Clinical trial NCT05759143: Enhancing Information Management for Young Adults After Genetic Cancer Risk Testing
Official title: Enhancing Information Management for Young Adults After Genetic Cancer Risk Testing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Genetic Predisposition to Disease
Genetic Predisposition
Keywords: Genetic Predisposition to Disease
Genetic Predisposition
Genetic Testing
Cancer Risk Syndromes
VUS
Variant of Uncertain Significance
Pathogenic Variant
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Nest Genomics
First posted: 2023-03-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Primary outcomes:
measure: Proportion of Participant Utilization (Feasibility)
timeFrame: 2 hours
measure: Proportion of Clinician Utilization (Feasibility)
timeFrame: 2 hours
measure: Proportion of Clinicians with FIM (Feasibility of Intervention Measure) Score > 4
timeFrame: At post-visit survey, up to 2 hours
measure: Proportion of Participants with AIM (Acceptability of Intervention Measure) Score > 4
timeFrame: At post-visit survey, up to 30 days
measure: Proportion of Clinicians with AIM Score > 4
timeFrame: at post-visit survey, up to 2 hours
Secondary outcomes:
measure: Change in knowledge of cancer risk
timeFrame: Baseline and post visit up to 2 hours
measure: Change in Recommended screening
timeFrame: Baseline and post visit up to 2 hours
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Jennifer Mack, MD
role: PRINCIPAL_INVESTIGATOR
References: