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Supportive Care Intervention-Pancreas (SCI-P)

10 мая 2016 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

60

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Соединенные Штаты
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Соединенные Штаты, 15232
        • University of Pittsburgh Cancer Institute (UPCI), Hillman Cancer Center

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Поддерживающая терапия
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Supportive Care Intervention
Monthly (minimum) patient & caregiver visits with a Supportive Care physician, embedded within their standard oncological care (through collaboration with oncology providers).
Поведенческий: Embedded Supportive Care
Без вмешательства: Usual Care
Participants will receive standard oncology care from their oncology providers.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
trial feasibility
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
change in patient quality of life
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
patient illness understanding and care preferences
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

University of Pittsburgh

Следователи

  • Главный следователь: Yael Schenker, MD, MAS, University of Pittsburgh

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 июля 2013 г.

Первичное завершение (Действительный)

1 августа 2015 г.

Завершение исследования (Действительный)

1 августа 2015 г.

Даты регистрации исследования

Первый отправленный

7 июня 2013 г.

Впервые представлено, что соответствует критериям контроля качества

24 июня 2013 г.

Первый опубликованный (Оценивать)

25 июня 2013 г.

Обновления учебных записей

Последнее опубликованное обновление (Оценивать)

12 мая 2016 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

10 мая 2016 г.

Последняя проверка

1 мая 2016 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • PRO13020507

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Клинические исследования Продвинутый рак поджелудочной железы

Клинические исследования Embedded Supportive Care

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