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

OPTimizing Treatment Focused Genetic Testing IN Cancer - OPT-IN

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Pancreatic Cancer; Ovarian Cancer; Prostate Cancer
• Intervention / Treatment: Other: Chatbot; Other: Video 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
• Enrollment (Actual): 301
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Other: Chatbot; Interactive text chat designed to mirror the educational components of a traditional genetic counseling visit
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	Other: Video Education; Brief video designed to mirror the educational components of a traditional genetic counseling visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The measurement of genetic testing uptake	The proportion of participants who consent to genetic testing in each study arm	2 years
Meaningful cancer treatment changes	Assessed by chart review. Participants with positive genetic test results will be reviewed for changes in cancer treatment.	2 years
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Intent to disclose genetic test results	Three items will assess participants' intentions to disclose genetic testing results	1 day (at time of intervention)
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
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
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)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2019
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: August 20, 2019
• First Submitted That Met QC Criteria: August 22, 2019
• First Posted (Actual): August 26, 2019

Study Record Updates

• Last Update Posted (Actual): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Other Cancer
• Other Study ID Numbers: 19-068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No