Enhancing Information Management for Young Adults After Genetic Cancer Risk Testing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nest Platform.
- Who it may be relevant to
- Registry conditions: Genetic Predisposition to Disease, Genetic Predisposition. Basic parameters: 18 years — 39 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
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.
Interventions
- Behavioral Nest Platform
Patient- and clinician-facing portal via secure link
Primary outcome measures
- Proportion of Participant Utilization (Feasibility) [Time frame: 2 hours]
- Proportion of Clinician Utilization (Feasibility) [Time frame: 2 hours]
- Proportion of Clinicians with FIM (Feasibility of Intervention Measure) Score > 4 [Time frame: At post-visit survey, up to 2 hours]
- Proportion of Participants with AIM (Acceptability of Intervention Measure) Score > 4 [Time frame: At post-visit survey, up to 30 days]
- Proportion of Clinicians with AIM Score > 4 [Time frame: at post-visit survey, up to 2 hours]
Secondary outcome measures (2)
- Change in knowledge of cancer risk [Time frame: Baseline and post visit up to 2 hours]
- Change in Recommended screening [Time frame: Baseline and post visit up to 2 hours]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Dana Farber Cancer Institute — Boston
Identifiers
NCT: NCT05759143 · 22-657