- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Central Denmark Region
-
Aarhus, Central Denmark Region, Danimarca, 8000
- Aarhus University Hospital
-
-
Region Of Southwest Denmark
-
Esbjerg, Region Of Southwest Denmark, Danimarca, 6700
- Hospital of Southwest Jutland
-
Odense, Region Of Southwest Denmark, Danimarca, 5000
- Odense University Hospital
-
Odense, Region Of Southwest Denmark, Danimarca, 5000
- The Academy of Music and Dramatic Arts, Southern Denmark
-
-
Region Zealand
-
Roskilde, Region Zealand, Danimarca, 4000
- Roskilde Sygehus
-
-
The Capital Region Of Denmark
-
Copenhagen, The Capital Region Of Denmark, Danimarca, 2100
- Rigshospitalet
-
Copenhagen, The Capital Region Of Denmark, Danimarca, 2730
- Herlev Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Live music
Patient preferred live music during chemotherapy session.
|
|
Comparatore attivo: Taped music
Patient preferred taped music during chemotherapy
|
|
Nessun intervento: Control
Usual care during chemotherapy
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Anxiety (STAI)
Lasso di tempo: Measurement of STAI after the 5. chemotherapy (on average 8 weeks after inclusion)
|
STAI-S Spielberger State-Trait Anxiety Scale-State
|
Measurement of STAI after the 5. chemotherapy (on average 8 weeks after inclusion)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Serum catecholamines
Lasso di tempo: Measured before and after each chemotherapy (at baseline and on average after 2, 4, 6, and 8 weeks after inclusion)
|
Blood samples
|
Measured before and after each chemotherapy (at baseline and on average after 2, 4, 6, and 8 weeks after inclusion)
|
Nausea
Lasso di tempo: Between each visit (at baseline and on average after 1, 3, 5, and 7 weeks after inclusion)
|
Patient diary
|
Between each visit (at baseline and on average after 1, 3, 5, and 7 weeks after inclusion)
|
Quality of life
Lasso di tempo: 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
|
Visit 1, 2, 4, 6, 7. (at basline and on average after 2, 4, 6, and 8 weeks after inclusion)
|
Anxiety (HADS)
Lasso di tempo: Visit 1, 2, 3 and 4 (at baseline and on average 2, 4, 6 weeks after inclusion)
|
Hospital Anxiety and Depression Scale (HADS)
|
Visit 1, 2, 3 and 4 (at baseline and on average 2, 4, 6 weeks after inclusion)
|
Distress
Lasso di tempo: Visit 1, 2, 4 and 6 (at basline and on average after 2, 4, 6, and 8 weeks after inclusion)
|
questionaire: The Distress Thermometer
|
Visit 1, 2, 4 and 6 (at basline and on average after 2, 4, 6, and 8 weeks after inclusion)
|
Anxiety (STAI)
Lasso di tempo: 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
|
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.
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Margrethe L Bro, PhD student, IRS, Southern Denmark. Assistant professor at The Academy of Music in Southern Denmark
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- S-20120118
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Non Hodgkin´s Lymphomas
-
Standard Process Inc.Nutrasource Pharmaceutical and Nutraceutical Services, Inc.CompletatoS-adenosilomocisteina elevataStati Uniti
-
National Taiwan University HospitalCompletato
-
Cairo UniversitySamuel Bekhet Moawad; Ahmed Shaker Ragab; Michael Wahib WadidCompletatoSAB guidato da U/S VS SAB guidato da U/S combinato con blocco del nervo pettorale modificatoEgitto
-
Lundquist Institute for Biomedical Innovation at...Thrasher Research FundCompletatoS. Aureus Colonizzazione orofaringeaStati Uniti
-
Biotronik, Inc.TerminatoSicurezza ed efficacia del piombo Siello SStati Uniti
-
The First Affiliated Hospital with Nanjing Medical...ReclutamentoUso di oppioidi, non specificato | S-ketaminaCina
-
Sandwell & West Birmingham Hospitals NHS TrustBirmingham QualitySconosciutoControllo qualità esterno | Tiopurina S-metil transferasi (TPMT)Regno Unito
-
Peking University First HospitalReclutamentoFusione della colonna vertebrale | Analgesia postoperatoria | S-ketaminaCina
-
HemaQuest Pharmaceuticals Inc.TerminatoAnemia falciforme | Anemia falciforme | Malattie dell'anemia falciforme | Malattia dell'emoglobina S | Disturbo falciforme dovuto all'emoglobina SStati Uniti, Libano, Egitto, Canada, Giamaica
-
HemaQuest Pharmaceuticals Inc.CompletatoAnemia falciforme | Anemia falciforme | Malattie dell'anemia falciforme | Malattia dell'emoglobina S | Disturbo falciforme dovuto all'emoglobina SStati Uniti, Libano, Canada, Egitto, Giamaica
Prove cliniche su Live music
-
Fondation Oeuvre de la Croix Saint-SimonRitirato
-
Assistance Publique - Hôpitaux de ParisNon ancora reclutamentoDolore | Dolore, Postoperatorio | Ansia | Chirurgia toracica | Dolore, petto | Ansia postoperatoria
-
University of Maryland, BaltimoreMedical Technology Enterprise Consortium (MTEC)Completato
-
University Medical Center GroningenGGZ Drenthe Mental Health InstitutionReclutamentoRischio cardiovascolare | Depressione, Unipolare | Depressione, bipolareOlanda
-
Johns Hopkins UniversityAttivo, non reclutanteMalattia renale allo stadio terminaleStati Uniti
-
Hospices Civils de LyonReclutamentoDisturbo comportamentale | Musico-terapiaFrancia
-
Center Eugene MarquisCompletatoEffetto collaterale della radioterapiaFrancia
-
NSCB Medical CollegeCompletatoNormale Sano Termine Appropriato per la data NeonatoIndia
-
University of California, IrvineNon ancora reclutamento
-
Healthy Relationships CaliforniaReclutamentoModalità del programmaStati Uniti