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:

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.

Study Overview

• Status: Completed
• Conditions: Non Hodgkin´s Lymphomas; Hodgkin´s Lymphomas
• Intervention / Treatment: Other: Live music; Other: Taped music

• Study Type: Interventional
• Enrollment (Actual): 143
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Live music; Patient preferred live music during chemotherapy session.	Other: Live music
Active Comparator: Taped music; Patient preferred taped music during chemotherapy	Other: Taped music
No Intervention: Control; Usual care during chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety (STAI)	STAI-S Spielberger State-Trait Anxiety Scale-State	Measurement of STAI after the 5. chemotherapy (on average 8 weeks after inclusion)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum catecholamines	Blood samples	Measured before and after each chemotherapy (at baseline and on average after 2, 4, 6, and 8 weeks after inclusion)
Nausea	Patient diary	Between each visit (at baseline and on average after 1, 3, 5, and 7 weeks after inclusion)
Quality of life	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)	Hospital Anxiety and Depression Scale (HADS)	Visit 1, 2, 3 and 4 (at baseline and on average 2, 4, 6 weeks after inclusion)
Distress	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)	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.

Collaborators and Investigators

• Sponsor: Margrethe Langer Bro
• Collaborators: University of Aarhus; Danish Cancer Society
• Investigators: Principal Investigator: Margrethe L Bro, PhD student, IRS, Southern Denmark. Assistant professor at The Academy of Music in Southern Denmark

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: April 9, 2013
• First Submitted That Met QC Criteria: June 3, 2013
• First Posted (Estimate): June 6, 2013

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 17, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Chemotherapy; Malignant Lymphoma; Music therapy
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma
• Other Study ID Numbers: S-20120118

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No