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Trial registered on ANZCTR


Registration number
ACTRN12621001274864p
Ethics application status
Submitted, not yet approved
Date submitted
19/07/2021
Date registered
20/09/2021
Date last updated
20/09/2021
Date data sharing statement initially provided
20/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A phase 2 clinical trial examining the feasibility of SingINg For breathing in chronic obstructive pulmonary disease (COPD) aNd interstitial lung disease (ILD) pAtients
Scientific title
A clinical trial examining the feasibility of SingINg For breathing in COPD aNd ILD pAtients
Secondary ID [1] 304727 0
Nil
Universal Trial Number (UTN)
Trial acronym
SINFONIA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic obstructive pulmonary disease 322747 0
interstitial lung disease 322748 0
Condition category
Condition code
Respiratory 320339 320339 0 0
Chronic obstructive pulmonary disease
Respiratory 320340 320340 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phase 2 is a double-arm, randomised, blinded-analysis, mixed-methods feasibility 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] 321104 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] 328191 0
Phase 2 (feasibility outcome) - Outcome is composite of number of participants enrolled, randomised and completed at 6 months. Completion is defined as intervention arm attending 8 of 12 session over 12 weeks and control arm completing 12 week assessment. Outcome will be assessed by audit of enrolment, randomisation, and attendance logs.
Timepoint [1] 328191 0
6 months post study commencement
Secondary outcome [1] 400960 0
Phase 2 preliminary efficacy outcome - Between arm difference in quality of life measured using the SF-36
Timepoint [1] 400960 0
Measured at baseline and 4 weeks, 8 weeks, and 12 weeks post baseline.
Secondary outcome [2] 400961 0
Between arm difference in depression and anxiety measured using the HADS scale
Timepoint [2] 400961 0
Measured at baseline and 12 weeks post baseline.
Secondary outcome [3] 400962 0
Between arm difference in breathlessness measured using the Dyspnoea-12
Timepoint [3] 400962 0
Measured at baseline and 4 weeks, 8 weeks, and 12 weeks post baseline.
Secondary outcome [4] 400963 0
Between arm difference in loneliness measured using the UCLA-3 short form
Timepoint [4] 400963 0
Measured at baseline and 12 weeks post baseline.
Secondary outcome [5] 400964 0
Between arm difference in healthcare utilisation measured by self-reported healthcare utilisation questionnaire designed for this study at monthly intervals
Timepoint [5] 400964 0
Measured at baseline and 4 weeks, 8 weeks, and 12 weeks post baseline.
Secondary outcome [6] 400965 0
Between arm difference in breathlessness measured using the mastery subdomain of the CRQ
Timepoint [6] 400965 0
Measured at baseline and 12 weeks post baseline.
Secondary outcome [7] 400966 0
Between arm difference in carer quality of life measured on the CareQOL and SF-36 (optional outcome dependant on carer enrolment)
Timepoint [7] 400966 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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19937 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 19938 0
The Alfred - Melbourne
Recruitment hospital [3] 19939 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [4] 19940 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 34639 0
3050 - Parkville
Recruitment postcode(s) [2] 34640 0
3004 - Melbourne
Recruitment postcode(s) [3] 34641 0
3084 - Heidelberg
Recruitment postcode(s) [4] 34642 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 309102 0
Charities/Societies/Foundations
Name [1] 309102 0
Windermere Foundation
Address [1] 309102 0
Level 10, 530 Collins Street
Melbourne VIC 3000
Country [1] 309102 0
Australia
Primary sponsor type
Hospital
Name
St Vincents Hospital Melbourne
Address
41 Victoria Parade
Fitzroy, VIC 3065
Country
Australia
Secondary sponsor category [1] 310049 0
None
Name [1] 310049 0
Address [1] 310049 0
Country [1] 310049 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308968 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 308968 0
41 Victoria Parade
Fitzroy, VIC 3065
Ethics committee country [1] 308968 0
Australia
Date submitted for ethics approval [1] 308968 0
13/09/2021
Approval date [1] 308968 0
Ethics approval number [1] 308968 0

Summary
Brief summary
This study is being conducted to determine the feasibility, acceptability, and effectiveness of online singing groups as an intervention for wellbeing and symptom management in participants with COPD and interstitial lung disease (ILD) in Australia. Online delivery is important to determine feasibility and acceptability of alternative delivery models to improve accessibility and equity. Previous studies have shown some benefits to singing groups for COPD patients, but no randomized, controlled trials have been conducted in Australia or in participants with ILD. Singing is not anticipated to present risks or adverse effects based on previous cilnical trials and widespread implementation in the UK.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112514 0
A/Prof Natasha Smallwood
Address 112514 0
Dept of Immunology & Respiratory medicine, Central Clinical School, Monash University, The Alfred Centre, The Alfred Hospital, 55 Commercial Road, Prahran, Vic 3004
Country 112514 0
Australia
Phone 112514 0
+61 03 9903 8735
Fax 112514 0
Email 112514 0
natasha.smallwood@monash.edu
Contact person for public queries
Name 112515 0
A/Prof Natasha Smallwood
Address 112515 0
Dept of Immunology & Respiratory medicine, Central Clinical School, Monash University, The Alfred Centre, The Alfred Hospital, 55 Commercial Road, Prahran, Vic 3004
Country 112515 0
Australia
Phone 112515 0
+61 03 9903 8735
Fax 112515 0
Email 112515 0
natasha.smallwood@monash.edu
Contact person for scientific queries
Name 112516 0
A/Prof Natasha Smallwood
Address 112516 0
Dept of Immunology & Respiratory medicine, Central Clinical School, Monash University, The Alfred Centre, The Alfred Hospital, 55 Commercial Road, Prahran, Vic 3004
Country 112516 0
Australia
Phone 112516 0
+61 03 9903 8735
Fax 112516 0
Email 112516 0
natasha.smallwood@monash.edu

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?
Study protocol
How or where can supporting documents be obtained?
Type [1] 12596 0
Study protocol
Citation [1] 12596 0
Link [1] 12596 0
Email [1] 12596 0
natasha.smallwood@monash.edu
Other [1] 12596 0
Attachment [1] 12596 0
Summary results
No Results