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CompletedNCT05470920Updated Oct 2, 2026

Genetic Testing Decision Aid

An interventional study of Electronic Decision Aid and Pre-Test Genetic Counseling in Epithelial Ovarian Carcinoma and Pancreas Adenocarcinoma, sponsored by Massachusetts General Hospital. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Health services research

Updated Oct 2, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
297
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Epithelial Ovarian Carcinoma
  • Pancreas Adenocarcinoma

Keywords

  • pancreas adenocarcinoma.
  • epithelial ovarian carcinoma
  • decision aid
  • inherited cancer syndrome
  • genetic testing
03

In context

Carcinoma, Ovarian Epithelial

1,617 studies on the registry are indexed under Carcinoma, Ovarian Epithelial; 246 are open to participants now.

This study's enrollment of 297 is above the median of 47 across 1,194 interventional studies indexed under Carcinoma, Ovarian Epithelial.

Browse Carcinoma, Ovarian Epithelial studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
297 participants (actual)

Study arms

  • Experimental
    Electronic decision aid arm

    Receive decision aid followed by an appointment with their oncologist.

    Behavioral: Electronic Decision Aid

  • Active comparator
    Genetic counselor Arm

    Receive pretest counseling with a genetic counselor.

    Behavioral: Pre-Test Genetic Counseling

Interventions

  • BehavioralElectronic Decision Aid

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

  • BehavioralPre-Test Genetic Counseling

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 week after genetics session

  2. 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.

    Time frame: baseline (prior to participant completing either genetics sessions) to 1-week following session, approximately 2 weeks

  3. 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.

    Time frame: 1 week after genetics session

Secondary outcomes

  1. Average time between genetic testing recommendation and sample collection

    Difference between the two study arms in the time it takes between participants being recommended for genetic testing and a sample being collected.

    Time frame: Initial recorded recommendation/referral for genetic testing until the date of sample collection, assessed up to 6 months

  2. Average Duration of Decision Making Process

    Amount of time patients spend learning and making a decision about genetic testing in both arms of the study.

    Time frame: Approximately 30 minutes - 1 hour

  3. Ratio of the number of participants who chose each of the three panels offered

    Ratios of participants who choose the small, intermediate, and broad testing panel in both arms of the study.

    Time frame: At the conclusion of genetics session (day 1)

  4. Percentage of participants choosing genetic testing

    Percentage of participants in each arm of the study who choose to get genetic testing after the educational intervention

    Time frame: At the conclusion of genetics session (day 1)

07

Study locations

2 sites
  • Massachusetts General Hospital
    Boston, Massachusetts 02115, United States
  • Mass General at North Shore Cancer Center
    Danvers, Massachusetts 01923, United States
08

References and documents

Study documents

  • Informed consent form · Aug 6, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap

09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Completed
changed Oct 2, 2026
Primary completion
Sep 30, 2026→May 19, 2026 (actual)
Oct 2, 2026
Study completion
Dec 31, 2026→May 19, 2026 (actual)
Oct 2, 2026
Enrollment
350 (estimated)→297 (actual)
Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    Recruiting→Completed
    Primary completion Sep 30, 2026→May 19, 2026 (now actual)
    Study completion Dec 31, 2026→May 19, 2026 (now actual)
    Enrollment 350 (estimated)→297 (actual)
    + 5 other changes: verification date, oversight details, contact details, site details and documents

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05470920
Lead sponsor
Massachusetts General Hospital
Collaborators
National Cancer Institute (NCI)
Responsible party
Daniel C Chung (Principal Investigator, Massachusetts General Hospital) — Principal investigator
First posted
Jul 22, 2022
Start date
Oct 14, 2022
Primary completion
May 19, 2026
Completion
May 19, 2026
Last update
Oct 2, 2026

Study contacts

Daniel C. Chung, MD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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