Video-Based Intervention in Reducing Anxiety in Patients Undergoing Lung Cancer Screening
Pilot Study of a Video-Based Intervention to Reduce Psychological Harm Associated With Lung Cancer Screening
Обзор исследования
Статус
Подробное описание
PRIMARY OBJECTIVES:
I. Test the feasibility and acceptability of the video-based intervention.
SECONDARY OBJECTIVES:
I. To describe incidence, degree, and duration of screen-related anxiety among individuals scheduled to undergo low-dose computed tomography (CT) scan (LDCT) for lung cancer screening (LCS).
II. To describe baseline patient characteristics and pre-screening anxiety levels.
III. To describe the preliminary outcomes on screen-related anxiety for patients both not in the intervention group and those in the intervention group.
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP I: Patients receive standard of care following LCS consisting of routine visits and telephone contact with the LCS program nurse practitioner and coordinator.
GROUP II: Patients undergo a video-based intervention prior to undergoing LCS. Patients watch a 5-minute video that focuses on preparing patients for LCS by providing information on the following: program team and contact information; reason to be screened; screening eligibility; how screening is performed; what to expect on the day of screening; what to expect after screening; what to expect if result is positive; what to expect if result is negative; and risks of screening. Patients also receive an educational handbook. Patients with positive scans (a Lung-Imaging Reporting and Data Systems [RADS] 3 or 4) receive additional brochure and nursing support within 1 week after notification of scan results.
After completion of LCS, patients are followed up at 1 week and then at 3 and 7 months.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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California
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Duarte, California, Соединенные Штаты, 91010
- City of Hope Medical Center
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- This study will be conducted in people scheduled to undergo baseline LDCT as part of the City of Hope (COH) LCS program
- There are no restrictions related to performance status and life expectancy
- All subjects must have the ability to understand and the willingness to participate in the informed consent process, although a waiver of written informed consent is obtained for this study
Exclusion Criteria:
- Patients who do not speak or read, because all intervention materials, including the video and written materials are in English
- Subjects, who in the opinion of the investigator, may not be able to comply with study procedures
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Активный компаратор: Group I (standard of care)
Patients receive standard of care following LCS consisting of routine visits and telephone contact with the LCS program nurse practitioner and coordinator.
|
Дополнительные исследования
Дополнительные исследования
Другие имена:
Другие имена:
|
|
Экспериментальный: Group II (video-based intervention)
Patients undergo a video-based intervention prior to undergoing LCS.
Patients watch a 5-minute video that focuses on preparing patients for LCS by providing information on the following: program team and contact information; reason to be screened; screening eligibility; how screening is performed; what to expect on the day of screening; what to expect after screening; what to expect if result is positive; what to expect if result is negative; and risks of screening.
Patients also receive an educational handbook.
Patients with positive scans (a Lung-RADS 3 or 4) receive additional brochure and nursing support within 1 week after notification of scan results.
|
Дополнительные исследования
Дополнительные исследования
Другие имена:
Undergo video-based intervention
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Percent of patients who complete the intervention
Временное ограничение: Baseline
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Descriptive statistics will be presented on participation in all components of the intervention.
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Baseline
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Patient satisfaction with the timing, content, and delivery of the video-based intervention assessed by survey
Временное ограничение: Up to 7 months
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This self-reported measure will be completed by subjects who received the intervention.
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Up to 7 months
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Patient screen-related anxiety as assessed by the mean score of the State Trait Anxiety Inventory (STAI)
Временное ограничение: Baseline to 7 months
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The survey is used to diagnose anxiety and to distinguish it from depressive syndromes, with items rated on a 4-point scale (with 1 being "Almost Never" and 4 being "Almost Always").
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Baseline to 7 months
|
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Health-related quality of life as assessed by the mean survey score of the Short Form-12 (SF-12) questionnaire
Временное ограничение: Up to 7 months
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The SF-12 is designed for assessment of general health status and contains 7 items that measure physical functioning, role functioning, bodily pain, energy/fatigue, social functioning, mental health, emotional functioning, general health perceptions, and changes in health.
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Up to 7 months
|
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Consequences of screening, assessed by the mean survey score of the Consequences of Screening in Lung Cancer (COS-LC) questionnaire
Временное ограничение: Up to 7 months
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This questionnaire is a non-validated adapted version of a validated two part tool used to assess the psychological impact to breast cancer screening using mammography.
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Up to 7 months
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Соавторы и исследователи
Спонсор
Соавторы
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
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 14169 (Другой идентификатор: City of Hope Medical Center)
- NCI-2014-02220 (Идентификатор реестра: CTRP (Clinical Trial Reporting Program))
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