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
Online singing lessons tested for lung cancer survivors
Plain English Summary
Singing Training vs Usual Care 6-18 Months After Surgical Resection for Non-small Cell Lung Cancer (NSCLC) is a Not Applicable clinical trial sponsored by Zealand University Hospital studying Non-Small Cell Lung Cancer, Chronic Obstructive Lung Disease. This study tests if online singing lessons can help people who had lung cancer surgery feel better. It is for patients 6-18 months after surgery for lung cancer who still have symptoms. Participants will either join online singing lessons twice a week or continue with their usual care. There are no specific alternative treatments being tested in this trial, but patients can continue other exercise or singing activities. The trial aims to enroll 100 participants.
Official 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, 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you had surgery for early-stage lung cancer 6-18 months ago and still have symptoms. You cannot join if you have unstable heart conditions, severe memory problems, need more cancer treatment, or if your cancer has returned. You need to be able to speak and understand Danish and have a computer or tablet with internet access. No prior singing experience is needed. This trial is studying Non-Small Cell Lung Cancer, Chronic Obstructive Lung Disease, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The main goal is to see if singing lessons improve physical ability and how good patients feel overall after 10 weeks. The specific primary outcome measures are: Change in Physical capacity (Changes pre-post 10 weeks (measured at all assessment points).); Perceived exertion (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) (Changes pre-post 10 weeks (measured at all assessment points).). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial addresses a gap in care by exploring a new, accessible way to improve the quality of life and reduce symptoms for lung cancer survivors who often experience persistent issues after surgery. This research targets Non-Small Cell Lung Cancer, Chronic Obstructive Lung Disease, where improved treatment options are needed.
Investor Insight
This trial explores a novel, low-cost, and accessible intervention for a common patient group, potentially offering a new rehabilitation option and expanding the market for digital health solutions in
Is This Trial Right for Me?
Ask your doctor if this trial is right for you and what the singing lessons involve. You will participate in online singing sessions twice a week for 10 weeks. You can continue with other exercise or singing activities you normally do. This trial is currently recruiting participants. The trial is being conducted at 5 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: CROSSOVER
- Masking: TRIPLE
- Enrollment: 100 participants
Interventions
- BEHAVIORAL: Singing training (Singing for Lung Health (SLH)) — 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 w
- BEHAVIORAL: Control group: Usual care — The control group will receive usual care, i.e., no specific additional intervention above those which the person usually engages with.
Primary Outcomes
- Change in Physical capacity (Changes pre-post 10 weeks (measured at all assessment points).)
- Perceived exertion (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) (Changes pre-post 10 weeks (measured at all assessment points).)
Secondary Outcomes
- Change in Quality of life (Pre-post 10 weeks)
- Change in Symptoms burden (Changes pre-post 10 weeks (measured at all assessment points).)
- Change in symptoms burden (Changes pre-post 10 weeks (measured at all assessment points).)
- Change in symptoms burden: Dyspnoea (Changes pre-post 10 weeks (measured at all assessment points).)
- Change in symptoms burden: Breathing vigilance (Changes pre-post 10 weeks (measured at all assessment points).)
Full Eligibility Criteria
Inclusion Criteria: 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: 1. 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"), 2. Surgery for stage I lung cancer 6-18 months (+/- one month) earlier, 3. Motivated for participating in the project (and acceptance of randomisation procedure), 4. Access to a computer or a tablet with internet access, 5. Ability to speak and understand Danish, 6. Acceptance of the scheduled times of the singing intervention twice a week. Exclusion Criteria: 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.
Trial Locations
- August Krogh Section for Molecular and Human Physiology, Department of Nutrition, Exercise, and Sports, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
- Department of Respiratory Medicine, Bispebjerg Hospital, Copenhagen, Denmark
- Department of Medicine Roskilde and Næstved, Zealand University Hospital, Næstved, Denmark
- Department of Respiratory Medicine, Odense University Hospital, Odense, Denmark
- Department of Respiratory Medicine, Lillebaelt Hospital, Vejle, Denmark
Frequently Asked Questions
What is clinical trial NCT07460999?
NCT07460999 is a Not Applicable INTERVENTIONAL study titled "Singing Training vs Usual Care 6-18 Months After Surgical Resection for Non-small Cell Lung Cancer (NSCLC)." It is currently recruiting and is sponsored by Zealand University Hospital. The trial targets enrollment of 100 participants.
What conditions does NCT07460999 study?
This trial investigates treatments for Non-Small Cell Lung Cancer, Chronic Obstructive Lung Disease. The primary condition under study is Non-Small Cell Lung Cancer.
What treatments are being tested in NCT07460999?
The interventions being studied include: Singing training (Singing for Lung Health (SLH)) (BEHAVIORAL), Control group: Usual care (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 w
What does Not Applicable mean for NCT07460999?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07460999?
This trial is currently "Recruiting." It started on 2026-03-01. The estimated completion date is 2027-10-01.
Who is sponsoring NCT07460999?
NCT07460999 is sponsored by Zealand University Hospital. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07460999?
The trial aims to enroll 100 participants. The trial is currently recruiting and accepting new participants.
How is NCT07460999 designed?
This is a interventional study, uses randomized allocation, follows a crossover design, employs triple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT07460999?
The primary outcome measures are: Change in Physical capacity (Changes pre-post 10 weeks (measured at all assessment points).); Perceived exertion (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) (Changes pre-post 10 weeks (measured at all assessment points).). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07460999 being conducted?
This trial is being conducted at 5 sites, including Copenhagen; Næstved; Odense; Vejle and 1 more sites (Denmark).
Where can I find official information about NCT07460999?
The official record for NCT07460999 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07460999. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07460999 testing in simple terms?
This study tests if online singing lessons can help people who had lung cancer surgery feel better. It is for patients 6-18 months after surgery for lung cancer who still have symptoms.
Why is this trial significant?
This trial addresses a gap in care by exploring a new, accessible way to improve the quality of life and reduce symptoms for lung cancer survivors who often experience persistent issues after surgery.
What are the potential risks of participating in NCT07460999?
Potential side effects are generally mild and related to vocal strain or physical exertion during exercises. There is a small risk of vocal cord irritation or temporary hoarseness. Some participants might experience fatigue from the exercises. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07460999?
Ask your doctor if this trial is right for you and what the singing lessons involve. You will participate in online singing sessions twice a week for 10 weeks. You can continue with other exercise or singing activities you normally do. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07460999 signal from an investment perspective?
This trial explores a novel, low-cost, and accessible intervention for a common patient group, potentially offering a new rehabilitation option and expanding the market for digital health solutions in This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will either join online singing lessons twice a week or continue with their usual care. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.