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Understanding Value in Metastatic Breast Cancer

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03257917
Enrollment
100
Registered
2017-08-22
Start date
2017-06-13
Completion date
2019-07-12
Last updated
2019-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Breast Cancer

Keywords

Financial Burden, Out of Pocket expenses, Time spent on Healthcare, Metastatic Breast Cancer

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.

Interventions

OTHERUnderstanding 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.

Sponsors

Genentech, Inc.
CollaboratorINDUSTRY
University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 90 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Post-cancer diagnosis cost2 yearsbased on a validated survey

Secondary

MeasureTime frameDescription
Do patient characteristics (sociodemographics, cancer characteristics, health status, healthcare utilization) influence the total cost of care or financial burden?2 Years
Does treatment type (chemotherapy vs. hormone therapy) 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 financial burden or total cost of care influence treatment adherence?2 years
Time loss experienced by patients with metastatic breast cancer.2 yearsbased on a validated survey
Does financial burden or total cost of care influence perception of or preference for shared decision-making?2 years
Describe the cost experienced by patients with metastatic breast cancer.2 years
Describe the productivity loss experienced by patients with metastatic breast cancer.2 years
Does clinical trial participation influence the total cost of care or financial burden?2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026