- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02200133
Randomized Study of Individualized Care Plans for Hematopoietic Cell Transplant Survivors
Studieoversigt
Status
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Arizona
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Scottsdale, Arizona, Forenede Stater, 85259-5499
- Mayo Clinic
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Florida
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Gainesville, Florida, Forenede Stater, 32608
- University of Florida, Shands Hospital
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Illinois
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Maywood, Illinois, Forenede Stater, 60153
- Loyola Medical Center
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Kansas
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Westwood, Kansas, Forenede Stater, 66205
- University of Kansas Cancer Center
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Massachusetts
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Worcester, Massachusetts, Forenede Stater, 01655
- University of Massachusetts Memorial Medical Center
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Michigan
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Detroit, Michigan, Forenede Stater, 48201
- Karmanos Cancer Institute
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55455
- University of Minnesota Medical Center
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic Rochester
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New York
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Buffalo, New York, Forenede Stater, 14263
- Roswell Park Cancer Institute
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27599
- UNC Chapel Hill
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Ohio
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Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic
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Cleveland, Ohio, Forenede Stater, 44106
- University Hospitals Case Medical Center
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Columbus, Ohio, Forenede Stater, 43210
- Ohio State University
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- University of Pennsylvania
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37232
- Vanderbilt-Ingram Cancer Center
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Texas
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Dallas, Texas, Forenede Stater, 75246
- Baylor University Medical Center
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Washington
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Seattle, Washington, Forenede Stater, 98109
- Fred Hutchinson Cancer Research Center
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
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: 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 indgriben: Usual care (no SCP)
|
Hvad måler undersøgelsen?
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
|
Samarbejdspartnere og efterforskere
Efterforskere
- 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
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 13-SCP
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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