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2023-04-14
2025-10-31
2027-10-31
205
NCT05677048
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
INTERVENTIONAL
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-12-14 | N/A | 2025-09-04 |
2023-01-05 | N/A | 2025-09-08 |
2023-01-10 | N/A | 2025-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Health Services Research
Allocation:
Randomized
Interventional Model:
Factorial
Masking:
None
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 te | |
| 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
BEHAVIORAL: IGNITE-TX Group
BEHAVIORAL: IGNITE-TX and free genetic testing and counseling group
|
| 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 platf | BEHAVIORAL: Free genetic testing and counseling group
BEHAVIORAL: IGNITE-TX Group
BEHAVIORAL: IGNITE-TX and free genetic testing and counseling group
|
| 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 contac | BEHAVIORAL: Free genetic testing and counseling group
BEHAVIORAL: IGNITE-TX Group
BEHAVIORAL: IGNITE-TX and free genetic testing and counseling group
|
| Primary Outcome Measures | Measure Description | 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 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
