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Trial Title:
Enhancing Information Management for Young Adults After Genetic Cancer Risk Testing
NCT ID:
NCT05759143
Condition:
Genetic Predisposition to Disease
Genetic Predisposition
Conditions: Official terms:
Disease Susceptibility
Genetic Predisposition to Disease
Conditions: Keywords:
Genetic Predisposition to Disease
Genetic Predisposition
Genetic Testing
Cancer Risk Syndromes
VUS
Variant of Uncertain Significance
Pathogenic Variant
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Nest Platform
Description:
Patient- and clinician-facing portal via secure link
Arm group label:
Nest Pilot Phase
Arm group label:
Nest Refinement Phase
Summary:
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
39 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02115
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Mack, MD
Phone:
617-632-6622
Email:
JMACK@PARTNERS.ORG
Investigator:
Last name:
Jennifer Mack, MD
Email:
Principal Investigator
Start date:
May 1, 2023
Completion date:
March 30, 2026
Lead sponsor:
Agency:
Dana-Farber Cancer Institute
Agency class:
Other
Collaborator:
Agency:
Nest Genomics
Agency class:
Industry
Source:
Dana-Farber Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05759143
