Effects and Mechanisms of Online Delivered Singing Training vs Usual Care in Patients With Persistent Symptoms 6-18 Months After Surgical Resection for Non-small Cell Lung Cancer (NSCLC) - a Multi-centre RCT
Phase: NA
Conditions: Non-Small Cell Lung Cancer, Chronic Obstructive Lung Disease
Sponsor: Zealand University Hospital

 
1 
Study Protocol 
 
 
 
Project title:  
Effects and mechanisms of online delivered singing training (Singing for Lung Health) vs 
usual care in patients with persistent symptoms 6-18 months after surgical resection for non-
small cell lung cancer (NSCLC) – a multi-centre cross-over randomised controlled trial 
 
 
Approved by:  
The Scientific Ethical Committee Region Zealand, Denmark 
 
Registration number: SJ-1027 
 
 
Initial approval date: August 18, 2023 
Updated approval date: October 8, 2025 
 
 
 

 
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Research group 
Principal investigator 
Mette Kaasgaard, Associate Professor, PhD, MSc, classical singer and singing pedagogue 
Email: mkaasgaard@health.sdu.dk   
 
Primary institutional and academic affiliations, and research group members 
Dept. of Regional Health Research, Faculty of Health Sciences, University of Southern 
Denmark & Pulmonary Research Unit Region Zealand (PLUZ), Dept. of Respiratory 
Medicine, Zealand University Hospital, Naestved and Roskilde Hospital, Denmark. 
• Uffe Bødtger, Professor, head of research, respiratory consultant, PhD. 
 
Respiratory Research Unit, Dept. of Medicine, Lillebaelt Hospital, Vejle, Denmark 
• Morten Hornemann Borg, Associate Professor, respiratory consultant, head of 
“Lungepakken” at Lillebaelt Hospital, PhD 
• Ole Hilberg, Professor, head of research, respiratory consultant, DMSc 
 
Respiratory Research Unit (ODIN), Dept. of Respiratory Medicine, Department of Clinical 
Medicine, Faculty of Health Sciences, University of Southern Denmark. 
• Christian Borbjerg Laursen, head of research, Professor, respiratory consultant, PhD. 
 
Dept. of Respiratory Medicine, Bispebjerg Hospital, Department of Clinical Medicine, 
Faculty of Health Sciences, Copenhagen University.  
• Pernille Kristiansen, respiratory consultant.  
• Anne Orholm, respiratory consultant, PhD.  
 
August Krogh Section for Molecular and Human Physiology, Dept. of Nutrition, Exercise 
and Sports, Faculty of Health and Medical Sciences, University of Copenhagen.  
• Morten Hostrup, Associate Professor, physiologist, MD, PhD. 
 
Additional Danish project affiliations 
Dept. of Heart, Lung and Vascular Surgery, Dept. T, Odense University Hospital (OUH) 
• Erik Jakobsen, Chief respiratory consultant, Dr.Med., MPM, head of ”Dansk Lunge 
Cancer Register (DLCR)”. 
 
Dept. of Thoracic Surgery, Rigshospitalet, Dept. of Clinical Medicine, Faculty of Health 
Sciences, University of Copenhagen.  
• Rene Horsleben Petersen, Professor, head of research, respiratory consultant, PhD.  
 
Dept. of Oncology, Odense University Hospital. 
• Lotte Holm Land, Associate Professor, oncology consultant, PhD. 
 
Danish Research Center for Lung Cancer. 
• Ole Hilberg, head, Professor, respiratory consultant, DMSc. 
 
International project affiliations 
• Stephen Clift, Prof. Emeritus, Sidney De Haan Research Centre for Arts and Health, 
Canterbury Christ Church University. Visiting Prof. International Centre for 
Community Music, York St John University. Visiting Professor, School of Music, 
University of Leeds. Professorial Fellow, Royal Society for Public Health, UK 

 
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1. Short summary 
People who have undergone curative surgery for non-small cell lung cancer (NSCLC) often 
experience reduced quality of life (QoL), a high burden of symptoms, and physical 
deconditioning. Current Danish rehabilitation offers are heterogeneous and inconsistent and 
not tailored to the specific needs of this population. Additionally, some patients continue to 
suffer from persistent physical symptoms months or even years after surgery, yet no targeted 
support is currently available for them. 
Singing - delivered as a structured form of training - has shown benefits in improving both 
physical and psychological outcomes in individuals with chronic obstructive pulmonary 
disease (COPD). Although singing has not yet been studied in NSCLC patients, the two 
conditions share overlapping symptoms and characteristics. Therefore, this study aims to 
explore whether a singing-based intervention can help reduce symptom burden and improve 
physical function and QoL in NSCLC patients 6 to 18 months post-surgery. To test this, we 
will conduct a multi-centre, cross-over randomised controlled trial (RCT), comparing a 
singing intervention to usual care. Given that travel and distance often pose significant 
barriers to participation, the intervention will be delivered online. 
 
 
2. Background 
2.1 Prevalence and impact 
Lung cancer is now the most common cancer in Denmark (incidence 5000 new cases/year), 
representing 13% of total cancer incidences. At the same time, 5-year survival is increasing 
along with the prevalence of long-term survivors [1–5]. The main curative treatment for non-
small cell lung cancer (NSCLC) is surgical resection of low-stage lung cancer i.e., localised 
disease with no metastatic spread. Curative treatment may also be achieved by stereotactic 
radiation therapy (low-stage disease) or concomitant radio-chemotherapy (locally advanced 
disease) [2, 6].  
 
However, compared to age-matched controls, patients with lung cancer have persistently 
reduced quality of life (QoL), decreased psychological well-being, reduced physical and 
social activity, deconditioning, symptom clusters (e.g., dyspnoea, cough, pain, fatigue, 
dysphonia). In addition,  many are affected by comorbidities (some, but not all, tobacco-
related) [2–4, 7], with a particular frequent overlap between lung cancer and COPD [2, 4, 8]. 
 
2.2 Follow-up programme after NSCLC surgery 
Usual procedure after NSCLC surgery consists of follow-up consultation with conversation, 
computed tomography (CT) scan after three months, and e.g., lung function testing. 
Subsequently, CT scans will be performed every three months in two years (for low stage 
cancer, however, every six months) and CT scans every six months in the next three years 
[9].  
 
Besides, the recommended follow-up programme after NSCLC surgery includes 
rehabilitation with e.g. exercise training, smoking cessation, education, and self-management 
as key components [2, 4, 8, 10, 11]. The programmes are, however, heterogeneous and there 
is currently no lung cancer-specific community-based rehabilitation programme available that 
addresses the long-term decline in physical capacity, QoL, and social activity after curative 
intended treatment in NSCLC [4, 7, 12].  
Most commonly, people after NSCLC surgery are offered a general rehabilitation programme 
in a municipal setting [7, 12, 13], but may also be referred for e.g., pulmonary rehabilitation 
(PR), which is a multidisciplinary, multi-faceted, and comprehensive intervention based on 

 
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evidence-based activities, recommended by the European Respiratory Society (ERS) and the 
American Thoracic Society (ATS) to reduce symptoms, increase quality of life, and to 
optimise functional capacity [2, 4, 14, 15].  
 
It is recommended that the rehabilitation offer for lung cancer includes a combined 
intervention consisting of aerobic training and strength training, either alone or combined 
with respiratory muscle training [16]. A Cochrane review (Cavalheri, et al., 2019) concluded 
high evidence that rehabilitation with exercise training improved physical capacity and 
physical fitness, and suggested low-moderate evidence regarding improved Health-Related 
QoL and dyspnoea [17]. Additionally, in 2025, a Core Outcomes Set, based on a Delphi 
consensus study (Edbrooke, et al., 2025), concluded that critical outcomes are: physical 
function, HRQoL, breathlessness, activities of daily living, emotional and mental well-being 
and pain [18] 
 
Our recent study (Kaasgaard, et al., 2024) about availability, type, and content of Danish 
community-based rehabilitation offers (n=100), confirmed that the rehabilitation programme 
is offered as heterogeneous models including cancer rehabilitation (across different cancer 
diseases), individual training, online training, or pulmonary rehabilitation (PR) [19]. 
Nevertheless, a disease-specific offer was related to improved QoL and to higher satisfaction 
and experienced relevance [19]. Barriers to offering such model may, however, include lack 
of attention towards the disease-specific needs, a limited number of lung cancer patients in 
each municipality, and transportation issues [19]. 
 
2.3 Long-term symptom burden after NSCLC surgery 
In our recent study [19] we, moreover, found that a large proportion of patients experience 
persistent symptoms five to six months after their NSCLC surgery and that the symptoms 
were mostly physiological-oriented, based on a researcher-developed questionnaire: Fatigue 
(78%), hyper-vigilance (74%), dyspnoea (65%), and pain (47%), although psychological-
oriented symptoms were also present: Worry about the future (40%), depressive symptoms 
(35%), and anxiety symptoms (29%). In addition, 27%, experienced having vocal problems. 
This pattern was confirmed in our subsequent cross-sectional study on QoL and symptom 
burden 6-12 months after NSCLC surgery (Kaasgaard, et al., 2025, under preparation for 
submission (approval numbers Region Zealand: 57069; Southern Region: 24/511. Study 
protocol available at Open Science Framework: osf.io/vmpft)), based on the The European 
Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC 
QLQ-C30) [20, 21] and clinically relevant cut-off score for any item: ≥ 2  [22], e.g.: Fatigue 
(58%), sleep disturbances (54%), and dyspnoea (69%). 
 
These findings are in line with the findings in other recent Danish studies that a considerable 
proportion of patients experience persistent symptoms long-term after their NSCLC surgery, 
such as fatigue, dyspnoea, pain, and cough [13, 23]. In addition, a systematic review found 
that a modest, yet significant, proportion of patients experience poor mental health-related 
QoL after their NSCLC surgery [24] and, moreover, persistent symptoms of dyspnoea and 
pain have been observed up to one year after surgical treatment in NSCLC patients [7, 23].  
 
Taken together, this implies signs of a neglected population of people who continue to 
experience persistent symptoms following surgical treatment for NSCLC. Yet, there is no 
standard offer available to support this subgroup of patients. 
 
2.4 Singing in respiratory disease 

 
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Singing has become increasingly popular for people with respiratory diseases [25–28] being 
an activity which both comprises elements of physiological training and psychosocial aspects 
[28–31] and, therefore, also seems likely to be able to address the unmet needs of lung cancer 
patients.  
 
Previous studies have suggested that lung patients gain a physiological training effect from 
participating in singing training [28–30, 32] and that singing training leads to increased 
respiratory control, less dyspnoea, improved QoL, and reduced anxiety and depression [26, 
33–38]. Moreover, singing is suggested to confer physiological training effects [28–30, 32] 
with work load equivalent to brisk walk pace [30, 39]. Furthermore, studies report that 
singing is perceived as a relevant and beneficial activity that improves well-being, and builds 
joy, meaning, and social cohesion [25, 28, 31, 32, 40, 41]. However, the vast majority of 
studies have overall mostly been small and heterogenous, though, and with contradictory 
findings, as clinical studies have widely not been able to confirm reportings of anecdotal-
oriented studies [42] and as there is an substantial lack of knowledge about the underpinning 
mechanisms of singing in people with respiratory diseases [30, 43].  
 
Moreover, there are different approaches to singing in people with respiratory diseases, both 
in general and used in scientific studies. However, mainly a traditional choir approach is 
adapted [25–27, 29]. The currently most well-documented, best-practice approach is Singing 
for Lung Health (SLH) which has been developed within a multidisciplinary healthcare 
setting in the UK since 2008 [28, 30]. SLH is a disease-specific approach that aims to target 
the specific challenges in respiratory diseases and provide health-promoting benefits through 
the use of exercises and songs as tools for purpose and further includes movement and 
dancing while singing [27, 28, 30–32].  
 
In our recent multicentre-RCT in COPD - Sing-a-Lung 1.0 -, we demonstrated that PR with 
SLH improved functional capacity and QoL in a dose-response manner and was non-inferior 
to PR with usual care delivery of PExT [44]. Furthermore, the trial suggested that SLH was 
related to improved respiratory strength and dyspnoea control [43, 44]. This RCT was 
conducted within a real-life community-based setting. It was the largest study on singing so 
far, had sufficient power to detect change (n=270), and, thus, represents a proof-of-concept 
study [44].  
 
Post-hoc explorations, further, indicated that singing was associated with relevant 
physiological improvements, e.g., respiratory strength and control, dyspnoea control, and 
heart-rate response. However, surprisingly, clinically relevant improvement in physical 
capacity and QoL were not significantly correlated [43].  
 
2.5 Singing in NSCLC? 
Singing has not yet been investigated in patients after NSCLC surgery, but a qualitative study 
exploring impact of group singing for patients with breast or colorectal cancer suggests that 
singing is a feasible activity that may improve resilience, confidence, and mood, and builds 
social support [45]. 
However, given that several epidemiological and common pathogenetic factors are shared 
between chronic obstructive pulmonary disease (COPD) and NSCLC patients [46] and that 
the incidence of lung cancer and COPD is often overlapping [2, 4, 8], results from Sing-a-
Lung 1.0 are likely to be transferrable specifically to people with lung cancer, and may 
address important needs of this overlooked group.  
 

 
6 
However, the limited number of lung cancer patients in each municipality and the 
heterogeneity of the current rehabilitation offer [19], lead to critical barriers and compromise 
the feasibility of an RCT equally to the one of Sing-a-Lung 1.0 with participants collected in 
groups of approximately 10 receiving SLH or PExT in their local community close to their 
home. Therefore, given that a substantial proportion of patients experience long-term 
persistent symptoms and given that singing may address these specific symptoms, we aim to 
focus on this group. Given that there is no programme available to support this patient group, 
we will compare singing with usual care using a cross-over RCT design. Additionally, we 
will conduct the study with online delivery of the singing intervention to account for the 
barriers regarding distance and transportation.  
 
2.6 Online delivery of singing  
Previous studies of singing for lung patients have mostly been based on face-to-face delivery, 
however, a number of studies have also investigated singing for lung patients (or with 
respiratory-related symptoms) based on online delivery [47–51] and found that online 
delivery is feasible and well-accepted [47, 48, 51]. 
 
 
3. Aims and Hypotheses 
In the main study, we aim to investigate whether a 10 weeks’ course of online singing 
training (delivered as SLH) improves key physiological and psychosocial outcomes, as well 
as reduces symptom burden compared to usual care in patients who display long-term 
symptoms 6-18 months after curative intended NSCLC surgery.  
 
In an exploratory study of a sub-cohort, we aim to investigate the underpinning mechanisms 
of singing compared to usual care, both in NSCLC alone and taking the NSCLC-COPD 
overlap into account. Specifically, we aim to explore the physiological adaptations and to 
explore the correlation between objective and subjective improvements.  
 
In the main study, we hypothesise that: 
SLH provides relevant and beneficial improvements in both physiological and psychological 
parameters and is superior to usual care, and. 
SLH relieves symptom burden and is superior to usual care.  
 
In the exploratory sub-study, we hypothesise that: 
SLH improves physical fitness, oxygenation, and inflammation and is superior to usual care. 
 
 
4. Materials and Methods 
4.1 Study design 
We will conduct a cross-over randomised controlled trial in patients with persistent 
symptoms 6-18 months after NSCLC surgery, i.e., after completion of any municipal 
rehabilitation offer shortly after surgery. Moreover, we will conduct an exploratory study in a 
sub-group of participants with additional advanced assessments of the physiological 
adaptations to singing.  
 
Participants will be randomised 2:1 in blocks of five to either Group 1, receiving 10 weeks’ 
online SLH or Group 2, receiving 10 weeks’ usual care followed by – to enhance willingness 
to participate - 10 weeks’ online SLH.  
 

 
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For overview of groups, please see 4.5 Randomisation procedure, and for overview of the 
overall study, please see Figure 3.  
 
Additionally, we will include a qualitative documentation (in the form of a visual production) 
on the intervention and on patient perspectives, specifically focusing on the experience of 
participating in the intervention and how the tools are adapted/integrated, e.g., related to 
change in breathing pattern, control over the respiratory muscles, symptom management, and 
capability to perform physical exercise. The visual production will be facilitated by 
photograph and producer, David Kahr (https://www.davidkahr.dk). 
 
4.2 Setting 
The overall project will be run between Q4 2025 and Q4 2028 with active intervention phase 
between Q4 2025 and Q3 2027.  
 
The intervention will be held via a video conferencing application (Zoom Video 
Communications, ‘Zoom’), delivered by three specialised singing teachers. 
 
The following sites are involved in the project:   
Site 1: Department of Medicine, Zealand University Hospital, Roksilde and Næstved, 
Næstved Hospital, Ringstedgade 61, DK-4700 Naestved. 
 
Site 2: Department of Respiratory Medicine, Bispebjerg Hospital, Bispebjerg Bakke 23, DK-
2400 København NV.  
 
Site 3: Department of Respiratory Medicine, Lillebaelt Hospital, Vejle, Kabbeltoft 25, DK-
7100 Vejle, respectively (with assistance from Department of Oncology, Lillebaelt Hospital, 
Kabbeltoft 25, DK-7100 Vejle).  
 
Site 4: Department of Respiratory Medicine, Odense University Hospital, J. B. Winsløws Vej 
4, DK-5000 Odense (with assistance from Department of Oncology, Odense University 
Hospital, J. B. Winsløws Vej 4, DK-5000 Odense).  
 
Site 5: August Krogh Section for Molecular and Human Physiology, Department of 
Nutrition, Exercise and Sports, Faculty of Health and Medical Sciences, University of 
Copenhagen, Universitetsparken 3, DK-2100 København Ø (August Krogh Section for 
Molecular and Human Physiology is a research site with comprehensive experience with 
planning and conduct of all procedures related to clinical research, including recruitment, 
basic and advances data collection, analysis, and dissemination).  
  
See 4.4 and 4.5 for description of procedures and data collection at the sites. 
 
4.3 Participants 
Patients who display persistent symptoms 6-18 months (+/- one month) after surgical 
resection of localised lung cancer with video-assisted thoracoscopy (VATS) will be invited to 
participate in the study.  
 
Inclusion criteria for the study include:  
Persistent symptoms, i.e., an EORTC-QLQ-C30 symptom domain score (in any item) of  ≥2 
(= "clinically relevant symptom or problem that should have healthcare professional 
attention")[20–22],  

 
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Surgery for stage I lung cancer 6-18 months (+/- one month) earlier,  
Motivated for participating in the project (and acceptance of randomisation procedure), 
Access to a computer or a tablet with internet access, 
Ability to speak and understand Danish, 
Acceptance of the scheduled times of the singing intervention twice a week. 
 
Exclusion criteria include:  
1) Unstable coronary diseases, 
2) Severe cognitive disabilities (e.g., dementia), 
3) Indication for adjuvant chemotherapy or other antineoplastic therapy, 
4) Signs of lung cancer recurrence at regular follow-up CT scan.  
 
No previous singing experience or musical competence is required. Participants will be 
informed that they are allowed to participate in additional offer of structured or unstructured 
offer physical exercise training and/or singing along with the project. 
 
4.4 Recruitment procedure  
Participants will be recruited using the following methods:  
 
Retrospectively: At study onset: Participants from our recent cross-sectional study 
(Kaasgaard, et al., 2025, under preparation for submission) who provided consent and 
indicated to be interested in being part of the study, will be contacted and receive information 
about the project, directly via telephone or secure video-link by the study coordinator (doctor 
or nurse) at Site 1 and 2, respectively. If interested, patients will be screened according to 
EORTC-QLQ-C30 symptom domains and cut-off for any item: ≥ 2 (see inclusion criteria 1). 
 
Retrospectively: At study onset: Each site retrieves patient lists from the Danish Lung Cancer 
Registry (DLCR) and/or from patient records related to their own, local patients having 
undergone NSCLC surgery within the past 6-18 months. Based on study inclusion criteria 2-5 
and exclusion criteria 1-4, eligible patients will be contacted and receive information about 
the project, directly via telephone or secure video-link by the study coordinator at each site. If 
interested, patients will be screened according to EORTC-QLQ-C30 symptom domains and 
cut-off for any item: ≥ 2 (see inclusion criteria 1).  
 
Prospectively: Ongoingly: Identification at each site of own, new local patients having 
undergone NSCLC surgery, based on patient records related to their own, local patients (i.e., 
if not identified as part of recruitment procedure point 2). Based on study inclusion criteria 2-
6 and all exclusion criteria, eligible patients will be contacted and receive information about 
the project, directly in person, via telephone, or by secure video-link by the study coordinator 
at each site. If interested, patients will be screened according to EORTC-QLQ-C30 symptom 
domains and cut-off for any item: ≥ 2 (see inclusion criteria 1).  
 
Patients will be offered to receive the information on another day and to bring a relative. 
After the oral information, patients will receive informed written information about the 
project and about their basic rights, either directly or via digital mail (“e-boks”) and will be 
able to read the relevant information materials at home. 2-3 days after receiving the written 
information, patients will be contacted via telephone or secure video-link by the study 
coordinator at each site and asked whether they will provide consent to participate.  
 
Procedure specific to the involved sites:   

 
9 
 
Site 1 is responsible for recruitment and data collection for the main study concerning 
patients from own site who live close to Næstved and/or who prefer to be assessed there.  
 
Patients from Site 2 (and patients from Site 1 living close to Copenhagen area and/or who 
prefer to be assessed in Copenhagen) will be screened and identified according to in- and 
exclusion criteria (see above) in connection with telephone calls for information from recent 
CT control. Patients will receive provisional information about the study via telephone. 
Patients will be able to provide provisional oral consent to be contacted by Site 5 and to 
receive the written information materials and a link to study questionnaires via “e-boks”. Site 
5 will then contact the patients by telephone within one week and arrange a date and time for 
receiving of the full information about the project, via telephone, by secure video-link, or – if 
the patient prefers so - directly in person. Subsequently, Site 5 is responsible for recruitment 
and data collection for the main study and for the exploratory sub-study. In case that the 
patient does not wish to confirm the oral consent, the patient is considered screen failure, and 
all information about name, telephone number, and any entered data from study 
questionnaires will be deleted.    
 
Site 3 is responsible for recruitment and data collection for the main study concerning 
patients from own site.  
 
Site 4 will collaborate with the local Department of Oncology who will screen and identify 
patients according to in- and exclusion criteria in connection with standard telephone calls 
with patient information concerning their recent CT control. If considered eligible, patients 
will receive provisional information about the study. Patients will be able to provide 
provisional oral consent to be contacted by Site 4 and to receive the written information 
materials and a link to study questionnaires via “e-boks”. Site 4 will then contact the 
patients within one week by telephone and arrange a date and time for receiving of the full 
information about the project via telephone, by secure video-link, or – if the patient prefers so 
- directly in person. Subsequently, Site 4 is responsible for the final recruitment (retrieval of 
written consent) and data collection for the main study. In case that the patient does not wish 
to confirm the oral consent, the patient is considered screen failure, and all information about 
name, telephone number, and any entered data from study questionnaires will be deleted.    
  
In all cases, before signing the written informed consent, participants will - if requested - be 
offered extra time to consider participation in the project. Moreover, they will be able to 
receive further information about the project. For detailed descriptions of procedures, please 
see Appendix 4.1, 4.2, and 5 to the protocol for the scientific ethics committee (Region 
Zealand, Denmark). 
 
Provided written informed consent gives the project responsible, sponsor and sponsor’s 
representatives, and possibly the relevant control authority, direct access (according to the 
Scientific Ethical Committees Act §3, stk. 3 and according to Danish health legislation 
(“Sundhedsloven”) §46, stk. 1) to retrieval of relevant data from databases and medical 
journals on: Age, lung function, prescribed medication, hospitalisations, ”performance status” 
after NSCLC surgery (Eastern Cooperative Oncology Group (ECOG) performance status 
scale), lung cancer stage and type (TNM; tumor, nodule, metastasis), and co-morbidities. 
These data will provide information about the patient’s health conditions, which is a 
necessary for conduct of the research project, data analyses, and for mandatory control 
purposes, including self-control, quality control, and monitoring.  

 
10 
 
Patients with surgical TNM above stage I or non-NSCLC pathology are considered screen 
failures and will be excluded.  
 
The study coordinators inform the patients about the dates and times for the next intervention 
group onset and inform the principal investigator about the status of recruitment ongoingly. 
The patient will receive a thorough written guide with instructions for entering the Zoom 
platform.   
 
Every month (the first week in the month), a new intervention group will be starting with 
recruited patients since last intervention group onset. If the number of recruited patients is 
less than four, however, the intervention group onset is postponed until the following month.  
 
4.5 Randomisation procedure  
Included study participants will be block randomised (using sealed envelopes) by the PI to 
either:  
 
Group 1: 10 weeks’ online SLH, or  
Group 2: 10 weeks’ usual care followed by 10 weeks’ online SLH.  
 
Participants are informed about the randomisation immediately after the first baseline 
assessment by the local study coordinator. If assigned to Group 1, participants are also 
informed about the time for the intervention (weekdays and times during the 10 weeks). 
 
Each site will collect patients ongoingly during the trial period or until number needed to 
treat (total including expected drop-out: n=100) is reached (see 4.10 Analysis). 
 
4.6 Data collection procedure  
Study participants will be assessed by a local study nurse or by a research assistant.  
 
Study coordinators are responsible for contacting the local study participants and arranging 
time for assessments (with physical show-up). See descriptions of site-related procedures 
concerning recruitment and data collection under 4.4. 
 
The participants will be assessed at the following time points:  
 
Group 1:  
T0: Baseline (at randomisation), 
T1: Follow-up 11-14 weeks later).  
 
Group 2:  
T0: Baseline (at randomisation), 
T1: Follow-up 11-14 weeks later).  
T2: Follow-up: Withing three weeks after the SLH intervention (approximately 11-14 weeks 
after T1).  
 
Given that there is no structured, active ingredient in the usual care component, a wash-out 
period between crossing of interventions is not needed. 
 

 
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The assessors will be blinded to randomisation all time points and participants are instructed 
not to speak to the participants about the randomisation.  
 
The assessors are responsible for entering data. For data collection and data storage, we will 
use web-based, software and secure database, SurveyXact by Ramboll (Rambøll 
Management Consulting, Aarhus, Denmark) or metadata-driven database (EDC software, 
REDCap (Research Electronic Data Capture, Vanderbilt University, USA)). A research 
assistant will assist in data cleaning, validation, and management.  
 
Each site receives its own closed profile (data access group) for data entry and data collection 
and is responsible for anonymisation (pseudonymisation) of site-specific data. The PI will not 
be able to access data directly in REDCap until data is fully anonymised. The anonymised 
data will be sent via encrypted e-mail and accessed by Site 1-researchers for combined 
analysis, reporting, and publication of results. 
 
In case of detection of significant depressive symptoms at any time point (assessed by 
Hospital Anxiety and Depression Scale (HADS), sub-scale depression, max 21, cut-off ≥11), 
the assessor will inform the local study coordinator (or doctor) who will then contact the 
patient directly and refer to hospital psychologist or general practitioner to evaluate any need 
for treatment of depression.  
 
4.7 Intervention: Singing training (Singing for Lung Health (SLH)) 
The study intervention is singing training, which will be conducted according to an 
intervention protocol based on the SLH-approach [28–31] (see also the main RCT article; 
Supplementary Materials, Appendix S2 and S3 for specific descriptions of content, 
methodology, and approach of SLH [29], reported and described using the Consensus on 
Exercise Reporting Template (CERT) tool [52]). The singing training will be delivered by 
three professional singing teachers specifically trained and experienced within the SLH-
approach. 
 
Sessions will be held online, lasting for 1½ hour twice a week during the 10 weeks’ 
intervention phase. Sessions will include physical, vocal, and breathing exercises and musical 
repertoire, specifically designed to improve strength, endurance, and flexibility of the 
respiratory muscles. Besides, the intervention will include movement, dancing, and artefacts 
for playful games along with singing. Each session will consist of 20 minutes of physical 
warm-ups, 20 minutes of vocal warm-up with rhythm and pitch games, 40 minutes of singing 
(including a 5 minute-break), and 10 minutes of cooling down, e.g., mindfulness or 
relaxation.  
 
The singing teachers will be supervised during the intervention phase by Associate Professor, 
Mette Kaasgaard, in collaboration with the SLH-team, and a logbook will be kept for 
documentation and to ensure programme fidelity. 
 
4.8 Control: Usual care 
The control group will receive usual care, i.e., no specific additional intervention above those 
which the person usually engages with. 
 
4.9 Outcomes and measures 

 
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At baseline, basic characteristics will be collected, including sex, age, BMI, socio-
demographics, smoking history, health care utilisation, exacerbations, medicine consumption, 
comorbidities, and expectations towards benefits of singing. 
 
Primary study outcome is change in physical capacity, assessed with the Six Minute Walking 
Test (6MWT). Secondary outcomes include both objective outcomes and subjective, patient-
reported outcomes, e.g., QoL symptom burden, symptoms of anxiety and depression, airway 
physiology, activity of daily living, health care usage, adherence, and drop-out-rate.  
 
Specific outcomes and measures are displayed in the tables below: 
 
4.9.1 Baseline characteristics  
 
Characteristics/Status 
Information 
Status retrieved from 
Danish Lung Cancer 
Registry (DLCR) 
CPR-number  
Date of surgery  
Lung cancer stage 
Lung cancer type 
Pathology classification 
Surgery type 
Localisation 
Risk factors 
Complications 
Lung function before surgery (Forced Expiratory Volume 
(FEV1% of predicted) and diffusion capacity for carbon 
monoxide (DLCO% of predicted)) 
BMI 
Former lung cancer surgery 
Admission 
Status retrieved from 
patient record 
Comorbidities 
Medicine consumption (prescriptions) 
Self-reported 
information 
Socio-demographic characteristics 
Municipality 
Smoking history, smoking status 
Information about previous attended rehabilitation after surgery 
(setting, type, content, duration, intensity, adherence, perceived 
benefits, perceived satisfaction/relevance) 
Co-morbidities and medicine consumption 
Disease-related GP and hospital visits 
Expectations towards benefits of singing 
 
 
4.9.2 Outcomes and measures in the main study  
 
Study outcomes 
Measures 
Primary outcome 
Measures 
Physical Capacity 
Six Minute Walking Test (6MWT) [53, 53]. 
Perceived exertion (BORG dyspnoea scale) [53, 54]  
Secondary outcomes 
Measures 

 
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Quality of Life  
EORTC 30 item Quality of Life Questionnaire (QLQ-C30) (QoL 
domains) [20, 21]).  
The European Organization for Research and Treatment of 
Cancer (EORTC) Quality of Life Lung Cancer Module 
Questionnaire (QLQ-LC13) (QoL domains) [20, 55]. 
St. George’s Respiratory Questionnaire (SGRQ) [56, 57]. 
Symptom burden 
EORTC 30 item Quality of Life Questionnaire (QLQ-C30) 
(symptom domains [20, 21]). 
EORTC Quality of Life Lung Cancer Module Questionnaire 
(QLQ-LC13) (symptom domains) [20, 55]. 
Breathing vigilance (Breathing Vigilance Questionnaire). 
Dyspnoea (mMRC (Modified Medical Research Council) 
Dyspnoea Scale) [58].  
Symptoms of anxiety 
and depression 
Hospital Anxiety and Depression Scale (HADS) [59]. 
Consumption of psychoactive drugs (yes/no; self-reported). 
Airway physiology 
Lung function (Body Plethysmography): 
Forced Expiratory Volume (FEV1 in litres and % predicted), 
Forced Vital Capacity (FVC in litres and % predicted), 
FEV1%/FVC% ratio [65]. 
Diffusion capacity for carbon monoxide (DLCO % predicted).  
Hyperinflation (RV, TLC, operating lung volumes). 
Adherence and drop-
out 
Continuously registered by the singing teachers and study nurses. 
Adverse events 
Any adverse events registered continuously  
 
 
4.9.3 Additional outcomes and measures in sub-study of physiological mechanisms 
 
Study outcomes 
Measures 
Primary outcome 
 
Aerobic 
fitness/Maximal 
oxygen uptake 
VO2-max (Cycling Test for VO2 Max Estimate; 70% of 
maximum heart rate for 20 minutes continuously) 
Secondary outcomes 
Measures 
Perceived exertion 
BORG dyspnoea scale [53, 54] 
Peripheral 
oxygenation 
Peripheral oxygenation (SpO2) (pulse oximeter) 
Respiratory muscle 
strength 
In- and expiratory pressures (MIP and MEP) (PowerBreathe) 
[65]. 
In- and expiratory muscle strength and endurance [65] 
Heart rate 
Maximum and recovery 
Blood samples: 
Metabolism, 
oxygenation, stress 
response, 
inflammation, and 
inflammatory drivers. 
Lactate dehydrogenase (LDH) 
Acid/base 
Saturation 
Catecholamines 
Inflammatory markers (TNF-α, IL-1β, IL-6) 
C-reactive protein (CRP) 
Leukocyte differential count 
JAK2V617F mutation 

 
14 
 
 
4.10 Analysis 
An a priori statistical power analysis calculation showed that the needed sample size is n=78 
study participants and including an expected drop-out-rate of 20%, an overall total sample of 
n=100 study participants is needed. In the power analysis, we considered data from previous 
studies on the primary study outcome, 6MWT distance, with a minimal important difference 
of ≥ 30 m [29, 66–68], with the final calculation based on findings from our previous RCT on 
singing for COPD with a pre-post difference of mean 13.1±36.3 m after 10 weeks of singing 
in pulmonary rehabilitation for COPD [44]. 
 
Statistical power analysis calculations; primary study outcome: 6MWD 
Estimated sample size for two-sample comparison of means 
Test H0: n1 = n2, where n1 is the mean in population 1 and n2 is the mean in population 
2 
Assumptions: 
α (two-tailed)  0.05 
β  
             0.2 
Effect size  
Group 1: 5 m; Group 2: 15 m 
SD 
 
15 
Estimated required sample sizes (based on power: 80 %): 
n1 =       26 
n2 =       52 
 
Quantitative data from questionnaires and closed question fields will be described with 
number and percentage (categorical data) and either mean +/- standard deviation (normally 
distributed continuous data) or median and range (not normally distributed continuous data). 
Differences in within-groups and between-groups effects will be investigated with relevant 
test for continuous (independent samples, paired-samples, related-samples), and categorical 
data (Chi2 or Fischer’s test) and differences quantified and reported with p-values and 95% 
Confidence Intervals (CI). Findings related to primary and secondary outcomes will be 
stratified in reaching of MID/MCID or not (reported as number and percentage). Association 
and independence between objective and subjective outcomes will be explored using 
Cochran-Mantel-Haenszel test for 2x2 tables. Multivariable mixed-effects regression models 
will also be included to elucidate any relevant correlations and associations. Missing data will 
be handled using multiple imputation and sensitivity analyses performed using the principles 
of last observation carried forward or next observation carried backward [69].  
 
Data will be analysed at Site 1: Department of Respiratory Medicine, Zealand University 
Hospital, Næstved, Ringstedgade 61, DK-4700 Naestved. Main analyses will be performed 
by Associate Professor Mette Kaasgaard, and advanced analyses of physiological parameters 
will be performed in collaboration with Associate Professor Morten Hostrup.  
 
Blinded results (presented as Treatment 0 compared to Treatment 1) of the study will be 
presented to the research group, who will interpret and discuss the blinded results [70].  
 
In the discussion, we will include experiences from recent mappings on cancer rehabilitation 
from the Danish Cancer Society and REHPA (Da: “Videncenter for rehabilitering og 
palliation”) [12, 71, 72] and findings from our previous studies on lung cancer rehabilitation 
[19] and QoL and symptom burden after NSCLC surgery (Kaasgaard, et al., 2025, under 

 
15 
preparation for submission). Besides, experiences and reports from e.g. the European Lung 
Foundation will be included.  
 
CONSORT 2010 Statement checklist for randomised controlled trials [73] will be used for 
study reporting. Statistical analyses will be performed using statistical software STATA 18.1, 
StataCorp LLC, Texas, USA, and SPSS 31.0, IBM, New York, USA). Statistical significance 
will be reported as p <0.05.  
 
 
5. Organisation  
The project facilitates cross-disciplinary research (respiratory medicine, oncology, surgery, 
respiratory physiology, physiotherapy, rehabilitation medicine, qualitative research, health 
economics, and “Arts-in-Health”-aspects).  
 
The following institutions, researchers, and stakeholders will be involved in the project: 
 
• Pulmonary Research Unit Zealand (PLUZ), Department of Respiratory Medicine, 
Zealand University Hospital, Roskilde and Naestved Hospital: Associate Professor, 
PhD, Mette Kaasgaard; Professor, head of research, respiratory consultant, PhD, Uffe 
Bødtger. 
• Department of Respiratory Medicine, Lillebaelt Hospital, Vejle: Professor, DMSc, 
respiratory consultant, Ole Hilberg; Professor, DMSc, respiratory consultant, Anders 
Løkke; Associate Professor, respiratory consultant, PhD, head of “Lungepakken” at 
Lillebaelt Hospital, Morten Hornemann Borg. 
• Respiratory Research Unit (ODIN), Department of Respiratory Medicine, Odense 
University Hospital, Odense, Denmark (Christian Borbjerg Laursen, Professor, head 
of research, respiratory consultant, PhD). 
• Department of Respiratory Medicine, Bispebjerg Hospital & Department of Clinical 
Medicine, Faculty of Health Sciences, Copenhagen University: Respiratory 
consultant, Pernille Kristiansen; Respiratory consultant, PhD, Anne Orholm. 
• Department of Oncology, Lillebaelt Hospital, Kabbeltoft 25, DK-7100 Vejle.  
• Department of Oncology, Odense University Hospital, J. B. Winsløws Vej 4, DK-
5000 Odense 
• August Krogh Section for Molecular and Human Physiology, Department of 
Nutrition, Exercise and Sports, Faculty of Health and Medical Sciences, University of 
Copenhagen: Associate Professor, physiologist, MD, PhD, Morten Hostrup. 
• Danish Research Center for Lung Cancer: Professor, DMSc, respiratory consultant, 
Ole Hilberg. 
 
Several international collaborations with world leading experts - including concerning 
methodological framework of the singing approach applied – was established during Sing-a-
Lung 1.0 (and this will be continued and expanded during the present project), e.g., with: 
 
• Stephen Clift, Professor Emeritus, Sidney De Haan Research Centre for Arts and 
Health, Canterbury Christ Church University. Visiting Professor, International Centre 
for Community Music, York St John University. Visiting Professor, School of Music, 
University of Leeds. Professorial Fellow, Royal Society for Public Health, UK. 
 
 
6. Involving of patients  

 
16 
We aim to involve patients in all phases of the project. Patients have already been involved in 
the process of final designing the study protocol in terms of defining relevant and preferred 
outcomes of rehabilitation, via the updated Core Outcomes Set for pulmonary rehabilitation 
for patients with lung cancer (Edbrooke, L., et al., 2025) [18]. Furthermore, patients have 
been involved in terms of their view on potential benefits of singing and any interest and 
concerns regarding participating in a study (in the cross-sectional study, Kaasgaard, et al., 
2025, under preparation for submission). Subsequently, we aim to involve patients in the 
development and qualification for the recruitment procedure, comprising written information 
materials as well as enactment-training concerning oral information provided by the health-
professionals. Further, the assessment procedure will be tested in patients before onset of the 
study.  
 
In the mandatory training of disease-specific methodology for singing teachers (facilitators of 
the intervention), patient perspectives will be included. Here, we will gain first-hand 
experience directly from a number of patients with lung cancer, who will visit the training 
workshop and provide important perspectives on the impact and challenges of the disease and 
feedback on exercises, repertoire, and approach.  
 
Besides, the qualitative documentation (in the form of a visual production) will be made to 
involve patient-perspectives, focusing on the experience of participating in the intervention 
and how the tools are adapted/integrated, e.g., related to change in breathing pattern, control 
over the respiratory muscles, symptom management, and capability to perform physical 
exercise. In addition, the visual production will serve as documentation about the project for 
future use in dissemination situations (e.g., presentation at scientific conferences) and will 
provide insight into the project and the intervention. This will be useful to health-
professionals, facilitators, politicians, health authorities, media, and for future research, 
including implementation research.  
 
 
7. Possible risks 
The research group is not familiar with any side-effects related to participation in the 
intervention, SLH. Previous studies have described singing as a safe and well-accepted 
activity [28, 29, 33, 38] and the research group is not familiar with any side effects of 
participation in the intervention and we expect that the participants will benefit positively 
from the intervention. 
Any adverse events that do arise will be addressed in regular research group meetings, with 
strategies for the future mitigation of these events strategised in collaboration with the local 
ethics committee, where necessary. 
 
 
8. Ethics 
Approvals will be sought at the local scientific ethics committee (Region Zealand, Denmark) 
and The Danish Data Protection Agency. The study will be conducted in accordance with the 
Helsinki Declaration and according to the General Data Protection Regulation and The 
Danish Data Protection Act. Study participants are covered by the Danish Patient 
Compensation.  
 
 
9. Dissemination 

 
17 
The trial protocol will be registered in a relevant public database (e.g. ClinicalTrials.gov) and 
all results, positive, negative or inconclusive, will be reported in accordance with 
recommendations from The International Committee of Medical Journal Editors (ICMJE) and 
made publicly available in peer-reviewed journals, social media channels, news media, and at 
conferences, scientific meetings, seminars, etcetera. Results will be reported based on 
relevant EQUATOR guidelines, and authorship will be awarded according to Vancouver 
regulations ("Uniform Requirements").  
 
 
10. Funding 
Currently, funding for salaries, equipment and running cost has been obtained from The 
Danish National Research Center for Lung Cancer, Danish Cancer Society (DKK 150,000), 
The Danish Health Foundation (DKK 500,000), The Danish Lung Foundation (DKK 
150,000), Region Zealand (DKK 342,857), Danish Cancer Society (DKK 1,750,000 kr.), 
Novo Nordisk Foundation (DKK 3,707,217). Further funding has been applied for (awaits 
feed-back). In case of further funding obtained, the Ethical Committee will be informed, and 
the patient information (Appendix 5.1) will be updated.  
 
Funding will be used for salaries (PI/Ass. Professor (Mette Kaasgaard), project nurses, 
research assistants, statistical advice, and singing teachers), for equipment (measurement 
devices, digital pianos, singing books, and computer hardware and software), and for running 
costs (analyses, information materials, training of singing teachers, travel, conference, 
publication, and overhead). Participants will not receive economic compensation for 
participation. No member of the research group has any financial or personal conflict of 
interest in the project or in connection to the funding bodies. 
 
A detailed budget has been made and additional funding for all salaries, equipment, and 
running expenses will be sought throughout the course of the project. 
 
 
11. Expected results and perspectives 
Overall, we expect that singing training supports and strengthens physiological and 
psychological/existential parameters, relieves symptom burden, and, moreover, may break 
the vicious circle of loneliness, isolation, and hopelessness which many people with lung 
diseases – including patients with lung cancer – experience.  
 
If the study demonstrates that singing is an effective, relevant, and feasible modality for 
patients with lung cancer, the study may form the basis for further research. Furthermore, the 
project may generate hypotheses for future studies applying other research approaches.  
 
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