Breast CancerGeneBOPPNCT04330716
Genetic Testing for Breast, Ovarian, Pancreatic, and Prostate Cancers
A study testing Standard Genetic Counseling and Educational Video in people with Breast Cancer and Ovarian Cancer, run by Dana-Farber Cancer Institute at 6 sites in United States.
Trial summary
This study is evaluating the effect of two pre-test education methods on participants interested in genetic testing for hereditary cancer risk. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Ovarian Cancer, Pancreatic Cancer
- What is being tested?
- Standard Genetic Counseling and Educational Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 269 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Dec 2020to 31 Dec 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Potentially eligible participants will be identified via medical record screening and/or in accordance with their clinical visit. A HIPAA waiver of authorization will be obtained by the enrolling Institution as needed to have access to the subject's medical record information for screening of eligibility.
- A member of the study team will approach the potentially eligible participant in clinic and discuss the trial. Potentially eligible participants may choose to discuss participation further with their physician at their appointment
- Age ≥ 18 years
- Breast, ovarian, pancreatic, or metastatic prostate cancer
- No prior cancer genetic testing
- Ability to understand and the willingness to sign an informed consent document
Who cannot join
- Pregnant
- Prisoners
- Inability to understand English as a spoken language in a healthcare context
- Known hematologic malignancy (e.g. CLL)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute at St. Elizabeth's Medical Center
Brighton, Massachusetts, 02135
Dana-Farber/New Hampshire Oncology-Hematology
Londonderry, New Hampshire, 03053
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center
Milford, Massachusetts, 01757
Lifespan Cancer Institute at Rhode Island Hospital
Providence, Rhode Island, 02903
Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital
Weymouth, Massachusetts, 02190
About this study
Official title: Genetic Testing for Breast, Ovarian, Pancreatic, and Prostate Cancers - GeneBOPP
This study is evaluating the effect of two pre-test education methods on participants interested in genetic testing for hereditary cancer risk.
Read the detailed description
This prospective, randomized controlled trial will evaluate the effect of two pre-test education methods on the level of participation in genetic testing for hereditary cancer risk. A prospective study examines outcomes before the development of a disease.
- The research study procedures include screening for eligibility, randomization and a series of questionnaires.
- Participants will be randomized, or assigned by chance, to one of two methods of pre-genetic test education and after completing either pre-test education participants will be offered the opportunity to have genetic testing performed
Two methods of pre-genetic test education:
- video education
- in-person counseling
- Genetic testing will be performed by blood draw.
- It is expected that 500 people will participate in this study
- Participants will be in the research study for up to 5 yrs after enrollment
- Being tested
- Standard Genetic Counseling, Educational Video
- Keywords
- Breast Cancer, Ovarian Cancer, Pancreatic Cancer, Metastatic Prostate Cancer, Genetic Counseling, Genetic Testing
- 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.
Standard Genetic CounselingBehavioural
Standard of care genetic counseling
Educational VideoBehavioural
Video tutorial about genetic testing
| Study group | Role | What they receive |
|---|---|---|
| Group A: Standard genetic counseling | Active comparator | Will receive standard genetic counseling prior to genetic testing. Receives: Behavioral: Standard Genetic Counseling |
| Group B: Educational video | Experimental | 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. Receives: Behavioral: Educational Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients who have germline genetic tests
Measurement of genetic testing uptake in breast, ovarian, pancreatic, and prostate cancer patients randomized to pre-genetic test (pre-test) in-person counseling with a genetic counselor per standard of care or video education.This comparison will use a two-sided Fisher exact test
Measured: Up to 3 years
Secondary outcomes (9)
Patient Satisfaction Survey following intervention
Measurement and comparison by randomized arm and communication of results of patient satisfaction using survey instruments. Administered immediately following the intervention. The survey evaluates the subject's satisfaction with the genetic testing process for both arms.
Measured: Immediately following intervention
Result Disclosure Preference following intervention
Measurement and comparison by randomized arm and communication of results of patient disclosure preferences using survey instruments. Administered immediately following the intervention.
Measured: Immediately following intervention
Patient Satisfaction 2 months following intervention
Measurement and comparison by randomized arm and communication of results of patient satisfaction using survey instruments. Administered two months after the intervention. The survey evaluates the subject's satisfaction with the genetic testing process for both arms.
Measured: after results have been received, two months post-intervention
Psychological distress following intervention
MICRA is a widely used validated 25-item measure that assesses psychosocial consequences associated with genetic testing for cancer. Section 1 contains 3 sub-scales: the Positive sub-scale (4 items), the Distress sub-scale (6 items), and the Uncertainty sub-scale (9 items) and two other items that do not fit into either sub-scale. Section 2 contains two items for participants who have children. Section 3 contains 2 items for participants who have/have had cancer. Responses are indicated on a 4 point scale for experiences in the past week. A higher score in the sub-scales or total scale indicated greater distress. The positive sub-scale is reverse scored to reflect this.
Measured: after results have been received, two months post-intervention
Knowledge about genetics testing
Measurement and comparison by randomized arm and communication of results of Patient knowledge about genetics testing using survey instruments. Knowledge about genetic testing is evaluated through a Knowledge of Multigene Panel Testing survey immediately following the intervention.
Measured: Immediately following intervention
Decisional Regret
Measurement and comparison by randomized arm and communication of results of Patient decisional regret to have genetic testing. Decisional regret is evaluated through a decisional regret survey that is administered two months after intervention.
Measured: after results have been received, two months post-intervention
Family communication of genetic test results
Measurement of family communication. Family communication survey is administered two months following the intervention.
Measured: after results have been received, two months post-intervention
Positive Results impact
Measurement of impact of positive results for patients who tested positive for a genetic mutation. This survey is administered four months post-intervention.
Measured: after results have been received, four months post-intervention
Cascade testing in positives
Measurement of cascade testing for patients who tested positive for a genetic mutation. This survey is administered four months post-intervention.
Measured: after results have been received, four months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start1 Dec 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ambry Genetics
- Responsible party
- Principal investigator, Huma Rana, MD, Dana-Farber Cancer Institute
- Investigators
- Huma Rana, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330716
- Sponsor's protocol ID
- 19-652
- Acronym
- GeneBOPP
- Status last verified
- Jan 2024
- First submitted
- 17 Mar 2020
- Last updated
- 19 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 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Testing for Breast, Ovarian, Pancreatic, and Prostate Cancers - GeneBOPP
- ClinicalTrials.gov ID
- NCT04330716
- Acronym / sponsor ID
- GeneBOPP / 19-652
- Keywords
- Breast Cancer, Ovarian Cancer, Pancreatic Cancer, Metastatic Prostate Cancer, Genetic Counseling, Genetic Testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Ambry Genetics
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 1 Apr 2020 (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 study is evaluating the effect of two pre-test education methods on participants interested in genetic testing for hereditary cancer risk.
Detailed description
This prospective, randomized controlled trial will evaluate the effect of two pre-test education methods on the level of participation in genetic testing for hereditary cancer risk. A prospective study examines outcomes before the development of a disease.
- The research study procedures include screening for eligibility, randomization and a series of questionnaires.
- Participants will be randomized, or assigned by chance, to one of two methods of pre-genetic test education and after completing either pre-test education participants will be offered the opportunity to have genetic testing performed
Two methods of pre-genetic test education:
- video education
- in-person counseling
- Genetic testing will be performed by blood draw.
- It is expected that 500 people will participate in this study
- Participants will be in the research study for up to 5 yrs after enrollment
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Standard genetic counseling | Active comparator | Behavioral: Standard Genetic CounselingWill receive standard genetic counseling prior to genetic testing. |
| Group B: Educational video | Experimental | Behavioral: Educational VideoWill 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Potentially eligible participants will be identified via medical record screening and/or in accordance with their clinical visit. A HIPAA waiver of authorization will be obtained by the enrolling Institution as needed to have access to the subject's medical record information for screening of eligibility.
- A member of the study team will approach the potentially eligible participant in clinic and discuss the trial. Potentially eligible participants may choose to discuss participation further with their physician at their appointment
- Age ≥ 18 years
- Breast, ovarian, pancreatic, or metastatic prostate cancer
- No prior cancer genetic testing
Key exclusion criteria (4 listed)
- Pregnant
- Prisoners
- Inability to understand English as a spoken language in a healthcare context
- Known hematologic malignancy (e.g. CLL)
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 |
|---|---|---|
| Standard Genetic CounselingStandard of care genetic counseling | Behavioural | Group A: Standard genetic counseling |
| Educational VideoVideo tutorial about genetic testing | Behavioural | Group B: Educational video |
Primary outcome
Rate of patients who have germline genetic tests
Time frame: Up to 3 years
Measurement of genetic testing uptake in breast, ovarian, pancreatic, and prostate cancer patients randomized to pre-genetic test (pre-test) in-person counseling with a genetic counselor per standard of care or video education.This comparison will use a two-sided Fisher exact test
9 secondary outcomes
Patient Satisfaction Survey following intervention
Time frame: Immediately following intervention
Result Disclosure Preference following intervention
Time frame: Immediately following intervention
Patient Satisfaction 2 months following intervention
Time frame: after results have been received, two months post-intervention
Psychological distress following intervention
Time frame: after results have been received, two months post-intervention
Knowledge about genetics testing
Time frame: Immediately following intervention
Decisional Regret
Time frame: after results have been received, two months post-intervention
Family communication of genetic test results
Time frame: after results have been received, two months post-intervention
Positive Results impact
Time frame: after results have been received, four months post-intervention
Cascade testing in positives
Time frame: after results have been received, four months post-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 19 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 Rana, MD principal investigator
Dana-Farber Cancer Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Genetic Counseling and Educational Video in people with Breast Cancer and Ovarian Cancer, run by Dana-Farber Cancer Institute at 6 sites 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 6 inclusion and 4 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 19 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 6 sites 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?
Rate of patients who have germline genetic tests (time frame: Up to 3 years). 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 19 Jan 2024.