Clinical trial NCT05470920: Genetic Testing Decision Aid
Official title: Randomized, Controlled Trial of an Electronic Decision Aid for Genetic Testing in Inherited Cancer Syndromes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epithelial Ovarian Carcinoma
Pancreas Adenocarcinoma
Keywords: pancreas adenocarcinoma.
epithelial ovarian carcinoma
decision aid
inherited cancer syndrome
genetic testing
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-07-22
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Eligibility criteria: 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

Primary outcomes:
measure: Average change in knowledge survey score
timeFrame: baseline (prior to participant completing either genetics sessions) to 1-week following session, approximately 2 weeks
measure: Decisional Conflict Scores
timeFrame: 1 week after genetics session
measure: Shared Decision Making Process Scores
timeFrame: 1 week after genetics session
Secondary outcomes:
measure: Average time between genetic testing recommendation and sample collection
timeFrame: Initial recorded recommendation/referral for genetic testing until the date of sample collection, assessed up to 6 months
measure: Average Duration of Decision Making Process
timeFrame: Approximately 30 minutes - 1 hour
measure: Ratio of the number of participants who chose each of the three panels offered
timeFrame: At the conclusion of genetics session (day 1)
measure: Percentage of participants choosing genetic testing
timeFrame: At the conclusion of genetics session (day 1)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Danvers
country: United States
facility: Mass General at North Shore Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Daniel C. Chung, MD
role: PRINCIPAL_INVESTIGATOR
References: