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Randomized Study of Individualized Care Plans for Hematopoietic Cell Transplant Survivors

5. september 2017 oppdatert av: Center for International Blood and Marrow Transplant Research
This randomized study will compare a personalized Survivorship Care Plan (SCP) template with usual care (no SCP). The investigators hypothesize that the personalized SCP that incorporates patient specific treatment exposures and provides a framework for long term followup based on those exposures and subsequent risks for late complications will enhance patient survivorship confidence in knowledge, increase adherence to recommended healthcare, improve health behaviors and reduce HCT-related emotional distress.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This randomized study will compare a personalized Survivorship Care Plan (SCP) template with usual care (no SCP). The investigators hypothesize that the personalized SCP that incorporates patient specific treatment exposures and provides a framework for long term followup based on those exposures and subsequent risks for late complications will enhance patient survivorship confidence in knowledge, increase adherence to recommended healthcare, improve health behaviors and reduce hematopoietic cell transplant (HCT) - related emotional distress.

The randomized study design will be able to evaluate the efficacy of individualized SCP in enhancing transplant survivor knowledge, health behaviors and health care utilization for recommended preventive care. Most transplant centers do not use a standardized SCP for their HCT recipients, and hence, the control arm would represent prevalent standard of care (e.g., discharge summary, provider-to-provider communication).

Transplant centers that will participate in this study will represent a spectrum of center types (e.g., geographic location, center volume, resources and infrastructure) and patient populations (e.g., healthcare disparities, urban/rural population, distance from transplant center). Usual care for each center will be documented at the time of determining center eligibility. The study principal investigators, in consultation with the protocol team, will make the determination about center eligibility after reviewing the centers "usual care" procedures. In order to avoid contamination of the study intervention, centers will be asked not to change their follow-up practices for the period they are enrolling patients on the study.

The primary objective of the investigators study is to evaluate the impact of an individualized SCP on survivor knowledge about past diagnostic and treatment details, confidence in knowledge about prevention and treatment of late-effects, access to resources and familial risk of cancer. For this objective, the investigators will compare the change in score on the Confidence in Survivorship Information instrument from baseline to 6 months after the study intervention.

Secondary objectives will investigate the influence of individualized SCP on standardized measures of HCT related distress, knowledge of recommended care, health behaviors, self-efficacy, and health care utilization.

Studietype

Intervensjonell

Registrering (Forventet)

495

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Arizona
      • Scottsdale, Arizona, Forente stater, 85259-5499
        • Mayo Clinic
    • Florida
      • Gainesville, Florida, Forente stater, 32608
        • University of Florida, Shands Hospital
    • Illinois
      • Maywood, Illinois, Forente stater, 60153
        • Loyola Medical Center
    • Kansas
      • Westwood, Kansas, Forente stater, 66205
        • University of Kansas Cancer Center
    • Massachusetts
      • Worcester, Massachusetts, Forente stater, 01655
        • University of Massachusetts Memorial Medical Center
    • Michigan
      • Detroit, Michigan, Forente stater, 48201
        • Karmanos Cancer Institute
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55455
        • University of Minnesota Medical Center
      • Rochester, Minnesota, Forente stater, 55905
        • Mayo Clinic Rochester
    • New York
      • Buffalo, New York, Forente stater, 14263
        • Roswell Park Cancer Institute
    • North Carolina
      • Chapel Hill, North Carolina, Forente stater, 27599
        • UNC Chapel Hill
    • Ohio
      • Cleveland, Ohio, Forente stater, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, Forente stater, 44106
        • University Hospitals Case Medical Center
      • Columbus, Ohio, Forente stater, 43210
        • Ohio State University
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • University of Pennsylvania
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37232
        • Vanderbilt-Ingram Cancer Center
    • Texas
      • Dallas, Texas, Forente stater, 75246
        • Baylor University Medical Center
    • Washington
      • Seattle, Washington, Forente stater, 98109
        • Fred Hutchinson Cancer Research Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Adult (≥ 18 years at time of allogeneic HCT recipient at participating transplant centers)
  • Survival 1-2 years after most recent HCT with no evidence of relapse, disease progression, or secondary cancer on last follow-up
  • All diagnoses will be eligible
  • All transplant types will be eligible (autologous or allogeneic related or unrelated)
  • All graft sources will be eligible (bone marrow, peripheral blood or umbilical cord blood)
  • All conditioning regimens will be eligible (in case of allogeneic HCT, patient could have received myeloablative or non-myeloablative/reduced-intensity conditioning)
  • Patient may have received more than one HCT
  • Patient must be proficient in English (written and spoken) to complete study assessments
  • Patient must have a valid mailing address within the United States to receive study materials
  • Signed informed consent form from patient

Exclusion Criteria:

- Patients who have received their transplant at a different transplant center will not be eligible for the study

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Individualized Survivorship Care Plan (SCP)
  • Participant information sheet and instructions on how to use the SCP
  • Patient version of individualized SCP that includes but is not limited to: (1) a treatment summary that consists of disease characteristics and treatment details (including HCT), and (2) recommendations for preventive care and screening for late complications based on patient treatment exposures (age, type of transplant, use of TBI, corticosteroid exposure as part of HCT, and history of GVHD)
  • Newest Vital Sign nutrition label to measure health literacy and its instructions
  • Participants may receive other materials their transplant center routinely provides to patients for follow-up care (e.g., discharge summary or clinic note)
Annen: Individualized Survivorship Care Plan (SCP)
The individualized SCP incorporates patient specific treatment exposures and provides a framework for long term followup based on those exposures and subsequent risks for late complications.
Ingen inngripen: Usual care (no SCP)
  • Materials that their transplant center routinely provides to patients for follow-up care
  • Newest Vital Sign nutrition label to measure health literacy and its instructions
  • Participants randomized to the usual care arm who complete the 6 month study assessments will receive their individualized SCP upon completion of the patient's participation. Participants who withdraw from the study or who do not complete the 6 month assessment will not receive the individualized SCP.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Change in Confidence in Survivorship Information instrument score
Tidsramme: baseline to 6 months after the study intervention
baseline to 6 months after the study intervention

Sekundære resultatmål

Resultatmål
Tidsramme
Change in HCT treatment distress instrument score
Tidsramme: baseline to 6 months after the study intervention
baseline to 6 months after the study intervention
Change in Health behaviors instrument score
Tidsramme: baseline to 6 months after the study intervention
baseline to 6 months after the study intervention
Changes in Healthcare utilization instrument score
Tidsramme: baseline to 6 months after the study intervention
baseline to 6 months after the study intervention
Change in Knowledge about transplant exposures instrument score
Tidsramme: baseline to 6 months after the study intervention
baseline to 6 months after the study intervention
Change in Quality of life instrument score
Tidsramme: baseline to 6 months after the study intervention
baseline to 6 months after the study intervention
Change in Self-efficacy instrument score
Tidsramme: baseline to 6 months after the study intervention
baseline to 6 months after the study intervention

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Center for International Blood and Marrow Transplant Research

Samarbeidspartnere

Patient-Centered Outcomes Research Institute
National Marrow Donor Program

Etterforskere

  • Studiestol: Elizabeth Murphy, EdD, RN, National Marrow Donor Program
  • Studiestol: Navneet Majhail, MD, MS, Cleveland Clinic Foundation; National Marrow Donor Program
  • Studiestol: K Scott Baker, MD, MS, Fred Hutchinson Cancer Center

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2015

Primær fullføring (Faktiske)

1. april 2017

Studiet fullført (Faktiske)

1. april 2017

Datoer for studieregistrering

Først innsendt

21. juli 2014

Først innsendt som oppfylte QC-kriteriene

24. juli 2014

Først lagt ut (Anslag)

25. juli 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. september 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. september 2017

Sist bekreftet

1. september 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 13-SCP

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