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Supportive Care Intervention-Pancreas (SCI-P)

10 maggio 2016 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Stati Uniti, 15232
        • University of Pittsburgh Cancer Institute (UPCI), Hillman Cancer Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Supportive Care Intervention
Monthly (minimum) patient & caregiver visits with a Supportive Care physician, embedded within their standard oncological care (through collaboration with oncology providers).
Comportamentale: Embedded Supportive Care
Nessun intervento: Usual Care
Participants will receive standard oncology care from their oncology providers.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
trial feasibility
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
change in patient quality of life
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
patient illness understanding and care preferences
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Pittsburgh

Investigatori

  • Investigatore principale: Yael Schenker, MD, MAS, University of Pittsburgh

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 luglio 2013

Completamento primario (Effettivo)

1 agosto 2015

Completamento dello studio (Effettivo)

1 agosto 2015

Date di iscrizione allo studio

Primo inviato

7 giugno 2013

Primo inviato che soddisfa i criteri di controllo qualità

24 giugno 2013

Primo Inserito (Stima)

25 giugno 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

12 maggio 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 maggio 2016

Ultimo verificato

1 maggio 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PRO13020507

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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