Feasibility Study: IGNITE-TX (Identifying Individuals for Genetic Testing & Treatment) Intervention
Gynecologic Cancer, Ovary Cancer, Pancreatic Cancer
About this trial
This is an interventional health services research trial for Gynecologic Cancer
Eligibility Criteria
Probands Inclusion Criteria: 18 years of age or older Speaks and/or reads English or Spanish Has known deleterious/pathogenic mutation or suspected deleterious/pathogenic variant in BRCA1 or BRCA2 (HBOC) or MLH1, MSH2, MSH6, PMS2, or EPCAM (LS) Has access to the internet or phone and can send and receive email and/or text messages at a US telephone number Has at least one at-risk relative who meets inclusion criteria for first-degree relative Exclusion Criteria: Has no at-risk relatives meeting inclusion criteria Has negative germline genetic testing or only variant of uncertain significance Unwilling or unable to provide consent 4.2. AT-RISK RELATIVES (ARR) Inclusion Criteria: 18 years of age or older Speaks and reads English or Spanish Resides in the United States 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) Has access to internet or phone and can send and receive email and/or text messages at a US telephone number Exclusion Criteria: Unwilling or unable to provide consent Reports no known HBOC or LS variant within the family Has already been tested for the variant identified in the proband Already listed as an ARR for another proband
Sites / Locations
- MD Anderson Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
No Intervention
Experimental
Experimental
Experimental
Group 1 (Standard of Care Group)
Group 2 (Free genetic testing and counseling group)
Group 3 (IGNITE-TX Group)
Group 4 (IGNITE-TX and free genetic testing and counseling group)
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
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
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
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