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Trial registered on ANZCTR
Registration number
ACTRN12613000134729
Ethics application status
Approved
Date submitted
25/01/2013
Date registered
4/02/2013
Date last updated
8/02/2013
Type of registration
Prospectively registered
Titles & IDs
Public title
Using Mindfulness-Based Music Therapy for young people with cancer
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Scientific title
Mindfulness-Based Music Therapy (MBMT): A brief intervention to improve the wellbeing of adolescent and young adult cancer survivors
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Secondary ID [1]
281839
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cancer
288200
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Depression
288266
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Anxiety
288267
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Condition category
Condition code
Cancer
288568
288568
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0
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Any cancer
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Mental Health
288620
288620
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0
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Anxiety
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Mental Health
288633
288633
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0
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Depression
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Mindfulness-Based Music Thearpy (MBMT)
The intervention conists of 2 sessions with the music therapist which are anticpted to take between 30-50mins each. This will be provided through one-on-one and face-to-face sessions with a music therapist. The 2 sessions will be offered once a week over 2 weeks.
Music therapy involves personally tailored music experiences in the presence of a music therapist. The MBMT intervention will primarily involve the use of pre-recorded music that is used within the therapeutic process to teach the core skills of mindfulness. Mindfulness is an attention focusing technique that helps one to become more in contact with the present moment.
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Intervention code [1]
286400
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Treatment: Other
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Comparator / control treatment
Uncontrolled
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Depression as measured on the Depression Anxiety and Stress Scale (DASS21)
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Assessment method [1]
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Timepoint [1]
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Baseline, at 2 weeks and 8 weeks after intervention completion
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Primary outcome [2]
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Anxiety as measured on the Deperssion Anxiety and Stress Scale (DASS21)
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Assessment method [2]
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Timepoint [2]
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Baseline, at 2 weeks and 8 weeks after intervention completion
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Primary outcome [3]
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Quality of Life as measured on the Functional Assessment of Chronic Illness Therapy - Spiritual Wellbeing (FACIT-Sp)
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Assessment method [3]
288724
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Timepoint [3]
288724
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Baseline, at 2 weeks and 8 weeks after intervention completion
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Secondary outcome [1]
300838
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Mindfulness as measured on the Five Facet Mindfulness Questionnaire (FFMQ)
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Assessment method [1]
300838
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Timepoint [1]
300838
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Baseline, at 2 weeks and 8 weeks after intervention completion
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Secondary outcome [2]
300839
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Self-Compassion as measured on the Self-Compassion Scale (SCS)
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Assessment method [2]
300839
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Timepoint [2]
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Baseline, at 2 weeks and 8 weeks after intervention completion
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Eligibility
Key inclusion criteria
Existing adolescent and young adult cancer survivors as recorded on the Youth Cancer Service SA&NT database or actively attending treatment at metro Adelaide hospitals
Particpants must be fluent in English, and be willing and able to provide written informed consent
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Minimum age
14
Years
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Maximum age
25
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
A score in the Extremely Severe range of the depression subscale of the Depression Anxiety Stress Scale (DASS21)
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
8/04/2013
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
496
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Womens and Childrens Hospital - North Adelaide
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Recruitment hospital [2]
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The Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
6241
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5006 - North Adelaide
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Funding & Sponsors
Funding source category [1]
286625
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Government body
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Name [1]
286625
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Youth Cancer Service SA & NT
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Address [1]
286625
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Level 4 East Wing
Royal Adelaide Hospital
North Terrace SA 5000
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Country [1]
286625
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Australia
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Primary sponsor type
Individual
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Name
Melissa Bond
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Address
Level 3 East Wing
Royal Adelaide Hospital
North Terrace SA 5000
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
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Hayley Whitford
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Address [1]
285409
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c/- School of Psychology at the University of Adelaide
Level 4 Hughes Building
Adelaide SA 5005
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Country [1]
285409
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Australia
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Secondary sponsor category [2]
285410
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Individual
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Name [2]
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Carolyn Hart
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Address [2]
285410
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Michael Rice Centre for Haematology and Oncology
Women's and Children's Hospital
72 King William Road
North Adelaide SA 5006
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Country [2]
285410
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
288703
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Womens and Childrens Health Network Human Research Ethics Comittee
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Ethics committee address [1]
288703
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Level 2 Samuel Way Building
72 King William Road
NORTH ADELAIDE SA 5006
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Ethics committee country [1]
288703
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Australia
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Date submitted for ethics approval [1]
288703
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Approval date [1]
288703
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09/01/2013
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Ethics approval number [1]
288703
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2513/10/15
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Summary
Brief summary
This study will assess the effectiveness and feasiblity of a newly developed brief intervention for young persons with cancer termed Mindfulness-Based Music Therapy (MBMT).
Who is it for?
You may be eligible to join this study if you are a cancer survivor aged 14 to 25 years old, or are actively attending treatment at metro Adelaide hospitals. Participants must be fluent in English.
Trial details
All participants in the study will undergo at least two sessions with the music therapist. During meetings with the music therapist, participants will learn some attention focusing techniques ("mindfulness") and music therapy techniques. Participants will also be provided with some pre-recorded songs and voice recordings to practice the exercises at home on a regular basis.
Participants will be asked to complete questionnaires at baseline, 2 weeks and 8 weeks after the intervention completion in order to evaluate psychological wellbeing across the cancer journey. The intervention is expected to decrease psychological distress, and improve quality of life, mindfulness and self compassion.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
37350
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Ms Melissa Bond
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Address
37350
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Level 3 East Wing
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
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Country
37350
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Australia
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Phone
37350
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+61 08 82222922
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
37351
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Ms Melissa Bond
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Address
37351
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Level 3 East Wing
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
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Country
37351
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Australia
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Phone
37351
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+61 08 8222 2922
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Fax
37351
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Email
37351
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[email protected]
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Contact person for scientific queries
Name
37352
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Ms Melissa Bond
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Address
37352
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Level 3 East Wing
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
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Country
37352
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Australia
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Phone
37352
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+61 08 8222 2922
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Fax
37352
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Email
37352
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[email protected]
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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
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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