Feasibility Study: IGNITE-TX (Identifying Texans at Risk for Hereditary Cancer) Intervention

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05677048
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 52
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

To learn if using IGNITE-TX or other intervention (such as educational materials) can help to increase the rates of genetic testing among the family members of people who have been diagnosed with a hereditary cancer syndrome

Condition or Disease	Intervention/Treatment	Phase
Gynecologic Cancer; Ovary Cancer; Pancreatic Cancer; Breast Cancer; Lynch Syndrome; Hereditary Breast and Ovarian Cancer Syndrome; Colon Cancer; Endometrial Cancer; Uterus Cancer	Behavioral: Free genetic testing and counseling group; Behavioral: IGNITE-TX Group; Behavioral: IGNITE-TX and free genetic testing and counseling group	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Feasibility Study: IGNITE-TX (Identifying Texans at Risk for Hereditary Cancer) Intervention
• Anticipated Study Start Date: Jun 30, 2023
• Anticipated Primary Completion Date: Oct 31, 2025
• Anticipated Study Completion Date: Oct 31, 2027

Arms and Interventions

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.
Experimental: Group 2 (Free genetic testing and counseling group) Enrolled relatives receive a letter with information to access telegenetic counseling and genetic testing at no cost to the participant	Behavioral: Free genetic testing and counseling group; Option to access no-cost telegenetic counseling and genetic testing
Experimental: Group 3 (IGNITE-TX Group) Enrolled relatives receive a letter with information to access the IGNITE-TX online educational "Hub" and access services of a family genetic navigator.	Behavioral: IGNITE-TX Group; Access online educational materials through the IGNITE-TX platform and receive assistance from a family genetic navigator
Experimental: Group 4 (IGNITE-TX and free genetic testing and counseling group) Enrolled relatives receives a letter with information to access telegenetic counseling and genetic testing at no cost to the participant and information to access the IGNITE-TX online educational "Hub" as well as access to 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

Outcome Measures

Primary Outcome Measures

1. Measure enrollment of probands and at-risk relatives over a 6-month period [Up to 6 months]

2. Measure response rate to baseline and follow-up surveys by probands and at-risk relatives [Up to 6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Probands

Inclusion Criteria:

1. 18 years of age or older

2. Speaks and/or reads English or Spanish

3. Resides in the state of Texas

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

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

6. 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

At Risk Relative (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 firstdegree 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MD Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• MD Anderson Cancer Center

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT05677048
• Other Study ID Numbers: 2022-0712; FP00015533; NCI-2022-10573
• First Posted: Jan 10, 2023
• Last Update Posted: Jan 12, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Ovarian Neoplasms; Endometrial Neoplasms; Colorectal Neoplasms, Hereditary Nonpolyposis; Hereditary Breast and Ovarian Cancer Syndrome; Uterine Neoplasms; Syndrome

Study Results

No Results Posted as of Jan 12, 2023