An observational study in Metastatic Breast Cancer, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to female participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-08-26.
Sponsored by University of Alabama at Birmingham · Observational
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Among 46 studies in Breast Neoplasms by University of Alabama at Birmingham — 7 open to participants now, 11 under way, none of them phase 3. Breast Neoplasms · University of Alabama at Birmingham.
Among the 46 studies in Breast Neoplasms by University of Alabama at Birmingham, this one is one of 3 that started in 2017, is one of 3 observational ones, and was the 21st registered.
14,829 studies on the registry are indexed under Breast Neoplasms; 3,318 are open to participants now.
Browse Breast Neoplasms studies →7 of the 46 studies in Breast Neoplasms by University of Alabama at Birmingham are open now, in 1 country. Recruiting first, the newest first:
University of Alabama at Birmingham · Sites in United States
Ages 18–50 · Women only
University of Alabama at Birmingham · Sites in United States
Ages 18+
University of Alabama at Birmingham · Sites in United States
Ages 18–90 · Women only
University of Alabama at Birmingham · Sites in United States
Ages 60+ · Women only
University of Alabama at Birmingham · Sites in United States
Ages 18+ · Women only
By country, each count listing its studies:
Of the 2,398 Breast Neoplasms studies recruiting now, 1,569 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.
This study: 18 Years to 90 Years · female.
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46 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 13
First in 2000; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 100 is below the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Median enrollment 35 across the 42 interventional studies, 200 across the 3 observational. Of the 32 that completed or were terminated, 11 (34%) have results posted.
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University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
3 of the studies in Breast Neoplasms by University of Alabama at Birmingham that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06924788University of Alabama at BirminghamVideo-Conferenced Stress Management and Relaxation Training (VSMART) For Alabama Breast Cancer Survivors | 2026-12-31 |
| NCT04332588University of Alabama at BirminghamMonitoring HER2+ Breast Cancer Neoadjuvant Treatment With Advanced PET/MRI | 2027-08 |
| NCT03368729University of Alabama at BirminghamNiraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer | 2027-11-01 |
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Among the 46 studies in Breast Neoplasms by University of Alabama at Birmingham, from their registry updates:
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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
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.
The participants will be derived from Metastatic Breast Cancer patients receiving care at UAB Kirklin Clinic.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Post-cancer diagnosis cost
based on a validated survey
Time frame: 2 years
Time loss experienced by patients with metastatic breast cancer.
based on a validated survey
Time frame: 2 years
Do patient characteristics (sociodemographics, cancer characteristics, health status, healthcare utilization) influence the total cost of care or financial burden?
Time frame: 2 Years
Does treatment type (chemotherapy vs. hormone therapy) influence the total cost of care or financial burden?
Time frame: 2 years
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
Does financial burden or total cost of care influence treatment adherence?
Time frame: 2 years
Does clinical trial participation influence the total cost of care or financial burden?
Time frame: 2 years
Does financial burden or total cost of care influence perception of or preference for shared decision-making?
Time frame: 2 years
Describe the cost experienced by patients with metastatic breast cancer.
Time frame: 2 years
Describe the productivity loss experienced by patients with metastatic breast cancer.
Time frame: 2 years
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2017 to primary completion in Jun 2019, 24 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham →