NCT Number: NCT01870479
Music & Cancer - Live Music During Chemotherapy
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Aarhus University Hospital, Aarhus, Central Jutland, Denmark
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Taped music
OtherPrimary outcomes
-
Anxiety (STAI)
Time frame: Measurement of STAI after the 5. chemotherapy (on average 8 weeks after inclusion)
STAI-S Spielberger State-Trait Anxiety Scale-State
Secondary outcomes
-
Serum catecholamines
Time frame: Measured before and after each chemotherapy (at baseline and on average after 2, 4, 6, and 8 weeks after inclusion)
Blood samples
-
Nausea
Time frame: Between each visit (at baseline and on average after 1, 3, 5, and 7 weeks after inclusion)
Patient diary
-
Quality of life
Time frame: 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
-
Anxiety (HADS)
Time frame: Visit 1, 2, 3 and 4 (at baseline and on average 2, 4, 6 weeks after inclusion)
Hospital Anxiety and Depression Scale (HADS)
-
Distress
Time frame: Visit 1, 2, 4 and 6 (at basline and on average after 2, 4, 6, and 8 weeks after inclusion)
questionaire: The Distress Thermometer
-
Anxiety (STAI)
Time frame: 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
Sponsors and collaborators
Lead sponsor
Margrethe Langer Bro
Other
Collaborators
- Danish Cancer Society
- University of Aarhus
Registry information
Official study title
Music & Cancer - Live Music During Chemotherapy. Randomized Study of the Effect of Live Music During Chemotherapy Treatment
Important dates
- Study start
- 2013
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Jun 6, 2013
- Registry last updated
- Jun 19, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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