OPTimizing Treatment Focused Genetic Testing IN Cancer
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1 other identifier
interventional
301
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Dec 2019
Typical duration for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2019
CompletedFirst Posted
Study publicly available on registry
August 26, 2019
CompletedStudy Start
First participant enrolled
December 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedJanuary 25, 2024
January 1, 2024
3 years
August 20, 2019
January 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (5)
Communication of results with family members
4 months post-result disclosure
Intent to disclose genetic test results
1 day (at time of intervention)
Cascade testing of family members
6 month post-result disclosure
Decisional regret
4 months post-result disclosure
Knowledge of multi-gene panel testing
1 day (at the time of intervention)
Study Arms (2)
Chatbot
EXPERIMENTAL* 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
Video Education
EXPERIMENTAL* 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
Interventions
Interactive text chat designed to mirror the educational components of a traditional genetic counseling visit
Brief video designed to mirror the educational components of a traditional genetic counseling visit
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Huma Q Rana, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 20, 2019
First Posted
August 26, 2019
Study Start
December 19, 2019
Primary Completion
November 30, 2022
Study Completion
November 30, 2022
Last Updated
January 25, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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
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