Breast Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer
Conditions
Keywords
Other Cancer
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.
Interventions
OTHERChatbot
Interactive text chat designed to mirror the educational components of a traditional genetic counseling visit
OTHERVideo Education
Brief video designed to mirror the educational components of a traditional genetic counseling visit
Sponsors
Dana-Farber Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The measurement of genetic testing uptake | 2 years | The proportion of participants who consent to genetic testing in each study arm |
| Meaningful cancer treatment changes | 2 years | Assessed by chart review. Participants with positive genetic test results will be reviewed for changes in cancer treatment. |
| Satisfaction with pre-genetic test education | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decisional regret | 4 months post-result disclosure | 5 items will be asked pertaining to reflecting on the decision of the participant about getting genetic testing after learning about their result. |
| Communication of results with family members | 4 months post-result disclosure | 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. |
| Knowledge of multi-gene panel testing | 1 day (at the time of intervention) | A 6 item survey evaluating participant's understanding of inherited genetic risk |
| Intent to disclose genetic test results | 1 day (at time of intervention) | Three items will assess participants' intentions to disclose genetic testing results |
| Cascade testing of family members | 6 month post-result disclosure | This will evaluate participant's discussions about genetic testing within the family for an understanding of how genetic testing information was communicated |
Countries
United States
Outcome results
None listed