Epithelial Ovarian Carcinoma, Pancreas Adenocarcinoma
Conditions
Keywords
pancreas adenocarcinoma., epithelial ovarian carcinoma, decision aid, inherited cancer syndrome, genetic testing
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
Interventions
BEHAVIORALElectronic Decision Aid
Decision aid followed by an appointment with an oncologist. Will complete surveys/questionnaires
BEHAVIORALPre-Test Genetic Counseling
Receive pretest counseling with a genetic counselor. Will complete surveys/questionnaires
Sponsors
National Cancer Institute (NCI)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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. |
Countries
United States
Contacts
Primary ContactDaniel C. Chung, MD
Backup ContactDanielle A Lynch, BS
Outcome results
None listed