Clinical trial NCT04066361: OPTimizing Treatment Focused Genetic Testing IN Cancer
Official title: OPTimizing Treatment Focused Genetic Testing IN Cancer - OPT-IN
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Ovarian Cancer
Pancreatic Cancer
Prostate Cancer
Keywords: Other Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2019-08-26
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: The measurement of genetic testing uptake
timeFrame: 2 years
measure: Meaningful cancer treatment changes
timeFrame: 2 years
measure: Satisfaction with pre-genetic test education
timeFrame: at time of post-counseling/video pre-result disclosure, on average 3 weeks
Secondary outcomes:
measure: Communication of results with family members
timeFrame: 4 months post-result disclosure
measure: Intent to disclose genetic test results
timeFrame: 1 day (at time of intervention)
measure: Cascade testing of family members
timeFrame: 6 month post-result disclosure
measure: Decisional regret
timeFrame: 4 months post-result disclosure
measure: Knowledge of multi-gene panel testing
timeFrame: 1 day (at the time of intervention)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Huma Q Rana, MD
role: PRINCIPAL_INVESTIGATOR
References: