Survey Administration for Breast Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Breast Carcinoma+1 More
Survey Administration - Other
Eligibility
18 - 65
Female
What conditions do you have?
Select

Study Summary

This trial is testing whether a genetic counseling patient preference (GCPP) intervention delivered via the EHR MyChart patient portal is non-inferior to conventional genetic counseling in terms of several outcomes, including adherence to screening recommendations, breast cancer knowledge, accurate perception of risk, breast cancer-specific worry, and satisfaction with counseling.

Eligible Conditions
  • Breast Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

6 Primary · 1 Secondary · Reporting Duration: Up to 14 months

Up to 14 months
Breast
Adherence to National Comprehensive Cancer Network (NCCN) guidelines of having a clinical encounter every 6-12 months
Adherence to other National Comprehensive Cancer Network (NCCN) recommended cancer screening (e.g. colorectal cancer screening)
Breast cancer-specific worry
Genetic counseling preferences
Post-test/counseling distress
Risk perception
Satisfaction with counseling

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Arm II (conventional genetic counseling)
1 of 2
Arm I (GCPP intervention)
1 of 2
Active Control
Experimental Treatment

1000 Total Participants · 2 Treatment Groups

Primary Treatment: Survey Administration · No Placebo Group · N/A

Arm I (GCPP intervention)Experimental Group · 2 Interventions: Educational Intervention, Survey Administration · Intervention Types: Other, Other
Arm II (conventional genetic counseling)ActiveComparator Group · 2 Interventions: Genetic Counseling, Survey Administration · Intervention Types: Other, Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 14 months

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
284 Previous Clinical Trials
284,865 Total Patients Enrolled
6 Trials studying Breast Carcinoma
1,129 Patients Enrolled for Breast Carcinoma
National Cancer Institute (NCI)NIH
12,990 Previous Clinical Trials
41,297,888 Total Patients Enrolled
84 Trials studying Breast Carcinoma
39,902 Patients Enrolled for Breast Carcinoma
Kevin Sweet, MS, LGCPrincipal InvestigatorOhio State University Comprehensive Cancer Center
1 Previous Clinical Trials
8 Total Patients Enrolled
1 Trials studying Breast Carcinoma
8 Patients Enrolled for Breast Carcinoma

Eligibility Criteria

Age 18 - 65 · Female Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are 30-64 years old.
Breast cancer risk assessment.
You are able to read and speak English.
You have provided your informed consent.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 17th, 2021

Last Reviewed: October 9th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.