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

Primary Purpose

Gynecologic Cancer, Ovary Cancer, Pancreatic Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Free genetic testing and counseling group
IGNITE-TX Group
IGNITE-TX and free genetic testing and counseling group
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Gynecologic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Probands Inclusion Criteria: 18 years of age or older Speaks and/or reads English or Spanish Has known deleterious/pathogenic mutation or suspected deleterious/pathogenic variant in BRCA1 or BRCA2 (HBOC) or MLH1, MSH2, MSH6, PMS2, or EPCAM (LS) Has access to the internet or phone and can send and receive email and/or text messages at a US telephone number Has at least one at-risk relative who meets inclusion criteria for first-degree relative Exclusion Criteria: Has no at-risk relatives meeting inclusion criteria Has negative germline genetic testing or only variant of uncertain significance Unwilling or unable to provide consent 4.2. AT-RISK RELATIVES (ARR) Inclusion Criteria: 18 years of age or older Speaks and reads English or Spanish Resides in the United States 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) Has access to internet or phone and can send and receive email and/or text messages at a US telephone number Exclusion Criteria: Unwilling or unable to provide consent Reports no known HBOC or LS variant within the family Has already been tested for the variant identified in the proband Already listed as an ARR for another proband

Sites / Locations

  • MD Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Group 1 (Standard of Care Group)

Group 2 (Free genetic testing and counseling group)

Group 3 (IGNITE-TX Group)

Group 4 (IGNITE-TX and free genetic testing and counseling group)

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 14, 2022
Last Updated
September 7, 2023
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05677048
Brief Title
Feasibility Study: IGNITE-TX (Identifying Individuals for Genetic Testing & Treatment) Intervention
Official Title
Feasibility Study: IGNITE-TX (Identifying Individuals for Genetic Testing & Treatment) Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2023 (Actual)
Primary Completion Date
October 31, 2025 (Anticipated)
Study Completion Date
October 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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: The enrollment of probands and (ARRs) at-risk relatives over a 6-month period The response rate to baseline and follow-up surveys by probands The response rate to baseline and follow-up surveys by (ARRs) at-risk relatives Secondary Objectives: The secondary objectives of this study are to: Measure (ARR) at-risk relatives completion of (CGT) cascade genetic testing among different study arms. Measure the proportion of enrolled (ARRs) at-risk relatives who make an informed decision about (CGT) cascade genetic testing. Measure the (ARR) at-risk relatives readiness for (CGT) cascade genetic testing Measure proband and (ARR) at-risk relatives change in genetics knowledge 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: The average website traffic of the IGNITE-TX "Hub" and module completion The average utilization of family genetic navigators by participants Estimate the intra-familial correlation (IFC) for (ARR) at-risk relatives completion of (CGT) cascade genetic testing 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecologic Cancer, Ovary Cancer, Pancreatic Cancer, Breast Cancer, Lynch Syndrome, Hereditary Breast and Ovarian Cancer Syndrome, Colon Cancer, Endometrial Cancer, Uterus Cancer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (Standard of Care Group)
Arm Type
No Intervention
Arm Description
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
Arm Title
Group 2 (Free genetic testing and counseling group)
Arm Type
Experimental
Arm Description
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
Arm Title
Group 3 (IGNITE-TX Group)
Arm Type
Experimental
Arm Description
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
Arm Title
Group 4 (IGNITE-TX and free genetic testing and counseling group)
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Free genetic testing and counseling group
Intervention Description
Option to access no-cost telegenetic counseling and genetic testing
Intervention Type
Behavioral
Intervention Name(s)
IGNITE-TX Group
Intervention Description
Access online educational materials through the IGNITE-TX platform and receive assistance from a family genetic navigator
Intervention Type
Behavioral
Intervention Name(s)
IGNITE-TX and free genetic testing and counseling group
Intervention Description
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
Primary Outcome Measure Information:
Title
Measure enrollment of probands and at-risk relatives over a 6-month period
Time Frame
Up to 6 months
Title
Measure response rate to baseline and follow-up surveys by probands and at-risk relatives
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Probands Inclusion Criteria: 18 years of age or older Speaks and/or reads English or Spanish Has known deleterious/pathogenic mutation or suspected deleterious/pathogenic variant in BRCA1 or BRCA2 (HBOC) or MLH1, MSH2, MSH6, PMS2, or EPCAM (LS) Has access to the internet or phone and can send and receive email and/or text messages at a US telephone number Has at least one at-risk relative who meets inclusion criteria for first-degree relative Exclusion Criteria: Has no at-risk relatives meeting inclusion criteria Has negative germline genetic testing or only variant of uncertain significance Unwilling or unable to provide consent 4.2. AT-RISK RELATIVES (ARR) Inclusion Criteria: 18 years of age or older Speaks and reads English or Spanish Resides in the United States 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) Has access to internet or phone and can send and receive email and/or text messages at a US telephone number Exclusion Criteria: Unwilling or unable to provide consent Reports no known HBOC or LS variant within the family Has already been tested for the variant identified in the proband Already listed as an ARR for another proband
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jose Rauh-Hain, MD,MPH
Phone
(713) 794-1759
Email
jarauh@mdanderson.org
First Name & Middle Initial & Last Name or Official Title & Degree
Ignite Study
Phone
713-794-1759
Email
ignitestudy@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Rauh-Hain, MD,MPH
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Rauh-Hain, MD, MPH
First Name & Middle Initial & Last Name & Degree
Jose Rauh-Hain, MD, MPH

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center

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

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