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

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ClinicalTrials.gov Identifier: NCT00795054
Recruitment Status : Completed
First Posted : November 21, 2008
Last Update Posted : October 6, 2015
Sponsor:
Collaborator:
National Marrow Donor Program
Information provided by (Responsible Party):
Center for International Blood and Marrow Transplant Research

Tracking Information
First Submitted Date November 19, 2008
First Posted Date November 21, 2008
Last Update Posted Date October 6, 2015
Study Start Date March 2009
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 20, 2008)
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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00795054 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 20, 2008)
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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Financial Impact of Allogeneic Stem Cell Transplantation on Patient and Family
Official Title The Financial Impact of Allogeneic Stem Cell Transplantation on Patient and Family: A Pilot Study
Brief Summary 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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Financial Impact of Stem Cell Transplantation
Intervention 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.
Study Groups/Cohorts allogeneic stem cell recipients
Pediatric and adult allogeneic stem cell transplant recipients and their care givers.
Intervention: Other: Household financial data collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 20, 2008)
30
Original Estimated Enrollment Same as current
Actual Study Completion Date August 2015
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00795054
Other Study ID Numbers CIBMTR HS 07-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Center for International Blood and Marrow Transplant Research
Study Sponsor Center for International Blood and Marrow Transplant Research
Collaborators 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
PRS Account Center for International Blood and Marrow Transplant Research
Verification Date October 2015