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

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04704193
• Collaborator: Boston Medical Center (Other), National Cancer Institute (NCI) (NIH)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 25.3
• Patients Per Site Per Month: 3.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Genetic Testing	Other: Survey of Decision Aid	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Development and Implementation of Electronic Decision Aids for Genetic Testing in Inherited Cancer Syndromes
• Actual Study Start Date: Nov 20, 2020
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Electronic Decision Aid Participants in this arm will complete an electronic decision aid for genetic testing.	Other: Survey of Decision Aid; The decision aid will be evaluated by a survey administered to those who have used the tool.

Outcome Measures

Primary Outcome Measures

1. Participant satisfaction with how educational information is presented in the decision aid [This outcome will be measured immediately following completion of 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.

Secondary Outcome Measures

1. Total time spent on decision aid [From the start of the decision aid to the completion of the decision aid]

   The total amount of minutes spent on the decision aid

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adults (18 years of age or older)

• Diagnosed with malignant ovarian tumor or malignant pancreatic adenocarcinoma

Exclusion Criteria:

• Children (<18 years of age)

• Unable to complete surveys

• Previous germline genetic testing

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Daniel C Chung, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daniel C Chung, Daniel C Chung, MD; Director, High-Risk GI Cancer Clinic, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT04704193
• Other Study ID Numbers: 2020P003422; U01CA243695-01
• First Posted: Jan 11, 2021
• Last Update Posted: Jan 4, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Daniel C Chung, Daniel C Chung, MD; Director, High-Risk GI Cancer Clinic, Massachusetts General Hospital: Decision Aid
• Additional relevant MeSH terms: Neoplastic Syndromes, Hereditary

Study Results

No Results Posted as of Jan 4, 2022