Implementing Surgery School Prehabilitation Using Telehealth (STTARRS)

University of Melbourne

Status: Enrolling

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06631872

4.2 19/02/2025

Details and patient eligibility

About

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.

Enrollment: 515 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Preparing for lung cancer (open or video assisted) or major abdominal cancer surgery (e.g. upper GI, hepatobiliary or 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 or 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.
• Current inpatients or incarcerated
• Surgery date booked <7 days from consent

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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515 participants in 4 patient groups

Tele-prehabilitation intervention (Intervention Group)

Experimental group

Description:

The Teleprehabilitaiton intervention (also known as Surgery School) is a one-off group based education session delivered online. Video presentations of 8-10 key prehabilitation education areas will be facilitated by a live clinician facilitator who will introduce the educational content and answer any questions. All standardised video presentations during the session will be made available to participants through an online password-protected video repository hosted on a video platform after the session and will be available until their surgery.

Treatment:

Behavioral: Tele-prehabilitation education session: Surgery School

Usual care alone (Control Group)

Active Comparator group

Description:

Participants allocated to the control group will receive usual care according to their health care team, which may consist of advice on smoking cessation, reduction of alcohol intake, nutritional counselling and medical optimisation in preoperative anaesthetic clinic visits. Participants will be asked to maintain their normal daily activities.

Treatment:

Other: Usual Care

Sub-study: Tele-prehabilitation and inspiratory muscle training program

Experimental group

Description:

Eligible participants awaiting lung cancer surgery that have been randomised into the intervention arm will be re-randomised to receive either the STTARRS (larger trial) intervention or the STTARRS intervention PLUS an individualised inspiratory muscle training and walking program delivered by a physiotherapist using telehealth in the lead up to their lung cancer surgery. The inspiratory muscle training program includes an inspiratory muscle training explanatory video and an individually prescribed dosage and resistance for inspiratory muscle training and walking program, delivered via telehealth.

Treatment:

Behavioral: Individualised Inspiratory Muscle Training and Walking Program

Behavioral: Tele-prehabilitation education session: Surgery School

Sub-study: Tele-prehabilitation intervention

Active Comparator group

Description:

The Teleprehabilitaiton intervention (also known as Surgery School) is a one-off group based education session delivered online. Video presentations of 8-10 key prehabilitation education areas will be facilitated by a live clinician facilitator who will introduce the educational content and answer any questions. All standardised video presentations during the session will be made available to participants through an online password-protected video repository hosted on a video platform after the session and will be available until their surgery.

Treatment:

Behavioral: Tele-prehabilitation education session: Surgery School