Genetic Testing Decision Aid
Randomized, Controlled Trial of an Electronic Decision Aid for Genetic Testing in Inherited Cancer Syndromes
2 other identifiers
interventional
350
1 country
2
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2022
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2022
CompletedFirst Posted
Study publicly available on registry
July 22, 2022
CompletedStudy Start
First participant enrolled
October 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
August 13, 2025
August 1, 2025
4 years
July 15, 2022
August 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Average change in knowledge survey score
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
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
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 Outcomes (4)
Average time between genetic testing recommendation and sample collection
Initial recorded recommendation/referral for genetic testing until the date of sample collection, assessed up to 6 months
Average Duration of Decision Making Process
Approximately 30 minutes - 1 hour
Ratio of the number of participants who chose each of the three panels offered
At the conclusion of genetics session (day 1)
Percentage of participants choosing genetic testing
At the conclusion of genetics session (day 1)
Study Arms (2)
Electronic decision aid arm
EXPERIMENTALReceive decision aid followed by an appointment with their oncologist.
Genetic counselor Arm
ACTIVE COMPARATORReceive pretest counseling with a genetic counselor.
Interventions
Decision aid followed by an appointment with an oncologist. Will complete surveys/questionnaires
Receive pretest counseling with a genetic counselor. Will complete surveys/questionnaires
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- National Cancer Institute (NCI)collaborator
Study Sites (2)
Massachusetts General Hospital
Boston, Massachusetts, 02115, United States
Mass General at North Shore Cancer Center
Danvers, Massachusetts, 01923, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel C. Chung, MD
Massachusetts General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 15, 2022
First Posted
July 22, 2022
Study Start
October 14, 2022
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
August 13, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Partners Innovations team at http://www.partners.org/innovation
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.