CommunicationNCT03023735
Trial of Strategies to Communicate Genetic Information to Different Ethnic Subpopulations
An observational study of Communication, run by Stanford University at 1 site in United States.
Trial summary
The goal of this study is to better understand how clinicians give genetic risk information to patients from multi-ethnic groups and how patients understand this information and remember it and act upon it. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Communication
- What is being tested?
- None. This is an observational study
- How many people
- 597 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Mar 2024
- Phase
- Observational
- 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
Study population: Any patient referred to the breast cancer genetic risk counseling clinics in either of the two sites will be eligible to participate as long as they meet the inclusion and exclusion criteria.
Who may be able to join
- Cancer Patients
- Over 18 years of age.
Who cannot join
- Under 18
- Healthy Volunteers.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University, School of Medicine
Palo Alto, California, 94304
About this study
Official title: Trial of Strategies to Communicate Genetic Information to Different Ethnic and Racial Subpopulations
The goal of this study is to better understand how clinicians give genetic risk information to patients from multi-ethnic groups and how patients understand this information and remember it and act upon it. In addition investigators want to know how to better communicate with patients about complex health issues across the health literacy divide and communication gap that exists between doctors and their patients.
Read the detailed description
Any patient referred to the breast cancer and genetic risk counseling clinics in either of the two sites will be eligible to participate as long as they meet the inclusion and exclusion criteria. The research assistant in each site will meet with the patients and explain about the study goals and procedures and ask them to participate in the study. Those interested will be enrolled into the study after obtaining informed consent. For those who refuse to participate, reasons for refusal will be requested and catalogued. All study participants will be followed and the study measures will be tracked at Days 0, 30, 180 and 365. In addition, health care utilization (ER Visits, Hospitalizations, clinic visits, screening tests and procedures) will be tracked both through the electronic medical records and patient interviews (as some patients may seek care in other hospitals for emergencies etc.). Investigators currently do follow-up phone interviews routinely with our patients. Study measures will be administered as described above. For those who drop out from the study, reasons for withdrawal from the study will be explored and catalogued.
Procedures for Treatment Compliance and Treatment Non-completers:
(i) Compliance Procedures: Investigators will monitor degree of compliance with whether study measures were completed on Days 0,7,30 \& 365 intervention. Analyses will be done following the intent-to-treat principle.
(ii) Treatment Non-completers: For those who drop out from the study after Day 0, reasons for withdrawal from the study will be explored and catalogued. They will be asked for feedback about the study intervention and satisfaction with the experience (or the lack thereof).
Procedures for Data Collection: The participants will have the option of submitting the data in person or by phone to the project research associate. The PI will meet with the study personnel at least on a weekly basis to continuously monitor their performance and to ensure adherence to study methodology.
There are risks, discomforts, and inconveniences associated with any research study. These deserve careful thought. Participants should talk with the Protocol Director for any questions. Risks of answering the survey instruments and interview questions are minimal and may occasionally cause distress.
Audio recording of the patient interviews. Investigators will create verbatim transcripts to be analyzed using qualitative methods. Recordings will be stored for a period of 20 years and then erased.
- Conditions
- Communication
- Being tested
- None. This is an observational study
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None. This is an observational studyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome measure using health decisions and healthcare utilization
In this observational study, investigators propose to follow patients for a period of one to three years to track their cancer treatment and screening decisions (e.g. if they complete mammograms, MRI, surgery, chemotherapy, radiation therapy) as recommended by the clinical team and also ER visits, hospitalizations, ICU admissions and death.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startAug 2016
- Primary completionMar 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CommunicationStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 597 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern California
- Responsible party
- Principal investigator, VJ Periyakoil, Stanford University
- Investigators
- VJ Periyakoil, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023735
- Sponsor's protocol ID
- 37046
- Status last verified
- May 2022
- First submitted
- 6 Jan 2017
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Strategies to Communicate Genetic Information to Different Ethnic and Racial Subpopulations
- ClinicalTrials.gov ID
- NCT03023735
- Acronym / sponsor ID
- 37046
- Conditions
- Communication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 597 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- University of Southern California
- Study start
- Aug 2016
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 18 Jan 2017 (estimated)
- 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.
The goal of this study is to better understand how clinicians give genetic risk information to patients from multi-ethnic groups and how patients understand this information and remember it and act upon it. In addition investigators want to know how to better communicate with patients about complex health issues across the health literacy divide and communication gap that exists between doctors and their patients.
Detailed description
Any patient referred to the breast cancer and genetic risk counseling clinics in either of the two sites will be eligible to participate as long as they meet the inclusion and exclusion criteria. The research assistant in each site will meet with the patients and explain about the study goals and procedures and ask them to participate in the study. Those interested will be enrolled into the study after obtaining informed consent. For those who refuse to participate, reasons for refusal will be requested and catalogued. All study participants will be followed and the study measures will be tracked at Days 0, 30, 180 and 365. In addition, health care utilization (ER Visits, Hospitalizations, clinic visits, screening tests and procedures) will be tracked both through the electronic medical records and patient interviews (as some patients may seek care in other hospitals for emergencies etc.). Investigators currently do follow-up phone interviews routinely with our patients. Study measures will be administered as described above. For those who drop out from the study, reasons for withdrawal from the study will be explored and catalogued.
Procedures for Treatment Compliance and Treatment Non-completers:
(i) Compliance Procedures: Investigators will monitor degree of compliance with whether study measures were completed on Days 0,7,30 \& 365 intervention. Analyses will be done following the intent-to-treat principle.
(ii) Treatment Non-completers: For those who drop out from the study after Day 0, reasons for withdrawal from the study will be explored and catalogued. They will be asked for feedback about the study intervention and satisfaction with the experience (or the lack thereof).
Procedures for Data Collection: The participants will have the option of submitting the data in person or by phone to the project research associate. The PI will meet with the study personnel at least on a weekly basis to continuously monitor their performance and to ensure adherence to study methodology.
There are risks, discomforts, and inconveniences associated with any research study. These deserve careful thought. Participants should talk with the Protocol Director for any questions. Risks of answering the survey instruments and interview questions are minimal and may occasionally cause distress.
Audio recording of the patient interviews. Investigators will create verbatim transcripts to be analyzed using qualitative methods. Recordings will be stored for a period of 20 years and then erased.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient referred to the breast cancer genetic risk counseling clinics in either of the two sites will be eligible to participate as long as they meet the inclusion and exclusion criteria.
Key inclusion criteria (2 listed)
- Cancer Patients
- Over 18 years of age.
Key exclusion criteria (2 listed)
- Under 18
- Healthy Volunteers.
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 |
|---|---|---|
| None. This is an observational study | Other | – |
Primary outcome
Composite outcome measure using health decisions and healthcare utilization
Time frame: up to 3 years
In this observational study, investigators propose to follow patients for a period of one to three years to track their cancer treatment and screening decisions (e.g. if they complete mammograms, MRI, surgery, chemotherapy, radiation therapy) as recommended by the clinical team and also ER visits, hospitalizations, ICU admissions and death.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Individual participant dataSharing planned: Undecided
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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.
VJ Periyakoil principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Communication, run by Stanford University 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 1 Jun 2022. 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?
Results are not available in the source record.
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?
Composite outcome measure using health decisions and healthcare utilization (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 1 Jun 2022.