OPTimizing Treatment Focused Genetic Testing IN Cancer (OPT-IN)
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|ClinicalTrials.gov Identifier: NCT04066361|
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : February 24, 2021
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Ovarian Cancer Pancreatic Cancer Prostate Cancer||Other: Chatbot Other: Video Education||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||1200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||OPTimizing Treatment Focused Genetic Testing IN Cancer - OPT-IN|
|Actual Study Start Date :||December 19, 2019|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2028|
Interactive text chat designed to mirror the educational components of a traditional genetic counseling visit
Experimental: Video Education
Other: Video Education
Brief video designed to mirror the educational components of a traditional genetic counseling visit
- 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.
- 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".
- Communication of results with family members [ Time Frame: 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.
- Intent to disclose genetic test results [ Time Frame: 1 day (at time of intervention) ]Three items will assess participants' intentions to disclose genetic testing results
- Cascade testing of family members [ Time Frame: 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
- Decisional regret [ Time Frame: 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.
- Knowledge of multi-gene panel testing [ Time Frame: 1 day (at the time of intervention) ]A 6 item survey evaluating participant's understanding of inherited genetic risk
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066361
|Contact: Huma Q Rana, MD||617-632-6292||HumaQ_Rana@DFCI.HARVARD.EDU|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Huma Q Rana, MD 617-632-6292 HumaQ_Rana@DFCI.HARVARD.EDU|
|Contact: Abigeal K Lynch, BS AbigealK_Lynch@DFCI.HARVARD.EDU|
|Principal Investigator: Huma Q Rana, MD|
|Principal Investigator:||Huma Q Rana, MD||Dana-Farber Cancer Institute|