NCT07318363

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,100 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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: 1\. Analyze the correlation of CGT completion rates within families to understand the influence of familial relationships on genetic testing uptake. Exploratory Objective: Evaluate the effectiveness of social media as a mechanism to drive outreach, recruitment, and engagement with the IGNITE-TX intervention.

Conditions

• Communication
• Informed Decision-making

Interventions

Type	Name	Description
OTHER	IGNITE-TX program	Participants will complete a questionnaire
OTHER	Genetic Counseling and Testing	Participants will complete a questionnaire

Timeline

• Start date: 2026-06-01
• Primary completion: 2030-04-01
• Completion: 2032-04-01
• First posted: 2026-01-06
• Last updated: 2026-01-06

Locations

1 site across 1 country: United States