Singing Training vs Usual Care 6-18 Months After Surgical Resection for Non-small Cell Lung Cancer (NSCLC)

ConditionsNon-Small Cell Lung Cancer Chronic Obstructive Lung Disease

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorZealand University Hospital

About this trial

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, the present 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, a multi-centre randomised controlled trial (RCT) will be conducted, comparing a singing intervention to usual care. Given that travel and distance often pose significant barriers to participation, the intervention will be delivered online.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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"),

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,

Disqualifiers

Unstable coronary diseases,

Severe cognitive disabilities (e.g., dementia),

Indication for adjuvant chemotherapy or other antineoplastic therapy,

Signs of lung cancer recurrence at regular follow-up CT scan.

Trial design

Design model

Crossover

Treatments tested in this trial

Singing training (Singing for Lung Health (SLH))
Behavioral
10 weeks of singing training (conducted according to the Singing for Lung Health (SLH) approach). The singing training will be delivered online (1 1/2 hour twice a week) by professional singing teachers specifically trained and experienced within SLH. Sessions include physical, vocal, and breathing exercises and musical repertoire. Besides, movement, dancing, and artefacts for playful games are included along with singing. Each session consists of 20 min physical warm-ups, 20 min vocal warm-up with rhythm and pitch games, 40 min singing (incl. break), and 10 min cool-down.
Control group: Usual care
Behavioral
The control group will receive usual care, i.e., no specific additional intervention above those which the person usually engages with.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Intervention: Singing training (Singing for Lung Health (SLH))Experimental treatment 1 intervention

Group B: Control group: 1) Usual care, followed by Singing training (Singing for Lung Health (SLH))Other 2 interventions

Trial outcomes

Primary outcomes

Change in Physical capacity

Assessed with the Six Minute Walking Test (6MWT) (assessor-collected) , measured in meters walked in 6 minutes. Minimal important difference: \>30 m.

Time frame

Changes pre-post 10 weeks (measured at all assessment points).

Perceived exertion

Measured using BORG CR-10 dyspnoea scale (self-reported). The scale ranges from 0 to 10 points, where 0 represents no exertion/dyspnoea and 10 represents maximal exertion/dyspnoea. Minimal important difference: 1 point.

Time frame

Changes measured before and after performance of 6MWT; Changes pre-post 10 weeks (measured at all assessment points).

Change in Health-related quality of life (HRQoL)

St. George's Respiratory Questionnaire (SGRQ) (self-reported questionnaire). SGRQ has 50 items with 76 weighted responses and four scores: Total, Symptom, Activity, Impact. Each score ranges from 0 to 100, with 100 representing worst possible health status and 0 best possible. Minimal important differnence: -4 units.

Time frame

Changes pre-post 10 weeks (measured at all assessment points).

Secondary outcomes

Change in Quality of life

EORTC 30 item Quality of Life Questionnaire (QLQ-C30), v. 3.0 (self-reported questionnaire). Functional domains: Physical function, role functioning, emotional function, cognitive function, social function. QLQ-C30 has 30 items: 1-28 completed on a 4-point Likert scale (1=not at all, 2=a little, 3=quite a bit, and 4=very much); 29-30 completed on a 7-point scale defined by extremes (1=very poor, 7=excellent). Raw and transformed scores are calculated, based on instructions in the QLQ-C30 scoring manual. Calculated scores range: 0-100. For the Functional scale, 100 = highest possible level of functioning. Cutoffs for clinically important problems: based on EORTC Quality of Life Group (Physical functioning (≤83), role functioning (≤58), emotional functioning (≤71), cognitive functioning (≤75), social functioning (≤58))

Time frame

Pre-post 10 weeks

Change in Symptoms burden

EORTC 30 item Quality of Life Questionnaire (QLQ-C30), v. 3.0 (self-reported). Symptom domains: Fatigue, nausea/vomiting, pain, sleep disturbances, dyspnoea, appetite loss, constipation, diarrhea, financial concerns. QLQ-C30 has 30 items: For 1-28: 4-point Likert scale (1=not at all, 2=a little, 3=quite a bit, 4=very much); for 29-30: 7-point scale defined by extremes (1=very poor, 7=excellent). Raw and transformed scores are calculated, based on the QLQ-C30 scoring manual. Calculated scores range: 0-100. For the Symptom scale, 100 = highest possible symptom burden. Cutoffs for clinically important problems: EORTC Quality of Life Group: Fatigue (≥39), nausea/vomiting (≥8), pain (≥25), insomnia (≥50), dyspnoea (≥17), appetite loss (≥50), constipation (≥50), diarrhea (≥17), financial concerns (≥17). Danish Multi-disciplinary Cancer Groups: ≥2 = "clinically relevant symptom"; ≥3 = "severe/serious symptom" (pain, dyspnoea, nausea/vomiting: ≥2 = "severe/serious symptom").

Time frame

Changes pre-post 10 weeks (measured at all assessment points).

Change in symptoms burden

EORTC Quality of Life Lung Cancer Module Questionnaire (QLQ-LC13) is a supplementary lung cancer-specific questionnaire to be used in conjunction with the QLQ-C30. Both questionnaires developed and validated in patients with lung cancer (self-reported). The module consists of 13 items and comprises multi- and single-item measures of lung cancer-associated symptoms (i.e. coughing, haemoptysis, dyspnoea and pain). Scaling of items: 1 (Not at all) to 4 (Very much). Scoring: 0 to 100. (higher scores = increasing symptom levels. Minimal important difference not defined.

Time frame

Changes pre-post 10 weeks (measured at all assessment points).

Change in symptoms burden: Dyspnoea

mMRC (Modified Medical Research Council Dyspnoea Scale) (self-reported). The scale includes scores from 0-4, with grade 0 corresponding to "Dyspnoea only when strenuous exercise" and grade 4 corresponding to "Too dyspneic to leave house or breathless when dressing. Minimal important difference: 1 point.

Time frame

Changes pre-post 10 weeks (measured at all assessment points).

Other outcomes

Resting blood samples

Blood Cells: Hemoglobin (Hb) (mmol/L); Hematrocrit (Hct) (L/L or %); Thrombocytes (x109/L); Leukocyte differential count: (x109/L). Kidney function: eGFR (mL/min/1,73m2). Liver function: ASAT (U/L); ALAT (U/L); ALB (U/L); ALP (g/L). Metabolic function: Lactate dehydrogenase (LDH), mmol/L. Stress response: Epinephrine (Adrenaline) (nmol/L); Norepinephrine (Noradrenaline) (nmol/L); Dopamin (nmol/L). Inflammation and inflammatory drivers: C-reactive protein (CRP) (mg/L); Inflammatory cytokines (TNF-α, IL-1β, IL-6) (pg/mL); JAK2V617F mutation.

Time frame

Changes pre-post 10 weeks (measured at all assessment points).

Acute physiological response to maximal exercise (VO2max)

Metabolic markers: Lactate (mmol/L). Acid-base markers: pH; Partial pressure of carbon dioxide (pCO2) (mmHg); Bicarbonate (HCO3)(mmol/L). Oxygenation: Partial pressure of oxygen (pO2) (mmHg); Oxygen saturation (SaO2/SpO2) (%). Electrolyte and Ion Home: Potassium (mmol/L).

Time frame

Changes pre-post 10 weeks (measured at all assessment points).

Peripheral oxygenation

Peripheral oxygenation (SpO2) (pulse oximeter).

Time frame

Changes pre-post 10 weeks (measured at all assessment points).

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zealand University Hospital

Lead sponsor

Source ClinicalTrials.gov

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