Clinical trial NCT00795054: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Financial Impact of Stem Cell Transplantation
Keywords: Stem cell transplantation
Financial impact
Lead sponsor: Center for International Blood and Marrow Transplant Research
Sponsor class: NETWORK
Collaborators: name: National Marrow Donor Program
First posted: 2008-11-21
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
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
timeFrame: Pre-transplant and for 3 months post-transplant
Secondary outcomes:
measure: To determine the feasibility of conducting interviews to collect financial information at 6, 12, 18 and 24 months after allogeneic HSCT
timeFrame: 6, 12, 18 and 24 month time points post-transplant
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Minnesota / CIBMTR
name: Navneet Majhail, MD, MS
role: STUDY_CHAIR
affiliation: Medical College of Wisconsin / CIBMTR
name: Douglas Rizzo, MD, MS
role: STUDY_CHAIR
References: