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The Financial Impact of Allogeneic Stem Cell Transplantation on Patient and Family

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Marrow Donor Program
Information provided by (Responsible Party):
Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier:
NCT00795054
First received: November 19, 2008
Last updated: April 3, 2014
Last verified: April 2014

November 19, 2008
April 3, 2014
March 2009
September 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00795054 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
The Financial Impact of Allogeneic Stem Cell Transplantation on Patient and Family
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Pediatric and adult allogeneic stem cell transplant recipients and their care givers from three U.S. transplant medical centers.

Financial Impact of Stem Cell Transplantation
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.
allogeneic stem cell recipients
Pediatric and adult allogeneic stem cell transplant recipients and their care givers.
Intervention: Other: Household financial data collection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
December 2014
September 2012   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00795054
CIBMTR HS 07-02
No
Center for International Blood and Marrow Transplant Research
Center for International Blood and Marrow Transplant Research
National Marrow Donor Program
Study Chair: Navneet Majhail, MD, MS University of Minnesota / CIBMTR
Study Chair: Douglas Rizzo, MD, MS Medical College of Wisconsin / CIBMTR
Center for International Blood and Marrow Transplant Research
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP