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Studies

Interventional Recruiting

NCT06631872 on ClinicalTrials.gov

Implementing Surgery School Prehabilitation Using Telehealth

Official title: Implementing Tele-prehabilitation Education Into Cancer Care Pathways

  • Sponsor: University of Melbourne
  • Collaborators: Peter MacCallum Cancer Centre, Australia
  • Enrollment: 515 (Estimated)
  • Study start: 2025-01-22 (Actual)
  • Primary completion: 2027-07-01 (Estimated)
  • Study completion: 2028-07-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: This is a two-arm, multicentre, comparative, assessor-blinded, randomised, controlled, hybrid (Type 1; examining both efficacy and feasibility) superiority trial that includes one sub-study.
  • Masking: Single (Outcomes Assessor)
  • PrimaryPurpose: Supportive Care

Brief Summary

The physiological challenge of major surgery has been likened to running a marathon. In both cases, preparation is critical. Yet, many patients undergo major surgery without understanding the potential consequences.

The STTARRS trial aims to test the effect of an education program delivered via telehealth in people preparing for lung or major abdominal cancer surgery , compared with usual care on the development of a respiratory complications after surgery.

The secondary aims will be to determine the effect of the online education program for people preparing for lung or major abdominal cancer surgery compared to usual care on the following outcomes; acute hospital length of stay, surgical recovery, physical function and activity, self-efficacy, behaviour change, symptoms, health-related quality of life, number of days alive and out of hospital and health service usage and survival.

This trial includes one sub-study. The sub-study will recruit eligible people preparing for lung cancer surgery. In the sub-study, 35 participants will receive an individualised inspiratory muscle training and walking program delivered and monitored by telehealth in addition to the main STTARRS trial intervention before surgery.

Conditions

  • Adults Waiting to Undergo Lung Cancer or Major Abdominal, Open or Video Assisted Cancer Surgery

Intervention / Treatment

  • Behavioral: Tele-prehabilitation education session: Surgery School
  • Behavioral: Individualised Inspiratory Muscle Training and Walking Program
  • Other: Usual Care

Primary Outcome Measures

  • Post operative Pulmonary Complication (PPC) (Daily for up to 7 days post operatively or until hospital discharge.)
    Post operative pulmonary complications (PPC) will be assessed using the Melbourne Group Score (MGS). The MGS is an eight-item checklist. Minimum score 0, Maximum score 8. Participants are identifying as having a PPC if they score four or more in a 24-hour period.

Countries

Australia

Locations and Investigators

  • John Hunter Hospital, New Lambton Heights, Australia (Recruiting)
    • Jennifer Mackney, PhD
  • Calvary Mater Newcastle, Waratah, Australia (Recruiting)
    • Jennifer Mackney, PhD
  • Gold Coast University Hospital, Southport, Australia (Recruiting)
    • Hayley Edwards
  • Princess Alexandra Hospital, Woolloongabba, Australia (Recruiting)
    • Claire Hackett, BPHTY
  • North West Regional Hospital, Burnie, Australia (Not yet recruiting)
    • Ianthe Boden, PhD
  • Launceston General Hospital, Launceston, Australia (Recruiting)
    • Ianthe Boden, PhD
  • Austin Health, Heidelberg, Australia (Recruiting)
    • Sue Berney, PhD
  • Royal Melbourne Hospital, Melbourne, Australia (Recruiting)
    • Leonie Shaw, BAppSc(Phy)
  • Fiona Stanley Hospital, Perth, Australia (Recruiting)
    • Vinicius Cavalheri, PhD

Study Officials