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Trial registered on ANZCTR
Registration number
ACTRN12624001046594p
Ethics application status
Submitted, not yet approved
Date submitted
7/08/2024
Date registered
29/08/2024
Date last updated
29/08/2024
Date data sharing statement initially provided
29/08/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Expiratory Muscle Strength Training in Head and Neck Cancer Survivors with Dysphagia: A Pilot Study
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Scientific title
Effect of Expiratory Muscle Strength Training on Maximum Expiratory Pressure, Swallow Safety and Voice Function in Head and Neck Cancer Survivors with Dysphagia: A Pilot Study
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Secondary ID [1]
312698
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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:
Dysphagia
334721
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Dysphonia
334722
0
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Head and Neck Cancer
334731
0
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Condition category
Condition code
Respiratory
331282
331282
0
0
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Normal development and function of the respiratory system
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Physical Medicine / Rehabilitation
331283
331283
0
0
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Speech therapy
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Diet and Nutrition
331284
331284
0
0
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Other diet and nutrition disorders
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Cancer
331415
331415
0
0
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Head and neck
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Description:
The Expiratory Muscle Strength Training device (EMST150) is a one-way, adjustable spring-loaded valve that creates resistance against expiration. Its objective is to train the muscles required for exhalation, improving their capacity for coughing and swallowing.
Dose and Duration:
To use the hand-held device, patients take a deep breath and blow forcefully into the mouthpiece 5 times, 5 times a day, 5 days a week, for 5 weeks. Using the rotating knob, the device is calibrated to the optimum resistance for training, which is 75% of the patient’s maximum expiratory pressure.
No other speech pathology interventions will be provided during the 5-week period.
Mode of Delivery:
EMST is a speech pathology led intervention. The therapy program begins with a 1-hour in-person outpatient appointment with the speech pathologist, whereby baseline swallow and voice function measures are collected. Then, the EMST150 device is calibrated to the optimum training resistance by the speech pathologist and the participant is taught how to use the device.
After initial consultation, the participant completes the training in their home, and the speech pathologist provides weekly 15-minute telehealth appointments to recalibrate the device as necessary and ensure adherence to the training program.
At the completion of the 5-week therapy program, participants attend a 1-hour in-person outpatient speech pathology appointment to repeat swallow and voice function measures and establish a maintenance program.
Materials: Prior to commencing the therapy program, patients will be provided with
- Patient information sheet outlining the aims of the proposed project and any risks or contraindications for use of the EMST150 device.
- The EMST150 device and instructions manual
- Adherence diary
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Intervention code [1]
329227
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Treatment: Devices
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Comparator / control treatment
The study design is a prospective interventional pre-post pilot study assessing primary and secondary outcomes of laryngeal function as it relates to swallowing and voice. Participants will be their own control – meaning limiting factors such as diversity in this population will be minimised.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Maximum Expiratory Pressure (MEP)
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Assessment method [1]
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MEP in cmH2O will be calculated using the Micro Medical Respiratory Pressure Meter.
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Timepoint [1]
339040
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Immediately pre-intervention (week 1) and immediately post-intervention (week 5).
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Secondary outcome [1]
438334
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Dynamic Imaging Grade of Swallowing Toxicity (DIGEST)
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Assessment method [1]
438334
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During Flexible Nasendoscopy (FNE), participants will be asked to swallow a protocol of milk, puree fruit and diced fruit. The DIGEST is a validated tool used to rate the severity of dysphagia. It quantifies swallowing safety and efficiency through a Penetration-Aspiration Scale as well as percentage of pharyngeal residue. Patient response to the presence or absence of penetration and aspiration (i.e. coughing) will be documented.
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Timepoint [1]
438334
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Immediately pre-intervention (week 1) and immediately post-intervention (week 5).
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Secondary outcome [2]
438335
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MD Anderson Dysphagia Inventory (MDADI)
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Assessment method [2]
438335
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Patient reported outcomes will be collected via the MDADI, a validated self-administered questionnaire to assess the impact of dysphagia on quality of life.
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Timepoint [2]
438335
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Immediately pre-intervention (week 1) and immediately post-intervention (week 5).
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Secondary outcome [3]
438336
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Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
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Assessment method [3]
438336
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Participant’s voice quality will be graded following the CAPE-V protocol, a validated tool for auditory-perceptual rating of voicing.
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Timepoint [3]
438336
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Immediately pre-intervention (week 1) and immediately post-intervention (week 5).
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Secondary outcome [4]
438337
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Voice Handicap Index-10 (VHI-10)
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Assessment method [4]
438337
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Patient reported outcomes will be collected via the VHI-10, a reliable and validated self-administered questionnaire to assess the impact of dysphonia on quality of life.
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Timepoint [4]
438337
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Immediately pre-intervention (week 1) and immediately post-intervention (week 5).
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Secondary outcome [5]
438338
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False Vocal Fold (FVF) Behaviour
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Assessment method [5]
438338
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During FNE, participant's FVF behaviour during speaking tasks will be analysed and descriptively reported.
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Timepoint [5]
438338
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Immediately pre-intervention (week 1) and immediately post-intervention (week 5).
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Eligibility
Key inclusion criteria
Adult head and neck cancer survivors (age 18 years and over) who have completed treatment (surgery and or chemoradiotherapy) greater than 3 months ago (to exclude treatment effect) with associated dysphagia.
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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
• Patients with physical, language or cognitive barriers unable to perform or tolerate EMST and Flexible Nasendoscopy.
• Patients who are currently undergoing treatment for HNC.
• Patients where EMST is contraindicated, i.e. where the treating physician does not endorse the intervention, respiratory and cardiothoracic comorbidities, hypertension.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Outcomes collected from the primary and secondary measurements will be analysed and descriptively reported. Through collaboration with the Dr Liang Voice Program, the research team has access to a statistician who will assist with this component of the study.
We aim to have 37 participants partake in the study to determine the correlation between EMST and the primary and secondary outcomes with a precision of 0.5. However, due to the nature of the recruitment method, the final number of participants may differ.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/01/2025
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Actual
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Date of last participant enrolment
Anticipated
26/05/2025
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Actual
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Date of last data collection
Anticipated
30/06/2025
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Actual
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Sample size
Target
37
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
26906
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The Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
42968
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5000 - Adelaide
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Funding & Sponsors
Funding source category [1]
317131
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Other
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Name [1]
317131
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Central Adelaide Local Health Network Allied and Scientific Health Research Grant 2024-2025 Stream 1: Acraman Bequest
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Address [1]
317131
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Country [1]
317131
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Australia
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Primary sponsor type
Other
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Name
Central Adelaide Local Health Network Speech Pathology Department
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Address
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Country
Australia
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Secondary sponsor category [1]
319396
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None
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Name [1]
319396
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Address [1]
319396
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Country [1]
319396
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Other collaborator category [1]
283128
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University
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Name [1]
283128
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Dr Liang Voice Program, The University of Sydney
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Address [1]
283128
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Country [1]
283128
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Australia
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
315882
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Central Adelaide Local Health Network HREC
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Ethics committee address [1]
315882
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https://www.rah.sa.gov.au/research/for-researchers/central-adelaide-local-health-network-human-research-ethics-committee
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Ethics committee country [1]
315882
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Australia
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Date submitted for ethics approval [1]
315882
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08/08/2024
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Approval date [1]
315882
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Ethics approval number [1]
315882
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Summary
Brief summary
This study will investigate the effect of Expiratory Muscle Strength Training (EMST) on Maximum Expiratory Pressure (MEP) as well as swallowing safety and voice function in head and neck cancer (HNC) survivors with dysphagia Who is it for? You may be eligible to join this study if you are aged 18 years or above, have survived head and neck cancer, completed treatment (surgery and or chemoradiotherapy) more than 3 months ago and are experiencing associated dysphagia (difficulty swallowing). Study details: All participants in this study will receive an Expiratory Muscle Strength Training device (EMST150) to use 5 days a week over 5 weeks at home, Participants will be required to attend a 1-hour in-person speech pathology appointment week 1 and 5 of the study, with weekly 15-minute telehealth consultations week 2, 3 and 4. Participants will undergo some testing procedures pre and post the 5-week EMST therapy period to determine maximum expiratory pressure, swallowing safety, voice function and quality of life.
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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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Miss Chelsea McGuinness
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Address
136086
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Royal Adelaide Hospital, Port Rd, Adelaide SA 5000
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Country
136086
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Australia
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Phone
136086
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+61 421 400 887
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Fax
136086
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Email
136086
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[email protected]
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Contact person for public queries
Name
136087
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Chelsea McGuinness
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Address
136087
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Royal Adelaide Hospital, Port Rd, Adelaide SA 5000
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Country
136087
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Australia
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Phone
136087
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+61 421 400 887
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Fax
136087
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Email
136087
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[email protected]
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Contact person for scientific queries
Name
136088
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Chelsea McGuinness
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Address
136088
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Royal Adelaide Hospital, Port Rd, Adelaide SA 5000
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Country
136088
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Australia
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Phone
136088
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+61 421 400 887
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Fax
136088
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Email
136088
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Because of the heterogenous nature of the population, it is felt that if specific individual information were available, this would breach participant confidentiality and privacy. The purpose of the proposed study is the assess the effect of EMST in a head and neck cancer population, therefore the overall group results are felt to be more representative of the study's aims and objectives.
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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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