- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Central Denmark Region
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Aarhus, Central Denmark Region, Dinamarca, 8000
- Aarhus University Hospital
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Region Of Southwest Denmark
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Esbjerg, Region Of Southwest Denmark, Dinamarca, 6700
- Hospital of Southwest Jutland
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Odense, Region Of Southwest Denmark, Dinamarca, 5000
- Odense University Hospital
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Odense, Region Of Southwest Denmark, Dinamarca, 5000
- The Academy of Music and Dramatic Arts, Southern Denmark
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Region Zealand
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Roskilde, Region Zealand, Dinamarca, 4000
- Roskilde Sygehus
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The Capital Region Of Denmark
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Copenhagen, The Capital Region Of Denmark, Dinamarca, 2100
- Rigshospitalet
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Copenhagen, The Capital Region Of Denmark, Dinamarca, 2730
- Herlev Hospital
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Live music
Patient preferred live music during chemotherapy session.
|
|
Comparador activo: Taped music
Patient preferred taped music during chemotherapy
|
|
Sin intervención: Control
Usual care during chemotherapy
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Anxiety (STAI)
Periodo de tiempo: 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)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Serum catecholamines
Periodo de tiempo: 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
Periodo de tiempo: Between each visit (at baseline and on average after 1, 3, 5, and 7 weeks after inclusion)
|
Patient diary
|
Between each visit (at baseline and on average after 1, 3, 5, and 7 weeks after inclusion)
|
Quality of life
Periodo de tiempo: 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)
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Anxiety (HADS)
Periodo de tiempo: Visit 1, 2, 3 and 4 (at baseline and on average 2, 4, 6 weeks after inclusion)
|
Hospital Anxiety and Depression Scale (HADS)
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Visit 1, 2, 3 and 4 (at baseline and on average 2, 4, 6 weeks after inclusion)
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Distress
Periodo de tiempo: Visit 1, 2, 4 and 6 (at basline and on average after 2, 4, 6, and 8 weeks after inclusion)
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questionaire: The Distress Thermometer
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Visit 1, 2, 4 and 6 (at basline and on average after 2, 4, 6, and 8 weeks after inclusion)
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Anxiety (STAI)
Periodo de tiempo: 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.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Margrethe L Bro, PhD student, IRS, Southern Denmark. Assistant professor at The Academy of Music in Southern Denmark
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- S-20120118
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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