- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00795054
The Financial Impact of Allogeneic Stem Cell Transplantation on Patient and Family
5. oktober 2015 opdateret af: Center for International Blood and Marrow Transplant Research
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
30
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55455
- University of Minnesota
-
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New York
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Buffalo, New York, Forenede Stater, 14263
- Roswell Park Cancer Institute
-
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Wisconsin
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Milwaukee, Wisconsin, Forenede Stater, 53226
- Medical College of Wisconsin
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Pediatric and adult allogeneic stem cell transplant recipients and their care givers from three U.S. transplant medical centers.
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
allogeneic stem cell recipients
Pediatric and adult allogeneic stem cell transplant recipients and their care givers.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
To study the feasibility of using a patient maintained diary to capture out-of-pocket costs over the first 3 months following allogeneic HSCT
Tidsramme: Pre-transplant and for 3 months post-transplant
|
Pre-transplant and for 3 months post-transplant
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
To determine the feasibility of conducting interviews to collect financial information at 6, 12, 18 and 24 months after allogeneic HSCT
Tidsramme: 6, 12, 18 and 24 month time points post-transplant
|
6, 12, 18 and 24 month time points post-transplant
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Studiestol: Navneet Majhail, MD, MS, University of Minnesota / CIBMTR
- Studiestol: Douglas Rizzo, MD, MS, Medical College of Wisconsin / CIBMTR
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2009
Primær færdiggørelse (Faktiske)
1. september 2012
Studieafslutning (Faktiske)
1. august 2015
Datoer for studieregistrering
Først indsendt
19. november 2008
Først indsendt, der opfyldte QC-kriterier
20. november 2008
Først opslået (Skøn)
21. november 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
6. oktober 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. oktober 2015
Sidst verificeret
1. oktober 2015
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- CIBMTR HS 07-02
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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