Genetic Testing Decision Aid

Pancreas Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05470920
• Other study ID #: 22-155
• Secondary ID: U01CA243695
• Status: Recruiting
• Phase: N/A
• Start date: October 14, 2022
• Est. completion date: October 31, 2025

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: Daniel C. Chung, MD
• Phone: (617) 726-8687
• Email: Chung.daniel[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Carcinoma
• Ovarian Neoplasms
• Pancreas Adenocarcinoma

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Mass General at North Shore Cancer Center	Danvers	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	Initial recorded recommendation/referral for genetic testing until the date of sample collection, assessed up to 6 months
Secondary	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.	Approximately 30 minutes - 1 hour
Secondary	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.	At the conclusion of genetics session (day 1)
Secondary	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	At the conclusion of genetics session (day 1)