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Music & Cancer - Live Music During Chemotherapy

17 de junio de 2018 actualizado por: Margrethe Langer Bro

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:

  1. Have an ameliorating effect on physical and psychological symptoms during chemotherapy treatment
  2. May counteract the patients feeling of loss of identity and alienation in this particular group of cancer patients.
  3. Is more effective in patients with good musical abilities.
  4. Is more effective than taped music.

Method: Intervention groups:

  1. Listening to patient-preferred live music during chemotherapy
  2. Listening to patient-preferred taped music during chemotherapy
  3. 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

Terminado

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

143

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Central Denmark Region
      • Aarhus, Central Denmark Region, Dinamarca, 8000
        • Aarhus University Hospital
    • Region Of Southwest Denmark
      • Esbjerg, Region Of Southwest Denmark, Dinamarca, 6700
        • Hospital of Southwest Jutland
      • Odense, Region Of Southwest Denmark, Dinamarca, 5000
        • Odense University Hospital
      • Odense, Region Of Southwest Denmark, Dinamarca, 5000
        • The Academy of Music and Dramatic Arts, Southern Denmark
    • Region Zealand
      • Roskilde, Region Zealand, Dinamarca, 4000
        • Roskilde Sygehus
    • The Capital Region Of Denmark
      • Copenhagen, The Capital Region Of Denmark, Dinamarca, 2100
        • Rigshospitalet
      • Copenhagen, The Capital Region Of Denmark, Dinamarca, 2730
        • Herlev Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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)
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)
Visit 1, 2, 3 and 4 (at baseline and on average 2, 4, 6 weeks after inclusion)
Distress
Periodo de tiempo: 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)
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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

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

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de mayo de 2013

Finalización primaria (Actual)

1 de enero de 2017

Finalización del estudio (Actual)

1 de marzo de 2017

Fechas de registro del estudio

Enviado por primera vez

9 de abril de 2013

Primero enviado que cumplió con los criterios de control de calidad

3 de junio de 2013

Publicado por primera vez (Estimar)

6 de junio de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

19 de junio de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

17 de junio de 2018

Última verificación

1 de junio de 2018

Más información

Términos relacionados con este estudio

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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