- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT01870479
Music & Cancer - Live Music During Chemotherapy
Music & Cancer - Live Music During Chemotherapy. Randomized Study of the Effect of Live Music During Chemotherapy Treatment
Main purpose: To determine if live music moderates the level of chemotherapy related anxiety, in patients with haematological cancer
The investigators hypothesize that live music:
- Have an ameliorating effect on physical and psychological symptoms during chemotherapy treatment
- May counteract the patients feeling of loss of identity and alienation in this particular group of cancer patients.
- Is more effective in patients with good musical abilities.
- Is more effective than taped music.
Method: Intervention groups:
- Listening to patient-preferred live music during chemotherapy
- Listening to patient-preferred taped music during chemotherapy
- Standard care
Endpoints:
Primary: Level of anxiety measured by STAI. Secondary: Serum catecholamines.
Background: In order to establish the intervention procedures, the investigators have carried out a pilot study at the hematology department at Hospital of Southwest Denmark, including students from the Academy of Music and Dramatic Arts, Southern Denmark. The pilot results indicates that live music has an uplifting, pain relieving, and then releasing effect and that music has a positive impact on hospitalisation. According to the evaluation forms filled out by 243 cancer patients, the music experience has provided human anchorage/cohesion as a counterweight to disease fixation and alienation Chemotherapy involves major physical and psychological problems. Not much has been provided in the clinical setting which relieves the symptoms of anxiety associated with chemotherapy. A review of the literature illustrate the need for developing new potential areas of intervention that takes into account, that not only do cancer patients face challenges in everyday life ranging from physiological changes over social to psychological problems, but also during treatment procedures, which may cause a higher level of anxiety associated with these procedures, e.g., chemotherapy infusion.This project investigates to what degree live music may relieve some of these symptoms during treatment for haematological cancer. The project is created in order to both measure psychosocial effects as well as direct stress measures, i.e. serum catecholamine. These physiological changes are measured in order to shed light on the mechanism behind the potential effects of live music on discomfort in connection with chemotherapy treatment.
Perspectives: The vision of the project focus on strengthening the cancer patients' ability to cope with physiological and psychological issues during chemotherapy sessions and to make the patients conscious of music as an option in these coping efforts. Hopefully, the results will provide a scientific basis for an evaluation of the perspectives and the potentials of live music treatment during chemotherapy infusion among cancer patients.
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Central Denmark Region
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Aarhus, Central Denmark Region, Дания, 8000
- Aarhus University Hospital
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Region Of Southwest Denmark
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Esbjerg, Region Of Southwest Denmark, Дания, 6700
- Hospital of Southwest Jutland
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Odense, Region Of Southwest Denmark, Дания, 5000
- Odense University Hospital
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Odense, Region Of Southwest Denmark, Дания, 5000
- The Academy of Music and Dramatic Arts, Southern Denmark
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Region Zealand
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Roskilde, Region Zealand, Дания, 4000
- Roskilde Sygehus
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The Capital Region Of Denmark
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Copenhagen, The Capital Region Of Denmark, Дания, 2100
- Rigshospitalet
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Copenhagen, The Capital Region Of Denmark, Дания, 2730
- Herlev Hospital
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-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Age 18+
- Newly diagnosed with malignant lymphoma and planned first line chemotherapy treatment
- Able to give informed consent
Exclusion Criteria:
- Patients who do not speak or understand Danish
- Patients who are deaf or blind.
- Any comorbidity that postpone planed chemotherapy for more than 4 weeks
- Patients with alcohol or drugs misuse problems as stated in the medical record.
- Patients with untreated mental illness as identified in the medical record
Учебный план
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: Live music
Patient preferred live music during chemotherapy session.
|
|
|
Активный компаратор: Taped music
Patient preferred taped music during chemotherapy
|
|
|
Без вмешательства: Control
Usual care during chemotherapy
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Anxiety (STAI)
Временное ограничение: Measurement of STAI after the 5. chemotherapy (on average 8 weeks after inclusion)
|
STAI-S Spielberger State-Trait Anxiety Scale-State
|
Measurement of STAI after the 5. chemotherapy (on average 8 weeks after inclusion)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Serum catecholamines
Временное ограничение: Measured before and after each chemotherapy (at baseline and on average after 2, 4, 6, and 8 weeks after inclusion)
|
Blood samples
|
Measured before and after each chemotherapy (at baseline and on average after 2, 4, 6, and 8 weeks after inclusion)
|
|
Nausea
Временное ограничение: Between each visit (at baseline and on average after 1, 3, 5, and 7 weeks after inclusion)
|
Patient diary
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Between each visit (at baseline and on average after 1, 3, 5, and 7 weeks after inclusion)
|
|
Quality of life
Временное ограничение: Visit 1, 2, 4, 6, 7. (at basline and on average after 2, 4, 6, and 8 weeks after inclusion)
|
Quality of Life Questionnaire: QLQ-C30
|
Visit 1, 2, 4, 6, 7. (at basline and on average after 2, 4, 6, and 8 weeks after inclusion)
|
|
Anxiety (HADS)
Временное ограничение: Visit 1, 2, 3 and 4 (at baseline and on average 2, 4, 6 weeks after inclusion)
|
Hospital Anxiety and Depression Scale (HADS)
|
Visit 1, 2, 3 and 4 (at baseline and on average 2, 4, 6 weeks after inclusion)
|
|
Distress
Временное ограничение: Visit 1, 2, 4 and 6 (at basline and on average after 2, 4, 6, and 8 weeks after inclusion)
|
questionaire: The Distress Thermometer
|
Visit 1, 2, 4 and 6 (at basline and on average after 2, 4, 6, and 8 weeks after inclusion)
|
|
Anxiety (STAI)
Временное ограничение: Measurement of STAI at baseline and after each chemotherapy 1 to 5 (on average 2, 4, 6 and 8 weeks after inclusion) as well as differences from baseline.
|
STAI-S Spielberger State-Trait Anxiety Scale-State
|
Measurement of STAI at baseline and after each chemotherapy 1 to 5 (on average 2, 4, 6 and 8 weeks after inclusion) as well as differences from baseline.
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Margrethe L Bro, PhD student, IRS, Southern Denmark. Assistant professor at The Academy of Music in Southern Denmark
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
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
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- S-20120118
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
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