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OpenTrials
Completed

NCT Number: NCT03257917

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

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Key information

Age range

18 year–90 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Understanding value in Metastatic Breast Cancer

Other

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.

Primary outcomes

  1. Post-cancer diagnosis cost

    Time frame: 2 years

    based on a validated survey

Secondary outcomes

  1. Time loss experienced by patients with metastatic breast cancer.

    Time frame: 2 years

    based on a validated survey

  2. Do patient characteristics (sociodemographics, cancer characteristics, health status, healthcare utilization) influence the total cost of care or financial burden?

    Time frame: 2 Years

  3. Does treatment type (chemotherapy vs. hormone therapy) influence the total cost of care or financial burden?

    Time frame: 2 years

  4. What is the trajectory of financial burden or total cost of care over time (year pre-MBC diagnosis vs. post-MBC diagnosis)?

    Time frame: 2 Years

  5. Does financial burden or total cost of care influence treatment adherence?

    Time frame: 2 years

  6. Does clinical trial participation influence the total cost of care or financial burden?

    Time frame: 2 years

  7. Does financial burden or total cost of care influence perception of or preference for shared decision-making?

    Time frame: 2 years

  8. Describe the cost experienced by patients with metastatic breast cancer.

    Time frame: 2 years

  9. Describe the productivity loss experienced by patients with metastatic breast cancer.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 22, 2017
Registry last updated
Aug 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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