the IGNITE-TX Intervention and access to free genetic testing and counseling services, as well as access to assistance from family genetic navigator
Group II: Group 3 (IGNITE-TX Group)Experimental Treatment3 Interventions
Relatives of probands randomized to the IGNITE-TX intervention will receive a family letter after enrollment and baseline survey with their personal access codes (not to be shared) to the IGNITE-TX "Hub" (access online educational material through a platform). Relatives will have also access services of a family genetic navigator. Study investigators and navigators will not directly provide genetic counseling and/or testing in this arm
Group III: Group 2 (Free genetic testing and counseling group)Experimental Treatment3 Interventions
Enrolled relatives will receive a letter and baseline survey with information to contact the tele-genetics company to arrange free genetic counseling and testing. This letter will be given to the relatives directly by the study
Group IV: Group 1 (Standard of Care Group)Active Control1 Intervention
Participants (probands, those with a hereditary cancer syndrome) are sent a family letter to share with relatives. The letter contains information about hereditary cancer syndromes and encourages relatives to participate in the study and to get genetic testing.
Relatives of probands randomized to the usual care arm will have access to the family letter if probands decide to share it with them, and will receive study surveys. The letter contains information about hereditary cancer syndromes and encourages relatives to participate in the study and to get genetic testing
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,316 Total Patients Enrolled
Jose Rauh-Hain, MD,MPHPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a close family member who also meets the trial's requirements.I am 18 years old or older.My family members do not qualify for this clinical trial.I can show that a close family member has a harmful gene variant linked to cancer.You have already been listed as an affected relative for another person in the study.I have been tested for the same genetic variant found in my family member.I can use the internet or a phone and can email or text with a US number.My family has no history of HBOC or Lynch syndrome.My genetic test for cancer did not show any harmful mutations.I can speak or read English or Spanish.I have a harmful mutation in BRCA1/2 or genes related to Lynch syndrome.
Research Study Groups:
This trial has the following groups:- Group 1: Group 2 (Free genetic testing and counseling group)
- Group 2: Group 1 (Standard of Care Group)
- Group 3: Group 3 (IGNITE-TX Group)
- Group 4: Group 4 (IGNITE-TX and free genetic testing and counseling group)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there opportunities to join this clinical investigation currently?
"The clinicaltrials.gov database reveals that this research initiative is not currently open for recruitment, as the most recent update was on January 11th 2023. However, there are 3,977 ongoing studies presently seeking prospective participants."
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