Cancer & Chemotherapy Symptom Management Using an Automated Telephone Reporting System
28 февраля 2017 г. обновлено: Kathleen Mooney, University of Utah
Telephone Linked Care for Cancer Symptom Management
The purpose of this study was to test the efficacy of a computer-based automated symptom monitoring telephone system used by patients who received chemotherapy for their cancer to communicate unrelieved symptoms they experienced to their oncology providers.
Обзор исследования
Подробное описание
The purpose of this study was to test the efficacy of a computer-based automated symptom monitoring telephone system used by patients who received chemotherapy for their cancer to communicate unrelieved symptoms they experienced to their oncology providers.
The symptoms monitored in the project were nausea/vomiting, pain, sore mouth, diarrhea, constipation, depressed mood, anxiety, trouble sleeping, and fatigue.
The study randomly assigned participants into either the intervention group or the group that received usual care from their oncology providers without alert notifications.
All participants called the automated system daily to report their symptom presence, severity, and distress.
When participants in the intervention group rated symptoms at moderate (4-7) to severe (8-10) levels an e-mail alert report of their symptom information was sent to the participant's medical oncologist and oncology nurse.
The usual care group also reported symptoms daily to the automated system but their information was not sent to the providers.
Participants in the usual care group were told daily to call their oncology provider if they had concerns about their symptoms.
The two study groups were compared over chemotherapy cycles 2 and 3 on symptom presence, severity, and distress.
Functional status, patient reported degree of symptom interference with normal activities, and work attendance if they had indicated that they worked during their treatment were also recorded.
In addition, the groups were compared for the number and purpose of unscheduled patient-provider contacts, visits to the emergency department or urgent care facility, and unscheduled hospitalizations.
Тип исследования
Интервенционный
Регистрация (Действительный)
250
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Massachusetts
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Boston, Massachusetts, Соединенные Штаты, 02118
- Boston Medical Center
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South Carolina
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Greer, South Carolina, Соединенные Штаты, 29650
- South Carolina Community Oncology Practice
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Utah
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Salt Lake City, Utah, Соединенные Штаты, 84112
- University of Utah Huntsman Cancer Institute
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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:
- Adult (18 or older)
- Histological Diagnosis of Cancer
- Life Expectancy of at least 6 months
- Cognitively able to participate (verified by provider team)
- Initiated a course of new Chemotherapy that is planned for a minimum of 3 cycles
- Had Poorly controlled symptoms during the first cycle of chemotherapy
- Care under the direction of one of the designated provider teams
- English or Spanish speaking
- Has access to a telephone on a daily basis
- Able to use the telephone unassisted
Exclusion Criteria:
- Receiving concurrent radiation therapy because they would be in daily contact with oncology care providers.
- Patients seeing the provider team for recommendation of chemotherapy regimen but other providers then administer treatment at different site
- Patients receiving a treatment regimen with only biotherapy agents or agents not associated with the symptoms monitored
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 |
|---|---|
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Экспериментальный: Provider Unrelieved Symptom Alert
Patients in the intervention arm called the automated monitoring system daily to report presence, severity and distress on a 1-10 scale for nine symptoms.
The system immediately sent an emailed symptom alert report to their oncologist and oncology nurse if symptoms exceeded preset thresholds (moderate to severe levels).
Two thresholds were set: a simple alert when severity or distress was 4 or greater on the 10 point scale and trend alerts based on a pattern of moderate severity over several days.
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The Provider Unrelieved Symptom Alert intervention sent an automatic symptom report to oncology providers (both physician and nurse) when the patient reported symptoms at a moderate to severe level (4-10 on a 0-10 scale).
The oncology providers used their clinical judgement in terms of what they did with the information received.
There was no prescribed response as part of the intervention.
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Без вмешательства: Attentional Control Usual Care Group
Patients in the usual care group called the automated monitoring system daily to report presence, severity and distress (1-10 scale) on 9 symptoms and also measured symptom interference with daily activities, functional status, work attendance, and unscheduled provider visits, urgent care and emergency department visits, and unscheduled hospitalizations.
The usual care group received equivalent contact time with the automated system including identical voice and assessment questions.
Data were not available for clinical action and not reported to the oncology providers.
On every call, usual care participants were reminded to call their oncology provider if they had symptom concerns, which is the usual practice in oncology settings to address unrelieved symptoms.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Patient reported symptom levels on a 0-10 scale
Временное ограничение: patients report symptoms daily for the duration of the study, an expected average of 6 weeks
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During daily automated calls, patients provided information about common chemotherapy symptoms.
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patients report symptoms daily for the duration of the study, an expected average of 6 weeks
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Medical Encounters Telephone Interview
Временное ограничение: participants will be followed for an expected average of 6 weeks
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When a patient reports during their daily phone call with the automated symptom monitoring system that they had been in contact with a health care provider, the research staff would conduct a short telephone interview to collect data about the nature of the medical encounter including whether the medical encounter was related to the symptoms being monitored by the system.
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participants will be followed for an expected average of 6 weeks
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Functional Status
Временное ограничение: monthly for the duration of the study, participants will be followed for an expected average of 6 weeks
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The SF-12 was administered monthly to measure functional status.
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monthly for the duration of the study, participants will be followed for an expected average of 6 weeks
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Work Attendance
Временное ограничение: reported daily, participants will be followed for an expected average of 6 weeks
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Patients who indicated at study enrollment that they planned to work during treatment answered a yes/no question during the automated symptom monitoring system call to report whether or not they worked the previous day.
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reported daily, participants will be followed for an expected average of 6 weeks
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Patient End of Study Telephone Interview
Временное ограничение: administered at the end of participation in the study, participants will be followed for an expected average of 6 weeks
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An End of Study Telephone Interview was conducted at the end of a patient's participation in the project to obtain data on patient satisfaction with the symptom monitoring system and to obtain suggestions for improvement of the system.
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administered at the end of participation in the study, participants will be followed for an expected average of 6 weeks
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Provider End of Study Interview
Временное ограничение: Once, at the end of participation which is an expected average of 24 months
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At the end of the study, participating providers were interviewed regarding the acceptability and use of the symptom alert reports and their suggestions for improvement.
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Once, at the end of participation which is an expected average of 24 months
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Соавторы
Следователи
- Главный следователь: Kathleen H Mooney, PhD, University of Utah
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 апреля 2001 г.
Первичное завершение (Действительный)
1 марта 2004 г.
Завершение исследования (Действительный)
1 марта 2004 г.
Даты регистрации исследования
Первый отправленный
22 октября 2013 г.
Впервые представлено, что соответствует критериям контроля качества
1 ноября 2013 г.
Первый опубликованный (Оценивать)
8 ноября 2013 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
1 марта 2017 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
28 февраля 2017 г.
Последняя проверка
1 февраля 2017 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- 7846-00
- R01CA089474 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
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. .