OPTimizing Treatment Focused Genetic Testing IN Cancer (OPT-IN)

• ClinicalTrials.gov Identifier: NCT04066361
• Recruitment Status: Completed
• First Posted: August 26, 2019
• Last Update Posted: January 25, 2024
• Sponsor: Dana-Farber Cancer Institute
• Information provided by (Responsible Party): Huma Rana, MD, Dana-Farber Cancer Institute

Tracking Information

• First Submitted Date: August 20, 2019
• First Posted Date: August 26, 2019
• Last Update Posted Date: January 25, 2024
• Actual Study Start Date: December 19, 2019
• Actual Primary Completion Date: November 30, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 22, 2019)

• 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".

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 30, 2019)

• 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

Original Secondary Outcome Measures (submitted: August 22, 2019)

• Communication of results with family members [ Time Frame: 1 month 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
• Proportion of participant enrolling in randomized cohort [ Time Frame: Pilot Phase Only, 1 year ]
  Analysis will be conducted for the pilot phase data to understand participant preferences for randomization

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: OPTimizing Treatment Focused Genetic Testing IN Cancer
• Official Title: OPTimizing Treatment Focused Genetic Testing IN Cancer - OPT-IN
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

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

Study Arms

• Experimental: Chatbot
  • 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
  Intervention: Other: Chatbot
• Experimental: Video Education
  • 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
  Intervention: Other: Video Education

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 24, 2024): 301
• Original Estimated Enrollment (submitted: August 22, 2019): 1200
• Actual Study Completion Date: November 30, 2022
• Actual Primary Completion Date: November 30, 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04066361
• Other Study ID Numbers: 19-068
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• URL: http://innovation@dfci.harvard.edu

• Current Responsible Party: Huma Rana, MD, Dana-Farber Cancer Institute
• Original Responsible Party: Huma Rana, Dana-Farber Cancer Institute, Principal Investigator
• Current Study Sponsor: Dana-Farber Cancer Institute
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Huma Q Rana, MD; Dana-Farber Cancer Institute

• PRS Account: Dana-Farber Cancer Institute
• Verification Date: January 2024