CClinicalTrials.gg
CompletedNCT00795054Updated Oct 6, 2015

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

An observational study in Financial Impact of Stem Cell Transplantation, sponsored by Center for International Blood and Marrow Transplant Research. Completed at 3 sites in United States. Per ClinicalTrials.gov, last updated 2015-10-06.

Sponsored by Center for International Blood and Marrow Transplant Research · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Financial Impact of Stem Cell Transplantation

Keywords

  • Stem cell transplantation
  • Financial impact
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In context

Lead sponsor

Center for International Blood and Marrow Transplant Research is the lead sponsor of 30 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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.

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

Exclusion Criteria:

  1. Recipients who have had a previous HSCT (autologous or allogeneic)
  2. Households with more than one transplant recipient
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (actual)

Groups and cohorts

  • allogeneic stem cell recipients

    Pediatric and adult allogeneic stem cell transplant recipients and their care givers.

    Other: Household financial data collection

Interventions

  • OtherHousehold 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.

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What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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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Study locations

3 sites
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
  • Roswell Park Cancer Institute
    Buffalo, New York 14263, United States
  • Medical College of Wisconsin
    Milwaukee, Wisconsin 53226, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00795054
Lead sponsor
Center for International Blood and Marrow Transplant Research
Collaborators
National Marrow Donor Program
Responsible party
Sponsor
First posted
Nov 21, 2008
Start date
Mar 2009
Primary completion
Sep 2012
Completion
Aug 2015
Last update
Oct 6, 2015

Study contacts

Navneet Majhail, MD, MS
study chair · University of Minnesota / CIBMTR
Douglas Rizzo, MD, MS
study chair · Medical College of Wisconsin / CIBMTR

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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