Genetic Testing Decision Aid

Not Applicable

Recruiting

• Conditions: Epithelial Ovarian Carcinoma; Pancreas Adenocarcinoma
• Interventions: Behavioral: Electronic Decision Aid; Behavioral: Pre-Test Genetic Counseling

• Registration Number: NCT05470920
• Lead Sponsor: Massachusetts General Hospital

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

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 Timeline

• Study First Submitted: 2022-07-15
• Study First Submitted QC: 2022-07-20
• Study First Posted: 2022-07-22
• Study Start: 2022-10-14
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-01
• Last Update Posted: 2024-03-04
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 350

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electronic decision aid arm	Electronic Decision Aid	Receive decision aid followed by an appointment with their oncologist.
Genetic counselor Arm	Pre-Test Genetic Counseling	Receive pretest counseling with a genetic counselor.

Primary Outcome Measures

Name	Time	Method
Shared Decision Making Process Scores	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.
Average change in knowledge survey score	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.
Decisional Conflict Scores	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.

Secondary Outcome Measures

Name	Time	Method
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	Difference between the two study arms in the time it takes between participants being recommended for genetic testing and a sample being collected.
Average Duration of Decision Making Process	Approximately 30 minutes - 1 hour	Amount of time patients spend learning and making a decision about genetic testing in both arms of the study.
Ratio of the number of participants who chose each of the three panels offered	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.
Percentage of participants choosing genetic testing	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

Trial Locations

Locations (2)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Mass General at North Shore Cancer Center; 🇺🇸 Danvers, Massachusetts, United States