Hodgkin´s Lymphomas Clinical Trial
Official title:
Music & Cancer - Live Music During Chemotherapy. Randomized Study of the Effect of Live Music During Chemotherapy Treatment
| NCT number | NCT01870479 |
| Other study ID # | S-20120118 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 2013 |
| Est. completion date | March 2017 |
| Verified date | June 2018 |
| Source | University of Southern Denmark |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 143 |
| Est. completion date | March 2017 |
| Est. primary completion date | January 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Aarhus University Hospital | Aarhus | Central Denmark Region |
| Denmark | Herlev Hospital | Copenhagen | The Capital Region Of Denmark |
| Denmark | Rigshospitalet | Copenhagen | The Capital Region Of Denmark |
| Denmark | Hospital of Southwest Jutland | Esbjerg | Region Of Southwest Denmark |
| Denmark | Odense University Hospital | Odense | Region Of Southwest Denmark |
| Denmark | The Academy of Music and Dramatic Arts, Southern Denmark | Odense | Region Of Southwest Denmark |
| Denmark | Roskilde Sygehus | Roskilde | Region Zealand |
| Lead Sponsor | Collaborator |
|---|---|
| Margrethe Langer Bro | Danish Cancer Society, University of Aarhus |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Anxiety (STAI) | STAI-S Spielberger State-Trait Anxiety Scale-State | Measurement of STAI after the 5. chemotherapy (on average 8 weeks after inclusion) | |
| Secondary | Serum catecholamines | Blood samples | Measured before and after each chemotherapy (at baseline and on average after 2, 4, 6, and 8 weeks after inclusion) | |
| Secondary | Nausea | Patient diary | Between each visit (at baseline and on average after 1, 3, 5, and 7 weeks after inclusion) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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. |