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Clinical Trials/NCT03257917
NCT03257917CompletedNot Applicable

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

University of Alabama at Birmingham1 site in 1 country100 target enrollmentStarted: June 13, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
1
Primary Endpoint
Post-cancer diagnosis cost

Study Overview

Brief 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

Detailed 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Post-cancer diagnosis cost

Time Frame: 2 years

based on a validated survey

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gabrielle Rocque

Assistant Professor

University of Alabama at Birmingham

Study Sites (1)

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