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The Financial Impact of Allogeneic Stem Cell Transplantation on Patient and Family
This study is not yet open for participant recruitment.
Verified by Center for International Blood and Marrow Transplant Research, November 2008
Sponsors and Collaborators: Center for International Blood and Marrow Transplant Research
National Marrow Donor Program
Information provided by: Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier: NCT00795054
  Purpose

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.


Condition Intervention
Allogeneic Stem Cell Transplant
Other: Household financial data collection

Drug Information available for: BaseLine
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: The Financial Impact of Allogeneic Stem Cell Transplantation on Patient and Family: A Pilot Study

Further study details as provided by Center for International Blood and Marrow Transplant Research:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 30
Study Start Date: January 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
allogeneic stem cell recipients
Pediatric and adult allogeneic stem cell transplant recipients and their care givers.
Other: Household financial data collection
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  1. Adult recipients and parents/guardians of pediatric (age 0-17 years) recipients of allogeneic HSCT
  2. Recipient has a primary caregiver, who is a member of the recipient's household
  3. Allogeneic HSCT using any donor cell source (related, unrelated, or cord blood)
  4. Any age at HSCT
  5. Diagnosis of primary disease for which HSCT is being performed must have been made within two years prior to transplantation
  6. Adult recipients, parents/guardians of pediatric recipients, and primary caregivers should be able to read, write, and understand the English language
  7. Signed informed consent from adult patient, caregiver and/or parent/guardian for study participation
  8. Signed consent to participate in the Center for International Blood and Marrow Transplant Research (CIBMTR) research database.

Exclusion Criteria:

  1. Recipients who have had a previous HSCT (autologous or allogeneic)
  2. Households with more than one transplant recipient
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00795054

Contacts
Contact: Sue Flesch 612 617-8303 sflesch@nmdp.org
Contact: Amy Foley, MA, CCRP 612 884-8605 afoley@nmdp.org

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Center for International Blood and Marrow Transplant Research
National Marrow Donor Program
Investigators
Study Chair: Navneet Majhail, MD, MS University of Minnesota / CIBMTR
Study Chair: Douglas Rizzo, MD, MS Medical College of Wisconsin / CIBMTR
  More Information

Responsible Party: National Marrow Donor Program ( Kate Pederson, MSW / Principal Investigator )
Study ID Numbers: CIBMTR HS 07-02
Study First Received: November 19, 2008
Last Updated: November 20, 2008
ClinicalTrials.gov Identifier: NCT00795054  
Health Authority: United States: Institutional Review Board

Keywords provided by Center for International Blood and Marrow Transplant Research:
Allogeneic stem cell transplant
Financial impact

ClinicalTrials.gov processed this record on January 14, 2009