We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Efficacy of Point Of Service Testing in MBC (EPOST MBC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03983577
Recruitment Status : Recruiting
First Posted : June 12, 2019
Last Update Posted : September 21, 2022
Information provided by (Responsible Party):
University of Kansas Medical Center

Brief Summary:
This study will assess the efficacy of an innovative point of service cancer genetics counseling delivery model for metastatic breast cancer (MBC) patients whom have received a referral for hereditary cancer genetic counseling and testing.

Condition or disease Intervention/treatment Phase
Metastatic Cancer Breast Cancer Other: Point of service delivery model Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Efficacy of Point Of Service Testing in Metastatic Breast Cancer
Actual Study Start Date : June 11, 2019
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Point of service delivery model
After the informed consent is signed, the participant will watch a standardized video on the principles of genetic testing. At the end of the video, the provider will return to answer any remaining questions. The participant will receive pre- and post- surveys for evaluation of the delivery model.
Other: Point of service delivery model
Participants will receive the pre-test survey, followed by the combined provider/telehealth genetic counseling education video for genetic testing. Afterwards, the participants will receive a post-test and patient satisfaction survey.

Primary Outcome Measures :
  1. Proportion of patients/participants that undergo hereditary cancer genetic testing after the telehealth intervention. [ Time Frame: 24 months ]
    Defined as the number of participants who opt to undergo hereditary cancer genetic testing as a percentage of the total number of participants enrolled.

Secondary Outcome Measures :
  1. Overall participant satisfaction [ Time Frame: 24 months ]
    Patient satisfaction will be assessed with an adapted Genetic Counseling Satisfaction Scale (aGCSS). Each item is scored from 1- 5, with 1 being strongly disagree and 5 being agree strongly. The scores are added then divided by 5 to give a mean score.

  2. Clinical decisional conflict score [ Time Frame: 24 months ]
    Decisional conflict will be assessed using the Decisional Conflict Scale (Sure Test Version). The 4 items are summed. Scores range from 0 (extremely high decisional conflict) to 4 (no decisional conflict). A score of less than or equal to 3 indicates decisional conflict.

  3. Overall participant anxiety [ Time Frame: 24 months ]
    Participant anxiety will be assessed with the Hospital Anxiety and Depression Scale (HADS-Anxiety scale). Each item is scored between 0- 3 with a total score between 0- 21 possible. Scores of 0-7 indicates normal; scores of 8-10 indicates borderline abnormal; scores of 11-21 indicates abnormal.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent.
  • Able to speak and read in the English language.
  • Have a diagnosis of human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancer.
  • Participants must be enrolled in the parent registry study.

Exclusion Criteria:

  • Genetic testing for a breast cancer gene (BRCA) BRCA1 and BRCA2 mutation completed after 2013 or any BRCA 1 and BRCA2 testing with large rearrangement testing. Prior genetic counseling is allowed.
  • Psychiatric illness/social situations that would limit compliance with study requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03983577

Layout table for location contacts
Contact: CT Nurse Navigator 913-945-7552 ctnursenav@kumc.edu

Layout table for location information
United States, Kansas
The University of Kansas Cancer Center, Westwood Campus Recruiting
Kansas City, Kansas, United States, 66205
Contact: Clinical Trials Nurse Navigator    913-945-7552    ctnursenav@kumc.edu   
Sponsors and Collaborators
University of Kansas Medical Center
Layout table for investigator information
Principal Investigator: Lauren Nye, MD University of Kansas
Layout table for additonal information
Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03983577    
Other Study ID Numbers: ePOST
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: September 21, 2022
Last Verified: September 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Kansas Medical Center:
genetic counseling
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases