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2022-10-14
2025-10-31
2025-10-31
350
NCT05470920
Massachusetts General Hospital
Massachusetts General Hospital
INTERVENTIONAL
Genetic Testing Decision Aid
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
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-07-15 | N/A | 2024-03-01 |
2022-07-20 | N/A | 2024-03-04 |
2022-07-22 | N/A | 2024-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Health Services Research
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Electronic decision aid arm Receive decision aid followed by an appointment with their oncologist. | BEHAVIORAL: Electronic Decision Aid
|
| ACTIVE_COMPARATOR: Genetic counselor Arm Receive pretest counseling with a genetic counselor. | BEHAVIORAL: Pre-Test Genetic Counseling
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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) |
| 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) |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Daniel C. Chung, MD Phone Number: (617) 726-8687 Email: Chung.daniel@mgh.harvard.edu |
Study Contact Backup Name: Danielle A Lynch, BS Phone Number: (617) 726-1355 Email: dlynch22@mgh.harvard.edu |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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