- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00795054
The Financial Impact of Allogeneic Stem Cell Transplantation on Patient and Family
October 5, 2015 updated by: Center for International Blood and Marrow Transplant Research
The Financial Impact of Allogeneic Stem Cell Transplantation on Patient and Family: A Pilot Study
The purpose of this pilot study is to determine the feasibility of conducting a study of out-of-pocket costs and the long-term financial impact of allogeneic stem cell transplant.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Allogeneic hematopoietic stem cell transplantation (HSCT) is the indicated treatment for many life-threatening illnesses affecting both adults and children.
Transplant recovery and late effects require long-term medical care.
At the same time that the family faces a medical crisis, a resulting financial crisis may also be pending, but is often pushed to the background due to the necessity of first preserving life.
A large proportion of patients undergoing HSCT incur significant financial burden from out-of-pocket costs and a decrease in household income.
Predetermined variables, both medical and demographic, gathered at the pre-transplant clinical consultation have the potential to predict the patients at greatest financial risk.
This study will describe both the out-of-pocket costs and the income changes that may result from HSCT to help patients and their caregivers have a clearer picture of these costs and develop a financial plan.
Health care providers can utilize this information to better inform patients and connect them to resources.
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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New York
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Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Pediatric and adult allogeneic stem cell transplant recipients and their care givers from three U.S. transplant medical centers.
Description
Inclusion Criteria:
- Adult recipients and parents/guardians of pediatric (age 0-17 years) recipients of allogeneic HSCT
- Recipient has a primary caregiver, who is a member of the recipient's household
- Allogeneic HSCT using any donor cell source (related, unrelated, or cord blood)
- Any age at HSCT
- Diagnosis of primary disease for which HSCT is being performed must have been made within two years prior to transplantation
- Adult recipients, parents/guardians of pediatric recipients, and primary caregivers should be able to read, write, and understand the English language
- Signed informed consent from adult patient, caregiver and/or parent/guardian for study participation
- Signed consent to participate in the Center for International Blood and Marrow Transplant Research (CIBMTR) research database.
Exclusion Criteria:
- Recipients who have had a previous HSCT (autologous or allogeneic)
- Households with more than one transplant recipient
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
allogeneic stem cell recipients
Pediatric and adult allogeneic stem cell transplant recipients and their care givers.
|
Baseline financial survey pre-transplant, financial diary post-transplant every two weeks for 3 months, and financial questionnaire via phone survey at 6, 12, 18 and 24 months post-transplant.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To study the feasibility of using a patient maintained diary to capture out-of-pocket costs over the first 3 months following allogeneic HSCT
Time Frame: Pre-transplant and for 3 months post-transplant
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Pre-transplant and for 3 months post-transplant
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the feasibility of conducting interviews to collect financial information at 6, 12, 18 and 24 months after allogeneic HSCT
Time Frame: 6, 12, 18 and 24 month time points post-transplant
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6, 12, 18 and 24 month time points post-transplant
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Navneet Majhail, MD, MS, University of Minnesota / CIBMTR
- Study Chair: Douglas Rizzo, MD, MS, Medical College of Wisconsin / CIBMTR
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Actual)
September 1, 2012
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
November 19, 2008
First Submitted That Met QC Criteria
November 20, 2008
First Posted (Estimate)
November 21, 2008
Study Record Updates
Last Update Posted (Estimate)
October 6, 2015
Last Update Submitted That Met QC Criteria
October 5, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- CIBMTR HS 07-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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