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

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ClinicalTrials.gov Identifier: NCT03983577
Recruitment Status : Recruiting
First Posted : June 12, 2019
Last Update Posted : September 30, 2019
Sponsor:
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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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 2021
Estimated Study Completion Date : August 2021

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.



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

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


Contacts
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Contact: CT Nurse Navigator 913-945-7552 ctnursenav@kumc.edu

Locations
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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
Investigators
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Principal Investigator: Lauren Nye, MD University of Kansas

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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03983577     History of Changes
Other Study ID Numbers: ePOST
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: July 2019

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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:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases