Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

MICT plan is containing usual care protocol and additional complete a total of 12 supervised moderate-intensity continuous training sessions in 2-3 weeks.

HIIT plan is containing usual care protocol and additional complete a total of 12 supervised high-intensity interval training training sessions in 2-3 weeks.

Usual care is including smoking cessation instruction, respiratory exercise, review by a specialist nurse, meeting with the surgeon and anesthetist, and receiving information about preparing for surgery.

Participants in MICT group will need to additional complete a total of 12 supervised training sessions in 2-3 weeks.After a warm-up of 5 minutes at 50% at peak WR, the patient start exercising at 60%-70% peak WR for 30-40 minutes (four 5-8 minutes sets, with a 2-min rest in between), and then the patients cooled down for 5 minutes at 50% peak WR. Moderate-intensity exercise training intensity control at 55-74% HRmax or 40-69% VO2peak or PRE12-13 as recommended by guidelines.

moderate-intensity continuous training

Participants in HIIT group will need to additional complete a total of 12 supervised training sessions in 2-3 weeks.After a 5-minute warm-up at 50% at peak WR, the patients complete 20 series of vigorous-intensity sprint (80%-100% peak WR for 30-60s) separated by a low-intensity recovery (30% peak WR or completely rest for 15s), and then the patients cooled down for 5 minutes at 50% peak WR. Participants will begin training at a relatively moderate intensity (60%-65% peak WR) for the first 3 sessions and gradually increase to the target intensity beginning on the 4th session. Intensity control of high-intensity exercise training at 75-90% HRmax or 70-85% VO2peak or PRE14-16 as recommended by guidelines.

high-intensity interval training

Huan Ma, PhD

Huan Ma

The goal of this clinical trail is to compare the effects of preoperative exercise training of different intensities on short-term cardiorespiratory function and postoperative outcomes in patients scheduled for lung resections.

Guangdong Provincial People's Hospital will be the lead center, with an additional 3 hospitals designated as satellite centers for the study. To sum up, these centers will recruit a total of 100 consenting patients. Following informed consent and baseline testing, participants will be randomized into one of the three groups in a 2:1:1 ratio: MICT, HIIT, or usual care (UC).

Participants in the MICT and HIIT groups perform a total of 12 sessions of supervised exercise training, while participants randomized to the UC group receive no extra rehabilitation or physical activity. All participants are followed-up at the completion of the intervention period.Primary outcomes including cardiopulmonary exercise function and pulmonary function will be measured at diagnosis (lung cancer patients scheduled for surgical treatment) (V1), baseline (V2), and post-intervention (V3). The baseline assessment includes medical history and examination. To lessen the psychological burden of the study on the patients, the baseline examination phase could not be repeated if the examinations had been completed during the screening phase and the date of completion was within 7 days prior to enrollment. The patient's postoperative complications, chest tube removal time and hospital length of stay (LOS) will be recorded on the day of discharge (V4). Patient-reported outcomes (PROs) will be measured at baseline (V2), post-intervention (V3), day of discharge (V4), 1 month postoperative (V5), and 3 months postoperative (V6) with ongoing follow-up. Participant blood samples and diaphragm ultrasound will be retained at baseline(V2) and post-intervention (V3) as available. Postoperative deaths will be followed up by telephone on the day of discharge (V4), 3 months postoperatively (V6), 1 year postoperatively (V7), 3 years postoperatively (V8), and 5 years postoperatively (V9).

Due to the nature of the study intervention, this study was an open trial and was not blinded to the patients and study executives. Only the outcome assessors and statistical analysts of the study will be blinded.

Short-term Effects of Preoperative Exercise in Moderate-to-high Perioperative Risk Lung Cancer Patients

Short-term Effects of Preoperative Exercise in Moderate-to-high Perioperative Risk Lung Cancer Patients(PRE-EXELUCA): a Multicenter Prospective Randomized Controlled Clinical Trial

The post-training change in cardiorespiratory fitness will be measured by the VO2peak in ml/kg/min.VO2peak will be evaluated by a cardiopulmonary exercise test.

Pulmonary function will be measured as the first step of the CPET. Predicted postoperative (PPO) lung functions will be calculated by the Forced Expiratory Volume in one second (FEV1). Pulmonary function in patients scheduled for wedge resection will be assessed as a predicted percentage of FEV1. Whereas participants planning to have segmentectomy or lobectomy will be evaluated with PPO FEV1 as a percentage of predicted value.

Postoperative complications will be recorded and graded specifically according to a modified version of the Thoracic Mortality and Morbidity (TMM) classification system, and related treatments will be recorded, with statistics on the incidence of TMM grade 2 or higher complications. In addition, chest tube duration and hospital LOS will be recorded.

Postoperative mortality will be recorded by calling.

The MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC), a validated lung cancer-specific scale, will be utilized to assesses patients' symptoms to measure patient-reported outcomes(PROs).MDASI-LC includes 16 symptom items with scores ranging from 0 (no symptom) to 10 (worst symptom imaginable) and six functional items with scores ranging from 0 (no interference) to 10 (complete interference).

Guangdong Provincial People's Hospital

Participants prescribed moderate intensity aerobic exercise using their rating of perceived exertion (RPE) with a goal of sustaining an intensity level of 12 to 14 for their prescribed duration.

Participants prescribed moderate intensity aerobic exercise using personalised heartrate zones with a goal of sustaining an intensity level by maintaining their heartrate above 50 percent of their heartrate reserve level for their prescribed duration.

Participants prescribed moderate intensity aerobic exercise using personalised heartrate zones with a goal of sustaining an intensity level by maintaining their heartrate above 50 percent of their heartrate reserve level for their prescribed duration

Exercise to a Heart Rate (HR) Zone

Nigel JM Noor, MBChB

Becky Ward

Nigel JM Noor

Leanne Ashrafian

Krishna Moorthy

Prehabilitation is the use of exercise prior to surgery to improve peoples' fitness, which leads to improved outcomes of surgery. This service is now being run remotely, however, there is little existing evidence to support the best practice for this. Currently, baseline fitness is assessed remotely using either a sit to stand test or a step test. Once completed people are prescribed regular exercises and asked to exercise to a level of intensity using a measure called Rating of Perceived Exertion (RPE). However, these measurements may not be reliable. We are carrying out a study to assess if another waking test (modified Rockport test) and asking patients to exercise to a target heart rate are better measures of assessing baseline fitness and exercise intensity.

All participants will receive weekly telephone calls to check their progress and be provided with a wrist worn fitness tracker (Fitbit). Participants will be randomised to one of two groups. The only difference between the groups will be the way the exercise is prescribed. In one group participants will be asked to complete the exercises to an exercise level they find "somewhat hard". The other group will be asked to complete the exercises to maintain a set heart rate.

All participants will be asked to complete an activity log (submitted weekly) as an online form. A small group of people (maximum 10) will be asked if they would like to complete an in-person baseline fitness assessment also, this is optional.

This study runs for up to eight weeks with participation ending after eight weeks or at the time of surgery, whichever is sooner. In the final week of participation, participants will be asked to complete an online questionnaire about their experience of using a wearable fitness tracker during the prehabilitation programme.

Optimising patients pre-operatively or "Prehabilitation" is a relatively new and evolving concept in patient care. Prehabilitation utilises prescribed exercise in the time prior to surgery with the aim of improving a patient's functional capacity enabling them to better withstand the stress of surgery. 1-3 This is required due to the physiological insult cause by surgery, particularly in those with cancer, which in turn results in a decline in patients' function.

Post-operative restorative rehabilitation programmes such as Enhanced Recovery After Surgery (ERAS) are commonplace and used with the aim of returning the patients' function towards their preoperative baseline. ERAS has been shown to improve postoperative outcomes, including length of stay, re-admission, and complication rates.4 Prehabilitation has been shown to both improve cardiovascular fitness prior to surgery5,6 and like ERAS reduce post-operative complications.7,8 However, despite this and unlike ERAS, it's use is still patchy, with no national protocols in existence.

Due to evidence demonstrating its effectiveness, the benefits of commissioning prehabilitation services have been acknowledged in several surgical fields,9 with national policy documents from NHS England placing an emphasis on preventative rehabilitation, delivered before and during cancer treatment.10 As such, the policy environment could be seen as favourable. However, there is little evidence available, and significant heterogeneity in that which is available, for how best to approach a prehabilitation service to achieve the best results.

Physical activity is a core component seen across all reported prehabilitation programmes. However, heterogeneity is seen across multimodal programmes, meaning the type of exercise, duration and supervision of physical activity is inconsistently administered between studies. Additional interventions such as dietary support, psychological wellbeing and smoking cessation are also variably addressed in some studies.

Accurate, reliable, and reproducible assessment of cardiopulmonary fitness is required to effectively prescribe and monitor patients as they progress through a prehabilitation programme. Currently, cardiopulmonary fitness assessment requires patients to attend for in person assessment to undergo Maximal or Submaximal exercise testing.

WEARABLE ACTIVITY TRACKING AND EHEALTH TECHNOLOGIES IN HEALTHCARE

Wearable "fitness tracking" technologies incorporating sensors which monitor activity and physiological parameters are now pervasive and are a rapidly expanding commercial industry worldwide with a market size valuation of USD 37.10 billion in 2020, and a projected compound annual growth rate of 15.9% from 2020 to 2027.11 With significant investment in this technology leading to increasing functionality, reliability and aesthetics it opens up the potential for use in a healthcare setting where to date their use has already been shown to be both feasible and insightful in the perioperative setting.12 Intuitively, these devices could provide a beneficial aid in prehabilitation programmes. However, a literature review found no studies have yet reported the use of wearable technologies on patients when used within a prehabilitation programme.

eHealth technologies are defined as the cost-effective and secure use of information and communications technologies in support of health and health-related fields13. They are already widely used by patients with 72% of internet users saying they looked online for health information of one kind or another within the past year14 and 69% of adults regularly tracking a health indicator like weight, diet, exercise routine, or symptom15. Utilising eHealth technology within prehabilitation may help to improve patient participation, particularly in home-based programmes. The assessment of exercise intensity is one possible area in which it could be used to overcome the limitations of self-assessment. Making it easier for patients to assess intensity and monitor the frequency that they are achieving their target activity may improve exercise behaviour and consequently improve the response to prehabilitation.

RATIONALE FOR CURRENT STUDY

Using fitness trackers in prehabilitation opens up the potential for remote programmes whilst maintaining objective measurement of heart rate and step count. Remote prehabilitation programmes, as opposed to in person individual or group sessions within a hospital setting are attractive to patients, health professionals and policy makers alike. For patients, the distance from home and the physical and financial demands of travel can negatively impact accessibility of programmes and the time available to complete exercises. Particularly pertinent for those travelling long distances to tertiary centres for cancer treatment and more recently with the risks of COVID-19 to those clinically vulnerable. Therefore, reducing unnecessary hospital visits is desirable. Remote assessment makes scheduling easier for clinicians and the use of wearable fitness trackers provides a more detailed understanding of individual parameters over longer periods, rather than a snapshot. For policy makers, remote assessment means reduced clinic and or gym space required, therefore reducing costs and reduced footfall (a key target resulting from the covid-19 pandemic) within the hospital to facilitate other scheduling commitments. Whilst many perceived benefits exist, it is also necessary to acknowledge that the use of fitness trackers and remote assessment may not benefit all, an area which will be addressed in this work. Whilst many remote programmes do now exist, the use of fitness trackers to support these programmes has not been assessed.

Exercise intensity Many reported programmes use a measure called Rating of Perceived Exertion (RPE) to measure exercise intensity. RPE is a widely used and validated scale that has been shown to accurately correspond to intensity measured by maximum heart rate (HRmax) in many different populations.16-18 However, as a self-reported measure, it is inherently prone to measurement bias; a preliminary study found that over 60% of RPE measurements made by patients during prehabilitation were overestimates of the actual achieved intensity measured by achieved heart rate. It is therefore proposed that using fitness trackers individuals could exercise to prescribed heart rate zones to improve achievement of their exercise targets. A heart rate zone is a range of heart rates which corresponds to a desired training effect for an individual. They can be calculated as a percentage of the heart rate reserve (HRR) which is the maximum heartrate (HRmax) an individual can achieve minus their resting heartrate (RHR).

Existing prehabilitation programs prescribe the intensity of aerobic exercises to patients by asking them to exercise to a rating of perceived exertion (RPE). As a self-reported measure, there is an inherent propensity towards measurement bias, with studies reporting over 60% of RPE measurements made by patients during prehabilitation as overestimates of the actual intensity achieved when measured by their heart rate. Therefore, I hypothesise that prescribing to a heart rate zone and providing a heart rate tracker to monitor this will increase the levels of moderate intensity exercise achieved.

Self-reporting and Adherence

Direct links have been reported between the amount of physical activity completed each week and post operative outcomes (lower risk of post-operative pneumonia with increasing volumes of activity completed in the pre-operative period). 19 However, current programmes are reliant on self-reported adherence, making assessment of the true benefits challenging. A previous study of the PREPARE programme found an average adherence of 64% to the prescribed exercise.20 Adherence to home-based exercises is often lower than supervised programmes 21 and exercise participation during chemotherapy is particularly challenging.22 It is therefore important to explore ways to remotely support and encourage patients to follow their exercise programmes during prehabilitation. Fitness trackers provide a potential objective measurement of adherence to prescribed targets.

It is beneficial to provide home (vs. hospital) based exercise programmes. However, their effectiveness dependent on patients' adherence to the prescribed physical exercises (currently self-reported via an activity log), where activity is frequently over-reported. Heart rate trackers provide data on activity level and therefore can be used remotely to determine compliance.

Patient satisfaction of using fitness trackers

Whilst the theory of using fitness trackers in remote prehabilitation is attractive, it is only beneficial if the target population are engaged, willing and able to use the devices for the desired purposes. It is important to acknowledge that the demographics of those undertaking prehabilitation for OG, HPB and LC resections may not be representative of the average and could find the use of these technologies challenging.

There is no current evidence to demonstrate that patients find the use of wearable fitness trackers in prehabilitation acceptable. The benefits of using wearable fitness trackers in prehabilitation will be reduced if compliance with the device is low (i.e., they do not wear them). Therefore, there is a need to assess the acceptability, usability, and user experience of using heart rate trackers in a prehabilitation setting.

A prospective, two-arm randomised parallel group clinical trial. Prehabilitation is routinely offered as the standard of care to all patients who are scheduled for curative resectional surgeries for upper gastrointestinal (UGI) cancer at Imperial College Healthcare Trust and lung cancer at Guy's and St Thomas' NHS Foundation Trust.

Consecutive patients referred for prehabilitation will be approached for enrolment into the study. If willing to participate, written informed consent will be gained (e-consent). Following enrolment all participants will be provided with a wearable fitness tracker and will be randomised to one of two groups (1:1 randomisation) - Group A or Group B. The only difference between the two groups is the prescription of exercise, all other activities and data collected are the same.

Randomisation following recruitment and using a computer programme.

Because of the nature of the study and the interventions offered, it will not be possible to blind participants or research assistants to allocation groups.

Assessment, Monitoring and Optimisation of Prehabilitation Patients Using Wearable Fitness Trackers

The primary outcome will compare between intervention and control groups the total number of minutes of moderate intensity exercise, i.e., exercise within target range as measure on the Fitbit over the 8 weeks of follow-up

A comparison of the volume of physical activity (mean MET min/week) achieved between the intervention and control groups over the 8 weeks of follow-up.

A comparison of weekly adherence (mean percentage of actual/prescribed MET minutes/week) between the intervention and control groups over the 8 weeks of follow-up.

Comparison between participants self-reported duration of exercises (minutes) and their recorded duration of achieving \>40% of their heart rate reserve (minutes).

Comparison between participants self-reported intensity of exercises and their recorded heart rate intensity data (RPE vs % of target HR zone achieved) .

Descriptive analysis assessing the acceptability of the intervention to the participants using a validated questionnaire at the end of the intervention period.

TAM - 12 questions (6 on perceived usefulness. 6 on perceived Ease-of-use) each graded on a 7 point Likert scale

Descriptive analysis of a validated questionnaire assessing usability of the intervention to the participants taken at the end of the intervention.

UMUX-lite - 2 questions graded on a 7 point Likert scale

Descriptive analysis of the participants user experiences of the intervention using a validated questionnaire at the end of the intervention.

UEQ - 26 pairs of contrasting attributes that may apply to the product each to be graded on a 7 point Likert scale

Imperial College Healthcare NHS Trust

Guy's and St Thomas' NHS Foundation Trust

Imperial College London

Symptoms and General Pathology

Postoperative Complications

A high-intensity, home-based, exercise program consisting of inspiratory muscle training (IMT), endurance- and functional strength exercise. The sessions will supervised by a physiotherapist during six occasions and start 2-3 weeks before surgery. IMT will be conducted with an intensity starting from 50 % of maximal capacity, with a self-reported effort of 5-7 on the Borgs CR-10 scale. Endurance and functional strength exercises will be performed at a self-reported effort of 7-8. Interval training, chair stand- and step-up exercises will be key components of the exercise program. Furthermore, the program will include task-specific exercises based on the participants self-expressed needs.

On non-supervised days, participants will perform IMT twice a day as well as endurance and strength training, 2-3 days per week with 1-2 days per week of active recovery in the form of moderate intensity walks. This will be monitored with an activity journal and an accelerometer.

Participants in the control group receive pre- and postoperative care as usual. In addition, they will be encouraged to follow the WHO guidelines of moderate intensity aerobic physical activity for at least 150 min per week. Their activity level will be monitored with an accelerometer.

Exercise

Elisabeth Rydwik, Assoc prof

This randomized controlled trial is a multicentre study designed to explore the effects of preoperative exercise on physical fitness, postoperative complications, recovery, and health-related quality of life in older individuals at risk scheduled to undergo colorectal cancer surgery. The hypothesis is that older patients with low preoperative physical capacity will benefit from preoperative exercise in terms of lower risk for postoperative complications and improved recovery after surgery.

Reduced physical capacity and performance associated with advancing age may decrease the ability to withstand the strain of a major surgical intervention. Exercise prior to surgery is a key component of prehabilitation. The goal of prehabilitation is to enhance preoperative physical fitness to attenuate postoperative decline and possibly decrease the risk of postoperative complications.

A previous observational study showed that better preoperative physical performance in measures of walking distance, leg strength, inspiratory muscle strength and maximal gait speed reduced the risk of severe postoperative complications for older patients undergoing abdominal cancer surgery. Furthermore, gait speed has been suggested to add information to current preoperative risk screening, where a cut of value of a maximal gait speed below 2 meters/second indicates a higher risk for postoperative complications.

This planned trial will be conducted in cooperation with the Karolinska University Hospital, Ersta Hospital, The Stockholm South General Hospital and several primary care units in Stockholm. To target older patients at risk, patients aged 65 and older with a maximal gait speed under 2 meters/second will be included. Participants will be randomized to either intervention- or control group and trained physiotherapists or nurses from the hospitals, will conduct the assessments. All baseline measures will be collected before randomization.

The implementation of standardized cancer care pathways in Sweden has led to reduced time between diagnosis to curative treatment. For colorectal surgery, the time from decision to treatment is set to two weeks. Therefore, an exercise program aimed to enhance physical function prior to surgery require a high intensity and high frequency approach. The exercise program will be home-based and consist of inspiratory muscle training, endurance- and strength exercise under the supervision of trained physiotherapists from primary care units. To assess feasibility of the planned intervention, a pilot study was conducted. The results showed high compliance and acceptability among the participants which provides a starting point for this larger study designed to explore the effects of preoperative exercise on:

1. Preoperative physical function in a short-term perspective
2. Postoperative complications and functional decline
3. Length of in-hospital stay, mortality, health-related quality of life, physical activity level and independency in activities in daily living in a long-term perspective

Optimizing Physical Function Before Cancer Surgery in Older People at Risk

Optimizing Physical Function Before Surgery: Effects on Complications and Physical Function After Gastrointestinal Cancer Surgery in Older People at Risk- A Randomized Controlled Trial

Data is not publicly available, but available upon request.

The Clavien-Dindo classification system will be used to describe the occurence of post-operative complications.

The 6-minute walk test will be used to assess physical endurance. The test requires subjects to walk as far as possible during 6 minutes. Outcome is metres walked.

The number of days spent at hospital. Data will be collected from the medical records. Outcome is number of days.

The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire core-30 (EORTC QLQ-C30) and the supplemental Elderly Cancer Patients Module will be used to assess quality of life. The scale is comprised of nine subscales: one global health status scale, five functioning scales and three symptom scales. The scales range from 0-100 scores. Higher scores for the global health status scale and functioning scales indicate better outcomes. For the symptom scales, higher scores indicate worse outcomes.

The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire for the Elderly Cancer Patients Module (EORTC QLQ-ELD14) will be used to assess quality of life. The scale is comprised of five subscales: mobility, family support, worries about the future, maintaining autonomy and purpose, and burden of illness. The scales range from 0-100 scores. For the family support scale and the autonomy and purpose scale, higher scores indicate better outcomes. For the mobility, worries and burden of illness scales, higher scores indicate worse outcomes.

Data on destination of discharge will be collected from the medical journal. The information will be categorized into home, rehabilitation facility or further care (in e.g a geriatric clinic or residential care).

The Postoperative Recovery Profile. The scale consists of physical symptoms, physical function, psychological and social impact and activity. The results are divided in 5 categories from not recovered at all to fully recovered.

Confusion Assessment Method consists of 9 item, if you fulfill one of the items 1-4, you are diagnosed with confusion.

The 30-second chair stand test will be used to measure functional lower extremity strength. Outcome is the number of times the patient comes to a full standing position in 30 seconds.

Micro respiratory pressure meter is measured using the MicroRPM.

The ADL-staircase is an hierarchical scale with 10 items including both personal and instrumental activities ranging from inpedendent to dependent.

Physical Activity Scale for the Elderly includes time spent in sitting, exercise, leisure, household/gardening and work/voluntary activities. It scores from 0 to 400, higher score indicate higher activity level.

Mortality data will be collected from medical records.

Karolinska Institutet

Associate Professor

Skin and Connective Tissue Diseases

Blood and Lymph Conditions

Breast Neoplasms

Lymphedema

Neoplasm Metastasis

Breast Diseases

Skin Diseases

Lymphatic Diseases

Individually tailored exercise consisting of aerobic, strength, and flexibility exercises is prescribed, self-exercise compliance monitoring through an application, and diet management education through nutritional counseling.

One session of flexibility exercise education, diet management education through nutritional counseling

Aerobic exercise: 30-40 minutes/time, 3-5 times a week, intensity of 4-6 points on the Rating of Perceived Exertion(RPE) 10-point scale(A simple conversation is possible during exercise, but the intensity is such that you feel out of breath) Strength training: 2-3 times a week, 3 sets of 10 repetitions per movement

* Upper extremities: Biceps brachii, triceps brachii, deltoid, pectoralis muscle exercise
* Lower extremities: gluteus maximus, hamstrings, quadriceps exercise Flexibility exercise: Stretching and mobility exercises reflecting post-surgery rehabilitation

Aerobic exercise, Strength training, Flexibility exercise

Jaeyong Jeon

Seungwoo Cha

Heejeong Kim

Chul Jung

Hwayeong Cheon

Junghwa Do

Woojin Jeong

Research purpose: Lymphedema is a very common complication in breast cancer patients. However, since there is currently no curable treatment, it is important to prevent and reduce the severity of lymphedema. The purpose of this study is to evaluate whether preoperative exercise is effective in preventing lymphedema after surgery. For secondary outcome, the preventive effects of exercise on other upper extremity dysfunctions (eg. pectoralis tightness, Axillary web syndrome, Adhesive capsulitis), which are common in breast cancer patients, were assessed.

Study subjects:

* Patients aged 20 or older who were first diagnosed with breast cancer
* BMI over 23
* Patients scheduled to undergo neoadjuvant chemotherapy before surgery Study design: Prospective randomized controlled comparative clinical study
* Intervention is performed for at least 3 months during the neoadjuvant chemotherapy period before surgery.
* Treatment group: Individually tailored exercise consisting of aerobic, strength, and flexibility exercises is prescribed, self-exercise compliance monitoring through an application, and diet management education through nutritional counseling.
* Control group: One session of flexibility exercise training, diet management education through nutritional counseling

Result variable:

* Primary outcome variable:

  1) Incidence and severity of postoperative lymphedema: bilateral upper limb volume, ICG lymphography
* Secondary outcome variables:

  1. Clinical information: Demographic, disease and treatment-related data
  2. Physical-related: height/weight/waist circumference measurement, body composition test, physical examination (axillary membrane evaluation)
  3. Upper extremity function (shortening of the pectoralis major muscle, adhesive capsulitis): evaluation of shoulder range of motion, upper extremity muscle strength/grip strength
  4. Quality of life assessment: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30(EORTC QLQ-C30), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast cancer module 23(EORTC QLQ-BR23)

Assessment Schedule:

* Initial treatment and evaluation: Immediately after breast cancer diagnosis
* Follow-up evaluation: Immediately after completion of exercise intervention (preoperatively), and at 1, 3, and 6 months postoperatively.

Number of study subjects:

* This study will be conducted as a preliminary study for future research, and will be conducted on a total of 60 patients (30 in the experimental group and 30 in the control group) with an allocation ratio between groups of 1:1.

* Patients aged 20 or older and younger than 80 years old who were first diagnosed with breast cancer
* BMI of 23 or higher
* Patients scheduled to undergo neoadjuvant chemotherapy before surgery

Effect of Preoperative Exercise on the Prevention of Secondary Lymphedema in Breast Cancer Patients

Using a tape measure, measure the circumference from the wrist to the armpit every 4cm, then apply the ΣCircumference2/π formula to calculate the volume of the upper limb.

Indocyanine green (ICG) contrast agent is injected subcutaneously in the distal area, and lymph fluid flowing to the proximal area through collateral lymphatic vessels is checked with an infrared camera.

After attaching electrodes to both hands and feet using the Inbody S10 equipment, quantitatively evaluate body composition by measuring human body impedance using multiple frequencies.

Measurements are made according to a standardized protocol using a goniometer.

Using a digital hand held dynamometer, the strength of elbow flexion and extension, shoulder abduction, and flexor extensor muscles was measured.

Measure grip strength using a digital hand held dynamometer

Evaluate the patient's quality of life through the corresponding questionnaire

Asan Medical Center

Professor

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Stomach Neoplasms

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Esophageal Cancer

Pancreatic Cancer

Stomach Cancer

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Ethanol

Anesthetics

Benzocaine

Tannic Acid

The main aim of the virtual multimodal hub is to prepare participants for surgery (including the role of Enhanced Recovery after Surgery (ERAS) pathway) and support declines in physiological and psychological function associated with preoperative treatments (e.g., chemo-radiotherapy) and major surgery. The post-hospital discharge interventions will focus on the recovery of activities of daily living, occupational tasks, and recreational activities. Aided by standardised assessment tools, a comprehensive holistic baseline (first preoperative multimodal session) and post-discharge (first postoperative multimodal session) assessment of patients' physical, nutritional, psychological and overall health status, presence of co-morbidities and medical history will determine the frequency, intensity, time, type, volume, and progression of the multimodal interventions.

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 the preoperative anaesthetic clinic visits. Participants will be asked to maintain their normal daily activities.

Aerobic (HIIT) Endurance Respiratory Muscle Strength Education

Preoperative Exercise

Aerobic Muscle Strength Walking Program Education

Postoperative Exercise

Malnutrition screening Weight monitoring Symptom management Dietetic counselling Nutrition support

Preoperative Nutrition

Postoperative Nutrition

CBT skills Skills training Emotional validation Behavioural activation Psycho-education

Preoperative Psychology

Postoperative Psychology

Comorbidities Managing pain Wound care Complications Surgical education ERAS

Preoperative Nursing

Managing pain Cardiovascular stability Wound care Bowel function/Stoma Complications Education

Postoperative Nursing

Weekly sessions moderated by a social worker including patients and carers:

Safe space Share experiences/ideas Support Education

Preoperative Peer Support Group

Postoperative Peer Support 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 the preoperative anaesthetic clinic visits.

Usual Care

Daniel Steffens, PhD

Michael Solomon, DMed

The provision of preoperative interventions (prehabilitation: including exercise, nutrition, and psychological treatment) have been reported to reduce postoperative complications by as much as 50% and reduce hospital stay by up to 4 days compared to standard of care. Postoperative multimodal interventions are likely to further benefit patients facing new challenges (e.g. stoma care), and reduce post discharge complications.

Therefore the Virtual Multimodal hub of PRIORITY-CONNECT 2 Pilot Trial aims to primarily; determine the feasibility of incorporating a virtual multimodal program into the preoperative and postoperative period for patients undergoing gastrointestinal cancer surgery, the acceptability to patients, clinicians and carers of the virtual multimodal program and the acceptability to patients of being randomised to the virtual multimodal program or usual care.

The secondary aim is to obtain pilot data on the likely difference in key outcomes (30 days postoperative complications, quality of life, days at home and alive at 30 days - DAH30, implementation outcomes and cost outcomes) to inform the development of a substantive randomised clinical trial.

Randomised Type I Hybrid Effectiveness-Implementation Trial

Consenting participants will undergo baseline assessment immediately prior to randomisation to intervention (virtual multimodal hub and usual care) or control group (usual care alone). The randomisation sequence will be prepared a priori using a central secure randomisation service (1:1 allocation ratio in random permuted blocks of sizes 4 or 2 stratified by hospital, to ensure balance intreatment assignment within hospital) to ensure concealment of treatment allocation and blinding of surgeon, all trial personnel and statistician. Due to the nature of the intervention, it is not possible to blind the clinicians delivering the intervention (virtual multimodal hub); however, the investigators will ensure that all patients' interactions are standardised.

PRIORITY-CONNECT 2 Pilot Trial

Virtual Multimodal Hub for Patients Undergoing Major Gastrointestinal Cancer Surgery - PRIORITY-CONNECT 2 Pilot Randomised Type I Hybrid Effectiveness-Implementation Trial

Feasibility will be determined by the following outcomes:

(i) Number of eligible participants recruited to the pilot trial; (ii) Retention rate: defined as the percentage of participants who completed the trial; (iii) Adherence rates: defined as the percentage of planned sessions attended by those who were randomised to the intervention group.

Patients, clinicians and carers acceptability to the virtual multimodal hub (Intervention) will be assessed with a semi-structured questionnaire administered at 3-months (last survey). The semi- structured questionnaire contains 11 questions and participants (Patients, clinicians and carers) will be instructed to use a 5-point Likert Scale to express how much they agree or disagree with each statement. In addition, patients will be asked how satisfied they were with the virtual multimodal program and if the program negatively affected them. The investigators have also taken the opportunity to seek further feedback about the virtual multimodal hub (open ended question). The questionnaire has been used on previous pilot trials.

Defined as any deviation from the normal postoperative course and classified according to the Clavien-Dindo classification. The risk of developing complications following gastrointestinal cancer surgery is highest in the first 30-days after surgery; this is a critical determinant of recovery, long-term outcomes, and gastrointestinal cancer treatment costs.

EORTC QLQ-C30 (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire) is a 30-item cancer-specific tool measuring five functioning scales, nine symptom scales, financial impact and overall QoL. This tool is a common (excellent reliability and validity) QoL tool for gastrointestinal cancer patients. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

EORTC QLQ-OG25 (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire) is a 25-item tool measuring function and symptoms specific to oesophoago-gastric cancer. This tool is a common (excellent reliability and validity) QoL tool for gastrointestinal cancer patients. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

EORTC QLQ-CR29 (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire) is a 29-item tool measuring function and symptoms specific to colorectal cancer. This tool is a common (excellent reliability and validity) QoL tool for gastrointestinal cancer patients. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

DAH-30, 90 (days at home 30, 90): Validated (Australian population) patient-centred outcome metrics that integrates length of hospital stay, discharge destination (other than home), hospital readmission and early death. The number of days at home - reduced by complications, discharge to a care facility, re-admission, and death is quantified as the days alive and at home during the 30 days after surgery. DAH-30, 90 is calculated using mortality and hospitalisation data from the date of the index surgery (= Day 0).

(Costs): Patient and health system resource use, including the cost of the virtual multimodal hub interventions, hospitalisations, will be collected (surveys) from randomisation (1-6 weeks prior to surgery) to 3 months post index surgery.

RE-AIM Framework, including:

Reach: Measured through trial participation, baseline characteristics (referral pathways, age, postcode, marital, work status, and Culturally And Linguistically Diverse \[CALD\]) of all potential participants.

RE-AIM Framework, including:

Effectiveness: Measured through clinical outcomes, healthcare utilisation, participant satisfaction.

RE-AIM Framework, including:

Adoption: Measured through referral rates, enablers and barriers (surveys with patients, carers, surgeons, clinical and administrative staff post intervention).

RE-AIM Framework, including:

Implementation: measured through; Individual level: Participant adherence to virtual. Centre level: Implementation process, concordance with intervention protocol.

RE-AIM Framework, including:

Maintenance: Measured through rates of referral over time of the study; stakeholder interviews regarding refinements and infrastructure needed to maintain and scale intervention beyond the project period.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Short-term Effects of Preoperative Exercise in Moderate-to-high Perioperative Risk Lung Cancer Patients	NCT06215326	Lung Cancer	moderate-intens... high-intensity ...	18 Years -	Guangdong Provincial People's Hospital
Assessment, Monitoring and Optimisation of Prehabilitation Patients Using Wearable Fitness Trackers	NCT06071650	Cancer	Exercise to a H...	18 Years - 80 Years	Imperial College London
Optimizing Physical Function Before Cancer Surgery in Older People at Risk	NCT04878185	Colorectal Canc... Postoperative C...	Exercise	65 Years -	Karolinska Institutet
Effect of Preoperative Exercise on the Prevention of Secondary Lymphedema in Breast Cancer Patients	NCT06421285	Breast Neoplasm...	Aerobic exercis...	20 Years - 80 Years	Asan Medical Center
Assessment, Monitoring and Optimisation of Prehabilitation Patients Using Wearable Fitness Trackers	NCT06071650	Cancer	Exercise to a H...	18 Years - 80 Years	Imperial College London
Short-term Effects of Preoperative Exercise in Moderate-to-high Perioperative Risk Lung Cancer Patients	NCT06215326	Lung Cancer	moderate-intens... high-intensity ...	18 Years -	Guangdong Provincial People's Hospital
PRIORITY-CONNECT 2 Pilot Trial	NCT06212700	Liver Cancer Pancreas Cancer Oesophageal Can... Gastric Cancer Colorectal Canc...	Preoperative Ex... Postoperative E... Preoperative Nu... Postoperative N... Preoperative Ps... Postoperative P... Preoperative Nu... Postoperative N... Preoperative Pe... Postoperative P... Usual Care	18 Years -	Surgical Outcomes Research Centre (SOuRCe)

Spots Global Cancer Trial Database for preoperative exercise