Feasibility Study: IGNITE-TX (Identifying Individuals for Genetic Testing & Treatment) Intervention
3 other identifiers
interventional
205
1 country
1
Brief Summary
This is a community-based study requiring participant-self-enrollment, that can help to increase the rates of genetic testing among the family members of people who have been diagnosed with a hereditary cancer syndrome. The two main factors in this study are the IGNITE-TX intervention (website and navigator) and the free genetic counseling and testing. The IGNITE-TX Intervention is an innovative multi-modal intervention, with two components: a) interactive web "IGNITE-TX Hub" and b) genetic family navigators.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2022
CompletedFirst Posted
Study publicly available on registry
January 10, 2023
CompletedStudy Start
First participant enrolled
April 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2027
March 9, 2026
March 1, 2026
4.6 years
December 14, 2022
March 5, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Measure enrollment of probands and at-risk relatives over a 6-month period
Up to 6 months
Measure response rate to baseline and follow-up surveys by probands and at-risk relatives
Up to 6 months
Study Arms (4)
Group 1 (Standard of Care Group)
NO INTERVENTIONParticipants (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
Group 2 (Free genetic testing and counseling group)
EXPERIMENTALEnrolled 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 3 (IGNITE-TX Group)
EXPERIMENTALRelatives 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 4 (IGNITE-TX and free genetic testing and counseling group)
EXPERIMENTALRelatives 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
Interventions
Option to access no-cost telegenetic counseling and genetic testing
Access online educational materials through the IGNITE-TX platform and receive assistance from a family genetic navigator
Option to access no-cost telegenetic counseling and genetic testing, access to online educational materials through the IGNITE-TX platform, and assistance from a family genetic navigator
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Has negative germline genetic testing or only variant of uncertain significance
- Unwilling or unable to provide consent 4.2. AT-RISK RELATIVES (ARR)
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jose Rauh-Hain, MD,MPH
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2022
First Posted
January 10, 2023
Study Start
April 14, 2023
Primary Completion (Estimated)
October 31, 2027
Study Completion (Estimated)
October 31, 2027
Last Updated
March 9, 2026
Record last verified: 2026-03