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

Study Overview
=================
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.

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

Conditions
-----------------
Financial Impact of Stem Cell Transplantation

Intervention / Treatment
-----------------
* Other: Household financial data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| allogeneic stem cell recipients<br>Pediatric and adult allogeneic stem cell transplant recipients and their care givers. | Other: Household financial data collection<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stem cell transplantation, Financial impact