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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05677048
Recruitment Status : Not yet recruiting
First Posted : January 10, 2023
Last Update Posted : January 12, 2023
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : June 30, 2023
Estimated Primary Completion Date : October 31, 2025
Estimated Study Completion Date : October 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genetic Testing

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Measure enrollment of probands and at-risk relatives over a 6-month period [ Time Frame: Up to 6 months ]
  2. Measure response rate to baseline and follow-up surveys by probands and at-risk relatives [ Time Frame: Up to 6 months ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05677048


Contacts
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Contact: Jose Rauh-Hain, MD,MPH (713) 794-1759 jarauh@mdanderson.org
Contact: Ignite Study 713-794-1759 ignitestudy@mdanderson.org

Locations
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United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Contact: Jose Rauh-Hain, MD, MPH         
Principal Investigator: Jose Rauh-Hain, MD, MPH         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Jose Rauh-Hain, MD,MPH M.D. Anderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT05677048    
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 )
First Posted: January 10, 2023    Key Record Dates
Last Update Posted: January 12, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Endometrial Neoplasms
Colorectal Neoplasms, Hereditary Nonpolyposis
Hereditary Breast and Ovarian Cancer Syndrome
Uterine Neoplasms
Syndrome
Disease
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Endocrine System Diseases
Ovarian Diseases
 Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Gonadal Disorders
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Uterine Diseases
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases