Implementing Tele-prehabilitation Education Into Cancer Care Pathways
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 515
- 试验地点
- 15
- 主要终点
- Post operative Pulmonary Complication (PPC)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Tele-prehabilitation intervention (Intervention Group)
The Teleprehabilitaiton intervention (also known as Surgery School) is a one-off group based education session delivered online. Video presentations of 7 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.
干预措施: Tele-prehabilitation education session: Surgery School (Behavioral)
Usual care alone (Control Group)
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.
干预措施: Usual Care (Other)
Sub-study: Tele-prehabilitation and inspiratory muscle training program
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.
干预措施: Tele-prehabilitation education session: Surgery School (Behavioral)
Sub-study: Tele-prehabilitation and inspiratory muscle training program
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.
干预措施: Individualised Inspiratory Muscle Training and Walking Program (Behavioral)
Sub-study: Tele-prehabilitation intervention
The Teleprehabilitaiton intervention (also known as Surgery School) is a one-off group based education session delivered online. Video presentations of 7 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.
干预措施: Tele-prehabilitation education session: Surgery School (Behavioral)
结局指标
主要结局
Post operative Pulmonary Complication (PPC)
时间窗: 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.
次要结局
- Postoperative complications(Postoperative day 3,5,10 unless discharge prior and 30 days post operative.)
- Number of days alive and out of hospital(30 days, 6 months and 12 months post operative)
- Diagnosis of pneumonia(Daily up to postoperative day 7 or until hospital discharge)
- Maximal Inspiratory Pressure (MIP)(Baseline and preoperatively at centres participating in the inspiratory muscle training sub study)
- Physical activity levels - subjective(Baseline, Preoperatively, 30 days post operative)
- Physical activity levels - objective(Baseline, Preoperatively, 30 days post operative)
- Video and Surgery School Session Attendance (Intervention group only)(Preoperative timepoint)
- Access to video outside the Surgery School Session (Intervention group only)(Preoperative timepoint)
- 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.)
- Behaviour Change(Preoperative timepoint, at hospital discharge (+3 days))
- Self-efficacy: Patient Activation Measure(Baseline, preoperative timepoint, 30 days and 6 months postoperative.)
- Treatment Burden: Multimorbidity Treatment Burden Questionnaire (MTBQ)(Baseline, preoperative timepoint, 30 days postoperative)
- Viewer perceptions of the intervention (intervention group only)(Preoperative timepoint)
- Acceptability(Preoperative timepoint, at hospital discharge (+3 days), 30 days post operative)
- Participant satisfaction: Australian Hospital Experience Question Set (AHPEQS)(30 days post operative)
- Health related quality of life: EORTC QLQ-C30(Baseline, Preoperative, 30 days, 6 months and 12 months post operative)
- Length of hospital stay(at hospital discharge)
- Health service use and costs(at hospital discharge, 30 days, 6 and 12 months post operative)
- Exploratory Outcomes(through study completion, up to 3 years)
- Diagnosis of pneumonia(Daily up to postoperative day 7 or until hospital discharge)
- Length of hospital stay(at hospital discharge)
- Physical activity levels - objective(Baseline, Preoperatively, 30 days post operative)
- Viewer perceptions of the intervention (intervention group only)(Preoperative timepoint)
- Feasibility of the teleprehabilitation program: Proportion of eligible patients participating(Time Frame: Through study recruitment, up to 2.5 years)
- Feasibility of the teleprehabilitation program: Representativeness(Time Frame: Through study recruitment, up to 2.5 years)
- Postoperative complications(Postoperative day 3,5,10 unless discharge prior and 30 days post operative.)
- Number of days alive and out of hospital(30 days, 6 months and 12 months post operative)
- Maximal Inspiratory Pressure (MIP)(Baseline and preoperatively at centres participating in the inspiratory muscle training sub study)
- 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.)
- Behaviour Change(Preoperative timepoint, at hospital discharge (+3 days))
- Acceptability(Preoperative timepoint, at hospital discharge (+3 days), 30 days post operative)
- Self-efficacy: Patient Activation Measure(Baseline, preoperative timepoint, 30 days and 6 months postoperative.)
- Treatment Burden: Multimorbidity Treatment Burden Questionnaire (MTBQ)(Baseline, preoperative timepoint, 30 days postoperative)
- Physical activity levels - subjective(Baseline, Preoperatively, 30 days post operative)
- Access to video outside the Surgery School Session (Intervention group only)(Preoperative timepoint)
- Video and Surgery School Session Attendance (Intervention group only)(Preoperative timepoint)
- Fidelity (treatment delivery): Tele-prehabilitation education session duration(Through study data collection, up to 2.5 years)
- Fidelity (treatment delivery): Number of videos accessed(Through study data collection, up to 2.5 years)
- Health related quality of life: EORTC QLQ-C30(Baseline, Preoperative, 30 days, 6 months and 12 months post operative)
- Health service use and costs(at hospital discharge, 30 days, 6 and 12 months post operative)
- Exploratory Outcomes(through study completion, up to 3 years)
- Feasibility of the teleprehabilitation program: Referral rates(Time Frame: Through study recruitment, up to 2.5 years)
- Feasibility of the teleprehabilitation program: reasons for declining(Time Frame: Through study recruitment, up to 2.5 years)
- Fidelity (treatment delivery): Number of video views(Through study data collection, up to 2.5 years)
- Fidelity (treatment delivery): Telehealth implementation process concordance with implementation protocol.(Through study data collection, up to 2.5 years)
- Fidelity (treatment receipt): participant retention at follow up(Through study data collection, up to 2.5 years)
- Fidelity (treatment delivery): viewing time(Through study data collection, up to 2.5 years)
- Fidelity (treatment receipt): participant attendance at telehealth zoom meeting(Through study data collection, up to 2.5 years)
- Participant satisfaction: Australian Hospital Experience Question Set (AHPEQS)(30 days post operative)
- 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)
- Fidelity (treatment receipt): number of questions(Through study data collection, up to 2.5 years)