Non Hodgkin´s LymphomasNCT01870479
Music & Cancer - Live Music During Chemotherapy
A study testing Live music and Taped music in people with Non Hodgkin´s Lymphomas and Hodgkin´s Lymphomas, run by Margrethe Langer Bro at 7 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Hodgkin´s Lymphomas, Hodgkin´s Lymphomas
- What is being tested?
- Live music and Taped music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 7 sitesDenmark
- Study dates
- May 2013to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18+
- Newly diagnosed with malignant lymphoma and planned first line chemotherapy treatment
- Able to give informed consent
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Denmark7 sites
Aarhus University Hospital
Aarhus, Central Jutland, 8000
Rigshospitalet
Copenhagen, The Capital Region of Denmark, 2100
Herlev Hospital
Copenhagen, The Capital Region of Denmark, 2730
Hospital of Southwest Jutland
Esbjerg, Region of Southwest Denmark, 6700
Odense University Hospital
Odense, Region of Southwest Denmark, 5000
The Academy of Music and Dramatic Arts, Southern Denmark
Odense, Region of Southwest Denmark, 5000
Roskilde Sygehus
Roskilde, Region Sjælland, 4000
About this study
Official title: 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:
Read more
- 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.
- Conditions
- Non Hodgkin´s Lymphomas, Hodgkin´s Lymphomas
- Being tested
- Live music, Taped music
- Keywords
- Malignant Lymphoma, Chemotherapy, Music therapy
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live musicOther
Taped musicOther
| Study group | Role | What they receive |
|---|---|---|
| Live music | Experimental | Patient preferred live music during chemotherapy session. Receives: Other: Live music |
| Taped music | Active comparator | Patient preferred taped music during chemotherapy Receives: Other: Taped music |
| Control | No intervention | Usual care during chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety (STAI)
STAI-S Spielberger State-Trait Anxiety Scale-State
Measured: Measurement of STAI after the 5. chemotherapy (on average 8 weeks after inclusion)
Secondary outcomes (6)
Serum catecholamines
Blood samples
Measured: Measured before and after each chemotherapy (at baseline and on average after 2, 4, 6, and 8 weeks after inclusion)
Nausea
Patient diary
Measured: 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
Measured: 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)
Measured: Visit 1, 2, 3 and 4 (at baseline and on average 2, 4, 6 weeks after inclusion)
Distress
questionaire: The Distress Thermometer
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionJan 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Hodgkin´s LymphomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Margrethe Langer Bro
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society, University of Aarhus
- Responsible party
- Sponsor-investigator, Margrethe Langer Bro, University of Southern Denmark
- Investigators
- Margrethe L Bro, PhD student, Principal investigator, IRS, Southern Denmark. Assistant professor at The Academy of Music in Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870479
- Sponsor's protocol ID
- S-20120118
- Status last verified
- Jun 2018
- First submitted
- 9 Apr 2013
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music & Cancer - Live Music During Chemotherapy. Randomized Study of the Effect of Live Music During Chemotherapy Treatment
- ClinicalTrials.gov ID
- NCT01870479
- Acronym / sponsor ID
- S-20120118
- Conditions
- Non Hodgkin´s Lymphomas, Hodgkin´s Lymphomas
- Keywords
- Malignant Lymphoma, Chemotherapy, Music therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Margrethe Langer BroUniversity, hospital or other
- Collaborators
- Danish Cancer Society, University of Aarhus
- Study start
- May 2013 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 6 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Live music | Experimental | Other: Live musicPatient preferred live music during chemotherapy session. |
| Taped music | Active comparator | Other: Taped musicPatient preferred taped music during chemotherapy |
| Control | No intervention | –Usual care during chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18+
- Newly diagnosed with malignant lymphoma and planned first line chemotherapy treatment
- Able to give informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Live music | Other | Live music |
| Taped music | Other | Taped music |
Primary outcome
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
6 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)
Nausea
Time frame: Between each visit (at baseline and on average after 1, 3, 5, and 7 weeks after inclusion)
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)
Anxiety (HADS)
Time frame: Visit 1, 2, 3 and 4 (at baseline and on average 2, 4, 6 weeks after inclusion)
Distress
Time frame: Visit 1, 2, 4 and 6 (at basline and on average after 2, 4, 6, and 8 weeks after inclusion)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margrethe L Bro, PhD student principal investigator
IRS, Southern Denmark. Assistant professor at The Academy of Music in Southern Denmark
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Live music and Taped music in people with Non Hodgkin´s Lymphomas and Hodgkin´s Lymphomas, run by Margrethe Langer Bro at 7 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (STAI) (time frame: Measurement of STAI after the 5. chemotherapy (on average 8 weeks after inclusion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2018.