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Understanding Value in Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT03257917
Recruitment Status : Completed
First Posted : August 22, 2017
Last Update Posted : August 26, 2019
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Gabrielle Rocque, University of Alabama at Birmingham

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

Condition or disease Intervention/treatment
Metastatic Breast Cancer Other: Understanding value in Metastatic Breast Cancer

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.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Understanding Out-of-pocket Expenses and Patient Time Spent on Healthcare in Metastatic Breast Cancer Patients (Understanding Value in Metastatic Breast Cancer)
Actual Study Start Date : June 13, 2017
Actual Primary Completion Date : June 24, 2019
Actual Study Completion Date : July 12, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer


Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Post-cancer diagnosis cost [ Time Frame: 2 years ]
    based on a validated survey


Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The participants will be derived from Metastatic Breast Cancer patients receiving care at UAB Kirklin Clinic.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03257917


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
Sponsors and Collaborators
University of Alabama at Birmingham
Genentech, Inc.
Investigators
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Principal Investigator: Gabrielle B Rocque, MD Assistant Professor

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Responsible Party: Gabrielle Rocque, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03257917     History of Changes
Other Study ID Numbers: IRB-170504005
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gabrielle Rocque, University of Alabama at Birmingham:
Financial Burden
Out of Pocket expenses
Time spent on Healthcare
Metastatic Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases