Communication, Informed Decision-making
Conditions
Brief summary
This trial aims to implement and compare an evidence- and theory-based intervention strategy (IGNITE-TX Intervention) to support probands and their ARRs in family communication, informed decision-making, and navigation to CGT with standard of care, free genetic testing/counseling, and intervention with free genetic testing/counseling.
Detailed description
Primary Objectives: 1. Determine the impact of IGNITE-TX on the uptake of cascade genetic testing (CGT) in at-risk relatives (ARRs) at 6 months. 2. 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. 3. 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.
Interventions
OTHERIGNITE-TX program
Participants will complete a questionnaire
OTHERGenetic Counseling and Testing
Participants will complete a questionnaire
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Probands: 1. 18 years of age or older 2. Speaks and reads English or Spanish 3. Resides in the United States 4. Has a pathogenic or suspected pathogenic variant in BRCA1, BRCA2, MLH1, MSH2/EPCAM, MSH6, or PMS2\* 5. Has access to the internet or phone and can send and receive email and/or text messages at a US telephone number. 6. 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): 1. 18 years of age or older 2. Speaks and reads English or Spanish 3. Resides in the United States 4. Has a first or second degree relative who has a deleterious/suspected deleterious HBOC or LS variant present 5. Has access to internet or phone and can send and receive email and/or text messages at a US telephone number SAB: 1\. Eligible SAB will include any groups connected to HBOC or Lynch syndrome, including those that focus on underserved populations or specific ethnic communities. Clinicians: 1\. 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: 1. Has no eligible at-risk relatives (ARRs) or is unable/unwilling to provide their contact information 2. Has negative germline genetic testing or only variant of uncertain significance 3. Unwilling or unable to provide consent At-Risk Relatives (ARR): 1. Unwilling or unable to provide consent 2. Reports no known HBOC or LS variant within the family 3. Has already been tested for the variant identified in the proband 4. Already listed as an ARR for another proband SAB: 1\. 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: 1\. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Adverse Events (AEs) | Through study completion; an average of 1 year | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 |
Countries
United States
Contacts
CONTACTJose Alejandro Rauh-Hain, MD, MPH
PRINCIPAL_INVESTIGATORJose Alejandro Rauh-Hain, MD, MPH
M.D. Anderson Cancer Center
Outcome results
None listed