Completed

NCT Number: NCT00795054

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

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.

Completed

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Key information

Conditions

Financial Impact of Stem Cell Transplantation

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota, Minneapolis, Minnesota, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult recipients and parents/guardians of pediatric (age 0-17 years) recipients of allogeneic HSCT
Recipient has a primary caregiver, who is a member of the recipient's household
Allogeneic HSCT using any donor cell source (related, unrelated, or cord blood)
Any age at HSCT
Diagnosis of primary disease for which HSCT is being performed must have been made within two years prior to transplantation
Adult recipients, parents/guardians of pediatric recipients, and primary caregivers should be able to read, write, and understand the English language
Signed informed consent from adult patient, caregiver and/or parent/guardian for study participation
Signed consent to participate in the Center for International Blood and Marrow Transplant Research (CIBMTR) research database.

Exclusion criteria

Recipients who have had a previous HSCT (autologous or allogeneic)
Households with more than one transplant recipient

Treatment and study plan

Household financial data collection

Other

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.

Primary outcomes

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

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

Sponsors and collaborators

Lead sponsor

Center for International Blood and Marrow Transplant Research

Network

Collaborators

National Marrow Donor Program

Registry information

Official study title

The Financial Impact of Allogeneic Stem Cell Transplantation on Patient and Family: A Pilot Study

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2015
First posted: Nov 21, 2008
Registry last updated: Oct 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.