Adults Waiting to Undergo Lung Cancer or Major Abdominal, Open or Video Assisted Cancer Surgery
Conditions
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.
Interventions
BEHAVIORALTele-prehabilitation education session: Surgery School
Online telehealth education program using videos and a live clinician facilitator
BEHAVIORALIndividualised Inspiratory Muscle Training and Walking Program
An individualised inspiratory muscle training and walking program delivered by a Physiotherapist using telehealth.
OTHERUsual Care
Usual care alone. Usual care will be reviewed every four months during the trial and site leads will be asked to provide information about any changes to usual hospital and medical care at their site.
Sponsors
University of Melbourne
Peter MacCallum Cancer Centre, Australia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnosis of pneumonia | Daily up to postoperative day 7 or until hospital discharge | Diagnosis of pneumonia (Y/N) classified according the centre for disease control definition. |
| Postoperative complications | Postoperative day 3,5,10 unless discharge prior and 30 days post operative. | Complications after surgery will be defined as any deviation from the normal postoperative course and classified according to the Clavien-Dindo classification. from Grade I through GradeV. Higher classifications indicating complications that require more complex interventions. |
| Number of days alive and out of hospital | 30 days, 6 months and 12 months post operative | DAoH-30, DAoH-180, DAoH-365 (days alive and out of hospital 30, 180, 365 days post operatively): a patient centric metric and composite outcome that integrates several clinically important outcomes: hospital length of stay, re-admission or discharge to a destination other than origin (usually home) as well as survival. Higher numbers indicate a greater time alive and out of hospital post operatively. |
| Maximal Inspiratory Pressure (MIP) | Baseline and preoperatively at centres participating in the inspiratory muscle training sub study | Maximal Inspiratory Pressure (cm H2O) will be assessed using a small handheld device using 3 tests of inspiratory muscle strength recording the highest value. Undertaken at centres participating in the sub study. |
| Physical activity levels - subjective | Baseline, Preoperatively, 30 days post operative | Physical activity levels will be documented subjectively using the International Physical Activity Questionnaire - Short Form (IPAQ-SF). The IPAQ-SF is a questionnaire used internationally to obtain comparable estimates of physical activity. The questionnaire comprises seven questions related to physical activity at different levels of intensity and sitting time. Results will be reported in categories (low activity levels, moderate activity levels or high activity levels) and a continuous variable (MET minutes a week). Higher METs or categories indicate higher levels of physical activity. |
| Physical activity levels - objective | Baseline, Preoperatively, 30 days post operative | Physical activity levels will be collected objectively using wearable monitors, such as fitbits for three days at baseline, three days after the intervention and at 30 days postoperatively. Physical activity variables will include the total number of daily steps, daily minutes of moderate to vigorous physical activity (MVPA), peak 1-minute cadence (the highest single minute of steps recorded), and peak 30-minute cadence (the average steps/min for the highest non-consecutive 30 minutes in a day). A minimum of 8 hours over 3 days is considered valid wear time for physical activity data. Values are described using mean +/- standard deviation and mean difference (MD) with 95% confidence intervals (95% CI). |
| Video and Surgery School Session Attendance (Intervention group only) | Preoperative timepoint | Attendance at Surgery School session, length of time attended the Surgery School session and number of questions asked during Surgery School session. |
| Access to video outside the Surgery School Session (Intervention group only) | Preoperative timepoint | The number of times the videos are accessed outside of the Surgery School session, site, day of week, time of day will be collected. Number of questions asked during Surgery School session. |
| Symptoms: electronic Edmonton Symptom Assessment System-revised ((e)ESAS-r) | Baseline (and repeated every 4 weeks for participants having treatment before surgery), Preoperative, Postoperative: 30 days. | The electronic Edmonton Symptom Assessment System-revised ((e)ESAS-r) is a 10-item assessment tool for self-reporting symptom intensity via electronic platforms for digital use. The (e)ESAS-r allows participants to rate the severity of common symptoms as well as the opportunity to rate 'other problems' as nominated by the participant on a scale from 0 to 10 with higher score indicating higher severity of symptoms |
| Behaviour Change | Preoperative timepoint, at hospital discharge (+3 days) | Behaviour change will be measured using a bespoke questionnaire: STTARRS behaviour change questionnaire (SBCQ) developed to assess patient action related to information (a) contained within the videos and surgery school session (intervention group) and (b) for usual care participants information provided to them through educational materials. This patient reported experience measure will measure responses to questions on a 5-point Likert scale (strongly disagree to strongly agree). Results will be presented descriptively. Higher responses on the likert scales indicates a higher agreement. |
| Self-efficacy: Patient Activation Measure | Baseline, preoperative timepoint, 30 days and 6 months postoperative. | Patient Activation Measure (PAM) is a questionnaire assessing three key domains: knowledge, skills, confidence to understand self-management ability. The PAM is a 13-item survey scored on a 100 point scale, with 4 activation levels validated for across time measures and used world-wide. PAM Levels 1 and 2 indicate lower patient activation, while PAM levels 3 and 4 indicate higher patient activation. |
| Treatment Burden: Multimorbidity Treatment Burden Questionnaire (MTBQ) | Baseline, preoperative timepoint, 30 days postoperative | Multimorbidity Treatment Burden Questionnaire (MTBQ) is a 13 item questionnaire that assesses the perception of the effort required to self-manage their medical conditions and the impact that this has on their wellbeing. The MTBQ has demonstrated good content and construct validity, reliability and responsiveness. The MTBQ is scored from 0-100 with higher scores indicating higher treatment burden which fall into four categories: no burden (score 0), low burden (score \<10), medium burden (10-22) and high burden (\>=22). |
| Viewer perceptions of the intervention (intervention group only) | Preoperative timepoint | Viewer perceptions of the intervention including perceived personal relevance will be assessed using a previously published questionnaire. The questionnaire includes questions on four domains: helpfulness, believability, novelty, and relevance of information. A total of 7 questions all rate on 0-6 Likert scales from strongly disagree to strongly agree, with higher score indicating stronger agreement and an additional yes/no question asked regarding whether participants intend to change any behaviours. |
| Feasibility of the teleprehabilitation program: Proportion of eligible patients participating | Time Frame: Through study recruitment, up to 2.5 years | Portion of eligible patients participating will be collected and reported as a percentage of all patients eligible for the trial. |
| Feasibility of the teleprehabilitation program: Representativeness | Time Frame: Through study recruitment, up to 2.5 years | Representativeness relative to a wider group of eligible patients presented descriptively |
| Feasibility of the teleprehabilitation program: Referral rates | Time Frame: Through study recruitment, up to 2.5 years | Actual teleprehabilitation referral rates as a % of total eligible to be referred |
| Feasibility of the teleprehabilitation program: reasons for declining | Time Frame: Through study recruitment, up to 2.5 years | Reasons for declining will be reported descriptively. |
| Acceptability | Preoperative timepoint, at hospital discharge (+3 days), 30 days post operative | Participants will be asked to complete a survey regarding trial acceptability. The survey questions will be based upon the Theoretical Framework of Acceptability. The framework comprises seven domains designed to assess acceptability elements: perceived effectiveness, self-efficacy, affective attitude, ethicality burden, intervention coherence and opportunity costs. |
| Fidelity (treatment delivery): Tele-prehabilitation education session duration | Through study data collection, up to 2.5 years | Treatment delivery: using duration of education session provided (minutes). |
| Fidelity (treatment delivery): Number of videos accessed | Through study data collection, up to 2.5 years | Treatment delivery: total number of videos accessed, presented descriptively and also by video title. |
| Fidelity (treatment delivery): Number of video views | Through study data collection, up to 2.5 years | Treatment delivery: using number of videos viewed, results presented descriptively . |
| Fidelity (treatment delivery): Telehealth implementation process concordance with implementation protocol. | Through study data collection, up to 2.5 years | Treatment delivery (centre level): using process concordance with implementation protocol. |
| Fidelity (treatment delivery): viewing time | Through study data collection, up to 2.5 years | Treatment delivery: using the time of participant viewing (minutes). |
| Fidelity (treatment receipt): participant attendance at telehealth meeting | Through study data collection, up to 2.5 years | Treatment receipt: % of participants who attend a session once booked in |
| Fidelity (treatment receipt): number of questions | Through study data collection, up to 2.5 years | Treatment receipt: the number of questions per session will be recorded. |
| Fidelity (treatment receipt): participant retention at follow up | Through study data collection, up to 2.5 years | Treatment receipt: the number of participants attending follow up will be recorded (% of total participants). |
| Participant satisfaction: Australian Hospital Experience Question Set (AHPEQS) | 30 days post operative | The Australian Hospital Patient Experience Question Set (AHPEQS) is a 12-item questionnaire (ten core items and two sub-items) used to measure patient satisfaction with recent treatment. Questions are measured on responses from always to never or didn't apply. Results will be reported descriptively with positive responses indicating greater satisfaction with recent treatment. |
| Health related quality of life: EORTC QLQ-C30 | Baseline, Preoperative, 30 days, 6 months and 12 months post operative | European Organisation for the Research and Treatment of Cancer (EORTC QLQ- C30) core questionnaire is a measure composed of five multi-item domains (physical, role, emotional, cognitive function and social functioning). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning. A high score for the global health status / quality of life represents a high quality of life but a high score for a symptom scale / item represents a high level of symptomatology / problems. The EORTC QLQ-C30 Summary score will also be reported and is calculated from the mean of 13 of the 15 QLQ-C30 scale, with higher score indicating a higher quality of life. This tool has established validity and reliability in cancer. |
| Postoperative Quality of Recovery: Postoperative Quality of Recovery Score (PostopQRS) | Preoperative timepoint, 3 days and 6 days postoperatively (if not discharged prior), 30 days and 6 months postoperative | The Postoperative Quality of Recovery Score (PostopQRS) is a multidimensional recovery assessment tool that is a verbal questionnaire. It has proven patient user acceptance and has been validated to be performed either face to face or over the telephone. The core domains include physiologic, nociceptive, functional, cognitive and emotional recovery and satisfaction with care, that is designed for use over multiple timepoints. The PostopQRS provides objective assessment of post-operative recovery, analysing the core domains of recovery, namely physiologic, nociceptive, functional, cognitive and emotional recovery compared to a unique individual preoperative baseline score. Recovery is then scored for each domain, and patients must recover in all tests within the domain to be scored as recovered. "All domains" recovery implies recovery in all of the five recovery domains. |
| Length of hospital stay | at hospital discharge | Length of hospital stay will be documented from the medical records by a blinded assessor at each centre. |
| Health service use and costs | at hospital discharge, 30 days, 6 and 12 months post operative | Captured in following ways: (i) hospital services and the use of health care services outside of hospital. (ii) Patients will be surveyed on their use of health services outside the hospital at 6 and 12 months postop follow-up using a questionnaire. (iii) Cost of program delivery |
| Exploratory Outcomes | through study completion, up to 3 years | Teleprehabilitation is an intervention suitable for patients of low to moderately high perioperative risk levels, however subgroup analyses based on risk provide the opportunity to explore if teleprehabilitation offers additional benefits to patients of increasing risk level. Surgical procedure: Differences in PPC rates between the two surgical groups (abdominal and lung) and between those receiving or not receiving neo-adjuvant therapy before abdominal cancer surgery will be explored. |
Countries
Australia
Contacts
CONTACTLinda Denehy, B AppSc (Physio), PhD
CONTACTJamie Waterland, B Physio(Hons), PhD
PRINCIPAL_INVESTIGATORLinda Denehy, B AppSc (Physio), PhD
University of Melbourne
Outcome results
None listed