ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12621001274864

Ethics application status

Approved

Date submitted

19/07/2021

Date registered

20/09/2021

Date last updated

23/08/2022

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]

Nil

Universal Trial Number (UTN)

Trial acronym

SINFONIA

Linked study record

Health condition

Health condition(s) or problem(s) studied:

chronic obstructive pulmonary disease

interstitial lung disease

Condition category

Condition code

Respiratory

Chronic obstructive pulmonary disease

Respiratory

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]

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]

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]

6 months post study commencement

Secondary outcome [1]

Phase 2 preliminary efficacy outcome - Between arm difference in quality of life measured using the SF-36

Timepoint [1]

Measured at baseline and 4 weeks, 8 weeks, and 12 weeks post baseline.

Secondary outcome [2]

Between arm difference in depression and anxiety measured using the HADS scale

Timepoint [2]

Measured at baseline and 12 weeks post baseline.

Secondary outcome [3]

Between arm difference in breathlessness measured using the Dyspnoea-12

Timepoint [3]

Measured at baseline and 4 weeks, 8 weeks, and 12 weeks post baseline.

Secondary outcome [4]

Between arm difference in loneliness measured using the UCLA-3 short form

Timepoint [4]

Measured at baseline and 12 weeks post baseline.

Secondary outcome [5]

Between arm difference in healthcare utilisation measured by self-reported healthcare utilisation questionnaire designed for this study at monthly intervals

Timepoint [5]

Measured at baseline and 4 weeks, 8 weeks, and 12 weeks post baseline.

Secondary outcome [6]

Between arm difference in breathlessness measured using the mastery subdomain of the CRQ

Timepoint [6]

Measured at baseline and 12 weeks post baseline.

Secondary outcome [7]

Between arm difference in carer quality of life measured on the CareQOL and SF-36 (optional outcome dependant on carer enrolment)

Timepoint [7]

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?

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

Recruiting

Date of first participant enrolment

Anticipated

1/10/2021

Actual

21/04/2022

Date of last participant enrolment

Anticipated

28/10/2022

Actual

Date of last data collection

Anticipated

28/01/2023

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Royal Melbourne Hospital - City campus - Parkville

Recruitment hospital [2]

The Alfred - Melbourne

Recruitment hospital [3]

Austin Health - Austin Hospital - Heidelberg

Recruitment hospital [4]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment postcode(s) [1]

3050 - Parkville

Recruitment postcode(s) [2]

3004 - Melbourne

Recruitment postcode(s) [3]

3084 - Heidelberg

Recruitment postcode(s) [4]

3065 - Fitzroy

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Windermere Foundation

Address [1]

Level 10, 530 Collins Street
Melbourne VIC 3000

Country [1]

Australia

Primary sponsor type

Hospital

Name

St Vincents Hospital Melbourne

Address

41 Victoria Parade
Fitzroy, VIC 3065

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincent's Hospital Melbourne Human Research Ethics Committee

Ethics committee address [1]

41 Victoria Parade
Fitzroy, VIC 3065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

13/09/2021

Approval date [1]

27/10/2021

Ethics approval number [1]

237/21

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

A/Prof Natasha Smallwood

Address

Dept of Immunology & Respiratory medicine, Central Clinical School, Monash University, The Alfred Centre, The Alfred Hospital, 55 Commercial Road, Prahran, Vic 3004

Country

Australia

Phone

+61 03 9903 8735

Fax

[email protected]

Contact person for public queries

Name

Natasha Smallwood

Address

Dept of Immunology & Respiratory medicine, Central Clinical School, Monash University, The Alfred Centre, The Alfred Hospital, 55 Commercial Road, Prahran, Vic 3004

Country

Australia

Phone

+61 03 9903 8735

Fax

[email protected]

Contact person for scientific queries

Name

Natasha Smallwood

Address

Dept of Immunology & Respiratory medicine, Central Clinical School, Monash University, The Alfred Centre, The Alfred Hospital, 55 Commercial Road, Prahran, Vic 3004

Country

Australia

Phone

+61 03 9903 8735

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Data is shared only in aggregate.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
12596	Study protocol			[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	SINFONIA study protocol: a phase II/III randomised controlled trial examining benefits of guided online group singing in people with chronic obstructive pulmonary disease and interstitial lung disease and their carers.	2022	https://dx.doi.org/10.1186/s12931-022-02133-3

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically