Psychological Interventions for Gynecologic Cancer
Обзор исследования
Подробное описание
Very little is known in the psycho-oncology literature about why psychological interventions are effective or for how long these interventions exert an impact. Given many cancer patients experience recurrence and/or progression, it is important to know whether our relatively brief interventions facilitate how patients cope with this most-feared medical event. From a theoretical perspective, the study will advance our understanding of the mechanisms for change for two common treatment approaches, supportive and cognitive behavioral therapies.
Subjects will be enrolled and upon completion of a baseline survey, randomized to into one of three arms - Communication Skills Intervention, Supportive Counseling, and Usual Care. Subjects will complete surveys during the course of the interventions.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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New Jersey
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Camden, New Jersey, Соединенные Штаты, 08103
- Cooper Health System
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Hamilton, New Jersey, Соединенные Штаты, 08690
- Cancer Institute of New Jersey At Hamilton
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Morristown, New Jersey, Соединенные Штаты, 07960
- Morristown Medical Center
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New Brunswick, New Jersey, Соединенные Штаты, 08903
- Rutgers Cancer Institute of New Jersey
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New York
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New York, New York, Соединенные Штаты, 10022
- Memorial Sloan Kettering Cancer Center
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Pennsylvania
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Philadelphia, Pennsylvania, Соединенные Штаты, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, Соединенные Штаты, 19107
- Thomas Jefferson University
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Philadelphia, Pennsylvania, Соединенные Штаты, 19107
- Jefferson University School of Medicine
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Philadelphia, Pennsylvania, Соединенные Штаты, 19111
- University of Pennsylvania Health System
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Newly diagnosed with any stage of primary ovarian cancer, primary peritoneal cancer, or primary fallopian tube cancer in the past 6 months
- Newly diagnosed with High Grade Stage 2, any grade Stage 3 or higher endometrial cancer in the past 6 months
- Newly diagnosed with Stage 2 or higher cervical cancer withing the past 6 months
- Newly diagnosed with any stage of Uterine cancer (both sarcoma and carcinosarcoma) in the past 6 months
- At the time of recruitment, the patient is on active treatment defined as either currently receiving chemotherapy or radiation or less than 6 months post-cancer surgery
- At the time of recruitment, a Karnofsky Performance Status of 80 or above or an Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- English speaking
- Lives within a two-hour commuting distance from the recruitment site
- No hearing impairment
- Has signed consent within 6 months of diagnosis date
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Факторное присвоение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Coping & Communication Skills
The CCI intervention focuses on bolstering stress management and problem solving abilities, identifying and expressing support needs constructively, facilitating the ability to cope with unchangeable issues, cognitive restructuring, and dealing effectively with body image and sexuality issues over seven weekly 60 minute sessions.
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Экспериментальный: Supportive Counseling (SC)
The SC intervention incorporates a supportive, non-directive counseling approach in seven weekly 60 minute sessions
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Без вмешательства: Usual Care (UC)
Patients receive standard psychological and emotional care (usual care [UC]) (i.e., social work consultations and referral to a psychiatrist or psychologist, if requested or deemed necessary by the attending physician).
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Do the two psychological interventions, CCI and SC, result in greater improvements in global psychological adaptation
Временное ограничение: 7 years
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Global Psychological distress: Depressive symptoms - The BDI is a 21-item scale which has been widely used in studies incorporating cognitive-behavioral interventions.The MHI-18 has subscales for Psychological Distress and Well-being. |
7 years
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Do the two psychological interventions, CCI and SC, result in greater improvements in cancer-specific psychological adaptation
Временное ограничение: 7 years
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Cancer-Specific Distress: Traumatic Stress. The Impact of Events Scale (IES) is a 15-item self-report measure focusing on intrusive and avoidant ideation related to gynecologic cancer and its treatment. Using a 4-point Likert scale, participants rated how true each statement has been for them during the past week (scale range = 0-75). Fear of Recurrence/Progression. The Concerns about Recurrence Scale (CARS) is a 26 item assessment of the nature of women's fears about cancer recurrence. |
7 years
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Do the two psychological interventions, CCI and SC, result in greater improvements in quality of life
Временное ограничение: 7 years
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Quality of Life-General. The Functional Assessment of Cancer Therapy - General (FACT-G) is a widely used measure of QOL. The FACT-G is comprised of 27 questions that assess well-being in four domains: physical, functional, social/family, and emotional. Spiritual well-being. The FACIT Spiritual well-being scale assesses a sense of meaning in life, harmony, peacefulness, sense of strength, and comfort from one's faith. The 12 item scale has two factors: Meaning/Peace and Faith. |
7 years
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Соавторы и исследователи
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 (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- 130909
- R01CA085566-06A1 (Грант/контракт NIH США)
- NCI-2012-00551 (Другой идентификатор: CTRP (Clinical Trails Reporting Program))
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. .