Efficacy of Point Of Service Testing in MBC

NCT03983577 | Unknown DMC

• 1 other identifier: ePOST
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Cancer; Breast Cancer

Keywords

genetic counseling

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Secondary Outcomes (3)

• Overall participant satisfaction

  24 months

• Clinical decisional conflict score

  24 months

• Overall participant anxiety

  24 months

Study Arms (1)

Point of service delivery model

EXPERIMENTAL

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

Interventions

Point of service delivery model OTHER

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.

Point of service delivery model

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

The University of Kansas Cancer Center, Westwood Campus

Kansas City, Kansas, 66205, United States

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis; Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lauren Nye, MD

  University of Kansas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CT Nurse Navigator

CONTACT

913-945-7552; ctnursenav@kumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 12, 2019
• Study Start: June 11, 2019
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2025
• Last Updated: September 25, 2023

Record last verified: 2023-09

Locations

US (1)