Genetic Testing Decision Aid
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Electronic Decision Aid, Pre-Test Genetic Counseling.
- Who it may be relevant to
- Registry conditions: Epithelial Ovarian Carcinoma, Pancreas Adenocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Randomized, Controlled Trial of an Electronic Decision Aid for Genetic Testing in Inherited Cancer Syndromes
Overview
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
Interventions
- Behavioral Electronic Decision Aid
Decision aid followed by an appointment with an oncologist. Will complete surveys/questionnaires - Behavioral Pre-Test Genetic Counseling
Receive pretest counseling with a genetic counselor. Will complete surveys/questionnaires
Primary outcome measures
- Average change in knowledge survey score [Time frame: baseline (prior to participant completing either genetics sessions) to 1-week following session, approximately 2 weeks]
- Decisional Conflict Scores [Time frame: 1 week after genetics session]
- Shared Decision Making Process Scores [Time frame: 1 week after genetics session]
Secondary outcome measures (4)
- Average time between genetic testing recommendation and sample collection [Time frame: Initial recorded recommendation/referral for genetic testing until the date of sample collection, assessed up to 6 months]
- Average Duration of Decision Making Process [Time frame: Approximately 30 minutes - 1 hour]
- Ratio of the number of participants who chose each of the three panels offered [Time frame: At the conclusion of genetics session (day 1)]
- Percentage of participants choosing genetic testing [Time frame: At the conclusion of genetics session (day 1)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 2 centers
- Massachusetts General Hospital — Boston
- Mass General at North Shore Cancer Center — Danvers
Identifiers
NCT: NCT05470920 · 22-155 · U01CA243695