OPTimizing Treatment Focused Genetic Testing IN Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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OPTimizing Treatment Focused Genetic Testing IN Cancer - OPT-IN

Conditions
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Breast Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer

Intervention / Treatment
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* Other: Chatbot
* Other: Video Education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chatbot<br>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 Chatbot education, participant is asked if they would like to proceed with genetic testing. Participant is asked to complete an electronic family history tool | Other: Chatbot<br>* Interactive text chat designed to mirror the educational components of a traditional genetic counseling visit<br>|
| Experimental: Video Education<br>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 genetic testing process and what to expect prior to genetic testing. After the video education, participant is asked if they would like to proceed with genetic testing. Participant is asked to complete an electronic family history tool | Other: Video Education<br>* Brief video designed to mirror the educational components of a traditional genetic counseling visit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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

| Outcome Measure | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Other Cancer