NCT01870479

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:

  1. 1.Have an ameliorating effect on physical and psychological symptoms during chemotherapy treatment
  2. 2.May counteract the patients feeling of loss of identity and alienation in this particular group of cancer patients.
  3. 3.Is more effective in patients with good musical abilities.
  4. 4.Is more effective than taped music.
  5. 5.Listening to patient-preferred live music during chemotherapy
  6. 6.Listening to patient-preferred taped music during chemotherapy
  7. 7.Standard care

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2013

Completed
22 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 6, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

June 19, 2018

Status Verified

June 1, 2018

Enrollment Period

3.7 years

First QC Date

April 9, 2013

Last Update Submit

June 17, 2018

Conditions

Non Hodgkin´s LymphomasHodgkin´s Lymphomas

Keywords

Malignant LymphomaChemotherapyMusic therapy

Outcome Measures

Primary Outcomes (1)

  • Anxiety (STAI)

    STAI-S Spielberger State-Trait Anxiety Scale-State

    Measurement of STAI after the 5. chemotherapy (on average 8 weeks after inclusion)

Secondary Outcomes (6)

  • Serum catecholamines

    Measured before and after each chemotherapy (at baseline and on average after 2, 4, 6, and 8 weeks after inclusion)

  • Nausea

    Between each visit (at baseline and on average after 1, 3, 5, and 7 weeks after inclusion)

  • Quality of life

    Visit 1, 2, 4, 6, 7. (at basline and on average after 2, 4, 6, and 8 weeks after inclusion)

  • Anxiety (HADS)

    Visit 1, 2, 3 and 4 (at baseline and on average 2, 4, 6 weeks after inclusion)

  • Distress

    Visit 1, 2, 4 and 6 (at basline and on average after 2, 4, 6, and 8 weeks after inclusion)

  • +1 more secondary outcomes

Study Arms (3)

Live music

EXPERIMENTAL

Patient preferred live music during chemotherapy session.

Other: Live music

Taped music

ACTIVE COMPARATOR

Patient preferred taped music during chemotherapy

Other: Taped music

Control

NO INTERVENTION

Usual care during chemotherapy

Interventions

Live musicOTHER
Live music
Taped musicOTHER
Taped music

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18+
  • Newly diagnosed with malignant lymphoma and planned first line chemotherapy treatment
  • Able to give informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Aarhus University Hospital

Aarhus, Central Jutland, 8000, Denmark

Location

Hospital of Southwest Jutland

Esbjerg, Region of Southwest Denmark, 6700, Denmark

Location

Odense University Hospital

Odense, Region of Southwest Denmark, 5000, Denmark

Location

The Academy of Music and Dramatic Arts, Southern Denmark

Odense, Region of Southwest Denmark, 5000, Denmark

Location

Roskilde Sygehus

Roskilde, Region Sjælland, 4000, Denmark

Location

Rigshospitalet

Copenhagen, The Capital Region of Denmark, 2100, Denmark

Location

Herlev Hospital

Copenhagen, The Capital Region of Denmark, 2730, Denmark

Location

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Margrethe L Bro, PhD student

    IRS, Southern Denmark. Assistant professor at The Academy of Music in Southern Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

April 9, 2013

First Posted

June 6, 2013

Study Start

May 1, 2013

Primary Completion

January 1, 2017

Study Completion

March 1, 2017

Last Updated

June 19, 2018

Record last verified: 2018-06

Locations

DK(7)