IGNITE-TX Phase III: (Identifying Individuals for Genetic Testing & Treatment) Intervention

Primary Objectives:

• Determine the impact of IGNITE-TX on the uptake of cascade genetic testing (CGT) in at-risk relatives (ARRs) at 6 months.
• Use a mixed methods approach, guided by the NIMHD framework, to evaluate the impact of IGNITE-TX on informational, social, and emotional support outcomes within families at 6 months.
• Employ formative and process evaluations and stakeholder engagement to guide IGNITE-TX implementation and dissemination through the RE-AIM QuEST framework.

Secondary Objective:

Analyze the correlation of CGT completion rates within families to understand the influence of familial relationships on genetic testing uptake.

Determine the impact of the IGNITE-TX Intervention on the uptake of CGT, informational, social, and emotional support outcomes within families at 12 months.

Exploratory Objective:

Evaluate the effectiveness of social media as a mechanism to drive outreach, recruitment, and engagement with the IGNITE-TX intervention.

Determine the impact of the IGNITE-TX Intervention on the uptake of CGT, informational, social, and emotional support outcomes within families at 12 months.

Inclusion criteria

Probands:

• 18 years of age or older
• Speaks and reads English or Spanish
• Resides in the United States
• Has a pathogenic or suspected pathogenic variant in BRCA1, BRCA2, MLH1, MSH2/EPCAM, MSH6, or PMS2*
• Has access to the internet or phone and can send and receive email and/or text messages at a US telephone number.
• Attests to have at least one at-risk relative who meets inclusion criteria for first-degree relative

• For cancer patients who are unaware of their mutation status, we will share existing local and national genetics resources, like those provided in the usual care family letter.

At-Risk Relatives (ARR):

• 18 years of age or older
• Speaks and reads English or Spanish
• Resides in the United States
• Has a first or second degree relative who has a deleterious/suspected deleterious HBOC or LS variant present
• Has access to internet or phone and can send and receive email and/or text messages at a US telephone number

SAB:

• Eligible SAB will include any groups connected to HBOC or Lynch syndrome, including those that focus on underserved populations or specific ethnic communities.

Clinicians:

• Eligible clinicians will include gynecologic oncologists, general gynecologists, medical oncologists, and advanced practice providers who interact with individuals diagnosed with HBOC or Lynch syndrome and/or their at-risk relatives.

Exclusion criteria

Probands:

• Has no eligible at-risk relatives (ARRs) or is unable/unwilling to provide their contact information
• Has negative germline genetic testing or only variant of uncertain significance
• Unwilling or unable to provide consent

At-Risk Relatives (ARR):

• 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

SAB:

• SAB members will be excluded if they are not connected to HBOC or Lynch syndrome-related groups or if their organizations do not focus on these conditions or the communities impacted by them.

Clinicians:

• Clinicians will be excluded if they do not provide direct care to individuals diagnosed with HBOC or Lynch syndrome or their at-risk relatives, or if they do not practice within the specified eligible clinician roles.