Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Nervous System Diseases

Symptoms and General Pathology

Rare Diseases

Pancreatic Neoplasms

Sarcopenia

Atrophy

Muscular Atrophy

Neuromuscular Manifestations

Neurologic Manifestations

Pathological Conditions, Anatomical

Pancreatic Cancer

4-week trimodal prehabilitation program: Exercise, nutritional supplementation, and psychological support

Prehabilitation program

perioperative immunonutrition by ORAL IMPACT

Oral Impact

Mehdi ELAMRANI, MD

Major digestive surgery is associated with a significant rate of postoperative complications. To improve postoperative outcome, efforts are focused on postoperative course leading to the concept of rehabilitation. However, the rehabilitation concept does not allow to improve muscular and functional reserves at the time of surgery. Sarcopenia is a condition characterized by loss of skeletal muscle mass and function. Also, the prevalence of sarcopenia in patients with cancer is high and has a prevalence of around 25% in patients with pancreatic cancer, with a considerable impact on postoperative and survival outcomes.

The hypothesis is the preoperative management of sarcopenia by a rehabilitation program could improve patients' operative outcomes by reducing the rate of postoperative complications.

Preoperative Prehabilitation for Sarcopenic Patients Prior to Pancreatic Surgery for Cancer

Prehabilitaion Program for Sarcopenic Patients Prior to Pancreaticoduodenectomy for Periampullary Malignant Tumors

Pancreatic fistula as defined by the International Study Group of pancreatic Fistula (ISGPF)

Grade \> IIIa (Clavien-Dindo classification)

self questionnaire to measure opinion with respect of rehabilitation program

EVAN-G general patient satisfaction questionnaire consisting of 26 items divided into 6 sub-sections scoring on a scale from 0 to 100. It is designed to report perioperative problems.

French self-administered instrument for measuring hospitalized patients' satisfaction based on the patient's point of view. QSH contained 45 items describing 9 dimensions, leading to 2 composite scores (staff and structure index)

The QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. The questionnaire includes one global health status/QoL scale, five functional scales and three symptom scale. Each scale is scored from 0 to 100. A high score on a scale indicate a good outcome for the dimension of QoL.

Groupement Interrégional de Recherche Clinique et d'Innovation

Santelys Association

University Hospital, Lille

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Group without prehabilitation program before surgery

Group will follows a prehabilitation program before surgery

physical, nutritional and psycho-social supports before surgery

Dominique GENRE, Dr

NACT is a heavy oncologic treatment, which can impair functional capacity, nutritional and emotional status. These three impairments are often ignored and not taken into account in the pre-therapeutic evaluations but are correlated with postoperative morbidity and mortality after major surgery.

Recently, a prehabilitation before surgery, including physical, nutritional and psycho-social support, has been defined. From a literature review, the maximum oxygen uptake (VO2 max) seems to constitute a strong evaluation factor reflecting physical fitness, easily measured with a cardiopulmonary exercise test (CPET) at maximal effort.

Several studies have shown beneficial effects of trimodal prehabilitation programs on postoperative functional capacity, return to daily activities and pain relief.

Home-based program and connected devices may improve the feasibility and the compliance to this program.

The hypothesis of this study is that performing a connected supervised home-based and patient-tailored multimodal prehabilitation program from diagnosis to surgery (with or without ERAS program) during NACRT, for patients managed for ovarian cancer, will limit physical fitness alteration and will positively affect postoperative outcomes.

Our study consists in an early and multidimensional (combining nutritional, physical, emotional and medical support) prehabilitation program during NACT for patients with ovarian cancer, in order to limit physical alteration before surgical treatment, and therefore improve postoperative outcomes. It will include a home-based prehabilitation program, in order to allow care access to all eligible patients.

The main objective will be to determine if a prehabilitation program during NACT, for patients treated for an advanced ovarian cancer will limit physical alteration before major abdomino-pelvic surgery, compared to a control group without prehabilitation program. The primary endpoint will be the comparison of the variation of VO2 max, between baseline and surgery, in the prehabilitation group vs control group: VO2 max will be measured with a cardiopulmonary exercise test (CPET) at maximal effort.

This prospective, multicentric randomized control trial will be conducted in 7 French comprehensive cancer Centers or University Hospital, in compliance with inclusion criteria. After an initial evaluation, patients will be randomized in two groups: Prehabilitation group (P group) and a Control group (C group).

For the P group, after baseline evaluation, we will be offering from diagnosis to surgery, during the NACT:

* A standardized, patient-tailored preoperative physical activity training program will be performed at home, from diagnosis to surgery. Supervision will be done with connected device (connected watches) and activity will be adapted,
* A nutritional care established in respect of the SFNEP-SFNCM guidelines. Nutritional support will be adapted by a dietician according to information transmitted daily (connected body fat weight scale),
* A psychological support with coping strategies.

For the C group: Patients with ovarian cancer will undergo NACT after baseline evaluation without prehabilitation program.

After NACT, for both groups, major abdomino-pelvic surgery will be done with or without ERAS pathway, according to the practice in each center.

Connected Prehabilitation Program During Neo Adjuvant Chemotherapy

Multicenter Randomized Study Comparing Neo Adjuvant Chemotherapy for Patients Managed for Ovarian Cancer With or Without a Connected Prehabilitation Program

CHANGE of VO2 max between baseline (inclusion) and surgery (preoperative), in the prehabilitation group vs control group. VO2 max will be measured during a cardiopulmonary exercise test (CPET).

o International Physical Activity Questionnaire (IPAQ) , administered at inclusion and at the time of surgery and after surgery

Muscular strength evaluated with dynamometer (brachial biceps)

Psychological status evaluated by the Hospital Anxiety and Depression Scale (HADS) (Annex 2)

Cancer related quality of life (QoL) evaluated by using the self-reported European Organization for Research and Treatment of Cancer (EORTC) core questionnaire (QLQ-C30) (Annex 3)

Motivation evaluated by a free interview and a coping strategy.

Muscle mass evaluated with the Computed tomography-derived

skeletal muscle index measured by skeletal muscle mass cross-sectional area at L3/height2

Institut Paoli-Calmettes

Multimodal prehabilitation intervention composed of exercise, nutritional supplement and psychological well-being

multimodal prehabilitation intervention composed of exercise, nutritional supplement and psychological well-being

Morgan Le Guen, MD

The process of enhancing functional capacity of the individual in anticipation of an upcoming stressor has been termed "prehabilitation". In the present pilot trial, the impact of a multimodal prehabilitation intervention composed of exercise, nutritional supplement and psychological well-being begun in the preoperative period will be evaluated.

Evaluation of the Benefits of a Prehabilitation Program : Pilot Study

Evaluation of the Benefits of a Program of Prehabilitation: Pilot Study

Hopital Foch

Head and Neck Neoplasms

Prospectively enrolling patients into a prehabilitation program for head and neck cancer.

Prospectively enrolling patients to a control arm with no intervention.

We will assess whether prehabilitation intervention helps mitigate adverse symptoms (e.g., anxiety, depression, suicidality, distress, nutritional status, dysphagia, sarcopenia, and well-being) on a sample of head and neck cancer patients. Subjects will attend a Prepare for Surgery Heal Faster session and meet with a physical therapist, registered dietician, speech language pathologist, and masters of social work at pre-treatment, 6-8 weeks post-treatment, and 5-6 months post-treatment completion.

Prehabilitation Program

Cheryl Hysjulien, PsyD

Head and neck cancer accounts for 3% of malignancies in the United States. However, the diagnosis and treatment for head and neck cancer is considered to be debilitating. Not because of its morbidity, but due to the extremely rigorous treatment course which has a profound impact on patients physical, social, and emotional functioning. Disfigurement and sensorimotor deficits further compound this impact. Head and neck cancer patients contend with treatments that can significantly affect their quality of life. Treatment regularly results in decreased functional capacity and decreased quality of life. Physical impairments are manifested through, but not limited to, disfigurement, deconditioning, communication issues, "swallowing, speech, breathing, and cancer-related fatigue". Premorbid factors such as preexisting anxiety and depression, chemical dependency, financial barriers, and lack of social support system are unique obstacles to the head and neck cancer population impacting treatment and outcomes. Due to these factors, patients experience higher rates of anxiety and depression, psychological distress, and fear of cancer recurrence. In fact, "compared with other survivors of cancer, head and neck cancer survivors are almost 2 times more likely to die from suicide". In view of the aforementioned research, Roger Maris Cancer Center's head and neck cancer will implement a prehabilitation program that evaluates each patient using standardized screening tools and provide personalized education and interventions. This project evaluates a more comprehensive and proactive multidisciplinary approach to improve treatment and outcomes in head and neck cancer patients.

Non-randomized prospective two-arm clinical trial

A Comprehensive Approach to Head and Neck Cancer Prehabilitation

The Behavioral Health Screening 6 (BHS-6) is a validated, self-report instrument assessing psychological health. Higher scores indicate greater psychological distress. Difference = (Treatment score - Control score).

The Columbia-Suicide Severity Rating Scale (C-SSRS) is a validated, self-report instrument assessing suicidality. Higher scores indicate greater suicidality. Difference = (Treatment score - Control score).

The National Comprehensive Cancer Network (NCCN) Distress Thermometer is a validated, self-report instrument assessing psychological health. Higher scores indicate greater psychological distress. Difference = (Treatment score - Control score).

The MD Anderson Dysphagia Inventory (MDADI) is a validated, self-report instrument of functional assessments of dysphasia and overall functioning. Higher scores indicate better quality of life and higher day-to-day functioning. Difference = (Treatment score - Control score).

The FACT-H\&N (Version 4) is a validated, self-report instrument of functional assessments of dysphasia and overall functioning. Higher scores indicate better quality of life and higher day-to-day functioning. Difference = (Treatment score - Control score).

Sarcopenia will be measured using bioimpedence spectroscopy technology (BIS), a validated noninvasive measure of volume of fluids in various parts of the body. Functional assessments (sit to stand, grip strength, and two-minute walk test) will be tested as possible predictors of sarcopenia.

Sarcopenia measures collected via computed tomography will be used to compare patients who completed the prehabilitation program and those who have not.

The Behavioral Health Screening 6 (BHS-6) is a validated self-report measure of psychological health, with higher scores indicating greater psychological distress. Change = (Post-treatment score - Baseline score).

The Columbia-Suicide Severity Rating Scale (C-SSRS) is a validated self-report measure of psychological health, with higher scores indicating greater psychological distress. Change = (Post-treatment score - Baseline score).

The National Comprehensive Cancer Network (NCCN) Distress Thermometer is a validated self-report measure of psychological health, with higher scores indicating greater psychological distress. Change = (Post-treatment score - Baseline score).

The 2-min walk test is a validated objective measure of physical functioning. Change = (Post-treatment score - Baseline score).

The 30 seconds sit to stand is a validated objective measure of physical functioning. Change = (Post-treatment score - Baseline score).

The grip strength is a validated objective measure of physical functioning. Change = (Post-treatment score - Baseline score).

The Nutrition Focused Physical Exam (NFPE) is a validated objective measure of physical functioning. Change = (Post-treatment score - Baseline score).

The MD Anderson Dysphagia Inventory (MDADI) is a validated, self-report instrument of functional assessments of dysphasia and overall functioning. Higher scores indicate better quality of life and higher day-to-day functioning. Change = (Post-treatment score - Baseline score).

The Bioelectic impedance spectroscopy (BIS) is a validated objective measure of physical functioning. Change = (Post-treatment score - Baseline score).

The FACT-H\&N (Version 4) is a validated, self-report instrument of functional assessments of overall functioning. Higher scores indicate better quality of life and higher day-to-day functioning. Change = (Post-treatment score - Baseline score).

University of North Dakota

Sanford Health

Frailty

The intervention will be a home-based total-body exercise training program (prehabilitation) based on a protocol with proven efficacy in improving the function of non-frail surgical patients in less than 4 weeks of preoperative utilization.Prehabilitation will consist of 3 components: 1) strength training; 2) aerobic exercise and 3) flexibility. Prehabilitation will be prescribed as 1-hour sessions performed a minimum of 3 times per week. Intervention group patients will also be provided with nutritional advice. In addition to paper-based materials outlining the prehabilitation program, weekly prehabilitation teaching sessions will be held at our Cancer Centre for patients randomized to the intervention group, and activity logs and weekly phone calls will be used to measure compliance and to answer questions. During the final week of the program, patients will also participate in a brief qualitative interview over the phone to explore their experience with the program.

Patients randomized to the control group will be provided standard perioperative care as per our institutional standards. They will receive the World Health Organization (WHO) Global Recommendations for Physical Activity for Health for people 60 years and above pamphlet, as well as Canada's Food Guide. In-hospital perioperative care, and postoperative care, will be at the discretion of each patient's surgeon and anesthesiologist.

Strength training: This component consists of 1 set of 10 repetitions of each exercise: a. push-ups (modified to the individual's level of function as either wall push-ups, knee push-ups, or full push-ups); b. seated row (performed with an elastic resistance band); c. chest fly (performed with an elastic resistance band); d. deltoid lift (performed with an elastic resistance band); e. biceps curls (performed with an elastic resistance band); f. triceps extensions (performed with an elastic resistance band); g. chair squats; h. hamstring curls; i. standing calf raises; j. abdominal crunches (modified to be performed seated in a chair)

Aerobics: Walking for 20 minutes at moderate intensity.

Flexibility: Chest, arm, leg and truck stretches, with each stretch to be held for 20 seconds, done for 2 repetitions.

Daniel I McIsaac, MD

The rapid aging of the population means that anesthesiologists care for elderly patients with increasing regularity. Although age is an independent predictor for adverse postoperative outcomes, significant outcome variation exists among older surgical patients. Frailty, a syndrome that describes an aggregate susceptibility to adverse health outcomes due to age-, and disease-related deficits that accumulate across multiple domains is a key predictor of adverse postoperative outcomes in elderly patients. Frail surgical patients are at increased risk of complications, institutionalization, death, and are high healthcare resource users.

Multiple stakeholders, including anesthesiologists and patients, have identified improving the outcomes of older patients and preoperative exercise training (prehabilitation) as 2 of the 10 most important areas for future perioperative research. Physical vulnerability is an important aspect of the frailty syndrome, and may be amenable to structured exercise therapy. However, the evidence for preoperative exercise training (prehabilitation) improving postoperative outcomes is obscured by methodological limitations and a focus on non-elderly patients. Recently, evidence has emerged that older and sicker patients may benefit most from prehab, however, this hypothesis has not been formally tested.

Because the complex needs of frail perioperative patients require a longitudinal and multidisciplinary approach, the investigators are developing a perioperative surgical home for the frail elderly (PSH-Frail). Development of the PSH-Frail is supported by a robust data collection system, including linkage of prospectively collected data to health administrative data infrastructure to improve efficiency and long-term follow up.

The investigators hypothesize that prehabilitation will be a vital intervention supported by the PSH frail, however, high quality evidence from randomized trials is needed to support its efficacy. Therefore, the investigators propose a single center randomized controlled trial of prehabilitation of frail elderly patients having elective abdominal and thoracic cancer surgery to improve postoperative function (primary outcome), and to decrease postoperative resource utilization (secondary outcomes).

Frailty is a key risk factor for adverse outcomes among the increasingly large number of older patients presenting for surgery. The complexity and risk profile of frail patients makes them a population who may derive significant benefit from the multidisciplinary and continuous care provided by a Perioperative Surgical Home (PSH) model of care. Development of an evidence-based PSH for the frail elderly (PSH-Frail) is the overarching goal of the investigator's research program. However, the PSH-Frail is a complex intervention, and will require high quality evidence to support inclusion of specific processes and interventions into the overall framework.

To date, the investigator's research group has undertaken prospective studies to support the routine and accurate identification of frail patients before surgery. The next step in the development of the PSH-Frail is testing interventions to improve the outcomes of frail elderly surgical patients. The role of preoperative exercise training (prehabilitation) in improving postoperative outcomes is a priority research area in perioperative medicine, and may provide its most significant impact in frail elderly patients. However, this hypothesis has not been formally tested.

Study design:

A single center, parallel arm randomized controlled trial of home-based prehabilitation vs. standard perioperative care in frail elderly patients undergoing elective surgery for intraabdominal cancer will be conducted. This will be a superiority trial to test the hypothesis that home-based prehabilitation will result in improved postoperative functional outcomes compared to standard care. This protocol is described in keeping with the Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT) guidelines).

Study setting:

This study will be performed at The Ottawa Hospital (TOH), a 900-bed tertiary care academic health sciences center serving a catchment area of 1.2 million people. TOH is the regional cancer referral center for the Eastern portion of the Canadian province of Ontario. On average, cancer patients are seen 4 weeks prior to surgery (as this is a provincial benchmark for cancer care).

Sample size:

To detect a clinically important 25 meter difference in the primary outcome between study arms, using a two-sided test at the 5% level of significance with 80% power, and assuming a standard deviation of 55 meters based on a previously published trial, we will require 77 patients per arm. To account for up to 20% attrition we will enroll 100 patients per arm.

Recruitment:

Patients will be recruited from the investigator's hospital's Cancer Assessment Center. Following cancer diagnosis, patients are seen by a surgeon 4 weeks prior to their scheduled operation. Following surgical assessment and confirmation of the decision to operate, patients who consent to consideration for research contact, and who meet all inclusion criteria except for frailty score, will be assessed by a trained clinician or clinical assistant using the Clinical Frailty Scale (CFS). Patients who score \>4/9 on the CFS will then be randomized after providing written informed consent.

Intervention:

The intervention will be a home-based total-body exercise training program (henceforth referred to as prehabilitation) based on a protocol with proven efficacy in improving the function of non-frail surgical patients in less than 4 weeks of preoperative utilization. Prehabilitation will consist of 3 components: 1) strength training; 2) aerobic exercise and 3) flexibility. Prehabilitation will be prescribed as 1-hour sessions performed a minimum of 3 times per week.

Control:

Patients randomized to the control group will be provided standard perioperative care as per institutional standards. Patients will receive the World Health Organization (WHO) Global Recommendations for Physical Activity for Health for people 65 years and above pamphlet, as well as Canada's Food Guide. In-hospital perioperative care, and postoperative care, will be at the discretion of each patient's surgeon and anesthesiologist.

The Prehabilitation Study: Exercise Before Surgery to Improve Patient Function in People

Functional capacity at baseline (surgical assessment typically 4 weeks prior to surgery) compared to postoperative functional capacity 30 days after surgery. The primary outcome of this study will be postoperative functional capacity, specifically the 6-minute walk test 30 days after surgery. A clinically relevant difference in this outcome is a change of 25 meters walked over 6 minutes.

Functional outcomes will be assessed using the Short Physical Performance Battery (SPPB).This is a validated, objective assessment, developed by National Institute on Ageing, to evaluate lower extremity functioning in older individuals through assessment of balance, gait speed and lower limb functional strength; each domain is assessed on a 4-point scale, and the overall performance is rated on a cumulative 12-point scale. Participants will complete this at baseline (surgical assessment typically 4 weeks prior to surgery) and at their post-operative surgical follow-up (approximately 30 days after surgery).

Measured using the EQ-5D30 (5-level version). The EQ-5D assesses domains of self-perceived mobility, self-care, usual activity participation, pain/discomfort, and anxiety depression which is captured as a overall health state score.

Measured using the EQ-5D30 (5-level version). The EQ-5D also uses a self-report 0-100 point scale relating the person's current health status to their best imaginable status

Measured using the WHODAS 2.0 instrument, a 30-day look-back multidimensional disability scale that is validated in a variety of disease states, including postoperatively.

Based on the National Surgical Quality Improvement Program definitions for medical complications, the type of medical complication will be collected.

Based on the National Surgical Quality Improvement Program definitions for surgical complications, the type of surgical complication will be collected.

The number of participants who experience all-cause mortality will be collected.

Number of days in hospital post-operatively

Number of patients discharged to an institution and/or re-admitted post-operatively

Amount of healthcare dollars spent will be generated using a validated algorithm in our administrative data

Ottawa Hospital Research Institute

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

The prehabilitation program includes combined high-intensity interval training on a cycle ergometer and machine-based resistance exercise of large muscle groups supervised by a physiotherapist. Exercise sessions will take place in physiotherapy departments at local hospitals or in municipality rehabilitation centres 3 times a week during the neoadjuvant chemotherapy period and ending in the week before breast surgery (maximum estimated 29 weeks depending on number of chemotherapy cycles, dose delays and time of breast surgery). Participants will be screened for psychological distress four times and in case of moderate-severe distress be advised to visit the local Cancer Society Support Center where participants will be assessed and offered free services based on their psychosocial needs and available offers. Participation will be monitored.

Susanne Dalton, Prof.

The Neo-Train study is a randomized controlled trial investigating the effects of supervised pre-operative aerobic and resistance exercise in patients with breast cancer during neoadjuvant chemotherapy.

The long neoadjuvant chemotherapy period in patients with breast cancer brings a time window of opportunity to investigate the potential of pre-operative exercise to increase treatment efficacy with improved tumour regression. A possible improvement in chemotherapy completion, lift in physical function, alleviated toxicities as well as changes in biological markers can also be investigated.

120 patients with newly diagnosed breast cancer who start neoadjuvant chemotherapy will be randomized to the intervention arm (n=60) and control arm (n=60).

Participants in the intervention arm will be prescribed a prehabilitation program consisting of thrice weekly combined supervised aerobic and resistance exercise during the neoadjuvant chemotherapy period. Participants will be screened for psychological distress four times and in case of moderate-severe distress be advised to visit the local Cancer Society Support Center where participants will be assessed and offered free services based on their psychosocial needs and available offers.

Participants in the control arm will receive usual care.

Outcomes will be measured at baseline (diagnosis), during neoadjuvant chemotherapy, during the week before breast surgery, at breast surgery and at 3 months follow up.

The participants will receive the recommended neoadjuvant chemotherapy regimens in Denmark - currently up to 24 weeks. With expected chemotherapy dose delays, the time of breast surgery is expected to be within 30 weeks from baseline. The treatment plans will be individually modified based on tumour response and expected side effects to treatment. A subgroup of participants may change neoadjuvant chemotherapy regimen and be referred to breast surgery early. In these participants, the last measurement during chemotherapy will be used, and the 3 months follow up measurement will still be scheduled at 3 months after breast surgery.

The study procedures will be pre-tested in a pilot study with 6 patients who will all receive the prehabilitation program.

Randomized controlled trial with an intervention arm and a control arm

Due to the nature of the intervention, it is not possible to blind the participants, care providers or investigators. However, the outcome assessors of the primary endpoint (MRI assessment) will not be informed of the patients' allocation. Further, the statistician and data manager are blinded as the group allocation will be coded.

Pre-operative Exercise During Neoadjuvant Chemotherapy in Patients With Breast Cancer

Neo-train: Pre-operative Exercise During Neoadjuvant Chemotherapy in Patients With Breast Cancer - a Randomized Controlled Trial

Change in the maximum diameter of the tumour visualized by magnetic resonance imaging (MRI).

Relative dose intensity in percentage defined as the ratio of received mg/m2 per week compared to planned mg/m2 per week according to standard guidelines.

Changes from baseline measured by bioelectrical impedance analysis.

Changes in VO2 max estimated from maximum power output from baseline measured by a progressive cycle ergometer test (watt max test).

Changes in 1 repetition maximum strength from baseline measured on leg press and pull down.

Changes in hand grip strength from baseline measured by hand-held dynamometer in kilograms. Maximum kilograms obtained of 3 measurements on each hand.

Changes in activity data measured by a wearable objective measurement device.

Changes in self-reported health-related quality of life from baseline assessed on the Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B).

Changes in self-reported general anxiety from baseline assessed on the Generalised Anxiety Disorder 7-item (GAD-7).

Changes in self-reported depression from baseline assessed on the Patient Health Questionnaire-9 (PHQ-9).

Changes in self-reported psychological distress from baseline assessed on the Distress Thermometer (DT).

Frequency of participants referred to municipal rehabilitation, participation and types of activities attended identified from a self-reported questionnaire.

Assessed by doctors' clinical examination of the breast.

Measured by a pathologist from the tumour surgical specimen at breast surgery.

Assessed by a pathologist from the tumour surgical specimen at breast surgery.

Description of tumour infiltrating lymphocyte population (percentage of cells) evaluated by a pathologist from the tumour biopsy specimen taken before chemotherapy and tumour surgical specimen at breast surgery.

Description of tumour vascularity density and structure evaluated by a pathologist from the tumour biopsy specimen taken before chemotherapy and tumour surgical specimen at breast surgery.

Changes in cell free DNA from blood samples. Furthermore, circulating tumour DNA will be investigated if possible.

Changes in glucose, hba1c, zinc, magnesium, phosphate and C reactive protein (CRP) levels from blood samples.

Changes in cytokines from blood samples before, during and after neoadjuvant chemotherapy.

In vitro cell proliferation response with sera collected from blood samples before and after exercise.

Incidence of breast cancer recurrence in percent

Danish Cancer Society

University Hospital Southampton NHS Foundation Trust

Region Zealand

Naestved, Slagelse and Ringsted Hospitals

Zealand University Hospital

Professor

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

The preoperative period (prehabilitation) represents a more appropriate time than the postoperative period to implement an intervention. Prehabilitation is a process of enhancing an individual's functional capacity before the scheduled surgery, aimed at improving the patient's tolerance to upcoming physiologic stress, by three principal elements: exercise training, nutritional intervention, and psychological support.

Common to both groups as part of the enhanced recovery after surgery (ERAS) protocol as the standard of care in our institution.

Sarah Atoui, MSc

Sender Liberman, MD

Franco Carli, MD

Main objective: To evaluate the bidirectional relationships between physical exercise and sleep parameters, as a part of multimodal prehabilitation intervention, on pre- and postoperative outcomes in surgical patients with colorectal cancer, in an RCT.

Secondary objective: to determine whether the levels of anxiety and depression affect these relationships.

Objectives are based on the overarching hypothesis that is sleep and physical activity influence each other through complex, reciprocal interactions including multiple physiological and psychological pathways. To achieve this, providing a multimodal prehabilitation, specifically physical exercise, involved in mental and physical health through different mechanisms, i.e., improving physical functioning and fitness, reducing side effects of cancer treatments, preventing bone loss and weight gain, improving the quality of life and sleep, decreasing symptoms of fatigue and depression.

The present is a pilot study aiming to evaluate the bidirectional relationships between sleep and physical exercise, and the preliminary outcome has important implications for informing both clinical and public health practice.

Research question: Does a multimodal intervention including physical exercise improve sleep quality and duration compared to standard of care, during the perioperative period? Conversely, does a better sleep quality and duration increases the level of physical exercise during the perioperative period? How the level of anxiety and depression will affect these relationships? If the Prehabilitation program specifically physical exercise will positively affect sleep quality and duration after surgery, in the way to be a protective factor of sleep to not be reduced by up to 55% compared to those receiving standard of care?

Participants will be referred by colorectal surgery of the MUHC-Montreal General Hospital; 100 participants will be studied. Inclusion: adult patients aged 18 years and older, of either sex undergoing colorectal cancer surgery. All adult persons scheduled for resection of malignant colorectal lesions will be included. Exclusion criteria: a compromised health status (American Society of Anesthesiologists \[ASA\] class 4-5) or comorbid medical conditions interfering with the ability to perform an exercise. Patients are unable to understand the information given, insufficient understanding of English or French language to provide informed consent or who are considered unable to perform study-specific procedures. Patients that diagnosis of a sleep disorder other than insomnia (e.g., sleep-disordered breathing) or received psychotherapy specifically for insomnia, as well as a night-shift worker in the past 3 months or the next 18 months will be excluded.

Study Design: Randomized controlled trial of two parallel arms: prehabilitation program and standard of care (SOC). Informed consent forms will be signed and dated before the conduct of any study-specific procedures. After baseline assessment, participants will be random, by a computer program, allocated to either an intervention or a control group. Duration and follow-up. The intervention will last for 4 weeks pre- and 8 weeks post-surgery, for a total of 12 weeks. Site visits will occur weekly before surgery and every 4 weeks after surgery. In that period, weekly phone calls will reinforce compliance and provide tips to help patients adhere to the treatment protocol. A dedicated and specially trained research team lead by a physician, a kinesiologist, a nutritionist and a psychologist will perform the measurements and collect the demographic and surgical details of all the patients, recording daily detailed information of clinical outcomes up to 8 weeks after surgery.

Interventions: Common to both groups: as part of the enhanced recovery after surgery (ERAS) protocol as the standard of care in our institution. All participants will wear an actigraphy to objectively assess their daily physical activity and their sleep behavior. The following outcomes will be assessed for all participants, at the baseline and will be repeated after 4 weeks, before and after the surgery: sleep behaviors included sleep quality and duration, assessed subjectively and objectively. Self-reported and objective outcome measurements will be assessed from all participants such as the 6-minute walk distance (6MWD), daily activity counts, exercise tolerance (CPET) and handgrip strength, Insomnia Severity Index (ISI), Chronotype, health-related quality of life assessed by using the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and the Hospital Anxiety and Depression Scale (HADS) used to assess emotional distress.

This is a randomized controlled pilot trial of patients with colorectal cancer scheduled for major abdominal surgery. The prehabilitation intervention group will be compared with the usual care for an average of 4 weeks before planned surgery. All participants will wear an actigraphy to objectively assess their daily physical activity and their sleep behavior.

The intervention will last for 4 weeks pre- and 8 weeks post-surgery, for a total of 12 weeks. Site visits will occur weekly before surgery and every 4 weeks after surgery. In that period, weekly phone calls will reinforce compliance and provide tips to help patients adhere to the treatment protocol. A dedicated and specially trained research team lead by a physician, a kinesiologist, a nutritionist and a psychologist will perform the measurements and collect the demographic and surgical details of all the patients, recording daily detailed information of clinical outcomes up to 8 weeks after surgery.

The Impact of Physical Exercise on Sleep in Colorectal Cancer Patients During Prehabilitation Period

The Impact of Physical Exercise on Sleep Quality and Duration in Colorectal Cancer Patients During Prehabilitation Period: A Pilot Study

To report the perceived severity of difficulties falling asleep, difficulties maintaining sleep and early morning awakenings, as well as the degree of dissatisfaction with current sleep, the degree to which sleep difficulties interfere with daytime functioning, the degree to which the deterioration of functioning related to the sleep problem is noticeable by others, and the level of distress or worry caused by the sleep difficulties.

The total score is interpreted as follows: the absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).

One hears about 'morning' and 'evening' types of people with 5 response categories.

A reliable and valid generic index of perceived health status for cancer patients and used on the previous study for patients undergoing scheduled colorectal surgery. 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.

12 items used to measures disability due to health conditions including diseases, illnesses, injuries, mental or emotional problems, and problems with alcohol or drugs.

The sum score for global disability therefore ranges from 0 (no disability) to 48 (complete disability).

Validated for oncologic patients, it comprises 4 scored domains: recent weight loss, food intake, symptoms, and activities and functions. PG-SGA Short Form is a patient-reported instrument for the assessment of nutrition status in patients with cancer. The PG-SGA Short Form numerical scoring range from 0 (no problems) to 36 (worst problem).

CPET has a growing role in major abdominal surgery to guide decision-making by clinicians and to evaluate the consequences of neo-adjuvant therapies and prehabilitation programs.

The term 'peak VO2' is used as a synonym for VO2 max throughout this text. Peak VO2 is considered abnormal when below 85% of the predicted value.

The VO2 value measured in the first ventilatory threshold (VT1) or anaerobic threshold (AT) is determined by the nonlinear increase of pulmonary ventilation (VE) in relation to VO2. The normal mean AT values expected for adults is around 40% to 65% of peak VO2.

Pulmonary ventilation (VE): Ventilation increases continuously during progressive effort on CPET and undergoes additional increases influenced by the anaerobic metabolism resulting from the accumulation of lactic acid, well defined as the first and second ventilatory thresholds. Periodic (or oscillatory) ventilation is defined as the resting oscillatory pattern that persists in ≥ 60% of the effort with an amplitude of ≥ 15% as compared to mean resting values.

CO2 production measured during cardiopulmonary exercise testing (CPET)

O2 consumption measured during cardiopulmonary exercise testing (CPET)

Respiratory coefficient or respiratory exchange ratio (R): expresses the ratio between CO2 production and O2 consumption (VCO2/VO2). It is currently the best non-invasive indicator of maximal or quasi-maximal exercise intensity. Values above 1.0 can reflect intense exercise, but those ≥ 1.10 are those searched on CPET, and have been accepted as a parameter of exhaustion or quasi-exhaustion.

Maximal strength will be recorded, according to standardized procedures. Isokinetic leg strength will be measured with a Biodex on the dominant side.

Loss of muscle strength was defined as \< 30kg (men) and \< 20 kg (women).

Height with a ruler on the wall measured in cm

Bodyweight will be measured by a digital scale by the Seca mBCA machine in kg

This questionnaire was developed to assess the global subjective sleep disturbances of the previous month. The PSQI is a 19-item self-report measure of broad sleep disturbances over the past month and yields 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, and daytime dysfunction), which are added to create a total score. Each score ranging from 0 to 3 and a total score range of 0-21, a score of 0 indicated no sleep problems and 3 indicated serious sleep problems.

Sleep quality will be objectively measured using the Actiwatch-2. The Actiwatch-2 (Philips, Respironics) is a small, waterproof, non-intrusive actigraphy device that is worn on the wrist of the non-dominant hand. By calculating orientation and movement, actigraphy records sleep-wake activity and provide an objective measure of sleep quality.

The CHAMPS is a self-reported measure of physical activity, comprising 41 activities evaluated according to the total number of hours done during an average week. The CHAMPS has been validated as a measure of increasing levels of physical activity in older adults.

1 METs), low-light (ie, \> 1 and ≤2 METs; eg, playing cards), high-light (ie, \>2 and \<3 METs; eg, light walking), moderate-to-vigorous physical activity (MVPA, ≥3 METs), and "total activity" (≥2 METs)

The Actiwatch-2 (Philips, Respironics) provide an objective measure of the daily activity counts.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Preoperative Prehabilitation for Sarcopenic Patients Prior to Pancreatic Surgery for Cancer	NCT04469504	Sarcopenia Pancreatic Canc...	Prehabilitation... Oral Impact	18 Years -	University Hospital, Lille
Preoperative Prehabilitation for Sarcopenic Patients Prior to Pancreatic Surgery for Cancer	NCT04469504	Sarcopenia Pancreatic Canc...	Prehabilitation... Oral Impact	18 Years -	University Hospital, Lille
Connected Prehabilitation Program During Neo Adjuvant Chemotherapy	NCT04451369	Ovarian Cancer	Prehabilitation...	18 Years -	Institut Paoli-Calmettes
Evaluation of the Benefits of a Prehabilitation Program : Pilot Study	NCT02878551	Surgery Cancer	Prehabilitation...	18 Years -	Hopital Foch
A Comprehensive Approach to Head and Neck Cancer Prehabilitation	NCT04617678	Cancer of Head ...	Prehabilitation...	18 Years -	Sanford Health
The Prehabilitation Study: Exercise Before Surgery to Improve Patient Function in People	NCT02934230	Cancer Frailty	Prehabilitation...	60 Years -	Ottawa Hospital Research Institute
Pre-operative Exercise During Neoadjuvant Chemotherapy in Patients With Breast Cancer	NCT04623554	Breast Cancer	Prehabilitation...	18 Years -	Zealand University Hospital
The Impact of Physical Exercise on Sleep in Colorectal Cancer Patients During Prehabilitation Period	NCT04270500	Colo-rectal Can... Surgery	Prehabilitation...	18 Years -	Montreal General Hospital
POP-UP: a Single-arm, Two-cohort Study: Trimodal Prehab for Upper GI and Pancreatic Cancer	NCT06275737	Pancreatic Duct... Esophageal Canc...	Prehabilitation...	18 Years -	GERCOR - Multidisciplinary Oncology Cooperative Group
Preoperative Prehabilitation for Sarcopenic Patients Prior to Pancreatic Surgery for Cancer	NCT04469504	Sarcopenia Pancreatic Canc...	Prehabilitation... Oral Impact	18 Years -	University Hospital, Lille
Esophageal Cancer Multimodal Prehabilitation Study	NCT06027515	Esophageal Canc... Esophageal Neop...	Prehabilitation...	65 Years -	Massachusetts General Hospital

Spots Global Cancer Trial Database for prehabilitation program