Genetic Testing Decision Aid

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05470920

Collaborator

National Cancer Institute (NCI) (NIH)

350

Enrollment

Locations

Arms

Anticipated Duration (Months)

175

Patients Per Site

5.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Epithelial Ovarian Carcinoma Pancreas Adenocarcinoma	Behavioral: Electronic Decision Aid Behavioral: Pre-Test Genetic Counseling	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

350 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Oct 31, 2025

Anticipated Study Completion Date :

Oct 31, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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