NCT05677048

Feasibility Study: IGNITE-TX (Identifying Individuals for Genetic Testing & Treatment) Intervention

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objectives: The primary objectives of this study are to assess the study feasibility by estimating: 1. The enrollment of probands and (ARRs) at-risk relatives over a 6-month period 2. The response rate to baseline and follow-up surveys by probands 3. The response rate to baseline and follow-up surveys by (ARRs) at-risk relatives Secondary Objectives: The secondary objectives of this study are to: 1. Measure (ARR) at-risk relatives completion of (CGT) cascade genetic testing among different study arms. 2. Measure the proportion of enrolled (ARRs) at-risk relatives who make an informed decision about (CGT) cascade genetic testing. 3. Measure the (ARR) at-risk relatives readiness for (CGT) cascade genetic testing 4. Measure proband and (ARR) at-risk relatives change in genetics knowledge 5. Measure proband readiness to communicate results of genetic testing with (ARR) at-risk relatives Secondary objectives in this feasibility study will be primary objectives in a larger study. This feasibility study is not powered to assess these objectives. Including them in this feasibility study will allow for assessment of our measurement tools (surveys from primary objectives) and offer insight into how the intervention may impact cascade genetic testing when implemented on a larger scale Exploratory Objectives: The exploratory objectives in this study are to estimate: 1. The average website traffic of the IGNITE-TX "Hub" and module completion 2. The average utilization of family genetic navigators by participants 3. Estimate the intra-familial correlation (IFC) for (ARR) at-risk relatives completion of (CGT) cascade genetic testing 4. Assess satisfaction with IGNITE-TX website modules and genetic navigator The exploratory objectives will allow for further evaluation of the IGNITE-TX website modules and navigator and understand how families with multiple (ARR)at-risk relatives respond to the intervention.

Conditions

• Gynecologic Cancer
• Ovary Cancer
• Pancreatic Cancer
• Breast Cancer
• Lynch Syndrome
• Hereditary Breast and Ovarian Cancer Syndrome
• Colon Cancer
• Endometrial Cancer
• Uterus Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Free genetic testing and counseling group	Option to access no-cost telegenetic counseling and genetic testing
BEHAVIORAL	IGNITE-TX Group	Access online educational materials through the IGNITE-TX platform and receive assistance from a family genetic navigator
BEHAVIORAL	IGNITE-TX and free genetic testing and counseling group	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

Timeline

• Start date: 2023-04-14
• Primary completion: 2027-10-31
• Completion: 2027-10-31
• First posted: 2023-01-10
• Last updated: 2026-03-09

Locations

1 site across 1 country: United States