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Trial Title:
Feasibility Study: IGNITE-TX (Identifying Individuals for Genetic Testing & Treatment) Intervention
NCT ID:
NCT05677048
Condition:
Gynecologic Cancer
Ovary Cancer
Pancreatic Cancer
Breast Cancer
Lynch Syndrome
Hereditary Breast and Ovarian Cancer Syndrome
Colon Cancer
Endometrial Cancer
Uterus Cancer
Conditions: Official terms:
Ovarian Neoplasms
Endometrial Neoplasms
Colorectal Neoplasms, Hereditary Nonpolyposis
Hereditary Breast and Ovarian Cancer Syndrome
Uterine Neoplasms
Syndrome
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Factorial Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Free genetic testing and counseling group
Description:
Option to access no-cost telegenetic counseling and genetic testing
Arm group label:
Group 2 (Free genetic testing and counseling group)
Arm group label:
Group 3 (IGNITE-TX Group)
Arm group label:
Group 4 (IGNITE-TX and free genetic testing and counseling group)
Intervention type:
Behavioral
Intervention name:
IGNITE-TX Group
Description:
Access online educational materials through the IGNITE-TX platform and receive assistance
from a family genetic navigator
Arm group label:
Group 2 (Free genetic testing and counseling group)
Arm group label:
Group 3 (IGNITE-TX Group)
Arm group label:
Group 4 (IGNITE-TX and free genetic testing and counseling group)
Intervention type:
Behavioral
Intervention name:
IGNITE-TX and free genetic testing and counseling group
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
Arm group label:
Group 2 (Free genetic testing and counseling group)
Arm group label:
Group 3 (IGNITE-TX Group)
Arm group label:
Group 4 (IGNITE-TX and free genetic testing and counseling group)
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:
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jose Rauh-Hain, MD, MPH
Investigator:
Last name:
Jose Rauh-Hain, MD, MPH
Email:
Principal Investigator
Start date:
April 14, 2023
Completion date:
October 31, 2027
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05677048
http://www.mdanderson.org
