Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000589280
Ethics application status
Approved
Date submitted
7/07/2009
Date registered
15/07/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised, single centre, controlled study to assess whether listening to self selected recorded music reduces the anxiety of patients undergoing their first radiotherapy treatment.
Scientific title
A randomised, single centre, controlled study to assess whether listening to self selected recorded music reduces the anxiety of patients undergoing their first radiotherapy treatment.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anyone diagnosed with cancer needing radiotherapy - radical intent for treatment 237169 0
anxiety during initial radiotherapy 237205 0
Condition category
Condition code
Cancer 237494 237494 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patient selected music for duration of the initial radiotherapy session, that is, first radiotherapy session only (up to one hour)
Intervention code [1] 236882 0
Treatment: Other
Comparator / control treatment
standard care initial radiotherapy with no music throughout
Control group
Active

Outcomes
Primary outcome [1] 238303 0
Comparison of the mean change in state anxiety score, on state-trait anxiety inventory, from baseline to post radiotherapy, between the two treatment arms.
Timepoint [1] 238303 0
State anxiety is assessed only at baseline, just prior to treatment, and post radiotherapy treatment, upon leaving the treatment rooms
Secondary outcome [1] 244693 0
Qualitative assessment of patients' subjective experiences of radiotherapy treatment in music and control groups will also be conducted
Timepoint [1] 244693 0
Subjective expereinces will be assessed post radiotherapy upon leaving the treatment room

Eligibility
Key inclusion criteria
Patients aged from 18; no prior radiotherapy received; diagnosed with cancer; radical intent for treatment; treatment sites: any site; out-patient
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
psychiatric problems with marked cognitive impairment; clinically deaf; poor English language skills

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible patients will be recruited and registered onto the study at the radiotherapy (RT) planning stage. Informed and written consent will be obtained at the simulator after a staff member (data collection designate) has explained the study. Those patients randomised to the intervention arm will subsequently be contacted by telephone and asked to bring along a CD or tape of music that they would wish to listen to during their first RT session
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation to treatment will be balanced by gender, using the minimization technique. Allocation concealment occured through the the staff member, who recruited participants, contacting the holder of the allocation schedule who was located in the statistics department
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Qualitative data accessing patients' subjective experiences of radiotherapy treatment in music and control groups
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 237273 0
University
Name [1] 237273 0
Faculty of Music, University of Melbourne
Country [1] 237273 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
St Andrews Place, East Melbourne, 3002
Victoria
Country
Australia
Secondary sponsor category [1] 236762 0
None
Name [1] 236762 0
nil
Address [1] 236762 0
nil
Country [1] 236762 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239374 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 239374 0
St Andrews Place
East Melbourne Vic 3002
Ethics committee country [1] 239374 0
Australia
Date submitted for ethics approval [1] 239374 0
Approval date [1] 239374 0
22/11/2005
Ethics approval number [1] 239374 0
E 41-05

Summary
Brief summary
The study is the first to investigate whether self selected music, played during the initial radiotherapy session, alters patients’ anxiety states. It uses a randomized, single centre, unblinded design with the outcome measure being the change in state-trait anxiety inventory (STAI) state anxiety score from baseline to post radiotherapy. The study sample size has adequate power to detect a clinically meaningful difference in anxiety between the two treatment arms should treatment be effective. Qualitative data collected after participants' radiotherapy treatments will also elucidate subjective experiences amongst participants receiving radiotherapy with music or standard care radiotherapy.
Trial website
Trial related presentations / publications
June, 2009.
Effect of self-selected music on adults’ anxiety and subjective experiences during their first radiotherapy treatment. Grand Round Presentation at Limerick Regional Hospital, Ireland. (C. O'Callaghan, M. Sproston, G. Wheeler et al).

July, 2008.
Effect of self-selected music on adults’ anxiety during their first radiotherapy treatment. (C. O’Callaghan, M. Sproston, G. Wheeler, et al) World Music Therapy Congress, Buenos Aires, Argentina.
Public notes

Contacts
Principal investigator
Name 29855 0
Address 29855 0
Country 29855 0
Phone 29855 0
Fax 29855 0
Email 29855 0
Contact person for public queries
Name 13102 0
Dr Clare O'Callaghan
Address 13102 0
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne, 3002
Victoria
Country 13102 0
Australia
Phone 13102 0
+61 3 9656 1031
Fax 13102 0
+61 3 9656 1410
Email 13102 0
[email protected]
Contact person for scientific queries
Name 4030 0
Dr Greg Wheeler
Address 4030 0
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne, 3002
Victoria
Country 4030 0
Australia
Phone 4030 0
+61 3 9656 1111
Fax 4030 0
Email 4030 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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