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

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

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

    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • University of Minnesota
    • New York
      • Buffalo, New York, Forenede Stater, 14263
        • Roswell Park Cancer Institute
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Medical College of Wisconsin

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:

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

Exclusion Criteria:

  1. Recipients who have had a previous HSCT (autologous or allogeneic)
  2. 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 .

Kliniske forsøg med Household financial data collection

3
Abonner