- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT00938769
Enhanced Self-Efficacy Training
Enhanced Self-Efficacy Training For Informal Cancer Caregivers
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Symptom management is essential in home caregiving. However, many informal caregivers are not confident of their ability to assist their their loved ones with their cancer symptoms at home. A low level of confidence or self-efficacy may negatively affect a caregiver's psychological well-being which is already vulnerable as a consequence of caregiving. Because of the reciprocal nature in a caregiver-patient dyad, caregiver decline is likely associated with patient decline. Improving caregivers' self-efficacy to manage their loved ones' cancer-related symptoms may mitigate their psychological decline and may positively affect patients' well-being by alleviating their symptom distress. Additionally, training in self-management of stress may promote coping among caregivers as many data show that caregiver stress is overwhelming.
This study will examine the effects of an Enhanced Caregiver Training protocol delivered to informal caregivers of cancer patients before hospital discharge. The primary aim is to test the effects of the training on caregivers' self-efficacy in cancer symptom management and self-efficacy in self-management of stress. The study will also look at the effects of this training on caregiver outcomes (depression, anxiety, quality of life, caregiver stress) and patient outcomes (symptom distress and intensity, depression, anxiety, quality of life). The study will use a treatment and attention-control group. Subjects in the treatment group will receive an individualized experiential caregiver training in strategies for managing patient's symptoms and in the use of pleasant imagery and muscle relaxation to manage stress, whereas subjects in the attention-control group will receive an informational session about cancer and resources for caregiving. Data will be collected before and after the training, and at 2 and 4 weeks after hospital discharge. Descriptive statistics and multivariate analysis including mixed models will be used for data analysis This study could have important implications for the nursing community on how to effectively prepare informal cancer caregivers for home caregiving prior to hospital discharge. The long term goal is to refine and expand the training so that it can be used to teach and support informal caregivers of patients suffering from other chronic illnesses, and to determine the cost-effectiveness of this training.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
North Carolina
-
Durham, North Carolina, Соединенные Штаты, 27705
- Duke University Medical Center
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria (patients):
- Diagnosis of cancer (liquid or solid tumor);
- Admitted to DUMC's 9100 or 9300 for cancer treatment or related complications;
- 18 years of age or older;
- Able to read, speak and write in English;
- Anticipates being discharged to home;
- Not referred to hospice;
- Will have home care needs after discharge;
- No major cognitive impairment;
- Has caregiver willing to do study training and surveys.
Inclusion Criteria (caregivers):
- 18 years of age or older;
- Able to read, speak and write in English;
- Interacts with, and provides most of the hands-on care to, patient who meets above criteria.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Исследования в области здравоохранения
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Другой: Self-Efficacy Training for Caregivers
The Enhanced Caregiver Training intervention will be delivered to informal caregivers of cancer patients before hospital discharge who are randomly selected to receive this intervention.
Subjects in the treatment group will receive an individualized experiential caregiver training in strategies for managing patient's symptoms and in the use of pleasant imagery and muscle relaxation to manage stress.
|
The Enhanced Caregiver Training intervention will be delivered to informal caregivers of cancer patients before hospital discharge who are randomly selected to receive this intervention. Subjects in the treatment group will receive an individualized experiential caregiver training in strategies for managing patient's symptoms and in the use of pleasant imagery and muscle relaxation to manage stress. 2-hour in-person instruction of home care issues for caregivers of patients with cancer. |
Другой: Comparison Conditions for Caregivers
Subjects randomly selected to participate in the attention control training will receive an informational session about cancer and resources for support.
|
Subjects randomly selected to participate in the attention control training will receive an informational session about cancer and resources for caregiving. 2-hour counseling session for cancer caregivers to locate community support resources |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
---|---|
Self-efficacy in symptom management
Временное ограничение: One month
|
One month
|
Вторичные показатели результатов
Мера результата |
Временное ограничение |
---|---|
Psychological well-being
Временное ограничение: One month
|
One month
|
Management of psychological distress
Временное ограничение: One month
|
One month
|
Quality of Life
Временное ограничение: One month
|
One month
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: James A Tulsky, MD, Duke University School of Nursing
- Главный следователь: Cristina Hendrix, PhD, Duke University School of Nursing
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- Pro00009040
- 1P01NR010948-01 (Грант/контракт NIH США)
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. .