Recruiting

Genetic Testing

Sponsor:

Massachusetts General Hospital

Code:

NCT05470920

Conditions

Epithelial Ovarian Carcinoma

Pancreas Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Electronic Decision Aid

Pre-Test Genetic Counseling

Study Details

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

Conditions

Epithelial Ovarian Carcinoma

Pancreas Adenocarcinoma

Study ID

NCT05470920

Start date

Oct 14, 2022

Status verified date

Aug, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

350 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Electronic decision aid arm

Receive decision aid followed by an appointment with their oncologist.

active comparator: Genetic counselor Arm

Receive pretest counseling with a genetic counselor.

Interventions

Electronic Decision Aid

Decision aid followed by an appointment with an oncologist. Will complete surveys/questionnaires

Pre-Test Genetic Counseling

Receive pretest counseling with a genetic counselor. Will complete surveys/questionnaires

Primary outcome measure

  • Average change in knowledge survey score [ Time Frame: 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 ]
  • Shared Decision Making Process Scores [ Time Frame: 1 week after genetics session ]

Central Contacts and Locations

Central contacts

Daniel C. Chung, MD

(617) 726-8687Chung.daniel@mgh.harvard.edu

Danielle A Lynch, BS

(617) 726-1355dlynch22@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Daniel C. Chung, MD

(617) 726-8687Chung.daniel@mgh.harvard.edu

Principal Investigator:

Daniel C. Chung, MD

Mass General at North Shore Cancer Center

Recruiting

Danvers, Massachusetts, United States, 01923

Contacts

Sara Bouberhan, MD

SBOUBERHAN@MGH.HARVARD.EDU

Principal Investigator:

Sara Bouberhan, MD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Aug 13, 2025

Last verified

Aug, 2025

Keywords

  • pancreas adenocarcinoma.
  • epithelial ovarian carcinoma
  • decision aid
  • inherited cancer syndrome
  • genetic testing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-08-13.