NCT03257917

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 13, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 26, 2017

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 22, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2019

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2019

Completed
Last Updated

August 26, 2019

Status Verified

August 1, 2019

Enrollment Period

2 years

First QC Date

July 26, 2017

Last Update Submit

August 22, 2019

Conditions

Keywords

Financial BurdenOut of Pocket expensesTime spent on HealthcareMetastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Post-cancer diagnosis cost

    based on a validated survey

    2 years

Secondary Outcomes (9)

  • Time loss experienced by patients with metastatic breast cancer.

    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

  • +4 more secondary outcomes

Interventions

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.

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The participants will be derived from Metastatic Breast Cancer patients receiving care at UAB Kirklin Clinic.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsFinancial Stress

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Gabrielle B Rocque, MD

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 26, 2017

First Posted

August 22, 2017

Study Start

June 13, 2017

Primary Completion

June 24, 2019

Study Completion

July 12, 2019

Last Updated

August 26, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations