Trial Review

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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
Scientific title
Mindfulness-Based Music Therapy (MBMT): A brief intervention to improve the wellbeing of adolescent and young adult cancer survivors
Secondary ID [1] 281839 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 288200 0
Depression 288266 0
Anxiety 288267 0
Condition category
Condition code
Cancer 288568 288568 0 0
Any cancer
Mental Health 288620 288620 0 0
Anxiety
Mental Health 288633 288633 0 0
Depression

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 286400 0
Treatment: Other
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288722 0
Depression as measured on the Depression Anxiety and Stress Scale (DASS21)
Timepoint [1] 288722 0
Baseline, at 2 weeks and 8 weeks after intervention completion
Primary outcome [2] 288723 0
Anxiety as measured on the Deperssion Anxiety and Stress Scale (DASS21)
Timepoint [2] 288723 0
Baseline, at 2 weeks and 8 weeks after intervention completion
Primary outcome [3] 288724 0
Quality of Life as measured on the Functional Assessment of Chronic Illness Therapy - Spiritual Wellbeing (FACIT-Sp)
Timepoint [3] 288724 0
Baseline, at 2 weeks and 8 weeks after intervention completion
Secondary outcome [1] 300838 0
Mindfulness as measured on the Five Facet Mindfulness Questionnaire (FFMQ)
Timepoint [1] 300838 0
Baseline, at 2 weeks and 8 weeks after intervention completion
Secondary outcome [2] 300839 0
Self-Compassion as measured on the Self-Compassion Scale (SCS)
Timepoint [2] 300839 0
Baseline, at 2 weeks and 8 weeks after intervention completion

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
Minimum age
14 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A score in the Extremely Severe range of the depression subscale of the Depression Anxiety Stress Scale (DASS21)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/04/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 496 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [2] 497 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 6241 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 286625 0
Government body
Name [1] 286625 0
Youth Cancer Service SA & NT
Country [1] 286625 0
Australia
Primary sponsor type
Individual
Name
Melissa Bond
Address
Level 3 East Wing
Royal Adelaide Hospital
North Terrace SA 5000
Country
Australia
Secondary sponsor category [1] 285409 0
Individual
Name [1] 285409 0
Hayley Whitford
Address [1] 285409 0
c/- School of Psychology at the University of Adelaide
Level 4 Hughes Building
Adelaide SA 5005
Country [1] 285409 0
Australia
Secondary sponsor category [2] 285410 0
Individual
Name [2] 285410 0
Carolyn Hart
Address [2] 285410 0
Michael Rice Centre for Haematology and Oncology
Women's and Children's Hospital
72 King William Road
North Adelaide SA 5006
Country [2] 285410 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288703 0
Womens and Childrens Health Network Human Research Ethics Comittee
Ethics committee address [1] 288703 0
Level 2 Samuel Way Building
72 King William Road
NORTH ADELAIDE SA 5006
Ethics committee country [1] 288703 0
Australia
Date submitted for ethics approval [1] 288703 0
Approval date [1] 288703 0
09/01/2013
Ethics approval number [1] 288703 0
2513/10/15

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37350 0
Ms Melissa Bond
Address 37350 0
Level 3 East Wing
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 37350 0
Australia
Phone 37350 0
+61 08 82222922
Fax 37350 0
Email 37350 0
melissa.bond@health.sa.gov.au
Contact person for public queries
Name 37351 0
Ms Melissa Bond
Address 37351 0
Level 3 East Wing
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 37351 0
Australia
Phone 37351 0
+61 08 8222 2922
Fax 37351 0
Email 37351 0
melissa.bond@health.sa.gov.au
Contact person for scientific queries
Name 37352 0
Ms Melissa Bond
Address 37352 0
Level 3 East Wing
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 37352 0
Australia
Phone 37352 0
+61 08 8222 2922
Fax 37352 0
Email 37352 0
melissa.bond@health.sa.gov.au

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.