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2019-12-19
2022-11-30
2022-11-30
301
NCT04066361
Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
INTERVENTIONAL
OPTimizing Treatment Focused Genetic Testing IN Cancer
This two-part randomized controlled trial aims to evaluate the impact of pre-test video education as compared to pre-test Chatbot education.
In this research study, the investigators are introducing the option of two alternatives to genetic counseling before genetic testing: Chatbot and video education. The first part of this research study is a Pilot Study, which is the first-time investigators are examining the use of a Chatbot to deliver pre-genetic test education. The Chatbot will converse with you about germline genetic testing by text message. The Pilot study will enroll 200 participants with a metastatic breast or ovarian cancer diagnosis and will assess the uptake of genetic testing among the two possible groups of pre-genetic test counseling. The second part of this research study will utilize findings from the Pilot Study for 1000 participants with a diagnosis of breast, ovarian, pancreatic or prostate cancer. In both parts of this research study, participants will be randomized to either the video education or Chatbot. Participants may request in-person genetic counseling after their respective education prior to testing. Other studies at both DFCI and outside institutions have started to investigate alternative methods of educating patients about genetic testing. These studies have suggested that alternatives to standard genetic counseling may increase access to genetic testing with similar satisfaction to standard of care. The investigators are hoping to get a sense of participants' preferences for pre genetic test education, understanding, and reactions to the alternative methods of genetic counseling. The investigators are also hoping to understand preferences for communication of their result and whether any treatment changes have been made after they receive their result.
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 |
|---|---|---|
2019-08-20 | N/A | 2024-01-24 |
2019-08-22 | N/A | 2024-01-25 |
2019-08-26 | N/A | 2024-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Chatbot * Participant is given a pamphlet introducing genetic testing * Participant is given information utilized for clinical, standard of care testing. * Will receive genetic information with a virtual interactive Chatbot prior to genetic testing. After the Cha | OTHER: Chatbot
|
| EXPERIMENTAL: Video Education * Participant is given a pamphlet introducing genetic testing * Participant is given information utilized for clinical, standard of care testing. * Participant will watch a brief educational video that is approximately 8 minutes in length about the geneti | OTHER: Video Education
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| The measurement of genetic testing uptake | The proportion of participants who consent to genetic testing in each study arm | 2 years |
| Meaningful cancer treatment changes | Assessed by chart review. Participants with positive genetic test results will be reviewed for changes in cancer treatment. | 2 years |
| Satisfaction with pre-genetic test education | A validated survey of participants' satisfaction with the genetic counseling and testing process will be used. For the survey at the time of post-counseling, the survey for the video education arm consists of 8 questions and the genetic counseling arm contains an additional question about perceived length of the visit. The parameters for measurement are "disagree strongly", "disagree", "neither agree or disagree", "agree", and "agree strongly". | at time of post-counseling/video pre-result disclosure, on average 3 weeks |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Communication of results with family members | For those participants who have tested positive for a mutation, 5 items will be asked pertaining to disclosure of genetic testing results to relatives that are derived from previous literature. | 4 months post-result disclosure |
| Intent to disclose genetic test results | Three items will assess participants' intentions to disclose genetic testing results | 1 day (at time of intervention) |
| Cascade testing of family members | This will evaluate participant's discussions about genetic testing within the family for an understanding of how genetic testing information was communicated | 6 month post-result disclosure |
| Decisional regret | 5 items will be asked pertaining to reflecting on the decision of the participant about getting genetic testing after learning about their result. | 4 months post-result disclosure |
| Knowledge of multi-gene panel testing | A 6 item survey evaluating participant's understanding of inherited genetic risk | 1 day (at the time of intervention) |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
