Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03023735 |
| Other study ID # |
37046 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 2016 |
| Est. completion date |
March 2024 |
Study information
| Verified date |
May 2022 |
| Source |
Stanford University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
