Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001280897p
Ethics application status
Submitted, not yet approved
Date submitted
15/09/2021
Date registered
22/09/2021
Date last updated
22/09/2021
Date data sharing statement initially provided
22/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A phase 3 clinical trial examining the effects of SingINg For breathing in chronic obstructive pulmonary disease (COPD) aNd interstitial lung disease (ILD) pAtients
Scientific title
A clinical trial examining the effects of SingINg For breathing on quality of life in COPD aNd ILD pAtients
Secondary ID [1] 305321 0
Nil
Universal Trial Number (UTN)
Trial acronym
SINFONIA
Linked study record
ACTRN12621001274864 is the pilot/feasibility study of this RCT

Health condition
Health condition(s) or problem(s) studied:
chronic obstructive pulmonary disease 323639 0
interstitial lung disease 323640 0
Condition category
Condition code
Respiratory 321175 321175 0 0
Chronic obstructive pulmonary disease
Respiratory 321176 321176 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phase 3 is a double-arm, randomised, analysis, mixed-methods intervention study of online singing group classes compared to standard care for participants with lung disease.

Arm 1: Intervention – Participation in an online group singing class each week for 12 weeks. Group singing classes will run for 90 minutes and include a warm-up exercise (~15-20 minutes), group singing exercises (~45-60), and a cool-down period (~15-20 minutes). Group singing content will be informed by international singing for lung health interventions and will be modified where required to suit the needs of individual participants. Participants are telephoned monthly to complete study questionnaires and encouraged to optionally sing regularly at home including using the currently available “Singing for breathing” CD developed by Phoene Cave (UK Singing for Lung Health investigator and group leader; description and download available from http://www.themusicalbreath.com/2021/05/13/singing-for-breathing-cd-downloads/). The "Singing for Breathing" CD contains physical warm-ups, breathing exercises, vocal exercises and songs.
Attendance in group singing classes will be recorded by the group singing leader and additional use of singing exercises will be recorded during monthly phone reviews.

Arm 2: Control – 12 weeks of standard of care. Participants are telephoned monthly to complete study questionnaires. Control arm participants will have the option of enrolling in 12-weeks of free online singing group classes at the completion of the study. No data will be collected for that period.

Carer enrolment is optional for both arms of both phases. If enrolled, carers will have the option to participate in singing groups and additional singing at home exercises. Carers will be asked to complete quality of life questionnaires at baseline, 4-weeks, 8-weeks, and 12-weeks.
Intervention code [1] 321724 0
Treatment: Other
Comparator / control treatment
Control group will complete 12 weeks of standard of care. This cohort of patients are often eligible for pulmonary rehabilitation (a well-established therapeutic program encompassing exercise, breath training, psychosocial counselling, and patient education) as their standard of care. Past completion of pulmonary rehabilitation is permitted but participants cannot be actively enrolled in pulmonary rehab during this trial. Other standard of care therapies, dependant on clinical indication, include but are not limited to:

- optimisation of medical therapy
- self-management education
- exacerbation action plans (if appropriate)
- education and provision of a breathlessness plan regarding non-pharmacological approaches to managing breathlessness: activity pacing, positions to ease breathlessness, breathing techniques and the use of the handheld fan
- low dose opioids for breathlessness if clinically indicated

Control arm participants will have the option of enrolling in 2-weeks of free online singing group classes hosted by the same organisation as the intervention classes at the completion of the study. No data will be collected for that period
Control group
Active

Outcomes
Primary outcome [1] 328966 0
Phase 3 (efficacy outcome) - Between arm difference in quality of life measured using the SF-36
Timepoint [1] 328966 0
Measured at baseline and 4 weeks, 8 weeks, and 12 weeks (primary endpoint) post baseline.
Secondary outcome [1] 400954 0
Phase 3 - Between arm difference in depression and anxiety measured using the HADS scale
Timepoint [1] 400954 0
Measured at baseline and 12 weeks post baseline.
Secondary outcome [2] 400955 0
Phase 3 - Between arm difference in breathlessness measured using the Dyspnoea-12
Timepoint [2] 400955 0
Measured at baseline and 4 weeks, 8 weeks, and 12 weeks post baseline.
Secondary outcome [3] 400956 0
Phase 3 - Between arm difference in loneliness measured using the UCLA-3 short form
Timepoint [3] 400956 0
Measured at baseline and 12 weeks post baseline.
Secondary outcome [4] 400957 0
Phase 3 - Between arm difference in healthcare utilisation measured by self-reported healthcare utilisation questionnaire designed for this study at monthly intervals
Timepoint [4] 400957 0
Measured at baseline and 4 weeks, 8 weeks, and 12 weeks post baseline.
Secondary outcome [5] 400958 0
Phase 3 - Between arm difference in breathlessness measured using the mastery subdomain of the CRQ
Timepoint [5] 400958 0
Measured at baseline and 12 weeks post baseline.
Secondary outcome [6] 400959 0
Phase 3 - Between arm difference in carer quality of life measured on the CareQOL and SF-36 (optional outcome dependant on carer enrolment)
Timepoint [6] 400959 0
SF-36 measured at baseline and 4 weeks, 8 weeks, and 12 weeks post baseline.
CareQOL measured at baseline and 12 weeks post baseline.

Eligibility
Key inclusion criteria
Patient Cohort:
1. Participants with a confirmed diagnosis of COPD or ILD
• Diagnosis confirmed on either CT chest scan (within the last 5 years) or lung function testing (within the last 2 years)
2. On stable treatment for at least 4 weeks
• Has not started any new or changed existing cardiorespiratory medications (including antibiotics and oral steroids). To be determined by study site clinician.
• Has not been admitted to hospital with an exacerbations of their underlying disease (COPD or ILD) within the past 4 weeks.
3. Modified Medical Research Council dyspnoea score grerater than or equal to 2
4. Aged 18 years or over
5. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Carers Cohort (optional):
1. Nominated carers of eligible patients will be eligible to participate.
2. Aged 18 years or over
3. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participants cannot be actively undertaking a centre-based pulmonary rehabilitation program. However past completion of such a program is permitted.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 20520 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 20521 0
The Alfred - Melbourne
Recruitment hospital [3] 20522 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [4] 20523 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 35299 0
3050 - Parkville
Recruitment postcode(s) [2] 35300 0
3004 - Melbourne
Recruitment postcode(s) [3] 35301 0
3084 - Heidelberg
Recruitment postcode(s) [4] 35302 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 309686 0
Charities/Societies/Foundations
Name [1] 309686 0
Windermere Foundation
Country [1] 309686 0
Australia
Primary sponsor type
Hospital
Name
St Vincents Hospital Melbourne
Address
41 Victoria Parade
Fitzroy, VIC 3065
Country
Australia
Secondary sponsor category [1] 310708 0
None
Name [1] 310708 0
Address [1] 310708 0
Country [1] 310708 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309454 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 309454 0
Ethics committee country [1] 309454 0
Australia
Date submitted for ethics approval [1] 309454 0
13/09/2021
Approval date [1] 309454 0
Ethics approval number [1] 309454 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114214 0
A/Prof Natasha Smallwood
Address 114214 0
Dept of Immunology & Respiratory medicine, Central Clinical School, Monash University, The Alfred Centre, The Alfred Hospital, 55 Commercial Road, Prahran, Vic 3004
Country 114214 0
Australia
Phone 114214 0
+61 03 9903 8735
Fax 114214 0
Email 114214 0
[email protected]
Contact person for public queries
Name 114215 0
Natasha Smallwood
Address 114215 0
Dept of Immunology & Respiratory medicine, Central Clinical School, Monash University, The Alfred Centre, The Alfred Hospital, 55 Commercial Road, Prahran, Vic 3004
Country 114215 0
Australia
Phone 114215 0
+61 03 9903 8735
Fax 114215 0
Email 114215 0
[email protected]
Contact person for scientific queries
Name 114216 0
Natasha Smallwood
Address 114216 0
Dept of Immunology & Respiratory medicine, Central Clinical School, Monash University, The Alfred Centre, The Alfred Hospital, 55 Commercial Road, Prahran, Vic 3004
Country 114216 0
Australia
Phone 114216 0
+61 03 9903 8735
Fax 114216 0
Email 114216 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data is shared only in aggregate.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13206Study protocol  [email protected]



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.