EPOST MBC: Efficacy of Point Of Service Testing in MBC
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Proportion of patients/participants that undergo hereditary cancer genetic testing after the telehealth intervention. [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
- Overall participant satisfaction [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.
- Clinical decisional conflict score [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.
- Overall participant anxiety [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent.
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Able to speak and read in the English language.
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Have a diagnosis of human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancer.
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Participants must be enrolled in the parent registry study.
Exclusion Criteria:
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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.
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Psychiatric illness/social situations that would limit compliance with study requirements.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Kansas Cancer Center, Westwood Campus | Kansas City | Kansas | United States | 66205 |
Sponsors and Collaborators
- University of Kansas Medical Center
Investigators
- Principal Investigator: Lauren Nye, MD, University of Kansas
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ePOST