- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01870479
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:
- 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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Central Denmark Region
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Aarhus, Central Denmark Region, Dänemark, 8000
- Aarhus University Hospital
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Region Of Southwest Denmark
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Esbjerg, Region Of Southwest Denmark, Dänemark, 6700
- Hospital of Southwest Jutland
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Odense, Region Of Southwest Denmark, Dänemark, 5000
- Odense University Hospital
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Odense, Region Of Southwest Denmark, Dänemark, 5000
- The Academy of Music and Dramatic Arts, Southern Denmark
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Region Zealand
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Roskilde, Region Zealand, Dänemark, 4000
- Roskilde Sygehus
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The Capital Region Of Denmark
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Copenhagen, The Capital Region Of Denmark, Dänemark, 2100
- Rigshospitalet
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Copenhagen, The Capital Region Of Denmark, Dänemark, 2730
- Herlev Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Live music
Patient preferred live music during chemotherapy session.
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Aktiver Komparator: Taped music
Patient preferred taped music during chemotherapy
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Kein Eingriff: Control
Usual care during chemotherapy
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Anxiety (STAI)
Zeitfenster: Measurement of STAI after the 5. chemotherapy (on average 8 weeks after inclusion)
|
STAI-S Spielberger State-Trait Anxiety Scale-State
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Measurement of STAI after the 5. chemotherapy (on average 8 weeks after inclusion)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Serum catecholamines
Zeitfenster: Measured before and after each chemotherapy (at baseline and on average after 2, 4, 6, and 8 weeks after inclusion)
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Blood samples
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Measured before and after each chemotherapy (at baseline and on average after 2, 4, 6, and 8 weeks after inclusion)
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Nausea
Zeitfenster: Between each visit (at baseline and on average after 1, 3, 5, and 7 weeks after inclusion)
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Patient diary
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Between each visit (at baseline and on average after 1, 3, 5, and 7 weeks after inclusion)
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Quality of life
Zeitfenster: Visit 1, 2, 4, 6, 7. (at basline and on average after 2, 4, 6, and 8 weeks after inclusion)
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Quality of Life Questionnaire: QLQ-C30
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Visit 1, 2, 4, 6, 7. (at basline and on average after 2, 4, 6, and 8 weeks after inclusion)
|
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Anxiety (HADS)
Zeitfenster: Visit 1, 2, 3 and 4 (at baseline and on average 2, 4, 6 weeks after inclusion)
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Hospital Anxiety and Depression Scale (HADS)
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Visit 1, 2, 3 and 4 (at baseline and on average 2, 4, 6 weeks after inclusion)
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Distress
Zeitfenster: Visit 1, 2, 4 and 6 (at basline and on average after 2, 4, 6, and 8 weeks after inclusion)
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questionaire: The Distress Thermometer
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Visit 1, 2, 4 and 6 (at basline and on average after 2, 4, 6, and 8 weeks after inclusion)
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Anxiety (STAI)
Zeitfenster: 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.
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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.
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Margrethe L Bro, PhD student, IRS, Southern Denmark. Assistant professor at The Academy of Music in Southern Denmark
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- S-20120118
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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