Genetic Testing Decision Aid

March 1, 2024 updated by: Daniel C Chung, Massachusetts General Hospital

Randomized, Controlled Trial of an Electronic Decision Aid for Genetic Testing in Inherited Cancer Syndromes

This is a randomized trial to evaluate the effectiveness of an electronic decision aid tool versus a traditional genetic counselor session for multi-gene panel testing for people with ovarian or pancreatic cancer

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The research study procedures include: screening for eligibility and study questionnaires that would be performed in conjunction with either the genetic counselor visit or use of the electronic decision aid. The study questionnaires include:

  • Knowledge Survey
  • Shared Decision Making Process Survey
  • Decisional Conflict Scale

The research study will last up to 2 weeks. It is expected that about 350 people will take part in this research study.

The National Cancer Institute (NCI) is supporting this research study by providing funding for the research

Study Type

Interventional

Enrollment (Estimated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
        • Principal Investigator:
          • Daniel C. Chung, MD
      • Danvers, Massachusetts, United States, 01923
        • Recruiting
        • Mass General at North Shore Cancer Center
        • Contact:
        • Principal Investigator:
          • Sara Bouberhan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years or older
  • Being seen in clinic at Massachusetts General Hospital or Boston Medical Center
  • Diagnosed with malignant epithelial ovarian carcinoma or malignant pancreatic adenocarcinoma.

Exclusion Criteria :

  • Unable or unwilling to provide informed consent, undergo randomization, or complete the surveys associated with the study
  • Previous germline genetic testing
  • History of hereditary pancreatitis
  • Members of the following vulnerable populations: adults unable to consent, individuals who are not yet adults

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electronic decision aid arm
Receive decision aid followed by an appointment with their oncologist.
Behavioral: Electronic Decision Aid
Decision aid followed by an appointment with an oncologist. Will complete surveys/questionnaires
Active Comparator: Genetic counselor Arm
Receive pretest counseling with a genetic counselor.
Behavioral: Pre-Test Genetic Counseling
Receive pretest counseling with a genetic counselor. Will complete surveys/questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average change in knowledge survey score
Time Frame: baseline (prior to participant completing either genetics sessions) to 1-week following session, approximately 2 weeks
Average change in score on a 10-question knowledge survey to assess basic information about genetics and genetic testing that was covered in their appointment. Scores on the scale range from 0-10. Higher values in the change in knowledge survey score suggest greater amount of knowledge gained in the genetics session.
baseline (prior to participant completing either genetics sessions) to 1-week following session, approximately 2 weeks
Decisional Conflict Scores
Time Frame: 1 week after genetics session
The decisional conflict score is a score ranging from 0-100 that is measured from a 10-question validated decisional conflict scale. The scale assesses participant's confidence in their decision with higher scores indicating higher decisional conflict.
1 week after genetics session
Shared Decision Making Process Scores
Time Frame: 1 week after genetics session
The shared decision making process score is a score on a scale of 1-4 based on responses on a validated 4-item shared-decision making scale. The scale assesses how well the decision aid/oncology provider, or the genetic counselor engaged in shared decision-making as perceived by the subject. Higher scores on this scale indicate more shared decision making.
1 week after genetics session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average time between genetic testing recommendation and sample collection
Time Frame: Initial recorded recommendation/referral for genetic testing until the date of sample collection, assessed up to 6 months
Difference between the two study arms in the time it takes between participants being recommended for genetic testing and a sample being collected.
Initial recorded recommendation/referral for genetic testing until the date of sample collection, assessed up to 6 months
Average Duration of Decision Making Process
Time Frame: Approximately 30 minutes - 1 hour
Amount of time patients spend learning and making a decision about genetic testing in both arms of the study.
Approximately 30 minutes - 1 hour
Ratio of the number of participants who chose each of the three panels offered
Time Frame: At the conclusion of genetics session (day 1)
Ratios of participants who choose the small, intermediate, and broad testing panel in both arms of the study.
At the conclusion of genetics session (day 1)
Percentage of participants choosing genetic testing
Time Frame: At the conclusion of genetics session (day 1)
Percentage of participants in each arm of the study who choose to get genetic testing after the educational intervention
At the conclusion of genetics session (day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

National Cancer Institute (NCI)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2022

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

October 31, 2025

Study Registration Dates

First Submitted

July 15, 2022

First Submitted That Met QC Criteria

July 20, 2022

First Posted (Actual)

July 22, 2022

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-155
  • U01CA243695 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 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 Partners Innovations team at http://www.partners.org/innovation

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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