The Financial Impact of Allogeneic Stem Cell Transplantation on Patient and Family
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| First Received Date ICMJE | November 19, 2008 | ||||||||
| Last Updated Date | July 31, 2012 | ||||||||
| Start Date ICMJE | March 2009 | ||||||||
| Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00795054 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Financial Impact of Allogeneic Stem Cell Transplantation on Patient and Family | ||||||||
| Official Title ICMJE | The Financial Impact of Allogeneic Stem Cell Transplantation on Patient and Family: A Pilot Study | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| 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. |
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| Condition ICMJE | Financial Impact of Stem Cell Transplantion | ||||||||
| Intervention ICMJE | Other: Household financial data collection
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. |
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| Study Group/Cohort (s) | allogeneic stem cell recipients
Pediatric and adult allogeneic stem cell transplant recipients and their care givers.
Intervention: Other: Household financial data collection |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Estimated Enrollment ICMJE | 30 | ||||||||
| Estimated Completion Date | September 2012 | ||||||||
| Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00795054 | ||||||||
| Other Study ID Numbers ICMJE | CIBMTR HS 07-02 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Center for International Blood and Marrow Transplant Research | ||||||||
| Study Sponsor ICMJE | Center for International Blood and Marrow Transplant Research | ||||||||
| Collaborators ICMJE | National Marrow Donor Program | ||||||||
| Investigators ICMJE |
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| Information Provided By | Center for International Blood and Marrow Transplant Research | ||||||||
| Verification Date | July 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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