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Supportive Care Intervention-Pancreas (SCI-P)

10 mai 2016 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

60

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Pennsylvania
      • Pittsburgh, Pennsylvania, États-Unis, 15232
        • University of Pittsburgh Cancer Institute (UPCI), Hillman Cancer Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Supportive Care Intervention
Monthly (minimum) patient & caregiver visits with a Supportive Care physician, embedded within their standard oncological care (through collaboration with oncology providers).
Comportemental: Embedded Supportive Care
Aucune intervention: Usual Care
Participants will receive standard oncology care from their oncology providers.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
trial feasibility
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
change in patient quality of life
Délai: 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
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
patient illness understanding and care preferences
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Pittsburgh

Les enquêteurs

  • Chercheur principal: Yael Schenker, MD, MAS, University of Pittsburgh

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 juillet 2013

Achèvement primaire (Réel)

1 août 2015

Achèvement de l'étude (Réel)

1 août 2015

Dates d'inscription aux études

Première soumission

7 juin 2013

Première soumission répondant aux critères de contrôle qualité

24 juin 2013

Première publication (Estimation)

25 juin 2013

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

12 mai 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 mai 2016

Dernière vérification

1 mai 2016

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • PRO13020507

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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