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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
2,100
Participants will complete a questionnaire
Participants will complete a questionnaire
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame: Through study completion; an average of 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.