Understanding Value in Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title:

Understanding Out-of-pocket Expenses and Patient Time Spent on Healthcare in Metastatic Breast Cancer Patients (Understanding Value in Metastatic Breast Cancer)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03257917
• Other study ID #: IRB-170504005
• Status: Completed
• Start date: June 13, 2017
• Est. completion date: July 12, 2019

Study information

• Verified date: August 2019
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The overall objective of this project is to gain knowledge about out-of-pocket (OOP) expenses and lost opportunity costs among metastatic breast cancer (MBC) patients. To achieve this objective, MBC patients will be asked to participate in a short, 37-question survey asking questions about the financial burden, OOP expenses, and opportunity costs related to their cancer care

Description:

The treating physician, PI or study coordinator will inform eligible MBC patients about the study via a letter (Appendix B) during or prior to their regular clinic visits in a waiting area. Prior to the survey administration, study coordinator will obtain all necessary signatures on the ICF from interested study participants in the private clinic room or infusion area. The survey (Appendix A) will consist of 37 survey questions, which should take patients less than 30 minutes to complete during their regularly scheduled clinic visit. Study participants will have the option of taking incomplete surveys home, completing, and mailing it back to us using stamped, self-addressed envelopes provided during their clinic visit. All consented participants will also be given the option to complete the survey over the phone with a study coordinator. Participants will be requested to provide their preferable times and days for a phone call with a coordinator. The study coordinator will call the patient and administer the same survey that would be given during a clinic visit. If participants prefer completing the survey in the clinic a research coordinator will remain in the room and will verbally facilitate the completion of the survey. Participants will be compensated in the form of merchandise at the time they agree to participate (the photo of sample merchandise is attached). Surveys will be collected by the study coordinator and stored in secure, locked rooms at the UAB Comprehensive Cancer Center, where the study coordinators will double-key enter de-identified survey responses into an encrypted, password protected, electronic database.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 12, 2019
• Est. primary completion date: June 24, 2019
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• All female MBC patients 18 years of age and older who have received treatment within the past two years at UAB

Exclusion Criteria:

• Non-English speakers, patients residing in nursing homes or receiving hospice care

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Other:
• Understanding value in Metastatic Breast Cancer
The overall objective of this project is to gain knowledge about out-of-pocket (OOP) expenses and lost opportunity costs among metastatic breast cancer (MBC) patients. To achieve this objective, MBC patients will be asked to participate in a short, 37-question survey asking questions about the financial burden, OOP expenses, and opportunity costs related to their cancer care.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-cancer diagnosis cost	based on a validated survey	2 years
Secondary	Time loss experienced by patients with metastatic breast cancer.	based on a validated survey	2 years
Secondary	Do patient characteristics (sociodemographics, cancer characteristics, health status, healthcare utilization) influence the total cost of care or financial burden?		2 Years
Secondary	Does treatment type (chemotherapy vs. hormone therapy) influence the total cost of care or financial burden?		2 years
Secondary	What is the trajectory of financial burden or total cost of care over time (year pre-MBC diagnosis vs. post-MBC diagnosis)?		2 Years
Secondary	Does financial burden or total cost of care influence treatment adherence?		2 years
Secondary	Does clinical trial participation influence the total cost of care or financial burden?		2 years
Secondary	Does financial burden or total cost of care influence perception of or preference for shared decision-making?		2 years
Secondary	Describe the cost experienced by patients with metastatic breast cancer.		2 years
Secondary	Describe the productivity loss experienced by patients with metastatic breast cancer.		2 years