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Facilitating Parent Adaptation to Pediatric Transplant: The P-SCIP Trial (P-SCIP)

9. marts 2016 opdateret af: Rutgers, The State University of New Jersey
The investigators have developed a parent social-cognitive processing intervention (P-SCIP) to help decrease distress among parent caregivers of children undergoing hematopoietic stem cell transplant (HSCT). The investigators will evaluate the efficacy of P-SCIP in reducing short- and long-term distress and parenting stress among 300 parents of children undergoing HSCT. P-SCIP will be delivered during the child's inpatient HSCT hospitalization and is specifically designed to improve parent social (e.g., sharing concerns) and cognitive (e.g., acceptance) processing of the transplant experience. The intervention includes five in-person sessions that are accompanied by an interactive CD-ROM. The CD-ROM complements the materials in the in-person sessions and provides parents with the opportunity to enhance and deepen their cognitive and social processing of the HSCT experience. The intervention will be tested against best-practices psychosocial care (BPC) available in four enriched pediatric HSCT settings across the United States. P-SCIP will be provided to both Spanish- and English-speaking parents. Participants will complete measures of psychological distress, well-being, and social and cognitive processing at the time of HSCT, two, six and twelve months after HSCT. Research questions will address the effects of P-SCIP versus BPC on parent psychological adaptation and social and cognitive processing, as well as evaluate parent personal resources as well as child medical course variables that contribute to intervention response. The investigators will also examine barriers to participation in the intervention by comparing barriers to participation among parents who refuse participation in the trial and parents who accept.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

212

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90027
        • Childrens Hospital Los Angeles
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Emory University/Childrens Healthcare of Atlanta
    • New Jersey
      • New Brunswick, New Jersey, Forenede Stater, 080903
        • Rutgers Cancer Institute of New Jersey
    • New York
      • New York, New York, Forenede Stater, 10021
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, Forenede Stater, 10032
        • Columbia University

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • biological or foster parent of children under 19 years of age who are scheduled for HSCT within the next month
  • participant is the primary caregiver
  • participant must have phone service
  • caregiver speaks, reads, and writes English or Spanish (Spanish is for Childrens Hospital Los Angeles and Columbia University only)

Exclusion Criteria:

  • pediatric patient has a diagnosis of medulloblastoma or other cancer of the brain

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: P-SCIP
Arm I (Parent Social-Cognitive Intervention Program [P-SCIP]): Participants undergo five 60-minute behavioral intervention sessions once or twice weekly for 3 weeks to learn how to engage in effective social and cognitive processing to deal with fears and worries about the transplant and transplant-related concerns. Participants receive a laptop computer and a CD-ROM after the first session.
Adfærdsmæssigt: Behavioral intervention sessions
Participants undergo five 60-minute behavioral intervention sessions once or twice weekly for 3 weeks to learn how to engage in effective social and cognitive processing to deal with fears and worries about the transplant and transplant-related concerns.
Andet: CD-ROM
Participants receive a laptop computer and a CD-ROM after the first session of behavioral intervention.
Eksperimentel: BPC
Arm II (Best-recommended Psychosocial Care [BPC]): Participants undergo usual care and receive a "Discovery to Recovery" DVD and pamphlet developed by the National Marrow Donor Program (NMDP) describing psychological issues associated with hematopoietic stem cell transplantation (HSCT), the booklet "Top Tips for Parent Caregivers During the BMT Process" published by National Marrow Donor Program-Link describing caregiver issues during HSCT and advice on how to handle them, 2 walkie-talkies, a laptop to view the DVD, and 5 hours of respite care from a child-life specialist once or twice weekly for 3 weeks.
Andet: DVD and pamphlet
Participants receive a "Discovery to Recovery" DVD and pamphlet developed by the National Marrow Donor Program (NMDP) describing psychological issues associated with hematopoietic stem cell transplantation (HSCT), the booklet "Top Tips for Parent Caregivers During the BMT Process" published by National Marrow Donor Program-Link describing caregiver issues during HSCT and advice on how to handle them, 2 walkie-talkies, a laptop to view the DVD.
Andet: Respite care
Participants receive 5 hours of respite care from a child-life specialist once or twice weekly for 3 weeks.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Beck Depression Inventory
Tidsramme: 7 years
7 years
Beck Anxiety Inventory
Tidsramme: 7 years
7 years
Mental Health Inventory
Tidsramme: 7 years
7 years
Impact of Events Scale-Revised
Tidsramme: 7 years
7 years
Axis I Structured Clinical Interview for DSM-IV (SCID)
Tidsramme: 7 years
7 years

Sekundære resultatmål

Resultatmål
Tidsramme
Fear Structure
Tidsramme: 7 years
7 years
Brief COPE
Tidsramme: 7 years
7 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Rutgers, The State University of New Jersey

Samarbejdspartnere

National Cancer Institute (NCI)
Memorial Sloan Kettering Cancer Center
Columbia University
Icahn School of Medicine at Mount Sinai
Emory University
Weill Medical College of Cornell University
Children's Hospital Los Angeles
University of Medicine and Dentistry of New Jersey
National Marrow Donor Program

Efterforskere

  • Ledende efterforsker: Sharon L Manne, Ph.D., Rutgers Cancer Institute of New Jersey

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. maj 2010

Primær færdiggørelse (Faktiske)

1. januar 2015

Studieafslutning (Faktiske)

1. maj 2015

Datoer for studieregistrering

Først indsendt

14. juli 2009

Først indsendt, der opfyldte QC-kriterier

14. juli 2009

Først opslået (Skøn)

15. juli 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. marts 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. marts 2016

Sidst verificeret

1. marts 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 130906
  • P30CA072720 (U.S. NIH-bevilling/kontrakt)
  • 1R01CA127488-01A1 (U.S. NIH-bevilling/kontrakt)
  • CDR0000632012 (Registry Identifier: PDQ (Physician Data Query))
  • FCCC-07848
  • 0220090280 (Anden identifikator: IRB Number)
  • IRB#07-848; 15032-01 (Anden identifikator: Fox Chase number)

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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