Clinical trial NCT06631872: Implementing Surgery School Prehabilitation Using Telehealth
Official title: Implementing Tele-prehabilitation Education Into Cancer Care Pathways
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Colorectal Cancer
Oesophageal Cancer
Pancreas Cancer
Gastric Cancer
Lead sponsor: University of Melbourne
Sponsor class: OTHER
Collaborators: name: Peter MacCallum Cancer Centre, Australia
First posted: 2024-10-08
Enrollment: 545
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: 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, 65 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.


Eligibility criteria: Inclusion Criteria:

* Preparing for lung cancer (open or video assisted) or major abdominal cancer surgery (upper GI, hepatobiliary and colorectal, open or video assisted).
* Provide consent
* Have primary treating surgeon approval
* Proficient in English to understand testing, video interventions as well as outcome assessments.

Exclusion Criteria:

* Concurrent, actively treated other malignancy of history of other malignancy treated within the past year,
* Severe or unstable psychiatric, cognitive or substance abuse disorders, such that precludes informed consent or interferes with cooperation with trial requirements or current inpatients.

Primary outcomes:
measure: Post operative Pulmonary Complication (PPC)
timeFrame: Daily for up to 7 days post operatively or until hospital discharge.
Secondary outcomes:
measure: Diagnosis of pneumonia
timeFrame: Daily up to postoperative day 7 or until hospital discharge
measure: Postoperative complications
timeFrame: Postoperative day 3,5,10 unless discharge prior and 30 days post operative.
measure: Number of days alive and out of hospital
timeFrame: 30 days, 6 months and 12 months post operative
measure: Maximal Inspiratory Pressure (MIP)
timeFrame: Baseline and preoperatively at centres participating in the inspiratory muscle training sub study
measure: Physical activity levels - subjective
timeFrame: Baseline, Preoperatively, 30 days post operative
measure: Physical activity levels - objective
timeFrame: Baseline, Preoperatively, 30 days post operative
measure: Video and Surgery School Session Attendance (Intervention group only)
timeFrame: Preoperative timepoint
measure: Access to video outside the Surgery School Session (Intervention group only)
timeFrame: Preoperative timepoint
measure: Symptoms: electronic Edmonton Symptom Assessment System-revised ((e)ESAS-r)
timeFrame: Baseline (and repeated every 4 weeks for participants having treatment before surgery), Preoperative, Postoperative: 30 days.
measure: Behaviour Change
timeFrame: Preoperative timepoint, at hospital discharge (+3 days)
measure: Self-efficacy: Patient Activation Measure
timeFrame: Baseline, preoperative timepoint, 30 days and 6 months postoperative.
measure: Treatment Burden: Multimorbidity Treatment Burden Questionnaire (MTBQ)
timeFrame: Baseline, preoperative timepoint, 30 days postoperative
measure: Viewer perceptions of the intervention (intervention group only)
timeFrame: Preoperative timepoint
measure: Feasibility of the teleprehabilitation program: Proportion of eligible patients participating
timeFrame: Time Frame: Through study recruitment, up to 2 years
measure: Feasibility of the teleprehabilitation program: Representativeness
timeFrame: Time Frame: Through study recruitment, up to 2 years
measure: Feasibility of the teleprehabilitation program: Referral rates
timeFrame: Time Frame: Through study recruitment, up to 2 years
measure: Feasibility of the teleprehabilitation program: reasons for declining
timeFrame: Time Frame: Through study recruitment, up to 2 years
measure: Acceptability
timeFrame: Preoperative timepoint, at hospital discharge (+3 days), 30 days post operative
measure: Fidelity (treatment delivery): Tele-prehabilitation education session duration
timeFrame: Through study data collection, up to 2 years
measure: Fidelity (treatment delivery): Number of videos accessed
timeFrame: Through study data collection, up to 2 years
measure: Fidelity (treatment delivery): Number of video views
timeFrame: Through study data collection, up to 2 years
measure: Fidelity (treatment delivery): Telehealth implementation process concordance with implementation protocol.
timeFrame: Through study data collection, up to 2 years
measure: Fidelity (treatment delivery): viewing time
timeFrame: Through study data collection, up to 2 years
measure: Fidelity (treatment receipt): participant attendance at telehealth zoom meeting
timeFrame: Through study data collection, up to 2 years
measure: Fidelity (treatment receipt): number of questions
timeFrame: Through study data collection, up to 2 years
measure: Fidelity (treatment receipt): participant retention at follow up
timeFrame: Through study data collection, up to 2 years
measure: Participant satisfaction: Australian Hospital Experience Question Set (AHPEQS)
timeFrame: 30 days post operative
measure: Health related quality of life: EORTC QLQ-C30
timeFrame: Baseline, Preoperative, 30 days, 6 months and 12 months post operative
measure: Postoperative Quality of Recovery: Postoperative Quality of Recovery Score (PostopQRS)
timeFrame: Preoperative timepoint, 3 days postoperatively, hospital discharge (if greater than 2 days after postoperative day 3 review), 30 days and 6 months postoperative
measure: Length of hospital stay
timeFrame: at hospital discharge
measure: Health service use and costs
timeFrame: at hospital discharge, 30 days, 6 and 12 months post operative
measure: Exploratory Outcomes
timeFrame: through study completion, up to 3 years
Other outcomes:
measure: Sex
timeFrame: Baseline
measure: Date of birth
timeFrame: Baseline
measure: Height
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
measure: Primary language spoken
timeFrame: Baseline
measure: Proposed surgery
timeFrame: Baseline
measure: Medical history
timeFrame: Baseline
measure: Social history: live alone
timeFrame: Baseline
measure: Social history: partner
timeFrame: Baseline
measure: Work status
timeFrame: Baseline
measure: Postcode
timeFrame: Baseline
measure: American Society of Anaesthesiologists (ASA) score
timeFrame: Baseline
measure: Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) score
timeFrame: Baseline
measure: Frailty
timeFrame: Baseline
measure: Survival
timeFrame: 12 months post operative
measure: Surgical and anaesthetic information
timeFrame: at hospital discharge
Locations:
city: New Lambton Heights
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Launceston
country: Australia
facility: Launceston General Hospital
state: Tasmania
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Perth
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
Study officials:
affiliation: University of Melbourne
name: Linda Denehy, B AppSc (Physio), PhD
role: PRINCIPAL_INVESTIGATOR
References: