Development and Implementation of Electronic Decision Aids for Genetic Testing in Inherited Cancer Syndromes

NCT04704193 | Completed Results

• 2 other identifiers: 2020P003422U01CA243695-01
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

An electronic decision aid will be used to assist individuals in choosing a multi-gene panel with their medical oncologist instead of a genetic counselor. A decision aid may facilitate quality decisions around the selection of a specific multi-gene panel without a genetic counselor. Upon completion of the decision aid, participants will be asked to indicate their decision about whether to pursue genetic testing and which specific multi-gene panel to pursue. A survey will then be administered to assess participants' opinions on the decision aid.

Conditions

Genetic Testing

Keywords

Decision Aid

Outcome Measures

Primary Outcomes (1)

• Participant Satisfaction With How Educational Information is Presented in the Decision Aid

  Measured with 6 items on a questionnaire that asks participants to rate the way certain information is presented on the decision aid. Each item is rated on a scale of 1 to 4, with 1 being poor and 4 being excellent.

  This outcome will be measured immediately following completion of the decision aid. The average completion time of the decision aid is 14 minutes.

Secondary Outcomes (1)

• Total Time Spent on Decision Aid

  From the start of the decision aid to the completion of the decision aid

Study Arms (1)

Electronic Decision Aid

EXPERIMENTAL

Participants in this arm will complete an electronic decision aid for genetic testing.

Other: Survey of Decision Aid

Interventions

Survey of Decision Aid OTHER

The decision aid will be evaluated by a survey administered to those who have used the tool.

Electronic Decision Aid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (18 years of age or older)
• Diagnosed with malignant ovarian tumor or malignant pancreatic adenocarcinoma

You may not qualify if:

• Children (\<18 years of age)
• Unable to complete surveys
• Previous germline genetic testing

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Boston Medical Center: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Results Point of Contact

• Title: Daniel Chung, MD
• Organization: Massachusetts General Hospital

chung.daniel@mgh.harvard.edu

617-726-8687

Study Officials

• Daniel C Chung, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Daniel C Chung, MD; Director, High-Risk GI Cancer Clinic

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 11, 2021
• Study Start: November 20, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 13, 2024
• Results First Posted: August 13, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)