Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Supportive Care Intervention-Pancreas (SCI-P)

10. Mai 2016 aktualisiert von: Yael Schenker, MD, MAS, University of Pittsburgh

A Pilot Trial of an Embedded Collaborative Model of Supportive Care for Pancreatic Cancer

This is a pilot, randomized controlled trial of an embedded collaborative model of supportive care designed to improve quality of life and decrease use of unwanted healthcare services at the end of life for patients with advanced pancreatic cancer. We will enroll 30 patients who are receiving treatment at the Hillman Cancer Center for recently diagnosed, locally advanced or metastatic pancreatic adenocarcinoma, as well as their accompanying caregivers and providers. Patients will be randomized to receive either the supportive care intervention or usual care. The purpose of this study is to refine an embedded collaborative model of supportive care and to develop protocols for recruitment, randomization, and longitudinal data collection.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

60

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Vereinigte Staaten, 15232
        • University of Pittsburgh Cancer Institute (UPCI), Hillman Cancer Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Patients:

    • Adults (≥ 18 years old)
    • Pathologically-confirmed locally advanced or metastatic pancreatic adenocarcinoma diagnosed within the past 8 weeks
    • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 (asymptomatic), 1 (symptomatic but fully ambulatory), or 2 (symptomatic and in bed <50% of the day)
    • Planning to receive continued care from an oncologist at the Hillman Cancer Center
    • Accompanied by a caregiver (family member or friend) at the first visit

  • Caregivers:

    • Adults (>= 18 years old)
    • Family member or friend of an eligible patient

Exclusion Criteria:

  • Patients:

    • Unable to read and respond to questions in English
    • Not planning to receive continued care from an oncologist at the Hillman Cancer Center
    • Pancreatic neuroendocrine cancer

  • Caregivers:

    • Unable to read and respond to questions in English

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Supportive Care Intervention
Monthly (minimum) patient & caregiver visits with a Supportive Care physician, embedded within their standard oncological care (through collaboration with oncology providers).
Verhalten: Embedded Supportive Care
Kein Eingriff: Usual Care
Participants will receive standard oncology care from their oncology providers.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
trial feasibility
Zeitfenster: up to 2 years
We will assess trial feasibility by monitoring number of eligible patients per clinic day, contact rates, interest rates, enrollment rates, randomization rates, intervention visit completion rates, and outcome assessment completion rates.
up to 2 years
acceptability of intervention participation
Zeitfenster: 3 months (+/- 3 weeks) from patient enrollment
We will report the percentage of patients and caregivers who found the intervention acceptable.
3 months (+/- 3 weeks) from patient enrollment
intervention fidelity
Zeitfenster: Up to 2 years
We will use post-visit checklists to characterize the number and types of recommended topics covered during each supportive care intervention visit.
Up to 2 years
perceived effectiveness
Zeitfenster: 3 months (+/- 3 weeks) from patient enrollment
We will report the percentage of patients and caregivers who perceived the intervention to be effective for treating symptoms, understanding their illness, coping, and planning for the future.
3 months (+/- 3 weeks) from patient enrollment

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
change in patient quality of life
Zeitfenster: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
We will summarize range and distribution of change in patient quality of life from baseline to 3 months using the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep). Because this is a pilot trial, we will not conduct formal tests of efficacy.
baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
patient healthcare utilization
Zeitfenster: up to 2 years
We will summarize range and distribution of the following patient healthcare utilization outcomes: number and types of chemotherapy regimens, frequency and timing of chemotherapy regimens, number and length (days) of hospital admissions, number and length (days) of ICU admissions, number of emergency department visits, frequency and timing (days before death) of hospice use, place of death. Because this is a pilot trial, we will not conduct formal tests of efficacy.
up to 2 years
patient quality of life
Zeitfenster: 3 months (+/- 3 weeks) from patient enrollment
We will summarize range and distribution of patient quality of life at 3 months using the FACT-Hep scale. Because this is a pilot trial, we will not conduct formal tests of efficacy.
3 months (+/- 3 weeks) from patient enrollment

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
patient illness understanding and care preferences
Zeitfenster: 3 months (+/- 3 weeks) from patient enrollment
We will assess range and distribution of patient illness understanding using validated questions about patients' perceptions of curability, life expectancy, acknowledgement of whether or not s/he has a terminal illness, and preferences for comfort-oriented vs life-prolonging treatment. Because this is a pilot trial, we will not conduct formal tests of efficacy.
3 months (+/- 3 weeks) from patient enrollment
change in patient anxiety symptoms
Zeitfenster: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
We will assess change in patient anxiety symptoms with the Hospital Anxiety and Depression Scale (HADS) administered at baseline and 3 months. HADS scores will be compiled to assess range and distribution. Because this is a pilot trial, we will not conduct formal tests of efficacy.
baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
change in patient distress
Zeitfenster: baseline (time of enrollment) to 3 months (+/- 3 weeks) after enrollment
We will summarize range and distribution of change in patient distress responses from baseline to 3 months, collected with the National Comprehensive Cancer Network (NCCN) Distress Thermometer tool, where patients rate their distress on a visual guide from 0, 'no distress' to 10, 'extreme distress.' Scores will be compiled to assess range and distribution at 3-months. Because this is a pilot trial, we will not conduct formal tests of efficacy.
baseline (time of enrollment) to 3 months (+/- 3 weeks) after enrollment
change in patient depressive symptoms
Zeitfenster: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
We will assess change in patient depression from baseline to 3 months with the Hospital Anxiety and Depression Scale (HADS) and the Primary Care Evaluation of Mental Disorders: Patient Health Questionnaire (PRIME-MD PHQ-9). HADS and PHQ-9 depression scores will be compiled to assess range and distribution at baseline and 3 months. Because this is a pilot trial, we will not conduct formal tests of efficacy.
baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
change in caregiver distress
Zeitfenster: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
We will summarize range and distribution of change in caregiver distress responses from baseline to 3 months, collected with the National Comprehensive Cancer Network (NCCN) Distress Thermometer tool. Because this is a pilot trial, we will not conduct formal tests of efficacy.
baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
change in caregiver burden
Zeitfenster: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
We will summarize the range and distribution of the reported change in caregiving burden from baseline to 3 months, collected with the Zarit Burden Interview and Family Member Concerns scale. Because this is a pilot trial, we will not conduct formal tests of efficacy.
baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
caregiver grief
Zeitfenster: 1-3 months after death of enrolled patient
We will assess caregiver grief after the death of their loved one (enrolled patient), if the patient dies during study participation and up to 2-year follow up. We will use the Inventory of Complicated Grief to assess how much and how often caregivers are affected by the loss of their loved one and summarize the range and distribution of this data. Because this is a pilot study, we will not conduct formal tests of efficacy.
1-3 months after death of enrolled patient
change in caregiver anxiety symptoms
Zeitfenster: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
We will assess change in caregiver anxiety symptoms from baseline to 3 months with the Hospital Anxiety and Depression Scale (HADS). HADS scores will be compiled to assess range and distribution. Because this is a pilot trial, we will not conduct formal tests of efficacy.
baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
change in caregiver depressive symptoms
Zeitfenster: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
We will assess change in caregiver depressive symptoms from baseline to 3 months with the Hospital Anxiety and Depression Scale (HADS). HADS scores will be compiled to assess range and distribution. Because this is a pilot trial, we will not conduct formal tests of efficacy.
baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
caregiver perceptions of circumstances surrounding death and preparedness for death
Zeitfenster: 1-3 months after death of enrolled patient
We will assess caregiver perceptions of circumstances surrounding death and preparedness for death using four previously validated questions. We will summarize range and distribution of responses. Because this is a pilot trial, we will not conduct formal tests of efficacy.
1-3 months after death of enrolled patient
quality of life of seriously ill patients
Zeitfenster: 3 months (+/- 3 weeks) after enrollment
We will summarize range and distribution of patient quality of life using the Quality of Life - Seriously Ill Patients (QUAL-E) score. Because this is a pilot trial, we will not conduct formal tests of efficacy.
3 months (+/- 3 weeks) after enrollment
patient emotional acceptance of illness
Zeitfenster: 3 months (+/- 3 weeks) after enrollment
We will summarize range and distribution of patient emotional acceptance of illness using the PEACE Scale. Because this is a pilot trial, we will not conduct formal tests of efficacy.
3 months (+/- 3 weeks) after enrollment
patient anxiety
Zeitfenster: 3 months (+/- 3 weeks) after enrollment
We will summarize range and distribution of patient anxiety using the Hospital Anxiety and Depression Scale (HADS). Because this is a pilot trial, we will not conduct formal tests of efficacy.
3 months (+/- 3 weeks) after enrollment
patient distress
Zeitfenster: 3 months (+/- 3 weeks) after enrollment
We will summarize range and distribution in patient distress responses, collected with the National Comprehensive Cancer Network (NCCN) Distress Thermometer tool, where patients rate their distress on a visual guide from 0, 'no distress' to 10, 'extreme distress.' Because this is a pilot trial, we will not conduct formal tests of efficacy.
3 months (+/- 3 weeks) after enrollment
patient depression
Zeitfenster: 3 months (+/- 3 weeks) after enrollment
We will assess patient depression from with the Hospital Anxiety and Depression Scale (HADS) and the Primary Care Evaluation of Mental Disorders: Patient Health Questionnaire (PRIME-MD PHQ-9). HADS and PHQ-9 depression scores will be compiled to assess range and distribution. Because this is a pilot trial, we will not conduct formal tests of efficacy.
3 months (+/- 3 weeks) after enrollment
caregiver distress
Zeitfenster: 3 months (+/- 3 weeks) after enrollment
We will summarize range and distribution in caregiver distress responses, collected with the National Comprehensive Cancer Network (NCCN) Distress Thermometer tool. Because this is a pilot trial, we will not conduct formal tests of efficacy.
3 months (+/- 3 weeks) after enrollment
caregiver burden
Zeitfenster: 3 months (+/- 3 weeks) after enrollment
We will summarize the range and distribution of the reported caregiving burden, collected with the Zarit Burden Interview and Family Member Concerns scale. Because this is a pilot trial, we will not conduct formal tests of efficacy.
3 months (+/- 3 weeks) after enrollment
caregiver anxiety symptoms
Zeitfenster: 3 months (+/- 3 weeks) after enrollment
We will assess caregiver anxiety symptoms with the Hospital Anxiety and Depression Scale (HADS). HADS scores will be compiled to assess range and distribution. Because this is a pilot trial, we will not conduct formal tests of efficacy.
3 months (+/- 3 weeks) after enrollment
caregiver depressive symptoms
Zeitfenster: 3 months (+/- 3 weeks) after enrollment
We will assess caregiver depressive symptoms with the Hospital Anxiety and Depression Scale (HADS). HADS scores will be compiled to assess range and distribution. Because this is a pilot trial, we will not conduct formal tests of efficacy.
3 months (+/- 3 weeks) after enrollment

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Pittsburgh

Ermittler

  • Hauptermittler: Yael Schenker, MD, MAS, University of Pittsburgh

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juli 2013

Primärer Abschluss (Tatsächlich)

1. August 2015

Studienabschluss (Tatsächlich)

1. August 2015

Studienanmeldedaten

Zuerst eingereicht

7. Juni 2013

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

24. Juni 2013

Zuerst gepostet (Schätzen)

25. Juni 2013

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

12. Mai 2016

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. Mai 2016

Zuletzt verifiziert

1. Mai 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • PRO13020507

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren