Enhancing Information Management for Young Adults After Genetic Cancer Risk Testing

Study Overview
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Brief Summary
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This research is being done to develop the electronic platform Nest for young adults (ages 18-39) who have had prior cancer genetic testing. The platform will give patients and their clinicians access to continuously updated information about both pathogenic variants and variants of uncertain significance (VUS). The name of the intervention used in this research study is: Nest portal (electronic platform for patients and clinicians)

Detailed Description
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The goal of the electronic platform Nest is to help patients understand and manage genetic test results and recommended care and to help clinicians with access to results and recommendations, facilitating orders, and documentation. The portal has two parts, one for participants and one for clinicians. For the first phase of the study, participants will give their feedback on the Nest portal's content and processes that will guide refinement of the portal. The Pilot phase will test the feasibility and acceptability of the intervention. The research study procedures include a baseline survey, using the portal after receiving a brief orientation from the study team, a follow-up survey, and then a 30-minute interview. Participants will be in this research study for up to 2 hours. It is expected that about 40 people will take part in this research study. The electronic platform is being developed by Nest Genomics.

Official Title
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Enhancing Information Management for Young Adults After Genetic Cancer Risk Testing

Conditions
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Genetic Predisposition to Disease, Genetic Predisposition

Intervention / Treatment
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* Behavioral: Nest Platform


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria AIM 1: YA Patients: Ages 18-39 years, inclusive. Has had previous cancer genetic testing, with a finding of a pathogenic variant or VUS; patient has previously received results from the clinical team. English-speaking and -reading. Receiving care at DFCI. Not undergoing active cancer therapy at the time of approach. Clinicians: Cancer risk physicians (oncologists, gastroenterologists, geneticists), oncologists, nurse practitioners, physician assistants, or genetic counselors. English-speaking and -reading. Cares for YAs aged 18-39 with cancer risk syndromes. Inclusion Criteria AIM 2: YA Patients: Ages 18-39 years, inclusive. Has had previous cancer genetic testing, with a finding of a pathogenic variant or VUS; patient has previously received results from the clinical team. English-speaking and -reading. Receiving care at Dana-Farber Cancer Institute. Did not participate in a stakeholder interview (Aim 1). Not undergoing active cancer therapy at the time of approach. Clinicians: Oncologists, nurse practitioners, cancer risk physicians, or genetic counselors. English-speaking and -reading. Caring for a participating YA.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nest Refinement Phase<br>20 participants and clinicians will complete study procedures as outlined: Nest portal orientation and access. Semi-structured, 30-minute interviews. Solicited feedback on content and processes will refine the intervention for a pilot phase. | Behavioral: Nest Platform<br>* Patient- and clinician-facing portal via secure link<br>|
| Experimental: Nest Pilot Phase<br>10 Participants and 10 clinicians will complete study procedures as outlined: Baseline survey (participant). Standard clinic visit. Nest portal orientation and access (participant and clinician). Post-visit survey (participant and clinician). Brief, 30-minute, semi-structured interview (participant and clinician). | Behavioral: Nest Platform<br>* Patient- and clinician-facing portal via secure link<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participant Utilization (Feasibility) | Defined as > 70% of consenting participants who use the intervention. | 2 hours | 
| Proportion of Clinician Utilization (Feasibility) | Defined as > 70% of consenting clinicians who use the intervention. | 2 hours | 
| Proportion of Clinicians with FIM (Feasibility of Intervention Measure) Score > 4 | Defined as >70% of clinicians consider the intervention feasible as assessed by the post-visit survey. | At post-visit survey, up to 2 hours | 
| Proportion of Participants with AIM (Acceptability of Intervention Measure) Score > 4 | Defined as > 70% of young adult participants consider the intervention successful as measured by a post-visit AIM score >4 | At post-visit survey, up to 30 days | 
| Proportion of Clinicians with AIM Score > 4 | Defined as > 70% of clinicians consider the intervention successful as measured by a post-visit AIM score >4 | at post-visit survey, up to 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in knowledge of cancer risk | Change in cancer knowledge will be assessed by participant survey at baseline and post visit. | Baseline and post visit up to 2 hours | 
| Change in Recommended screening | Change in Recommended screening will be assessed by participant survey at baseline and post visit. | Baseline and post visit up to 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Genetic Predisposition to Disease, Genetic Predisposition, Genetic Testing, Cancer Risk Syndromes, VUS, Variant of Uncertain Significance, Pathogenic Variant