9 times online course and 3-days workshop for 6 months .

Participants in control group will receive usual course.

9 times online course and 3-days workshop for 6 months of psychological Empowerment Courses.

Multi-Psychological Empowerment Courses

Yun Hsiang Lee, PhD

In the first-year project of this study, oncology nurses have reported experiencing massive stress, insufficient communication ability, and the need for communication-related training. 70% of them had moderate or higher severity of workload, fatigue, and psychological distress (at the measure point) before being provided with Basic Remote Psychological Support Course (BRPSC). A month after BRPSC, some oncology nurses have indicated/affirmed the benefits of undergoing the comprehensive psycho oncology education training courses. Thus, the second- and third-year continuation projects are focused on the development and delivery of Multi-Psychological Empowerment Courses (MPEC) for oncology nurses

The Effectiveness of "Multi-Psychological Empowerment" Courses

The Effectiveness of "Multi-Psychological Empowerment" Courses Through Remote, Digital Media, Workshop Intervention for Oncology Nurses on Physical and Psychological Status, Self-Efficacy and Communication Ability

The change in oncology nurses' physical and psychological state will be measured by physical and psychological state survey. It use Numerical Rating Scale(VRS) 0-10. It is a 11 Point Likert Scale (e. g. 0 is no pain; 10 is unbearable pain).

The change in oncology nurses' workload will be measured by the self-designed scale using VRS (Numerical Rating Scale). It measures the subjective perception of oncology nurses about their workload in the past week, with scores ranging from 0 to 10.The higher the score, the greater the workload of the oncology nurses.

Oncology nurses' self-efficacy were measured by self efficacy scale. There are 10 questions about the level of confidence in these situations. It's a 4 point (1-4),higher the score means the more confident you have. There is also 11 point (0-10) scale that higher the score means the more confident you are in caring for patients.

Oncology nurses' communication skills were measured by communication ability scale.It is a 5 Liker scale(1-5),higher scores represent better communication skills.

Oncology nurses' empathy were measured by Efferson Empathy Scale. It is a 7 Liker scale(1-7),higher scores means someone have more empathy.

Oncology nurses' spiritual well-being were measured by FACIT-Sp.It is a 5 Liker scale(0-4),higher scores represent better well-being.

Oncology nurses' burnout will be measured by Burnout Inventory survey.It is a 7 Liker scale(0-6),higher scores represent high level burnout .

National Taiwan University Hospital

Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Postoperative Complications

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Micronutrients

Herbal and Botanical

Ethanol

Vitamins

Cola

Usual care group will follow the usual institutional pre-surgery care..

PPP group will include 3 complementary modules: (i) supervised physical exercise, (ii) dietary behavior change, and (iii) psychological support.

This intervention will include 3 complementary modules: (i) supervised physical exercise: aerobic and strength High Intensity Interval Training (HIIT), 3 times per week (ii) dietary behavior change: nutritional talk + an informative brochure + a video summary, a session per week and (iii) psychological support: psychoeducation, written and verbal emotional expression, promotion of coping strategies, progressive muscle relaxation training, problem-solving and social skills, and self-efficacy enhancing, among others. This psychological component will also include counseling regarding smoking and alcohol cessation and sleep hygiene.

Prehabilitation program (4 week before the surgery)

This intervention will include 3 complementary modules: (i) supervised physical exercise: aerobic and strength High Intensity Interval Training (HIIT), 3 times per week (ii) dietary behavior change: nutritional talk + an informative brochure + a video summary, a session per week and (iii) psychological support: psychoeducation, written and verbal emotional expression, promotion of coping strategies, progressive muscle relaxation training, problem-solving and social skills, and self-efficacy enhancing, among others. This psychological component will also include counseling regarding smoking and alcohol cessation and sleep hygiene.

NOTE: Both preoperative and postoperative programs will be administer to the participants assigned to the intervention group.

Postoperative program (12 week after the surgery)

Usual care group will follow the usual institutional pre-surgery care: (i) medication management, (ii) assessment of the surgery-derived risks, (iii) smoking cessation and peri-operative blood management. A trained nutritionist will evaluate the nutritional status of all patients at the baseline providing oral protein/vitamin supplementation, when necessary. Patients allocated to the control group will receive basic expert' advice on lifestyle changes.

Usual Care

Francisco J Amaro-Gahete, PhD, MD

ONCOFIT is a randomized clinical trial with a two-arm parallel design aimed at determining the influence of a multidisciplinary prehabilitation + postoperative program on post-surgery complications in patients undergoing resection of colon cancer. This intervention will include supervised physical exercise, dietary behavior change, and psychological support comparing its influence to the standard care.

Nowadays, colon cancer is one of the most common types of tumors worldwide being surgical resection the elective therapy for its curation. However, a surgery is a stressful procedure that may involve several postoperative complications. Risk factors for such undesirable events are closely related to lifestyle issues including decreased physical activity levels or dietary unhealthy habits. Recent studies have suggested that the implementation of multidisciplinary prehabilitation and postoperative interventions based on lifestyle habits may be a potential strategy for accelerate post-surgical recovery. To the best of our knowledge, the combined effect of a Prehabilitation + Postoperative Programs (PPP) on post-surgery complications and functional capacity of patients undergoing resection of colon cancer remains unclear. ONCOFIT is a randomized clinical trial with a two-arm parallel design aimed at determining the influence of a multidisciplinary PPP on post-surgery complications in patients undergoing resection of colon cancer. This intervention will include supervised physical exercise, dietary behavior change, and psychological support comparing its influence to the standard care. Primary and secondary endpoints will be assessed at baseline, at preoperative conditions, at the end of the PPP intervention and 1-year post-surgery, including: post-surgery complications, prolonged hospital length of stay, readmissions and emergency department call within 1-year after surgery, functional capacity, patient' reported outcome measures targeted, anthropometry and body composition, clinical markers, physical activity levels and sedentariness, dietary habits, others unhealthy habits, sleep quality and fecal microbiota diversity and composition. Considering the feasibility of the present intervention in a real-life scenario, ONCOFIT will contribute to the standardization of a cost-effective strategy for preventing and improving health-related consequences in patients undergoing resection of colon cancer with an important clinical and economic impact, not only in the scientific community but also in the clinical practice.

Multidisciplinary Prehabilitation and Postoperative Rehabilitation in Patients Undergoing Resection of Colon Cancer

Multidisciplinary Prehabilitation and Postoperative Rehabilitation for Avoiding Complications in Patients Undergoing Resection of Colon Cancer: ONCOFIT Study

Post-surgery complications determined by the Comprehensive Complication Index (CCI). Minimum value: 0 // Maximum value: no upper limit. Higher scores mean a worse outcome.

Electronic medical records will be used to register data regarding primary and total prolonged hospital length of stay.

Electronic medical records will be used to register data regarding readmissions.

Electronic medical records will be used to register data regarding emergency department appointments.

Cardiorespiratory fitness measured by the 6-minute walking test (6MWT) distance, expresed in total m.

Muscular strength assessed by handgrip strength. Handgrip strength will be determined using a digital hand dynamometer and expressed as total kg.

The 36-Item Short Form Health Survey questionnaire (SF-36). Minimum value: 0 // Maximum value: 100. Higher scores mean a better outcome.

The Beck Depression Inventory-II questionnaire. Minimum value: 0 // Maximum value: 63. Higher scores mean a worse outcome.

The State-Trait Anxiety Inventory (STAI). Minimum value: 20 // Maximum value: 80. Higher scores mean a worse outcome.

The Life Orientation Test-Revised. Minimum value: 0 // Maximum value: 24. Higher scores mean a better outcome.

The Positive and Negative Affect Schedule (PANAS). Positive affect: Minimum value: 10 // Maximum value: 50. Higher scores mean a better outcome. Negative affect: Minimum value: 10 // Maximum value: 50. Higher scores mean a worse outcome.

The Satisfaction With Life Scale. Minimum value: 5 // Maximum value: 35. Higher scores mean a better outcome.

The Trait Meta-Mood Scale (TMMS-24) is a 24-item self-report instrument with three subscales measuring three key aspects of perceived emotional intelligence: Attention, Clarity and Repair. Each of these three subscales consists of eight items with a 5-point Likert response format (ranging from 1 to 5). Subscale total scores are obtained by summing responses to all items and thus range from 8 to 40, with higher scores indicating greater level of the characteristic assessed.

Neck, waist and hip circumferences will be assessed with an anthropometric tape measure (cm).

Body composition assessment will be obtained through a full-body dual energy X-ray absorptiometry scanner. Bone mineral density in g/cm2.

Body composition assessment will be obtained through a full-body dual energy X-ray absorptiometry scanner. Lean mass in kg.

Body composition assessment will be obtained through a full-body dual energy X-ray absorptiometry scanner. Fat mass in kg.

Body composition assessment will be obtained through a full-body dual energy X-ray absorptiometry scanner. Visceral adipose tissue in kg.

Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the glycemic profile. We will obtain plasma glucose (mg/dL) and insulin (mg/dL) levels.

Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the lipid profile.

Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the hepatic transaminases levels.

Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the red cells levels.

Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the immunological blood profiles. The following parameters will be obtained: Leukocytes (10\*3 uL), Neutrophils (10\*3 uL), Lymphocytes (10\*3 uL), Monocytes (10\*3 uL), Eosinophils (10\*3 uL), Basophils (10\*3 uL) and LUC cells (10\*3 uL).

Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the inflammatory factors levels (PCR, leptin, adiponectin, resistin, IL 6, IL 10 and PAI 1; all of them expressed as pg/mL)

Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the renal function parameters (creatinine and urea; both will be expressed in mg/dL)

Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the tumour markers levels (CA 19-9, CA 242, CA 72-4, TPA and TPS; all will be expressed as pg/mL))

Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the hormones levels (T3, T4, testosterone, cortisol, estrogens and DHEAs; all will be expressed as pg/mL))

The investigators will also asses systolic and diastolic blood pressure in the right arm at rest.

The investigators will calculate the homeostatic model assessment of insulin resistance index (HOMA). HOMA index was calculated as follows: (fasting glucose(mg/dl) x fasting serum insulin (μU/mL))/405.

The investigators will calculate the fatty liver index (FLI) as a validated surrogate marker of non-alcoholic fatty liver disease.

The investigators will calculate a cardiometabolic risk score based on the International Diabetes Federation (IDF) criteria. The cardiometabolic risk score is a continuous variable with a mean of 0 and a standard deviation of 1 by definition, with lower scores denoting a more favorable profile.

The International Physical Activity Questionnaire (IPAQ) will be used to evaluate the current physical activity level of the participants. The survey validity and reliability studies have been conducted in Turkey by Ozturk. The survey consists of 27 questions and 5 parts. Minimum value = 0 min/day of physical activity // Maximum value = 1440 min/day of physical activity. Higher scores imply a more physically active pattern.

A food frequency questionnaire (FFQ) conducted by a trained nutritionist. Based on dietary data from the FFQ, the investigators will calculate the Mediterranean Diet Score. Minimum value: 0 // Maximum value: 14. Higher scores mean a better outcome.

A seven-day self-reported tobacco and alcohol consumption logs will be used to determine smoking and alcohol intake registering total number of cigarettes and alcoholic units/day, time and situation in which both are consumed and cigarette type of alcoholic drink.

The Fagerström Test for Nicotine Dependence will be used to measure patients' nicotine dependence. Minimum value: 0 // Maximum value: 10. Higher scores mean a worse outcome.

Sleep quality will be determined by the Pittsburgh Sleep Quality Index (PSQI) scale. PSQI global score ranges from 0 to 21, with a score higher than 5 indicating poor sleep quality

A fecal sample (50-60 g) will be obtained and analyzed.

Hospital Clinico Universitario San Cecilio

Universidad de Córdoba

Universidad de Granada

Principal Investigator

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Behaviors and Mental Disorders

Wounds and Injuries

Carcinoma

COVID-19

Stress Disorders, Traumatic

Stress Disorders, Post-Traumatic

Pneumonia

Pneumonia, Viral

Communicable Diseases

Respiratory Tract Infections

Virus Diseases

Coronavirus Infections

Coronaviridae Infections

Nidovirales Infections

RNA Virus Infections

Lung Diseases

Respiratory Tract Diseases

Trauma and Stressor Related Disorders

Mental Disorders

Psychotic Disorders

Psychological care will be based on a monthly interview lasting approximately 45 minutes for 6 months.

Psychological support

Antony NARAYANASSAMY, M

In the context of the COVID-19 pandemic, concerns of the risk of infection may lead to fear, anxiety or psychological disorders that may become generalised and long-lasting, corresponding to post-traumatic stress disorder (PTSD). PTSD generally occurs in circumstances such as terrorist attacks, hostage-taking, bombings, aggression, accidents... The current health crisis also represents an increased risk of PTSD.

After the first moments of stress, the illness becomes more diffuse: personality change (introverted/extraverted), sleep disorders, heart problems, hypervigilance reaction, agoraphobia, symptoms of reminiscence, irritability, decreased concentration, memory loss... In some people, PTSD can lead to more disabling problems such as (crowd) avoidance.

In order to help patients with PTSD, clinical psychology offers therapeutic approaches which, starting from a debriefing with the patient, provide supportive therapy which (i) reassures by providing information on the symptomatology, in order to play down the present state of mind, (ii) allows for the expression of what was experienced during the event, (iii) initiates a process of elaboration of the trauma through transference.

A study initiated at the François Baclesse Centre during the first confinement, which included 735 patients from April to June 2020, made it possible to assess the impact of the pandemic linked to COVID-19 on the care of cancer patients treated in day hospitals, but also to evaluate the PTSD experienced by patients, sleep difficulties, quality of life, cognitive complaints and confinement conditions using validated questionnaires. This study showed that 21% of patients had proven PTSD and 23% had insomnia problem.

This study proposes to evaluate the value of adapted psychological care for patients with PTSD in relation to the pandemic on the improvement of PTSD, as well as on resilience, quality of life and sleep.

Psychological Care of Oncology Patients With Post-traumatic Stress in the Context of a COVID-19

Done with Connor-Davidson Resiliency Scale

Centre Francois Baclesse

60-minute once or twice a week for 6 months of Initial Remote Psychological Support Course .

Yun Hsiang Lee, Phd

When the patient's mood has not yet reached a moderate to high severity level, psychological support is usually provided by the clinical nurses. However, the result of past research showed that the needs of patients and their caregivers were not satisfied with the psychological level. Scholars pointed out that it may be related to factors such as excessive clinical workload or insufficient psychological support and care capacity. In addition, under the influence of COVID-19 in the past two years, medical staff are facing more physical and mental pressure. Oncology nurses have a heavy workload and are affected by the COVID 19 epidemic, which reflects that nurses need psychological support. Therefore, this study intends to reduce stress through remote physical and mental support activities, and use the Internet to intervene in guided relaxation and meditation. Considering the scheduling of clinical nurses, a remote and unstructured course content that does not require continuity will be selected, and then advanced to provide the empathetic care skills of oncology nurses.

The Effects of Multi-Psycho-Oncology Care Courses

The Effects of Multi-Psycho-Oncology Care Courses Through Remote Psychological Support, Emotional Awareness Situation Videos and Empathic Concern Intervention on Physical and Psychological Status, Self-Efficacy and Empathy in Oncology Nurses

Oncology nurses' physical and psychological state were measured by physical and psychological state survey. It use Numerical Rating Scale(VRS) 0-10. It is a 11 Point Likert Scale (e. g. 0 is no pain; 10 is unbearable pain).

Gland and Hormone Related Diseases

Rare Diseases

Anxiety Disorders

Adenocarcinoma

Pancreatic Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pancreatic Cancer

Quality of Life

specific questionnaires administration: EORTC QLQ 30, EORTC- PAN 26, HADS, Millon Clinical Multiaxial Inventory

psychological support

Giulia Bruna Delli Zotti

Maria Maddalena Valente

Michele Reni, MD

The aim of this study is the evaluation of psychological aspects, such as anxiety-depressive patterns, quality of life, personality and other psychopathological syndromes of patients who receive a diagnosis of pancreatic cancer and who face chemotherapy treatment, radio-chemotherapy or surgery

Pancreatic cancer is an aggressive disease whose prognosis is generally unfavorable: less than 20% of patients results eligible for resection treatment with potentially curative purposes and only in 2019 in Italy 13,500 new cases were estimated. It represents one of the poorest prognosis with 8.1% survival at 5 years and 3% at 10 years.

Its treatments can have a negative effect on the quality of life linked to the health of patients (HRQoL). Over the past 20 years, the quality of life assessment has become an important component of evaluating new therapeutic approaches, providing indications on the patient's perception of the benefits of the treatments to which he undergoes. Therefore, an accurate assessment of HRQoL using valid and standardized tools is crucial to highlight the costs and benefits of the different therapeutic options and the clinical utility of the data.

Description of the intervention (schedule of visits):

Visit 1 (screening). Patients will be informed about the study. Once patients agree with the inclusion in the study the investigators will evaluate the inclusion and exclusion criteria. Those patients who meet all the inclusion criteria and none of the exclusion criteria will be finally included in the study. In this visit, patients, tumor-related variables, and general patients' features will be recorded, and all questionnaires will be administered EORTC QLQ 30, EORTC- PAN 26, HADS, Millon Clinical Multiaxial Inventory).

Enrolled patients will make a first psychological visit within one month of the initial diagnosis and before starting active medical treatment (chemotherapy, radiochemotherapy, surgery). During this visit, they will be asked to complete questionnaires aimed at assessing the quality of life (EORCT QLQ 30, EORCT PAN26) of the anxiety-depressant aspects related to the disease (HADS) and of the personological functioning (MCMI-III) to proceed psychological evaluation.

During the visit 2 (2-3 months after the first dose of planned chemotherapy and following an instrumental re-evaluation), the quality of life and the anxiety-depression symptoms related to the disease will be re-evaluated (EORCT QLQ 30, EORCT PAN26; HADS)

The researcher will record in a dedicated database all patient information, such as:

* Personal data (gender, age, schooling)
* Onset and related timing of anxiety disorders or mood before the disease onset
* Psychological or psychiatric visits before the disease onset
* Psychotropic drugs use/abuse
* Psychotherapeutic or psychological path in progress
* Family, social, religious /spiritual resources
* Eligibility for surgery
* Stage of illness
* Clinical treatment (type of chemotherapy, radiochemotherapy)
* Therapeutic result (response, progression stability)
* Any serious adverse events (SAE).

The same variables recorded at Visit 1 will be checked again.

Power size calculation:

The number of patients was calculated taking into account the main outcome. Assuming a positive correlation coefficient of 0.3 (effect size) between the change in anxiety depression levels and self-perceived quality of life, an 85% power, a 5% significance level and a drop-out percentage / missing data equal to 30%, it is estimated a sample size of 75 patients.

Analysis Of The Anxiety-Depressive Pattern, Quality Of Life And Assessment Of Personality in Patients With Pancreatic Ductal Adenocarcinoma (PACT24)

Analysis of Anxiety-depressive Patterns, Quality of Life and Personality Assessment in Patients With Pancreatic Cancer: Outcome of Adaptation to Disease and Clinical Treatments

The prevalence and variations of the anxious and depressive symptoms related to the disease condition (HADS questionnaire) during the disease course

The quality of life self-perceived by the patient (EORTC QLQ 30 - PAN 26 questionnaires) and its variations during the disease path

The influence of a maladaptive personality profiles and psychopathological aspects vs adaptive personality profiles and absence of disease psychopathological aspects (Millon Cutt off \<75) on the quality of self-perceived life (EORTC QLQ 30 questionnaire) and on disease-related anxiety-depressive symptoms (HADS questionnaire) during the treatment through a psychodiagnostic assessment

Michele Reni

Nutritional and Metabolic Diseases

Wasting Syndrome

Cachexia

Psychological support will be given to the experimental group.

Nutrition education will be given to the experimental group.

psychological support and nutritional education will be given to the experimental group.

No intervention will be applied to the control group

psychological support will be given to the patients in the experimental group.

nutritional education will be given to the patients in the experimental group.

nutritional education

psychological support and nutritional education will be given to the patients in the experimental group.

psychological support and nutritional education

no intervation

With the project investigators propose, investigators aim to find answers to the following questions: The fact that irisin and atropine are slimming the proteins that cause an increase in weight loss, and the excessive wasting (cachexia) in some types of cancer makes us wondering whether these factors may be cachectic factors for some GIS and US cancers? It is aimed to determine the relationship between irisin, atropine, some cachectic factors (PIF, ZAG), and cytokines (TNF-α, IL-1, IL-6) at tissue and plasma levels in these types of cancer. In addition, will psycho and nutrition education be applied to patients have an effect on cachexia? Experimental approaches to be used to find answers to such questions make this project unique.

Cancer is the excessive and uncontrolled proliferation of a group of cells in the body. Problems experienced in cancers (cachectic cancers) which are known to be more underweight than other types of cancer; nutritional deficiencies, increasing muscle and adipose tissue atrophy, and psychological problems accompanying cachexia. Weight loss is approximately 60-80% in some GIS and US cancers. Although the mechanism of weight loss in cancer has not been fully elucidated, the importance of proinflammatory cytokines (Tumor necrosis faktör-α (TNF-α), Interleukin-1 (IL-1), Interleukin-6 (IL-6) factors over-synthesized by the body and factors causing muscle and fat atrophy (Proteolysis inducing factors (PIF)and Zinc- α-2 glycoprotein (ZAG) released from tumor cells, is known, but new and more precise agents for the treatment of cachexia are under investigation.

With the project investigators propose, investigators aim to find answers to the following questions: The fact that irisin and adropin are slimming the proteins that cause an increase in weight loss, and the excessive wasting (cachexia) in some types of cancer makes us wonder whether these factors may be cachectic factors for some GIS and US cancers? It is aimed to determine the relationship between irisin, atropine, some cachectic factors (PIF, ZAG), and cytokines (TNF-α, IL-1, IL-6) at tissue and plasma levels in these types of cancer. In addition, will psychoeducation and nutrition education be applied to patients have an effect on cachexia? Experimental approaches to be used to find answers to such questions make this project unique.

In this project, first of all, irisin and atropine will be compared to a combination of cachectic factors and cytokines due to, whether the effect of irisin and atropine on the formation of cancer cachexia at the level of gene and protein in tissue and plasma samples taken from 240 patients diagnosed with GIS (gastric, colon) and UC (bladder, renal) cancer. Nutritional and psychological education will be provided at regular intervals and the patient parameters will be remeasured at the plasma levels. In addition, body mass index monitoring and routine biochemical tests of all patients will be performed during this period. Statistically, Student-t will be used in binary comparisons and ANOVA tests will be used in triple comparisons.

If our hypothesis is realized, new cachectic factors have been identified, specific markers have been identified for GIS and UC cancers, the effect of psychological and nutritional education on cachexia will be answered within the scope of this project.

In line with the data to be obtained from this project in terms of career planning, atrophy and cachexia can be slowed down by injection of irisin and atropine to animals with cachectic cancer models in future projects and it can be planned to treat cancer types with high attenuation. In cancer patients, whose name creates fear in the society, affects people both physiologically and psychologically, and leads people to the bottom in the weakening coexistence, investigators aim to prevent psychological improvement as well as to prevent nutritional deficiencies and to increase the life expectancy in a lifetime. This multicenter and interdisciplinary project that investigators envisaged will enable us to show that investigators are ready for international projects.

1. st group of cancer patients given psychological support
2. nd group of cancer patients given nutrition education
3. rd group of cancer patients who received psychological support and nutrition education
4. th group of cancer patients who will not receive any support

Participants in the study will not know which group.

Slimming Myokines, Cancers,Nutritional and Psychology Support

Investigation of the Slimming Myokines as Biomarkers Potential for Some Gastrointestinal (GIS) and Urinarysystem (US) Cancers and on the Effects of Nutritional and Psychology of Concerned Patients

The scale is applied to patients with physical illness and those applying to primary health care services. The scale consists of 14 questions in total. Seven of them (odd numbers) measure anxiety and the other seven (even numbers) measure depression. Scoring; Each item is scored differently. Items 1, 3, 5, 6, 8, 10, 11, and 13 show decreasing severity and the scoring is 3,2,1, 0. On the other hand, the 2nd, 4th, 7th, 9th, 12th, and 14th items are scored as 0,1,2,3. The total scores of the subscales are obtained by summing these item scores. While collecting the 1st, 3rd, 5th, 7th, 9th, 11th, and 13th items for the anxiety subscale; for depression subscale; The scores of the 2nd, 4th, 6th, 8th, 10th, 12th, and 14th items are added up. Interpretation; As a result of the study conducted in Turkey, the cut-off score for the anxiety subscale was found to be 10/11 and 7/8 for the depression subscale. Accordingly, those above these scores are considered at risk.

Turkish validity and reliability were performed in 2019 in cancer patients. The scale is a 10-point Likert-type scale that measures holistic well-being with 30 items and 7 dimensions and is graded from completely disagree (1) to completely agree (10). Sub-dimensions of the scale: Non-attachment (18, 12, 24, 5, 25), distressing emotion (6, 21, 1, 28, 3), distressing perception (17, 8, 7, 29, 30), spiritual deterioration (20, 26, 2, 4), cognitive awareness (22, 13, 19, 11), general mood (15, 10, 14, 23), spiritual self-care (9, 16, 27). The 4th item in the scale is reverse coded. There is no cut-off point in the scale. The highest score that can be obtained from the scale is 300, and the lowest score is 30. Cronbach's alpha value ranged from 0.670 to 0.892.

After reaching a sufficient number of patients, slimming myokines, cachectic factors, cytokines protein levels will be measured by the commercial kits ELISA (Enzyme-Linked Immunosorbent Assay) method.ELISA technique is the gold standard for quantitation of soluble proteins and provides rapid and consistent results that are easy to analyze.

Hemoglobin (Hgb( g/dL); grams of hemoglobin per deciliter.

Especially body mass indexes of all patients weight and height will be combined to report BMI in kg/m\^2 will be measured again at the beginning of the study and after the nutrition and psychological training.

C-reactive protein (CRP(mg/L) milligrams of CRP per liter. It is possible to say that high CRP levels indicate an acute inflammatory reaction or an infection in the body, and a decrease in CRP levels indicates that the inflammatory reaction or infection has started to decrease

Aspartate transaminase (AST(U/L) units of AST per liter.Plasma AST (aspartate transaminase) level is commonly measured clinically as a biomarker for liver health. The test is part of blood panels.

Alanine transaminase (ALT (U/L) units of ALT per liter. Plasma ALT level is commonly measured clinically as a biomarker for liver health. The test is part of blood panels.

Urea (mg/dL)milligrams of urea per deciliter. Blood urea nitrogen (BUN) is a medical test that measures the amount of urea nitrogen found in the blood. The liver produces urea in the urea cycle as a waste product of the digestion of protein. Normal human adult blood should contain 6 to 20 mg/dL (2.1 to 7.1 mmol/L) of urea nitrogen.

Total protein (g/dL) grams of total protein per deciliter. A total protein test is requested if you have a complaint about your nutritional status, such as weight loss. In the presence of symptoms suggestive of liver or kidney diseases or in the presence of symptoms such as fluid pooling (edema) in the tissues, it may be requested together with other tests.

Creatinine(mg/dL) milligrams of creatinine per deciliter. Normal creatinine values average 0.6-1.3 mg/dL. If this value is above 2.0, renal failure is considered. However, in some cases, it has been observed that the creatinine value increases due to the rapid muscle metabolism in athletes who do heavy sports.

Cancer antigen 15-3 (CA15-3) (U/mL) units of CA 15-3 per milliliter. Cancer antigen 15-3 is a protein made by a variety of cells, particularly breast cancer cells. The protein moves into the blood, where it can be measured.CA15-3 levels are higher than normal in most women with breast cancer that has spread to other parts of the body (called metastatic breast cancer). Not all types of breast cancer will cause CA 15-3 levels to rise, as some types of cancer cells don't over-produce the antigen.

Cancer antigen 19-9 (U/mL) units of CA 19-9 per milliliter. This test measures the amount of a protein called CA 19-9 (cancer antigen 19-9) in the blood. CA 19-9 is a type of tumor marker. Tumor markers are substances made by cancer cells or by normal cells in response to cancer in the body.

carcinoembryonic antigen (CEA)(ng/mL) nanograms of carcinoembryonic antigen per milliliter. Carcinoembryonic antigen (CEA) is a protein normally found in very low levels in the blood of adults. The CEA blood level may be increased in certain types of cancer and non-cancerous (benign) conditions. A CEA test is most commonly used for colorectal cancer.

All tissue samples will be studied simultaneously by taking sections from the FFPE block.

In our study, Invitrogen brand Pure Link to FFPE Total RNA isolation kit will be used. The operating procedure in the kit protocol will be followed. The spectrophotometric method will be used to determine the amount and quality of RNAs obtained before cDNA extraction.

1 μl of the obtained RNAs will be loaded into the BioSpec-Nano (Shimadzu, Kyoto, Japan) device for contamination and concentration determination. The 260/280 absorbance ratio should ideally be around 2 for RNA samples. Samples that are too far from this value mean that there is contamination and RNA isolation will be repeated. RNA concentrations will be diluted to 100 μg/ml so that the initial RNA amounts of all samples are equal before cDNA translation.

ipsogen RT Kit (cDNA synthesis kit) will be used to convert the obtained Total RNA to cDNA. The operating procedure in the kit's protocol will be followed. The mixtures created will be exposed to 25°C for 10 minutes, 50°C for 60 minutes, 85°C for 5 minutes, and 4°C for 5 minutes within the reverse transcription (RT) program. cDNAs will be stored at -20°C until Real-Time PCR is performed. If necessary, it will be stored at -80oC to prolong the lifetime of cDNAs.

The measurement of the slimming myokines, cachectic factors, cytokine parameters at the gene levels in the tissues is planned to be measured by the GeneaQ device will be used. The operating procedure in the kit's protocol will be followed.

T.C. ORDU ÜNİVERSİTESİ

assoc.prof

Structured Responsive Exercise Training Programme (SRETP) prior to surgery

Structured Responsive Exercise Training Programme (SRETP) and psychological support prior to surgery

SRETP will involve short periods of exercise at a high intensity interspersed with short periods of exercise at a moderate intensity (aerobic interval training). We will also include resistance training in each session. Exercise intensities during the interval exercise-training program are specific to each patient and derived from CPET. Moderate intensity exercise is below the anaerobic threshold (AT). Patients will exercise at 80% of oxygen uptake (VO2) obtained at the anaerobic threshold (80%AT) for moderate intensity exercise - 3 minutes. Severe exercise intensity is recognised as 50% of the difference between the VO2 AT and VO2 Peak (50%∆) - 2 minutes.

SRETP

Support sessions will be patient-centred, giving the patient an opportunity to raise any issues/concerns they are having, this may include (but will not be limited to) ways of coping with their reactions to cancer, family and relationship issues, exploring personal issues and dealing with practical issues. Patients will have access to other resources available at the cancer centres including but not restricted to further information about their condition and how to access financial support. These processes reflect the best practice currently being delivered by cancer support centre staff in the Wessex region. Any patient deemed at risk (i.e. from suicidal ideation or self harm) will be reported to their GP, followed up by a letter.

Sandy Jack, PhD

Malcolm West, PhD

Samantha Leggett

Trial Phase: Phase III: A multi-centre efficacy pragmatic factorial design randomised controlled trial with patient informed development and process evaluation

Indication: Patients undergoing major electively resectable intra - cavity cancer surgery with or without neoadjuvant cancer treatments (including chemotherapy (NAC), chemoradiotherapy (CRT), or immunotherapy).

Objective: To investigate the efficacy of a community based Structured Responsive Exercise-training Programme (SRETP) ± psychological support on surgical outcome by reducing postoperative length of stay (LOS) and complications.

Secondary Objective:

To investigate the efficacy of a community based Structured Responsive Exercise-training Programme (SRETP) ± psychological support to improve disease-free overall survival. Cardiopulmonary Exercise test (CPET) variables, physical activity, morbidity, radiological markers of sarcopenia, toxicity, tumour down-staging, tumour regression, disability adjusted survival (WHODAS) overall survival and quality of life (QoL).

Rationale: Fitter patients have better surgical outcomes. Poor physical fitness measured objectively using cardiopulmonary exercise testing has been associated with increased LOS, increased morbidity and mortality in many patient cohorts undergoing major cancer surgery. Chemotherapy and radiotherapy have detrimental effects on physical fitness, which may in turn have a detrimental effect on the patients' ability to withstand surgery. Research suggests psychological factors including depression and self-efficacy (confidence to manage cancer-related problems) prior to surgery predict recovery trajectories in health-related quality of life up to 2 years after major surgery for colorectal cancer.

The aim is to investigate whether SRETP (Prehabilitation) ± psychological support prior to and during cancer treatment before major elective surgery reduces LOS, increases survival and improves their ability to self manage. Additionally, we aim to see if this intervention can bring about long-term behavioural change in relation to physical activity.

Trial Design: Phase III: A pragmatic factorial design randomised controlled to assess the effectiveness of a prehabilitation programme delivered prior to cancer treatments and/or major cancer surgery in patients undergoing elective intra-cavity major cancer surgery in Wessex.

Sample size: 1560

Intervention:

1. An in-hospital transition to a community based Structured Responsive Exercise-Training Programme (SRETP) ± psychological support (delivered in community/ council gyms or Cancer Support Centers). The intervention/s will be delivered before surgery. Patients receiving neoadjuvant cancer treatments prior to surgery will receive the intervention during and after these treatments.
2. Control: Standard care with extra monitoring

2x2 factorial design randomised controlled interventional trial

Masking of CPET assessors and dual reporting, masking of personnel involved in outcome data collection, masking of sarcopenia assessors

The Wessex Fit-4-Cancer Surgery Trial

A Pragmatic Factorial Design Randomised Controlled Study to Assess the Efficacy of the Implementation of a Prehabilitation Programme in Patients Undergoing Elective Major Intra - Cavity Cancer Surgery in Wessex

Date of hospital admission minus date of discharge would equal length of post-operative stay (LOS).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effectiveness of "Multi-Psychological Empowerment" Courses	NCT05977504	Cancer Oncology Psychological Self Efficacy Communication	Multi-Psycholog...	20 Years -	National Taiwan University Hospital
Multidisciplinary Prehabilitation and Postoperative Rehabilitation in Patients Undergoing Resection of Colon Cancer	NCT05379205	Colon Cancer Postoperative C...	Prehabilitation... Postoperative p... Usual Care	40 Years - 85 Years	Universidad de Granada
Psychological Care of Oncology Patients With Post-traumatic Stress in the Context of a COVID-19	NCT04747249	Solid Carcinoma Post Traumatic ... Covid19	Psychological s...	18 Years -	Centre Francois Baclesse
The Effects of Multi-Psycho-Oncology Care Courses	NCT05776680	Cancer Psychological Oncology Empathy	Psychological s...	20 Years -	National Taiwan University Hospital
Analysis Of The Anxiety-Depressive Pattern, Quality Of Life And Assessment Of Personality in Patients With Pancreatic Ductal Adenocarcinoma (PACT24)	NCT04396093	Pancreas Adenoc...	psychological s...	18 Years -	IRCCS San Raffaele
Slimming Myokines, Cancers,Nutritional and Psychology Support	NCT05278078	Cancer	psychological s... nutritional edu... psychological s... no intervation	50 Years - 80 Years	T.C. ORDU ÜNİVERSİTESİ
Psychological Care of Oncology Patients With Post-traumatic Stress in the Context of a COVID-19	NCT04747249	Solid Carcinoma Post Traumatic ... Covid19	Psychological s...	18 Years -	Centre Francois Baclesse
The Effectiveness of "Multi-Psychological Empowerment" Courses	NCT05977504	Cancer Oncology Psychological Self Efficacy Communication	Multi-Psycholog...	20 Years -	National Taiwan University Hospital
Analysis Of The Anxiety-Depressive Pattern, Quality Of Life And Assessment Of Personality in Patients With Pancreatic Ductal Adenocarcinoma (PACT24)	NCT04396093	Pancreas Adenoc...	psychological s...	18 Years -	IRCCS San Raffaele
The Wessex Fit-4-Cancer Surgery Trial	NCT03509428	Cancer	SRETP Psychological s...	18 Years -	University Hospital Southampton NHS Foundation Trust
The Effectiveness of "Multi-Psychological Empowerment" Courses	NCT05977504	Cancer Oncology Psychological Self Efficacy Communication	Multi-Psycholog...	20 Years -	National Taiwan University Hospital
The Effects of Multi-Psycho-Oncology Care Courses	NCT05776680	Cancer Psychological Oncology Empathy	Psychological s...	20 Years -	National Taiwan University Hospital

Spots Global Cancer Trial Database for psychological support