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Randomized Study of Individualized Care Plans for Hematopoietic Cell Transplant Survivors

5 september 2017 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Verwacht)

495

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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)
Ander: 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.
Geen tussenkomst: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Center for International Blood and Marrow Transplant Research

Medewerkers

Patient-Centered Outcomes Research Institute
National Marrow Donor Program

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 april 2015

Primaire voltooiing (Werkelijk)

1 april 2017

Studie voltooiing (Werkelijk)

1 april 2017

Studieregistratiedata

Eerst ingediend

21 juli 2014

Eerst ingediend dat voldeed aan de QC-criteria

24 juli 2014

Eerst geplaatst (Schatting)

25 juli 2014

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 september 2017

Laatste update ingediend die voldeed aan QC-criteria

5 september 2017

Laatst geverifieerd

1 september 2017

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 13-SCP

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