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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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Key information

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

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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

Live Music

Other

Taped music

Other

Primary outcomes

  1. 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

  1. 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

  2. Nausea

    Time frame: Between each visit (at baseline and on average after 1, 3, 5, and 7 weeks after inclusion)

    Patient diary

  3. 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

  4. 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)

  5. 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

  6. 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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