Understanding Value in Metastatic Breast Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Other: Understanding value in Metastatic Breast Cancer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-cancer diagnosis cost | based on a validated survey | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time loss experienced by patients with metastatic breast cancer. | based on a validated survey | 2 years | 
| 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 | 
| Does clinical trial participation influence the total cost of care or financial burden? |  | 2 years | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Financial Burden, Out of Pocket expenses, Time spent on Healthcare, Metastatic Breast Cancer