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Trial registered on ANZCTR
Registration number
ACTRN12625000743460
Ethics application status
Approved
Date submitted
28/05/2025
Date registered
15/07/2025
Date last updated
15/07/2025
Date data sharing statement initially provided
15/07/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
The feasibility of yoga therapy for people with lung cancer: A pilot randomised controlled study
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Scientific title
The feasibility of yoga therapy for people with lung cancer: A pilot randomised controlled study
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Secondary ID [1]
314451
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lung Cancer
337489
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Condition category
Condition code
Cancer
333854
333854
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0
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Lung - Non small cell
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Physical Medicine / Rehabilitation
333980
333980
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0
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This study is a pilot and feasibility randomised controlled trial examining the effects of yoga on individuals with lung cancer who experience dyspnoea. Participants will be invited to join an 8-week yoga program. Each week, participants are required to attend two yoga sessions: one in-person session (60 minutes) at the NICM Health Research Institute in Westmead and one live online session (approximately 60 minutes) conducted via ZOOM. Additionally, participants have the option to attend a third online yoga session (approximately 60 minutes), which will be scheduled on a specific day and time each week. Attendance at this third session is voluntary.
Before starting the group classes, all participants will receive an online one-on-one introductory session. This session will help them become familiar with using ZOOM and ensure that they can see and be seen clearly by the yoga teacher during online sessions.
The yoga intervention is based on a Delphi study conducted with expert yoga therapists experienced in working with respiratory diseases, including lung cancer. The sequence of yoga postures and techniques used in the group sessions will be standardized across participants to ensure consistency. However, participants will also be encouraged to engage in brief, home-based yoga practices, consisting of a short, simple 10-minute routine that focuses on breathing exercises and relaxation techniques. These home practices are designed to be easy to follow and non-strenuous, promoting regular engagement and symptom management.
All yoga classes will be led by a qualified yoga therapist, with the support of two substitute teachers as needed. For both face-to-face and online sessions, the maximum group size is 5 participants and a qualified yoga therapist leading the session. The weekly sessions (both in-person and online) will include a range of low-intensity techniques, such as:
- Physical postures and movements (e.g., seated spinal twist, supported bridge pose, gentle chest openers)
- Breathing exercises (e.g., diaphragmatic breathing, alternate nostril breathing)
- Relaxation and mindfulness techniques
- Meditation practices (Om meditation).
The overall intensity of the sessions will be low to moderate and will be assessed using the Borg Rating of Perceived Exertion (RPE) scale. Participants will be advised to avoid any movements that cause discomfort or shortness of breath, and sessions will be adapted accordingly.
Participants will receive written and video instructions for the home practices and will be asked to document their engagement in a weekly yoga diary.
Adherence to the intervention will be monitored through:
- Attendance checklists for each group session (including the optional third session)
- Weekly yoga diaries to record home-based practice (duration and frequency) and any adverse events
- Regular phone check-ins (after the first session, then weekly) to assess health status, motivation, and barriers to practice
- Email or text reminders to encourage continued participation
All group sessions (both face-to-face and online) will be video recorded. Baseline measures will be taken in week 0, and final assessments will be conducted in week 9, at least 48 hours after the last scheduled yoga session.
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Intervention code [1]
331072
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Lifestyle
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Intervention code [2]
331176
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Rehabilitation
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Comparator / control treatment
The control group will be required to complete all assessment procedures but will be given no specific instructions for yoga or access to yoga therapy classes (i.e. usual care). In addition, all participants will receive a Cancer Council booklet (Victoria, 2021) to help them better understand optimal care. Video recordings of all instructed yoga sessions (in-person and online) will be provided to both group participants at the end of the study (i.e. after the final assessment).
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Control group
Active
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Outcomes
Primary outcome [1]
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Feasibility
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Assessment method [1]
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Feasibility of the study will be assessed as a composite outcome, based on the following three criteria: Recruitment feasibility: At least 50% of eligible patients consent to participate, as determined by an audit of screening and consent logs. Intervention adherence: At least 60% of participants attend at least 50% of the scheduled yoga sessions, as recorded in attendance logs maintained for each session (both in-person and online). Weekly engagement: At least 60% of participants complete at least one yoga session per week, as measured by attendance checklists and self-reported yoga diaries. All three criteria must be met for the study to be considered feasible.
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Timepoint [1]
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Feasibility assessed at the end of the study
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Primary outcome [2]
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Adverse events
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Assessment method [2]
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To assess adverse events in both groups, participants will receive a diary during the initial assessment and are asked to record any adverse events. A final assessment will be conducted to collect this information.
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Timepoint [2]
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Weekly until completion of the 8-week intervention.
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Primary outcome [3]
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Adherence
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Assessment method [3]
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Assessment of adherence will be made using logbooks.
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Timepoint [3]
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Adherence assessed at completion of the 8-week intervention.
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Secondary outcome [1]
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Dyspnoea
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Assessment method [1]
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Assessment of dyspnoea will be made using the Cancer Dyspnoea Scale
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Timepoint [1]
448178
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At baseline and week 9 post-intervention commencement
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Secondary outcome [2]
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Quality of life
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Assessment method [2]
448179
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Assessment of quality of life will be made using the European Organization for Research and Treatment of Cancer QLQ-C30
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Timepoint [2]
448179
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At baseline and week 9 post-intervention commencement
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Secondary outcome [3]
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Exercise Capacity
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Assessment method [3]
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Assessment of exercise capacity will be made using the 6-min walking test.
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Timepoint [3]
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At baseline and week 9 post-intervention commencement
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Secondary outcome [4]
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Pulmonary Functions
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Assessment method [4]
448181
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Assessment of pulmonary functions (Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC), FEV1/FVC ratio, Peak Expiratory Flow (PEF, in L/min), Forced Expiratory Flow at 25–75% of FVC (FEF 25-75)) will be made using the pulmonary function test. These measures will be assessed as a composite outcome.
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Timepoint [4]
448181
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At baseline and week 9 post-intervention commencement
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Secondary outcome [5]
448182
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Depression and Anxiety (Composite Outcome)
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Assessment method [5]
448182
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Assessment of depression and anxiety will be made using the 21-item Depression Anxiety Stress Scale questionnaire.
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Timepoint [5]
448182
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At baseline and week 9 post-intervention commencement
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Secondary outcome [6]
448183
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Peripheral Muscle Strength
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Assessment method [6]
448183
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To assess peripheral muscle strength, quadriceps muscle strength will be measured with a dynamometer (Lafayette Instrument Company, Lafayette, Indiana, ABD), handgrip strength will be measured using Jamar handheld dynamometer.
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Timepoint [6]
448183
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At baseline and week 9 post-intervention commencement
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Secondary outcome [7]
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Blood biomarkers
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Assessment method [7]
448184
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Assessment of blood biomarkers (endocannabinoids and related lipids blood biomarkers (Anandamide (AEA), 1-arachidonoylglycerol (1-AG), 2-arachidonoylglycerol (2-AG), palmitoylethanolamide (PEA), oleoylethanolamide (OEA), and stearoylethanolamide (SEA)); inflammatory blood biomarkers (Tumour necrosis factor alpha (TNF-a), interleukin-6 (IL-6), C-reactive protein (CRP)); tumour blood biomarkers (Carcinoembryonic antigen (CEA), neuron-specific enolase (NSE))) will be made using the blood sample test. All of these biomarkers will be assessed together as a composite secondary outcome.
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Timepoint [7]
448184
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At baseline and week 9 post-intervention commencement
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Secondary outcome [8]
448185
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Acceptability
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Assessment method [8]
448185
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Assessment of acceptability will be made using the Acceptability of Intervention Measure.
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Timepoint [8]
448185
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At completion of the 8-week intervention
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Secondary outcome [9]
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Response shift
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Assessment method [9]
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Assessment of response shift will be made using the then-test.
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Timepoint [9]
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At completion of the 8-week intervention
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Secondary outcome [10]
448187
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Recall bias of participants for quality of life prescribed at the beginning of the intervention.
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Assessment method [10]
448187
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Assessment of recall bias will be made using the prospective data collection. Each week, a brief five-question survey designed for this study will be completed by patients, addressing their physical health, psychological health, social functioning, general quality of life, and shortness of breath.
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Timepoint [10]
448187
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Weekly until completion of the 8-week intervention.
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Eligibility
Key inclusion criteria
1) 18 years of age or older;
2) diagnosed with any stages of non-small cell lung cancer who completed their last treatment 6 weeks ago);
3) currently experiencing dyspnoea (NRS equal to 3 or greater);
4) sufficient English to understand research procedures and provide written informed consent;
5) able to engage in yoga therapy independently (ECOG equals 0,1 or 2);
6) willing and available to complete all research procedures, including the 1-day face-to-face and 1 online yoga sessions per week.
(NRS: The 0-10 Numerical Rating Scale for dyspnoea is a subjective measurement tool used to assess the severity of a patient's dyspnoea. It asks the patient to rate their dyspnoea on a scale of 0 to 10, where 0 indicates no dyspnoea, and 10 indicates the most severe dyspnoea imaginable (Wysham et al., 2015); ECOG (Eastern Cooperative Oncology Group) Performance Status is a scale used to assess a patient's overall functional status and ability to carry out daily activities, particularly in cancer care. It ranges from 0 to 5, with 0 indicating that the patient is fully active and can carry out all normal activities without restriction and five indicating that the patient is deceased (Popovic et al., 2018)).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1) presence of any disease (comorbidities) that interferes with physical activity (eg. Severe COPD, symptomatic heart failure);
2) mental illnesses, serious cognitive disorders, speech disorders;
3) have been undertaking yoga classes or a personal yoga practice, an average of more than once a week, over the past three months.
4) Life expectancy < 3 months
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation sequence will be kept confidential by using a secure, web-based randomisation system. This ensures that both investigators and participants are unaware of the forthcoming allocations, effectively preventing selection bias by maintaining allocation concealment until the assignment occurs.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned to either the yoga group or the control group using block randomisation, with block lengths varying randomly. This process will be stratified by gender during the study period. The randomisation sequence will be generated using an online randomisation tool.
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
18/07/2025
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Actual
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Date of last participant enrolment
Anticipated
22/12/2025
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Actual
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Date of last data collection
Anticipated
6/03/2026
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
319294
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Government body
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Name [1]
319294
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Turkish Republic Ministry of National Education
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Address [1]
319294
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Country [1]
319294
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Turkey
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Primary sponsor type
Government body
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Name
Turkish Republic Ministry of National Education
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Address
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Country
Turkey
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Secondary sponsor category [1]
321767
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University
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Name [1]
321767
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Western Sydney University
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Address [1]
321767
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Country [1]
321767
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
317593
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Western Sydney Local Health District Human Research Ethics Committee
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Ethics committee address [1]
317593
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https://www.wslhd.health.nsw.gov.au/Education-Portal/Research/ethics-governance
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Ethics committee country [1]
317593
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Australia
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Date submitted for ethics approval [1]
317593
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30/08/2024
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Approval date [1]
317593
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25/02/2025
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Ethics approval number [1]
317593
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Summary
Brief summary
Shortness of breath, known as dyspnoea, is a common and distressing symptom experienced by lung cancer patients that can severely impact physical functioning and quality of life. Yoga is an ancient mind-body practice that may provide relief from dyspnoea in this cohort, however few quality studies have been conducted to test effectiveness. The purpose of this study is to determine if an 8 week yoga therapy is a feasibly treatment in lung cancer patients. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with non-small cell lung cancer and are experiencing shortness of breath. Study details Participants in this study will receive one of the two below treatments: Group 1: Participants in this group will receive an information booklet focussed on optimal care and receive video recordings of all yoga sessions 9 weeks after enrolment. Group 2: Participants in this group will take part in an 8-week yoga exercise intervention, requiring participants to attend one face-to-face session per week and up to two online sessions per week. The group that participants take part in will be determined randomly (by chance). Throughout the study, participants will be asked to complete questionnaires and complete physical exercise testing. It is hoped that this study will help determine whether an 8-week yoga intervention is a feasible treatment to address shortness of breath in lung cancer patients and provide information that will help inform a larger trial.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Bobby Cheema
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Address
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Western Sydney University School of Health Sciences Building 24, 183 Narellan Road Campbelltown NSW 2560 Australia
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Country
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Australia
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Phone
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+61 2 4620 3795
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Bobby Cheema
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Address
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Western Sydney University School of Health Sciences Building 24, 183 Narellan Road Campbelltown NSW 2560 Australia
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Country
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Australia
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Phone
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+61 2 4620 3795
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Fax
141523
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Email
141523
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[email protected]
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Contact person for scientific queries
Name
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Bobby Cheema
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Address
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Western Sydney University School of Health Sciences Building 24, 183 Narellan Road Campbelltown NSW 2560 Australia
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Country
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Australia
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Phone
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+61 2 4620 3795
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Fax
141524
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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