OPTimizing Treatment Focused Genetic Testing IN Cancer

Breast Cancer Clinical Trial

— OPT-IN  

Official title:

OPTimizing Treatment Focused Genetic Testing IN Cancer - OPT-IN

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04066361
• Other study ID #: 19-068
• Status: Completed
• Phase: N/A
• Start date: December 19, 2019
• Est. completion date: November 30, 2022

Study information

• Verified date: January 2024
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This two-part randomized controlled trial aims to evaluate the impact of pre-test video education as compared to pre-test Chatbot education.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Ovarian Cancer
• Pancreatic Cancer
• Prostate Cancer

Intervention

Other:
• Chatbot
Interactive text chat designed to mirror the educational components of a traditional genetic counseling visit
• Video Education
Brief video designed to mirror the educational components of a traditional genetic counseling visit

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The measurement of genetic testing uptake	The proportion of participants who consent to genetic testing in each study arm	2 years
Primary	Meaningful cancer treatment changes	Assessed by chart review. Participants with positive genetic test results will be reviewed for changes in cancer treatment.	2 years
Primary	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	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
Secondary	Intent to disclose genetic test results	Three items will assess participants' intentions to disclose genetic testing results	1 day (at time of intervention)
Secondary	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
Secondary	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
Secondary	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)