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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Gynecologic Cancer; Pancreatic Cancer; Lynch Syndrome; Endometrial Cancer; Colon Cancer; Hereditary Breast and Ovarian Cancer Syndrome; Uterus Cancer; Ovary Cancer
• Intervention / Treatment: Behavioral: Free genetic testing and counseling group; Behavioral: IGNITE-TX Group; Behavioral: IGNITE-TX and free genetic testing and counseling group

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jose Rauh-Hain, MD,MPH; Phone Number: (713) 794-1759; Email: jarauh@mdanderson.org
• Study Contact Backup: Name: Ignite Study; Phone Number: 713-794-1759; Email: ignitestudy@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson Cancer Center
      • Contact: Jose Rauh-Hain, MD, MPH
      • Principal Investigator: Jose Rauh-Hain, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group 1 (Standard of Care Group); Participants (probands, those with a hereditary cancer syndrome) are sent a family letter to share with relatives. The letter contains information about hereditary cancer syndromes and encourages relatives to participate in the study and to get genetic testing. Relatives of probands randomized to the usual care arm will have access to the family letter if probands decide to share it with them, and will receive study surveys. The letter contains information about hereditary cancer syndromes and encourages relatives to participate in the study and to get genetic testing
Experimental: Group 2 (Free genetic testing and counseling group); Enrolled relatives will receive a letter and baseline survey with information to contact the tele-genetics company to arrange free genetic counseling and testing. This letter will be given to the relatives directly by the study	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
Experimental: Group 3 (IGNITE-TX Group); Relatives of probands randomized to the IGNITE-TX intervention will receive a family letter after enrollment and baseline survey with their personal access codes (not to be shared) to the IGNITE-TX "Hub" (access online educational material through a platform). Relatives will have also access services of a family genetic navigator. Study investigators and navigators will not directly provide genetic counseling and/or testing in this arm	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
Experimental: Group 4 (IGNITE-TX and free genetic testing and counseling group); Relatives randomized to this arm will receive a family letter after enrollment and baseline survey with their personal access codes (not to be shared) to the IGNITE-TX "Hub" (access online educational material through a platform) and information to contact the tele genetics company. This arm will receive both the IGNITE-TX Intervention and access to free genetic testing and counseling services, as well as access to assistance from family genetic navigator	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measure enrollment of probands and at-risk relatives over a 6-month period	Up to 6 months
Measure response rate to baseline and follow-up surveys by probands and at-risk relatives	Up to 6 months

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Jose Rauh-Hain, MD,MPH, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2023
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: December 14, 2022
• First Submitted That Met QC Criteria: January 5, 2023
• First Posted (Actual): January 10, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Metabolic Diseases; Skin Diseases; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Uterine Diseases; Endocrine System Diseases; Disease; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Endocrine Gland Neoplasms; Breast Diseases; Genetic Diseases, Inborn; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Neoplastic Syndromes, Hereditary; DNA Repair-Deficiency Disorders; Breast Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Syndrome; Ovarian Neoplasms; Colorectal Neoplasms, Hereditary Nonpolyposis; Endometrial Neoplasms; Uterine Neoplasms; Hereditary Breast and Ovarian Cancer Syndrome
• Other Study ID Numbers: 2022-0712; FP00015533 (Other Grant/Funding Number: Foundation for Women's Cancer); NCI-2022-10573 (Other Identifier: NCI-CTRP Clinical Trials Registry)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No