Back to resultsEnhancing Information Management for Young Adults After Genetic Cancer Risk Testing
Primary Purpose
Genetic Predisposition to Disease, Genetic Predisposition
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nest Platform
Sponsored by
About this trial
This is an interventional health services research trial for Genetic Predisposition to Disease focused on measuring Genetic Predisposition to Disease, Genetic Predisposition, Genetic Testing, Cancer Risk Syndromes, VUS, Variant of Uncertain Significance, Pathogenic Variant
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.
Sites / Locations
- Dana Farber Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Nest Refinement Phase
Nest Pilot Phase
Arm Description
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.
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).
Outcomes
Primary Outcome Measures
Proportion of Participant Utilization (Feasibility)
Defined as > 70% of consenting participants who use the intervention.
Proportion of Clinician Utilization (Feasibility)
Defined as > 70% of consenting clinicians who use the intervention.
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.
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
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
Secondary Outcome Measures
Change in knowledge of cancer risk
Change in cancer knowledge will be assessed by participant survey at baseline and post visit.
Change in Recommended screening
Change in Recommended screening will be assessed by participant survey at baseline and post visit.
Full Information
NCT ID
NCT05759143
First Posted
February 24, 2023
Last Updated
March 6, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
Nest Genomics
1. Study Identification
Unique Protocol Identification Number
NCT05759143
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
March 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Nest Genomics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nest Refinement Phase
Arm Type
Experimental
Arm Description
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.
Arm Title
Nest Pilot Phase
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Nest Platform
Intervention Description
Patient- and clinician-facing portal via secure link
Primary Outcome Measure Information:
Title
Proportion of Participant Utilization (Feasibility)
Description
Defined as > 70% of consenting participants who use the intervention.
Time Frame
2 hours
Title
Proportion of Clinician Utilization (Feasibility)
Description
Defined as > 70% of consenting clinicians who use the intervention.
Time Frame
2 hours
Title
Proportion of Clinicians with FIM (Feasibility of Intervention Measure) Score > 4
Description
Defined as >70% of clinicians consider the intervention feasible as assessed by the post-visit survey.
Time Frame
At post-visit survey, up to 2 hours
Title
Proportion of Participants with AIM (Acceptability of Intervention Measure) Score > 4
Description
Defined as > 70% of young adult participants consider the intervention successful as measured by a post-visit AIM score >4
Time Frame
At post-visit survey, up to 30 days
Title
Proportion of Clinicians with AIM Score > 4
Description
Defined as > 70% of clinicians consider the intervention successful as measured by a post-visit AIM score >4
Time Frame
at post-visit survey, up to 2 hours
Secondary Outcome Measure Information:
Title
Change in knowledge of cancer risk
Description
Change in cancer knowledge will be assessed by participant survey at baseline and post visit.
Time Frame
Baseline and post visit up to 2 hours
Title
Change in Recommended screening
Description
Change in Recommended screening will be assessed by participant survey at baseline and post visit.
Time Frame
Baseline and post visit up to 2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Mack, MD
Phone
617-632-6818
Email
Jennifer_mack@dfci.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Mack, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
Learn more about this trial
Enhancing Information Management for Young Adults After Genetic Cancer Risk Testing
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