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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05677048
• Other study ID #: 2022-0712
• Secondary ID: FP00015533NCI-20
• Status: Recruiting
• Phase: N/A
• Start date: April 14, 2023
• Est. completion date: October 31, 2027

Study information

• Verified date: February 2024
• Source: M.D. Anderson Cancer Center
• Contact: Jose Rauh-Hain, MD,MPH
• Phone: (713) 794-1759
• Email: jarauh[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 31, 2027
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Probands

Inclusion Criteria:

1. 18 years of age or older

2. Speaks and/or reads English or Spanish

3. Has known deleterious/pathogenic mutation or suspected deleterious/pathogenic variant in BRCA1 or BRCA2 (HBOC) or MLH1, MSH2, MSH6, PMS2, or EPCAM (LS)

4. Has access to the internet or phone and can send and receive email and/or text messages at a US telephone number

5. Has at least one at-risk relative who meets inclusion criteria for first-degree relative

Exclusion Criteria:

1. Has no at-risk relatives meeting inclusion criteria

2. Has negative germline genetic testing or only variant of uncertain significance

3. Unwilling or unable to provide consent 4.2. AT-RISK RELATIVES (ARR)

Inclusion Criteria:

1. 18 years of age or older

2. Speaks and reads English or Spanish

3. Resides in the United States

4. Can provide proof of deleterious/suspected deleterious HBOC or LS variant present in a first degree relative (biological mother or father, biological child, or full sibling)

5. Has access to internet or phone and can send and receive email and/or text messages at a US telephone number

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Breast Cancer
• Colon Cancer
• Colorectal Neoplasms, Hereditary Nonpolyposis
• Endometrial Cancer
• Endometrial Neoplasms
• Gynecologic Cancer
• Hereditary Breast and Ovarian Cancer Syndrome
• Lynch Syndrome
• Ovarian Neoplasms
• Ovary Cancer
• Pancreatic Cancer
• Syndrome
• Uterine Neoplasms
• Uterus Cancer

Intervention

Behavioral:
• Free genetic testing and counseling group
Option to access no-cost telegenetic counseling and genetic testing
• IGNITE-TX Group
Access online educational materials through the IGNITE-TX platform and receive assistance from a family genetic navigator
• 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

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure enrollment of probands and at-risk relatives over a 6-month period		Up to 6 months
Primary	Measure response rate to baseline and follow-up surveys by probands and at-risk relatives		Up to 6 months

External Links

•   MD Anderson Cancer Center