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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
301
Interactive text chat designed to mirror the educational components of a traditional genetic counseling visit
Brief video designed to mirror the educational components of a traditional genetic counseling visit
Dana Farber Cancer Institute
Boston, Massachusetts, United States
The measurement of genetic testing uptake
The proportion of participants who consent to genetic testing in each study arm
Time frame: 2 years
Meaningful cancer treatment changes
Assessed by chart review. Participants with positive genetic test results will be reviewed for changes in cancer treatment.
Time frame: 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".
Time frame: at time of post-counseling/video pre-result disclosure, on average 3 weeks
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.
Time frame: 4 months post-result disclosure
Intent to disclose genetic test results
Three items will assess participants' intentions to disclose genetic testing results
Time frame: 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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.
Time frame: 4 months post-result disclosure
Knowledge of multi-gene panel testing
A 6 item survey evaluating participant's understanding of inherited genetic risk
Time frame: 1 day (at the time of intervention)