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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06716437
Registration number
NCT06716437
Ethics application status
Date submitted
25/11/2024
Date registered
4/12/2024
Date last updated
22/04/2025
Titles & IDs
Public title
Prehabilitation for Patients Undergoing Lung Cancer Surgery
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Scientific title
Digitally Enabled Prehabilitation in a Community-based Setting for Patients Undergoing Lung Cancer Surgery
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Secondary ID [1]
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30930
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Universal Trial Number (UTN)
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Trial acronym
DIGI-Lung
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lung Cancer (NSCLC)
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
BEHAVIORAL - Prehabilitation
Experimental: Prehabilitation arm - Patients will receive the prehabilitation program
BEHAVIORAL: Prehabilitation
Patients will undergo a physiotherapy-led digitally-enabled prehabilitation program before lung resection surgery.
The intervention will be delivered through a mobile app and supported by tele-health and will consist of:
i) watching six educational videos embedded on the app on relevant topics to prepare for surgery, such as the importance of physical fitness, breathing exercises after surgery, and pain management.
ii) a physical activity coaching program to increase daily activity with feedback iii) a home-based, unsupervised exercise program consisting of 10 whole body strengthening exercises delivered in a video format iv) an inspiratory muscle training program using a hand-held device to be performed twice daily.
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Intervention code [1]
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BEHAVIORAL
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Feasibility of the intervention
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Assessment method [1]
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Feasibility of the intervention determined by enrolment rate (number of patients who accept participation in the trial vs. number of eligible patients)
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Timepoint [1]
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From enrollment to the end of the study approximately one week after surgery
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Primary outcome [2]
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App usability and acceptability
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Assessment method [2]
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The app usability will be measured with a questionnaire (the mHealth App Usability Questionnaire). The questionnaire consists of 21 items on a likert scale ranging from 1 (disagree) to 7 (agree) assessing different domains of a mHealth app. A median of 4.5 out of 7 across all domains will be considered as high usability and acceptability.
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Timepoint [2]
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Within one week before surgery
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Secondary outcome [1]
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Safety of the intervention
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Assessment method [1]
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Adverse events, defined as any unexpected, undesirable event, such as injury, fall, and discomfort related to prehabilitation program will be recorded weekly through telehealth. They will be classified according to the Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.
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Timepoint [1]
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From enrollment to the end of the program before surgery
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Secondary outcome [2]
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Inspiratory Muscle Strength
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Assessment method [2]
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Maximal inspiratory pressure (MIP) registered at the mouth will be recorded using a specific device (BHC RP Check, Bird Health Care Australia).
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Timepoint [2]
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Within one week before surgery
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Secondary outcome [3]
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Diaphragmatic excursion and thickness
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Assessment method [3]
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Diaphragmatic excurssion will be measured with through Point of Care Ultrasound (POCUS) both at normal breathing and maximal inspiration. Diaphragmatic thickness will also be measured.
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Timepoint [3]
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Within one week before surgery
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Secondary outcome [4]
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Lung function
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Assessment method [4]
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Lung function parameters including forced vital capacity (FVC) and forced expiratory volume in the first second (FEV1) will be collected during a forced spirometry test. The tests will be conducted according to the international recommendations from the ATS/ERS.
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Timepoint [4]
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Within one week before surgery
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Secondary outcome [5]
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Self-efficacy
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Assessment method [5]
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Patient's perception of self-efficacy will be measured using a validated questionnaire (General Self-Efficacy Scale). The scale is 10-item each one measured on a likert-scale from 1 to 4. Total scores range from 10 to 40 with higher scores indicating higher self-efficacy.
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Timepoint [5]
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Within one week before surgery
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Secondary outcome [6]
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Participant satisfaction
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Assessment method [6]
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Participants' satisfaction with the intervention will be measured through the Australian Hospital Patient Experience Question Set (AHPEQS). The AHPEQS is a 12-item questionnaire with each question assessed on a likert-scale which measures the satisfaction with a healthcare intervention. There is no scoring for this scale.
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Timepoint [6]
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Within one week before surgery
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Secondary outcome [7]
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Health Related Quality of Life
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Assessment method [7]
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Heaht-related quality of life will be assessed using a validated questionnaire specific to cancer patients from the European Organization of Research in Cancer Treatment (EORTC QLQ C30). The questionnaire will be self-administered and consists of 30 questions on several domains of physical functioning, emotional functioning and cancer-related symptoms. Two main subscales are obtained from the questionnaire (one in function, one in symptoms) plus one item on global health. The score ranges from 0 to 100 with higher scores representing higher self-reported quality of life or higher symptom burden.
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Timepoint [7]
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Within one week before surgery
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Secondary outcome [8]
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Recovery from surgery
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Assessment method [8]
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Self-reported recovery from surgery will be measured using a validated questionnaire (the Quality of Recovery Questionnaire - QoR15).
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Timepoint [8]
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Within one week before surgery
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Eligibility
Key inclusion criteria
* Diagnosis of lung cancer and scheduled for lung resection surgery
* Ability to understand and speak English to follow instructions and complete the intended assessments.
* Age = 18 years at the point of baseline screening
* Provide written informed consent for the trial
* Sufficient digital literacy to use a smartphone and mobile app
* No contraindications for exercise
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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
* Other cancer diagnoses than lung cancer
* Surgery scheduled in less than one week
* Unstable psychiatric, cognitive or substance abuse disorders that would interfere with cooperation with the requirements of the trial
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Not applicable
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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
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/01/2025
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Date of last participant enrolment
Anticipated
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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
25
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The University of Melbourne, Department of Physiotherapy - Parkville
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Recruitment postcode(s) [1]
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3010 - Parkville
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Melbourne
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Melbourne Health
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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St Vincent's Hospital Melbourne
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
Major surgery has been linked to running a marathon as in both represent large endeavours where the body will experience an increase in demands to supply the necessary energy. It has been alledged that, as one would train to prepare for a marathon, the same should be applied to surgery. The process of getting ready and/or fitter for surgery is frequently referred to as prehabilitation and it usually involves interventions on improving nutrition and diet, getting fit and improve emotional wellness. Prehabilitation can improve the recovery after surgery and reduce the time spent in hospital afterwards. This research seeks to determine whether a home based program of increased physical activity and breathing training can improve patients' physical and respiratory function in preparation for lung cancer surgery.
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Trial website
https://clinicaltrials.gov/study/NCT06716437
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Trial related presentations / publications
Waterland JL, Ismail H, Amin B, Granger CL, Denehy L, Riedel B. Patient acceptance of prehabilitation for major surgery: an exploratory survey. Support Care Cancer. 2021 Feb;29(2):779-785. doi: 10.1007/s00520-020-05547-1. Epub 2020 May 28. Whish-Wilson GA, Edbrooke L, Cavalheri V, Denehy L, Seller D, Granger CL, Parry SM. Physiotherapy and Exercise Management of People Undergoing Surgery for Lung Cancer: A Survey of Current Practice across Australia and New Zealand. J Clin Med. 2023 Mar 9;12(6):2146. doi: 10.3390/jcm12062146. Kunadharaju R, Saradna A, Ray A, Yu H, Ji W, Zafron M, Mador MJ. Post-Operative Outcomes of Pre-Thoracic Surgery Respiratory Muscle Training vs Aerobic Exercise Training: A Systematic Review and Network Meta-analysis. Arch Phys Med Rehabil. 2023 May;104(5):790-798. doi: 10.1016/j.apmr.2022.10.015. Epub 2022 Dec 17. Ferreira V, Lawson C, Ekmekjian T, Carli F, Scheede-Bergdahl C, Chevalier S. Effects of preoperative nutrition and multimodal prehabilitation on functional capacity and postoperative complications in surgical lung cancer patients: a systematic review. Support Care Cancer. 2021 Oct;29(10):5597-5610. doi: 10.1007/s00520-021-06161-5. Epub 2021 Mar 25. Sebio Garcia R, Yanez Brage MI, Gimenez Moolhuyzen E, Granger CL, Denehy L. Functional and postoperative outcomes after preoperative exercise training in patients with lung cancer: a systematic review and meta-analysis. Interact Cardiovasc Thorac Surg. 2016 Sep;23(3):486-97. doi: 10.1093/icvts/ivw152. Epub 2016 May 25. Cavalheri V, Granger CL. Exercise training as part of lung cancer therapy. Respirology. 2020 Nov;25 Suppl 2:80-87. doi: 10.1111/resp.13869. Epub 2020 Jun 1. Cavalheri V, Granger C. Preoperative exercise training for patients with non-small cell lung cancer. Cochrane Database Syst Rev. 2017 Jun 7;6(6):CD012020. doi: 10.1002/14651858.CD012020.pub2.
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Public notes
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Contacts
Principal investigator
Name
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Linda Denehy, PhD
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Address
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University of Melbourne
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Lara Edbrooke, PhD
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Address
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Country
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Phone
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+61 3 90354213
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
Data sharing will be considered upon reasonable request made to the principal investigator
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06716437
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