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

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

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.

Source: View full study details on ClinicalTrials.gov

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August 29, 2023Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
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