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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04066361
Recruitment Status : Completed
First Posted : August 26, 2019
Last Update Posted : January 25, 2024
Sponsor:
Information provided by (Responsible Party):
Huma Rana, MD, Dana-Farber Cancer Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Ovarian Cancer Pancreatic Cancer Prostate Cancer Other: Chatbot Other: Video Education Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 301 participants
Allocation: Randomized
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
Actual Primary Completion Date : November 30, 2022
Actual Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genetic Testing

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. The measurement of genetic testing uptake [ Time Frame: 2 years ]
    The proportion of participants who consent to genetic testing in each study arm

  2. 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.

  3. 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".


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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.

  5. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
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Principal Investigator: Huma Q Rana, MD Dana-Farber Cancer Institute
More Information
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Responsible Party: Huma Rana, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT04066361    
Other Study ID Numbers: 19-068
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: January 25, 2024
Last Verified: January 2024
Individual Participant Data (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
Statistical Analysis Plan (SAP)
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Huma Rana, MD, Dana-Farber Cancer Institute:
Other Cancer