NCT03023735

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
597

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

6.6 years

First QC Date

January 6, 2017

Last Update Submit

May 31, 2022

Conditions

Communication

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to 3 years

Interventions

None. This is an observational studyOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Cancer Patients
  • Over 18 years of age.

You may not qualify if:

  • Under 18
  • Healthy Volunteers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University, School of Medicine

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • VJ Periyakoil

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

January 6, 2017

First Posted

January 18, 2017

Study Start

August 1, 2016

Primary Completion

March 1, 2023

Study Completion

March 1, 2024

Last Updated

June 1, 2022

Record last verified: 2022-05

Locations

US(1)