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

Behaviors and Mental Disorders

Frailty

Quality of Life

The intervention is individual and based on the Comprehensive Geriatric assessment (CGA) : collection of information on comorbidity, polypharmacy, physical, psychological and cognitive functions, nutrition as well as social status and support.

The results of the CGA, the eventual medical changes and recommendations regarding e.g. initiation of nutritional supplementation, home-care referral or referral to e.g. physiotherapist will be forwarded to the general practitioner and to the oncologist in charge of the treatment

Intervention is planned to be based on the findings of the geriatric assessment and could include optimizing on comorbidity, planning of physical exercise, improvement of the social situation and nutritional status.

Comprehensive geriatric assessment

Else Marie Damsgaard, Professor

A Feasibility study Geriatric assessment applied to patients with cancer of the head and neck, lung cancer, upper gastrointestinal cancer or colo-rectal cancer. On the day of planning the oncologic treatment Comprehensive Geriatric Assessment (CGA) will be offered to patients aged 70 years and up. Based on the CGA a tailored multidisciplinary intervention is planned with the patients. The study aims 1) to investigate if it is feasible to offer CGA to all elderly (+70 years) patients with the relevant cancer diagnoses as mentioned above in The Central Denmark Region (Region Midt) , 2) to estimate the proportion of frail, vulnerable or fit elderly cancer patients, 3) to investigate the impact of a CGA on the planned oncologic treatment intensity, and 4) to investigate the ability of CGA to predict complications to cancer treatment within a three months period.

Aim:

The study aims 1)to investigate if it is feasible to offer CGA to all elderly (+70 years) patients with the relevant cancer diagnoses as mentioned above in The Central Denmark Region (Region Midt) , 2) to estimate the proportion of frail, vulnerable or fit elderly cancer patients, 3) to investigate the impact of a CGA on the planned oncologic treatment intensity and 4)to investigate the ability of CGA to predict complications to cancer treatment within a three months period.

Method:

All patients referred to the oncology Departement aged 70 years or more with cancer of the head and neck, lung cancer, upper gastrointestinal cancer or colo-rectal cancer, Living in the Central Denmark Region (Region Midt) are offered af Comprehensive Geriatric Assessment (CGA) on the day of the visit to the oncology outpatient Clinic. Prior to the first visit to the oncology department, the patients are informed that a CGA is planned..The CGA will take place at the outpatient clinic. The results of the CGA, the eventual medical changes and recommendations regarding e.g. initiation of nutritional supplementation, home-care referral or referral to e.g. physiotherapist will be forwarded to the general practitioner and to the oncologist in charge of the treatment.

Outcome:

1. The possibility of offering CGA to elderly cancer patients in a larger area, the proportion of patients offered CGA by the oncogeriatric team compared to the actual number of elderly cancer patients assessed by oncologists during a three months period.
2. The number of frail vs. vulnerable vs. fit persons is estimated from hospital records and the CGA observations. Their dependency in Activities of Daily Living (ADL) and Instrumental Activities og Daily Living (IADL), their cognitive, depressive and nutritional status and the medication problems are registered as well as the changes in patient´s medication.
3. The impact of CGA on the oncologist´s treatment plan.
4. The Complications, defined as discontinuation of treatment, hospitalization for other reasons than planned cancer treatment, or death, within the first three month following CGA.

Suitability of an Organization With an Onco-geriatric Team to a Whole Region (Region Midt) of Denmark

Oncogeriatric Intervention and Follow-up at Home to Improve Quality of Life and the Possibility to Accomplish Cancer Treatment in Multimorbid Elderly

To analyse the association between the oncologist´s initial treatment plan (standard dose, reduced dose or supportive/palliative/no treatment) and the CGA conclusion (fit, vulnerable or frail) Pearson´s Chi-squared-test or Fisher´s Exact test is used.

In a subgroup analysis on the non-agreed category data on the CGA conclusion and the oncologist´s initial treatment plan. And furthermore to compare the oncologist´s final treatment intensity to the CGA recommendations Pearson´s Chi-squared-test or Fisher´s Exact test are used

Description of the proportion of patients who is available for CGA presented in percentage. Proportion of patients missed for CGA due to organisational issues or rejection to participate in the geriatric evaluation is presented in percentage.

Patient characteristics according to CGA status is presented in percentage

Danish Cancer Society

University of Aarhus

Rare Diseases

Acute Graft Versus Host Disease

children and adolescents between 6 months and 8 years post acute cancer treatment

* individually adjusted physical program consisting of strength and endurance training \> 3 times a week, 2 times guided by a physical therapist at the University Hospital or at a private practice, and ones a week by themselves at home recorded by an activity tracker. Follow-up is foreseen on monthly basis.
* multidisciplinary coaching (discipline depending on personal needs of patient) on a monthly basis. These coaching sessions could be in small groups or individual.

multidisciplinary intervention

Catharina Dhooge, MD, PhD

Ruth Van Der Looven, MD

Elise De Vos, MSc

Hanne Capiau, MSc

Catharina Dhooghe, PHD

Catharina Dhooghe, MD, PhD

Recent numbers display a 85% survival-rate in children after a very harmful disease such as cancer. However, the survivors still experience mild to severe side effects of the primary disease or treatment.

A long time follow-up in the University Hospital of Ghent in children with cancer displays important long term side effects such as: reduced muscle strength; reduced endurance capacity; reduced exercise tolerance; fatigue; disturbed body composition with increased risk for obesity and/or diabetes and osteoporosis; and neuropathic damage and myopathy. These physical complaints have a significant impact on the activities and participation in daily living.

The purpose of this interventional study is to create a rehabilitation program for children after acute cancer treatment. The goal is to minimalize the previous described long term side effects of the disease. The current study should allow us to determine the effects of the intervention at the level of functioning, activities and participation. In addition, we account for the environment and personal factors as described by the International Classification of Functioning, disability and health (ICF-criteria).

The study population consists of children between 8 and 11 years and adolescents of 12 to 21 years old. All participants receive a multidisciplinary treatment for 4 months, guided by a team which includes: oncologist, rehabilitation doctor, physical therapist, dietitian, psychologist, and occupational therapist.

At the beginning of the multidisciplinary program, the participants receive psychoeducation, diet advice, tips for participation, fatigue, and psychological well-being. In general, the rehabilitation program focusses on reintegration at school and leisure activity.

After the first assessment, an individually adjusted physical program consisting of strength and endurance training will be made. This physical program will be executed 3 times a week, 2 times guided by a physical therapist at the University Hospital or at a private practice, and ones a week by themselves at home recorded by an activity tracker. Follow-up is foreseen on monthly basis.

Participants will undergo assessment 3 times: 1) baseline (T0); 2) after 4 months treatment (T1); 3) after 1 year follow-up (T2).

The purpose of this program is to encourage patients at risk for increasing their healthy habits, exercise and participation in order to decrease long-term (side) effects.

Multidisciplinary Rehabilitation of Children and Adolescents After Acute Cancer Treatment

Maximal exercise test on a cycle ergometer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Suitability of an Organization With an Onco-geriatric Team to a Whole Region (Region Midt) of Denmark	NCT02072733	Elderly Cancer	Comprehensive g...	70 Years - 130 Years	University of Aarhus
Suitability of an Organization With an Onco-geriatric Team to a Whole Region (Region Midt) of Denmark	NCT02072733	Elderly Cancer	Comprehensive g...	70 Years - 130 Years	University of Aarhus
Multidisciplinary Rehabilitation of Children and Adolescents After Acute Cancer Treatment	NCT05154305	Cancer Survivor... Rehabilitation Exercise Therap...	multidisciplina...	8 Years - 21 Years	University Hospital, Ghent

Spots Global Cancer Trial Database for multidisciplinary intervention