Clinical trial NCT01870479: Music & Cancer - Live Music During Chemotherapy
Official title: Music & Cancer - Live Music During Chemotherapy. Randomized Study of the Effect of Live Music During Chemotherapy Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Hodgkin´s Lymphomas
Hodgkin´s Lymphomas
Keywords: Malignant Lymphoma
Chemotherapy
Music therapy
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
name: University of Aarhus
First posted: 2013-06-06
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Anxiety (STAI)
timeFrame: Measurement of STAI after the 5. chemotherapy (on average 8 weeks after inclusion)
Secondary outcomes:
measure: Serum catecholamines
timeFrame: Measured before and after each chemotherapy (at baseline and on average after 2, 4, 6, and 8 weeks after inclusion)
measure: Nausea
timeFrame: Between each visit (at baseline and on average after 1, 3, 5, and 7 weeks after inclusion)
measure: Quality of life
timeFrame: Visit 1, 2, 4, 6, 7. (at basline and on average after 2, 4, 6, and 8 weeks after inclusion)
measure: Anxiety (HADS)
timeFrame: Visit 1, 2, 3 and 4 (at baseline and on average 2, 4, 6 weeks after inclusion)
measure: Distress
timeFrame: Visit 1, 2, 4 and 6 (at basline and on average after 2, 4, 6, and 8 weeks after inclusion)
measure: Anxiety (STAI)
timeFrame: 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.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
state: Central Denmark Region
city: Esbjerg
country: Denmark
facility: Hospital of Southwest Jutland
state: Region Of Southwest Denmark
city: Odense
country: Denmark
facility: Odense University Hospital
state: Region Of Southwest Denmark
city: Odense
country: Denmark
facility: The Academy of Music and Dramatic Arts, Southern Denmark
state: Region Of Southwest Denmark
city: Roskilde
country: Denmark
facility: Roskilde Sygehus
state: Region Zealand
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: The Capital Region Of Denmark
city: Copenhagen
country: Denmark
facility: Herlev Hospital
state: The Capital Region Of Denmark
Study officials:
affiliation: IRS, Southern Denmark. Assistant professor at The Academy of Music in Southern Denmark
name: Margrethe L Bro, PhD student
role: PRINCIPAL_INVESTIGATOR
References: