OPTimizing Treatment Focused Genetic Testing IN Cancer - OPT-IN
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 301
- Locations
- 1
- Primary Endpoint
- Satisfaction with pre-genetic test education
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This two-part randomized controlled trial aims to evaluate the impact of pre-test video education as compared to pre-test Chatbot education.
Detailed Description
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.
Investigators
Huma Rana, MD
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
Inclusion Criteria
- •Adult patients over the age of 18
- •With a diagnosis of advanced cancer (defined as Stage 3 or 4), or
- •Any stage for pancreatic cancer and
- •No prior cancer genetic panel testing
Exclusion Criteria
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women (if known at the time of participation)
- •Prisoners
- •Non-English speakers
Outcomes
Primary Outcomes
Satisfaction with pre-genetic test education
Time Frame: at time of post-counseling/video pre-result disclosure, on average 3 weeks
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".
The measurement of genetic testing uptake
Time Frame: 2 years
The proportion of participants who consent to genetic testing in each study arm
Meaningful cancer treatment changes
Time Frame: 2 years
Assessed by chart review. Participants with positive genetic test results will be reviewed for changes in cancer treatment.
Secondary Outcomes
- Intent to disclose genetic test results(1 day (at time of intervention))
- Communication of results with family members(4 months post-result disclosure)
- Decisional regret(4 months post-result disclosure)
- Knowledge of multi-gene panel testing(1 day (at the time of intervention))
- Cascade testing of family members(6 month post-result disclosure)