search
Back to results

Music & Cancer - Live Music During Chemotherapy

Primary Purpose

Non Hodgkin´s Lymphomas, Hodgkin´s Lymphomas

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Live music
Taped music
Sponsored by
Margrethe Langer Bro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Non Hodgkin´s Lymphomas focused on measuring Malignant Lymphoma, Chemotherapy, Music therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aarhus University Hospital
  • Hospital of Southwest Jutland
  • Odense University Hospital
  • The Academy of Music and Dramatic Arts, Southern Denmark
  • Roskilde Sygehus
  • Rigshospitalet
  • Herlev Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Live music

Taped music

Control

Arm Description

Patient preferred live music during chemotherapy session.

Patient preferred taped music during chemotherapy

Usual care during chemotherapy

Outcomes

Primary Outcome Measures

Anxiety (STAI)
STAI-S Spielberger State-Trait Anxiety Scale-State

Secondary Outcome Measures

Serum catecholamines
Blood samples
Nausea
Patient diary
Quality of life
Quality of Life Questionnaire: QLQ-C30
Anxiety (HADS)
Hospital Anxiety and Depression Scale (HADS)
Distress
questionaire: The Distress Thermometer
Anxiety (STAI)
STAI-S Spielberger State-Trait Anxiety Scale-State

Full Information

First Posted
April 9, 2013
Last Updated
June 17, 2018
Sponsor
Margrethe Langer Bro
Collaborators
Danish Cancer Society, University of Aarhus
search

1. Study Identification

Unique Protocol Identification Number
NCT01870479
Brief Title
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

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
May 2013 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Margrethe Langer Bro
Collaborators
Danish Cancer Society, University of Aarhus

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: Have an ameliorating effect on physical and psychological symptoms during chemotherapy treatment May counteract the patients feeling of loss of identity and alienation in this particular group of cancer patients. Is more effective in patients with good musical abilities. Is more effective than taped music. Method: Intervention groups: Listening to patient-preferred live music during chemotherapy Listening to patient-preferred taped music during chemotherapy 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Hodgkin´s Lymphomas, Hodgkin´s Lymphomas
Keywords
Malignant Lymphoma, Chemotherapy, Music therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Live music
Arm Type
Experimental
Arm Description
Patient preferred live music during chemotherapy session.
Arm Title
Taped music
Arm Type
Active Comparator
Arm Description
Patient preferred taped music during chemotherapy
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care during chemotherapy
Intervention Type
Other
Intervention Name(s)
Live music
Intervention Type
Other
Intervention Name(s)
Taped music
Primary Outcome Measure Information:
Title
Anxiety (STAI)
Description
STAI-S Spielberger State-Trait Anxiety Scale-State
Time Frame
Measurement of STAI after the 5. chemotherapy (on average 8 weeks after inclusion)
Secondary Outcome Measure Information:
Title
Serum catecholamines
Description
Blood samples
Time Frame
Measured before and after each chemotherapy (at baseline and on average after 2, 4, 6, and 8 weeks after inclusion)
Title
Nausea
Description
Patient diary
Time Frame
Between each visit (at baseline and on average after 1, 3, 5, and 7 weeks after inclusion)
Title
Quality of life
Description
Quality of Life Questionnaire: QLQ-C30
Time Frame
Visit 1, 2, 4, 6, 7. (at basline and on average after 2, 4, 6, and 8 weeks after inclusion)
Title
Anxiety (HADS)
Description
Hospital Anxiety and Depression Scale (HADS)
Time Frame
Visit 1, 2, 3 and 4 (at baseline and on average 2, 4, 6 weeks after inclusion)
Title
Distress
Description
questionaire: The Distress Thermometer
Time Frame
Visit 1, 2, 4 and 6 (at basline and on average after 2, 4, 6, and 8 weeks after inclusion)
Title
Anxiety (STAI)
Description
STAI-S Spielberger State-Trait Anxiety Scale-State
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margrethe L Bro, PhD student
Organizational Affiliation
IRS, Southern Denmark. Assistant professor at The Academy of Music in Southern Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
State/Province
Central Denmark Region
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Hospital of Southwest Jutland
City
Esbjerg
State/Province
Region Of Southwest Denmark
ZIP/Postal Code
6700
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
State/Province
Region Of Southwest Denmark
ZIP/Postal Code
5000
Country
Denmark
Facility Name
The Academy of Music and Dramatic Arts, Southern Denmark
City
Odense
State/Province
Region Of Southwest Denmark
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Roskilde Sygehus
City
Roskilde
State/Province
Region Zealand
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Rigshospitalet
City
Copenhagen
State/Province
The Capital Region Of Denmark
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Herlev Hospital
City
Copenhagen
State/Province
The Capital Region Of Denmark
ZIP/Postal Code
2730
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

Music & Cancer - Live Music During Chemotherapy

We'll reach out to this number within 24 hrs