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

Primary Purpose

Metastatic Cancer, Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Point of service delivery model
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Metastatic Cancer focused on measuring genetic counseling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The University of Kansas Cancer Center, Westwood CampusRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Point of service delivery model

Arm Description

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.

Outcomes

Primary Outcome Measures

Proportion of patients/participants that undergo hereditary cancer genetic testing after the telehealth intervention.
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

Overall participant satisfaction
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.
Clinical decisional conflict score
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.
Overall participant anxiety
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.

Full Information

First Posted
June 7, 2019
Last Updated
September 21, 2023
Sponsor
University of Kansas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03983577
Brief Title
Efficacy of Point Of Service Testing in MBC
Acronym
EPOST MBC
Official Title
Efficacy of Point Of Service Testing in Metastatic Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 11, 2019 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer, Breast Cancer
Keywords
genetic counseling

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Point of service delivery model
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Point of service delivery model
Intervention Description
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 Measure Information:
Title
Proportion of patients/participants that undergo hereditary cancer genetic testing after the telehealth intervention.
Description
Defined as the number of participants who opt to undergo hereditary cancer genetic testing as a percentage of the total number of participants enrolled.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Overall participant satisfaction
Description
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.
Time Frame
24 months
Title
Clinical decisional conflict score
Description
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.
Time Frame
24 months
Title
Overall participant anxiety
Description
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.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CT Nurse Navigator
Phone
913-945-7552
Email
ctnursenav@kumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren Nye, MD
Organizational Affiliation
University of Kansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Kansas Cancer Center, Westwood Campus
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Nurse Navigator
Phone
913-945-7552
Email
ctnursenav@kumc.edu

12. IPD Sharing Statement

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Efficacy of Point Of Service Testing in MBC

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