Breast CancerOPT-INNCT04066361
OPTimizing Treatment Focused Genetic Testing IN Cancer
A study testing Chatbot and Video Education in people with Breast Cancer and Ovarian Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Ovarian Cancer, Pancreatic Cancer
- What is being tested?
- Chatbot and Video Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2019to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer
- Being tested
- Chatbot, Video Education
- Keywords
- Other Cancer
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChatbotOther
Interactive text chat designed to mirror the educational components of a traditional genetic counseling visit
Video EducationOther
Brief video designed to mirror the educational components of a traditional genetic counseling visit
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Chatbot |
| 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 Receives: Other: Video Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
The measurement of genetic testing uptake
The proportion of participants who consent to genetic testing in each study arm
Measured: 2 years
Meaningful cancer treatment changes
Assessed by chart review. Participants with positive genetic test results will be reviewed for changes in cancer treatment.
Measured: 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".
Measured: at time of post-counseling/video pre-result disclosure, on average 3 weeks
Secondary outcomes (5)
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.
Measured: 4 months post-result disclosure
Intent to disclose genetic test results
Three items will assess participants' intentions to disclose genetic testing results
Measured: 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
Measured: 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.
Measured: 4 months post-result disclosure
Knowledge of multi-gene panel testing
A 6 item survey evaluating participant's understanding of inherited genetic risk
Measured: 1 day (at the time of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start19 Dec 2019
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huma Rana, MD, Dana-Farber Cancer Institute
- Investigators
- Huma Q Rana, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04066361
- Sponsor's protocol ID
- 19-068
- Acronym
- OPT-IN
- Status last verified
- Jan 2024
- First submitted
- 20 Aug 2019
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTimizing Treatment Focused Genetic Testing IN Cancer - OPT-IN
- ClinicalTrials.gov ID
- NCT04066361
- Acronym / sponsor ID
- OPT-IN / 19-068
- Conditions
- Breast Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer
- Keywords
- Other Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 26 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chatbot | Experimental | Other: 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 |
| Video Education | Experimental | Other: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChatbotInteractive text chat designed to mirror the educational components of a traditional genetic counseling visit | Other | Chatbot |
| Video EducationBrief video designed to mirror the educational components of a traditional genetic counseling visit | Other | Video Education |
Primary outcome
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".
5 secondary outcomes
Communication of results with family members
Time frame: 4 months post-result disclosure
Intent to disclose genetic test results
Time frame: 1 day (at time of intervention)
Cascade testing of family members
Time frame: 6 month post-result disclosure
Decisional regret
Time frame: 4 months post-result disclosure
Knowledge of multi-gene panel testing
Time frame: 1 day (at the time of intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huma Q Rana, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chatbot and Video Education in people with Breast Cancer and Ovarian Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The measurement of genetic testing uptake (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.