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

Completed

• Conditions: Financial Impact of Stem Cell Transplantation
• Interventions: Other: Household financial data collection

• Registration Number: NCT00795054
• Lead Sponsor: Center for International Blood and Marrow Transplant Research

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 Timeline

• Study First Submitted: 2008-11-19
• Study First Submitted QC: 2008-11-20
• Study First Posted: 2008-11-21
• Study Start: 2009-03
• Primary Completion: 2012-09
• Study Completion: 2015-08
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-05
• Last Update Posted: 2015-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
allogeneic stem cell recipients	Household financial data collection	Pediatric and adult allogeneic stem cell transplant recipients and their care givers.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (3)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States