Financial Impact of Stem Cell TransplantationNCT00795054
The Financial Impact of Allogeneic Stem Cell Transplantation on Patient and Family
An observational study of Financial Impact of Stem Cell Transplantation, run by Center for International Blood and Marrow Transplant Research at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Financial Impact of Stem Cell Transplantation
- What is being tested?
- Household financial data collection
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2009to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pediatric and adult allogeneic stem cell transplant recipients and their care givers from three U.S. transplant medical centers.
Who may be able to join
- 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.
Who cannot join
- Recipients who have had a previous HSCT (autologous or allogeneic)
- Households with more than one transplant recipient
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: 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.
Read the 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.
- Being tested
- Household financial data collection
- Keywords
- Stem cell transplantation, Financial impact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Household financial data collectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| allogeneic stem cell recipients | Pediatric and adult allogeneic stem cell transplant recipients and their care givers. Receives: Other: Household financial data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the feasibility of using a patient maintained diary to capture out-of-pocket costs over the first 3 months following allogeneic HSCT
Measured: Pre-transplant and for 3 months post-transplant
Secondary outcomes (1)
To determine the feasibility of conducting interviews to collect financial information at 6, 12, 18 and 24 months after allogeneic HSCT
Measured: 6, 12, 18 and 24 month time points post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startMar 2009
- Primary completionSep 2012
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Financial Impact of Stem Cell TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for International Blood and Marrow Transplant Research
- Sponsor type
- Research network
- Collaborators
- National Marrow Donor Program
- Responsible party
- Sponsor
- Investigators
- Navneet Majhail, MD, MS, Study chair, University of Minnesota / CIBMTRDouglas Rizzo, MD, MS, Study chair, Medical College of Wisconsin / CIBMTR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795054
- Sponsor's protocol ID
- CIBMTR HS 07-02
- Status last verified
- Oct 2015
- First submitted
- 19 Nov 2008
- Last updated
- 6 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Financial Impact of Allogeneic Stem Cell Transplantation on Patient and Family: A Pilot Study
- ClinicalTrials.gov ID
- NCT00795054
- Acronym / sponsor ID
- CIBMTR HS 07-02
- Keywords
- Stem cell transplantation, Financial impact
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Center for International Blood and Marrow Transplant ResearchResearch network
- Collaborators
- National Marrow Donor Program
- Study start
- Mar 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 21 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| allogeneic stem cell recipients | – | Other: Household financial data collectionPediatric and adult allogeneic stem cell transplant recipients and their care givers. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pediatric and adult allogeneic stem cell transplant recipients and their care givers from three U.S. transplant medical centers.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- Recipients who have had a previous HSCT (autologous or allogeneic)
- Households with more than one transplant recipient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Household financial data collectionBaseline 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. | Other | allogeneic stem cell recipients |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2015.
Related trials for Financial Impact of Stem Cell Transplantation
Not yet recruitingObservational study
Impact of the Use of Allogeneic Hematopoietic Stem Cell Transplantation in Reunion Island Patients: Quality of Life, Determinants of Choices and Financial Repercussions
Allogeneic Hematopoietic Stem Cell Transplantation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Navneet Majhail, MD, MS study chair
University of Minnesota / CIBMTR
Douglas Rizzo, MD, MS study chair
Medical College of Wisconsin / CIBMTR
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Financial Impact of Stem Cell Transplantation, run by Center for International Blood and Marrow Transplant Research at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Pre-transplant and for 3 months post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2015.