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.

Study Overview

• Status: Completed
• Conditions: Financial Impact of Stem Cell Transplantation
• Intervention / Treatment: Other: Household financial data collection

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

Study Locations

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

Participation Criteria

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:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

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	Pre-transplant and for 3 months post-transplant

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	6, 12, 18 and 24 month time points post-transplant

Collaborators and Investigators

• 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

Study record dates

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

• Keywords: Stem cell transplantation; Financial impact
• Other Study ID Numbers: CIBMTR HS 07-02