Behaviors and Mental Disorders

All Conditions

Cognitive Dysfunction

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

The ImPACT program consists of 8 weekly 1-hour sessions with homework between sessions.

During the ImPACT program, the childhood cancer survivor and at least one parent collaborates on:

1. Becoming aware of the child's core strengths and difficulties
2. Helping the child to be optimally responsive to the guidance of the parent(s), and
3. Creating compensatory strategies to respond to real-world manifestations of the child's difficulties and helping the child implement these strategies at home.

ImPACT

Lisa M Wu, PhD

Cecilie R Buskbjerg, PhD

Cecilie R Buskbjerg, Ph.D.

The aim of the present pilot study is to evaluate the feasibility, acceptability, and preliminary efficacy of a novel, context-sensitive neuropsychological rehabilitation intervention for childhood cancer survivors and their families.

Cognitive impairment is the most common late effect in childhood cancer survivors, and despite the negative effects of these symptoms on quality of life, scholastic achievement and long-term socioeconomic outcomes, there continues to be no "gold standard" treatment for childhood cancer survivors with cognitive impairment.

Indeed, there is a dearth of research on interventions to treat cognitive impairment in childhood cancer survivors, and the relatively few studied interventions have proven limited effects. Arguably, four key elements are missing from a majority of studied interventions:1) transfer of learning to real-world functional outcomes, 2) awareness training to enhance compensatory strategy use, 3) inclusion of parents that could enhance transfer of learning to the home, and 4) recognition of the inter-related nature of cognitive, neurobehavioral, and psychological functions.

The "I'M aware: Parents and Children Together (ImPACT)" program is a novel, context-sensitive neuropsychological rehabilitation intervention that targets the above mentioned missing elements in previous rehabilitation efforts. The present pilot study aims to assess the feasibility, acceptability, and preliminary efficacy of this program in childhood cancer survivors with cognitive impairment in preparation for a large-scale randomized controlled trial.

Engaging Parents in Neuropsychological Rehabilitation for Childhood Cancer Survivors: The ImPACT Program - A Pilot Study

Engaging Parents in Neuropsychological Rehabilitation for Childhood Cancer Survivors: The "I'm Aware: Parents and Children Together" (ImPACT) Program - A Pilot Study

Following the T4 assessment, the child and parent(s) will be invited to participate in a 30-minutes semi-structured, audio recorded interview.

The parent-report screening version of the Behavior Rating Inventory of Executive Function 2nd Edition (BRIEF-2). 12 items: answer format range: 1-3; total score range: 12-36. Higher score indicates more impairment.

The parent-report version of the Pediatric Perceived Cognitive Function (PedsPCF) Short Form. 7 items: answer format range 1-5; total score range: 7-35. Lower score indicates more impairment.

The parent-report version of the Behavior Rating Inventory of Executive Function 2nd Edition (BRIEF-2). 63 items: answer format range: 1-3; total score range: 63-189. Higher score indicates more impairment.

The child-report version of the Behavior Rating Inventory of Executive Function 2nd Edition (BRIEF-2). 55 items: answer format range: 1-3; total score range: 55-165. Higher score indicates more impairment.

The child-report version of the Pediatric Perceived Cognitive Function (PedsPCF) Short Form. 7 items: answer format range 1-5; total score range: 7-35. Lower score indicates more impairment.

The parent-report version of the Pediatric Quality of Life (PedsQL) Core and Cancer scale. 23 items for the Core Scale, 25 items for the Cancer Scale: answer format range: 0-4; total score range: 0-100 (both scales). Lower scores indicate more impairment.

The parent-report version of the Pediatric Quality of Life Inventory (PedsQL) Core and Cancer scale. 23 items for the Core Scale, 25 items for the Cancer Scale: answer format range: 0-4; total score range: 0-100 (both scales). Lower scores indicate lower quality of life.

The child-report version of the Pediatric Quality of Life (PedsQL) Core and Cancer scale. 23 items for the Core Scale, 25 items for the Cancer Scale: answer format range: 0-4; total score range: 0-100 (both scales). Lower scores indicate more impairment.

The parent-report version of the Revised Children's Anxiety and Depression Scale (CADS) Short Form. 47 items: answer format range: 0-3; total score range: 0-27 (social phobia and panic disorder subscales), 0-30 (major depressive disorder subscale), 0-21 (social anxiety disorder subscale), 0-18 (generalized anxiety disorder and obsessive compulsive disorder subscales). Higher scores indicate more anxiety and depression.

The child-report version of the Revised Children's Anxiety and Depression Scale (CADS) Short Form. 47 items: answer format range: 0-3; total score range: 0-27 (social phobia and panic disorder subscales), 0-30 (major depressive disorder subscale), 0-21 (social anxiety disorder subscale), 0-18 (generalized anxiety disorder and obsessive compulsive disorder subscales). Higher scores indicate more anxiety and depression.

The parent-report version of the Pediatric Quality of Life - Multidimensional Fatigue Scale (PedsQL-MFS). 18 items: answer format range 0-4; total score range: 0-100. Lower score indicates more fatigue.

The child-report version of the Pediatric Quality of Life - Multidimensional Fatigue Scale (PedsQL-MFS). 18 items: answer format range 0-4; total score range: 0-100. Lower score indicates more fatigue.

The Parenting Sense of Competence Scale (PSC scale).17 items: answer format range 1-6; total score range: 16-102. Higher score indicates more competence.

The Parenting Sense of Competence Scale (PSC scale). 17 items: answer format range 1-6; total score range: 16-102. Higher score indicates more competence.

The 7-item interest/enjoyment subscale of the Intrinsic Motivation Inventory (IMI). 7 items: answer format range 1-7; total score range: 1-7. Higher score indicates more motivation.

The Client Satisfaction Questionnaire (CSQ-8). 8 items: answer format range 1-4; total score range: 8-32. Higher score indicates better satisfaction.

Standard neuropsychological test battery. Different scoring formats.

University of Aarhus

Aarhus University Hospital

Associate Professor

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Quality of Life

A consecutive sample of clinically localized prostate cancer patients treated with active surveillance, robot-assisted radical prostatectomy, intensity-modulated radiotherapy, or real-time brachytherapy in 18 Spanish hospitals.

It consists on monitoring the cancer with regular tests including PSA, blood test and digital rectal examination every 6 months, a magnetic resonance imaging and prostate biopsy at the first year, and based on clinical decision thereafter. If there was a change on the results, the patient is considered for treatment.

Active Surveillance

It consists on the removal of the prostate gland and seminal vesicles with neurovascular preservation whenever anatomically and oncologically possible, with the Da Vinci procedure. Access is made through 5 or 6 small incisions, less than 1 cm. An extended pelvic lymph node dissection is performed when the risk estimation of node involvement is above the 5%. After surgery, the patient will be hospitalized for about 3 days and will probably resume his work activity between 3 and 5 weeks.

Robot-Assisted Radical Prostatectomy

Patients in this group undergo volumetric modulated arc therapy under daily image-guided radiation therapy in the supine position. Radiation is delivered in 2-3 Gy daily fractions, 5 days per week, with a prescription dose of 60-70 Gy to the prostate.

Intensity-Modulated Radiotherapy

Patients in this group receive I125 permanent seeds (low dose rate). The images are obtained with a transrectal ultrasound probe and are transferred to a planning system for calculating the number and position of the seeds. The prescrption dose is 145 Gy to the reference isodose (100%).

Real-time brachytherapy

The purpose of this study is to evaluate the effectiveness of four of the nowadays most established primary treatments for patients with clinically localized prostate cancer (active surveillance, robot-assisted radical prostatectomy, intensity-modulated radiotherapy, and real-time brachytherapy) at short-, mid- and long-term follow-up. The primary aim is assessing the impact of treatments' side effects on patient's quality of life. As secondary objectives, biochemical disease-free survival, overall survival, and prostate cancer-specific survival will also be assessed.

Primary Objective:

To compare the impact of active surveillance, robot-assisted radical prostatectomy, intensity-modulated radiotherapy, and real-time brachytherapy in patients with localized prostate cancer, in Patient-Reported Outcome Measures, considering side effects and physical and mental health at short-, mid- and long-term follow-up.

Secondary Objectives:

To assess biochemical disease-free survival by treatment and risk group, at mid- and long-term follow-up.

To assess overall survival by treatment and risk group, at mid- and long-term follow-up.

To assess prostate cancer-specific survival by treatment and risk group, at mid- and long-term follow-up.

To assess perceived general health and cancer-specific quality of life by treatment and risk group, at short-, mid- and long-term follow-up.

To assess benefits and risks of the new treatment modalities for localized prostate cancer, compared with the traditional ones (open radical prostatectomy, external-beam radiotherapy and intersticial pre-planned brachytherapy).

To assess utilities with direct and indirect methods.

Outline:

This is a prospective observational study of a cohort with clinically localized prostate cancer treated with either active surveillance, robot-assisted radical prostatectomy, intensity-modulated radiotherapy, or real-time brachytherapy.

Participants are consecutively recruited in 18 Spanish hospital departments (located in six autonomous communities). Patients eligible for inclusion were: age 50-75, tumor stage T1c or T2a, N0 and M0; Gleason ≤ 6 (or 3+4 if T1c); Prostate Specific Antigen (PSA) ≤ 10 ng/mL; and to be treated with active surveillance, robot-assisted radical prostatectomy, intensity-modulated radiotherapy, or real-time brachytherapy. Patients were excluded when body mass index was \>33, they had undergone neoadjuvant hormonal treatment, previous pelvic treatments, and/or had presence of serious comorbidities. The decision regarding treatment is made jointly by patients and health professionals.

Demographic and clinical characteristics at baseline are recorded at clinical sites and include age, PSA, Gleason score, prostate volume, risk group and use of adjuvant hormonal treatment. According to the national health guidelines, participants will be visited every 6-12 months after treatment, and at least annualy thereafter.

Quality of Life questionnaires are administered centrally by telephone interview before treatment and during follow-up at 1, 3, 6, and 12 months after treatment the first year, and annually thereafter. Quality of Life evaluations are gathered using computer-assisted telephone administration and include: (1) the Expanded Prostate cancer Index Composite (EPIC), specifically designed to measure the impact of the different treatments; (2) 36-item Short-Form Health Survey version 2 (SF-36v2); (3) the EuroQol-5 Dimension (EQ-5D-5L); and (4) the Patient-Oriented Prostate Utility Scale (PORPUS).

The sample size calculated to detect small differences between groups (0.3 SD) on the EPIC or SF-36v2 scores was of 90 patients per treatment group, given a statistical power of at least 80% at a significance level of 5%, and loss to follow-up of 10%.

New Treatment Modalities for Localized Prostate Cancer

Comparative Effectiveness of New Treatment Modalities for Localized Prostate Cancer

Data processing complies with ethical principles and relevant national and international legislation (Reglamento General de Protección de Datos 2016/679 and Organic Law 3/2018, of December 5). The final data will only be accessible to people working on the study. No data used in the analyses and subsequent dissemination of the study results will contain any identifiable reference referring to the names of patients. Once the study is finished, the results will be communicated to the competent authorities, in accordance with local legislation.

Data and associated documentation will be made available to users only under a data sharing agreement that provides for:

* A commitment to use the data only for research purposes and not to identify any individual participant;
* A commitment to protect data through the use of appropiate information technology;
* A commitment to destroy or return the data after analyses are complete.

The Expanded Prostate Cancer Index Composite-26 (EPIC-26) is a prostate cancer-specific questionnaire that measures urinary, sexual, bowel, and hormonal domains, ranging from 0 to 100. Response options for each EPIC item are on a 4-, 5-, or 6-level Likert scale. Items are grouped in summary scores for sexual, bowel, and hormonal domains, and in 2 scores for the urinary domain (incontinence and irritative/obstructive symptoms), which are transformed linearly to a scale from 0 to 100, where higher scores indicate better outcomes.

Number of participants who are free of biochemical relapse after a specified duration of time. Biochemical relapse is measured by PSA levels. For patients treated with radical prostatectomy, biochemical relapse criteria of the American Urological Association is applied, and for patients treated with external radiotherapy or brachytherapy, criteria of the American Society for Therapeutic Radiology and Oncology is followed.

Number of participants who are alive after a specified duration of time. Vital status and data of death from any cause recorded by linkage with the National Institute of Statistics.

Number of participants who are not dead due to prostate cancer after a specified duration of time. Death due to prostate cancer according to the cause of death registered in the the National Institute of Statistics.

The 36-Item Short-Form Health Survey version 2 (SF-36v2) contains 36 items covering eight dimensions: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems and mental health. For each dimension, a score ranges from 0-100 (higher score indicate better health).Physical and mental component summaries are constructed, using recommended scoring algorithms. Summary scores are standardized to have a mean of 50 and standard deviation of 10 in the US general population.

The EuroQol-5 Dimensions (EQ-5D-5L) is a generic econometric instrument that contains five dimensions of health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) with five levels of severity in each dimension. From the possible combinations of scales and severity levels (3125 health states), a utility index is obtained, which ranges from 1 (perfect health) to negative values, 0 being the value attributed to death.

The Patient-Oriented Prostate Utility Scale (POPRUS) is a 10-attribute health state classification system that includes 5 broad items of health-related quality of life (pain, energy, social support, communication with doctor, and emotional well-being) and 5 prostate cancer-specific items (urinary frequency and incontinence, sexual function and desire, and bowel function. A multiattribute utility function is constructed using the patient-weighted utilities elicited with standard gamble. This utility index (PORPUS-U) ranges from 1 (perfect health) to 0 (dead).

Hospital Universitari de Bellvitge

Institut d'Investigació Biomèdica de Bellvitge

Hospitales Universitarios Virgen del Rocío

Hospital Regional Universitario Carlos Haya

Hospital del Mar

Hospital Universitario Rey Juan Carlos

Hospital Provincial de Castellon

Hospital Arnau de Vilanova

Hospital Universitario La Paz

Hospital Universitario La Fe

Hospital de Meixoeiro

Hospital Universitario 12 de Octubre

Hospital Universitario Reina Sofia de Cordoba

Hospital General Universitario de Valencia

Fundacion IMIM

Medical Doctor, PhD

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Arm A: Participants will be fitted with the THEYA Recovery bra

Arm B: Participants will be recommended or fitted with current recommended bra used in each hospital by the Breast Care Nurse Specialist

Post-operative Lingerie made from viscose derived bamboo

THEYA Recovery Range

Claire Kelly, Masters of Science

Amanda McCann, PhD

A randomised interventional comparative control study will be undertaken to compare the THEYA Recovery Range postoperatively for patients undergoing wider lumpectomies, partial mastectomies and total mastectomies to current practice using a mixed method combining quantitative and qualitative instruments. 100 female participants are hoped to be recruited following breast surgery after a newly diagnosed breast cancer.

This study will answer the research question:- "What is the clinical and psychosocial impact of the THEYA Recovery Range in comparison to recommended practice during and after breast cancer treatment?" This study will leverage the findings of a pilot study conducted by Applied Research Connected Healthcare (ARCH) measuring the usability of the THEYA Recovery Range.

This study aims to assess the participants' experience of recovery in the immediate post-operative period and the psychosocial effect of THEYA Recovery Range in comparison to current recommended practice.

Breast cancer is the second most common cancer worldwide, and the most frequent cancer among females with nearly 1.67 million new cases diagnosed in 2012 (WHO, 2012). Due to population increases, health service and cancer awareness, more women are diagnosed with breast cancer each year. Advances in diagnosis and in treatment have seen an increase in survival from breast cancer for Irish women in recent years (ABC, 2010). In Ireland, after non-melanoma skin cancer, breast cancer is the most common tumour diagnosed in women in 2008-2010. With an average annual amount of 2,767 women diagnosed with breast cancer in 2008-2010 (NCRI, 2013). As a result, more women are living with the permanent effects of breast cancer (Gho et al., 2010).

For patients' newly diagnosed with breast cancer, surgery is the first choice of treatment. 84% of females receive surgery as a form of treatment, be it as a single modality or in combination with radiotherapy, chemotherapy and/or hormone therapy (NCRI, 2012).

A randomized interventional comparative control study will be undertaken to compare the THEYA Recovery Range postoperatively for patients undergoing wider lumpectomies, partial mastectomies and total mastectomies using a mixed method combining quantitative and qualitative instruments. 100 female participants are hoped to be recruited following breast surgery after a newly diagnosed breast cancer.

Who can participate? Women over the age of 18 years with no upper age limit, with a newly diagnosed breast cancer that are planned to undergo breast surgery as treatment in a 3 month period from recruitment.

What does the study involve? Participants will be randomly assigned, by use of a sealed envelope into two groups: an intervention and a control group.

Women in the intervention group will be fitted by the investigator with a THEYA Recovery bra.

Women in the control group will have standard post-operative care, with recommended bra or fitted by the Breast Care Nurse Specialist.

All participants will complete three questionnaires before fitting : The Breast Q, The Body Image Scale and the EQ 5D 3L.

All participants will be asked to continue wearing bra for a period of three to four weeks, then re-assessed on return visit, with re-assessment of the three questionnaires. 30 partcipants will be randomly selected from the sealed envelope to undergo a semi-structured interview, in order to gain a better understanding of their experience.

What are the possible benefits and risks of participating? The benefits for participating include receiving the same level of care, and for those undergoing lumpectomy a free bra. The study aims to evaluate the patients requirements in post-operative lingerie in order to help and further assiss these women. As this is an area of minimal research. There are no risks envisaged from participating in this study.

Where is the study run from? The study is ran from The Beacon Hospital, Mater Misericordiae University Hospital, Mater Private Hospital and St.James's Hospital.

When is the study starting and how long is it expected to run for? The study is planned to start in November 2015 and is expected to run until December 2016.

Who is funding the study? The study is being funded from the Irish Research Council and THEYA as part of an Employment Based PostGraduate Award.

Who is the main contact? Claire Kelly, Researcher.

claire@theya.healthcare

Breast Surgery Recovery: The Clinical and Psychosocial Impact of THEYA Recovery Range

A qualitative semi-structured interview designed by the researcher to evaluate the lived experience of the participants.

The EQ-5D-3L measures the respondent's health related Quality of Life

100 represents the "Best imaginable health status' and 0 represents the 'Worst imaginable health status'

The scale consists of ten questions for assessment. Response options range from ''not at all'' (score 0), ''a little'' (score 1), ''quite a bit'' (score 2) to ''very much'' (score 3).

A total score ranging from 0 to 30 per patient with 0 representing no distress or symptoms, whereas increasing scores represent increasing distress and symptoms.

Breast-Q Questionnaire (measure through questionnaires the quality of life and psychosocial indicators specific to breast cancer survivors)

University College Dublin

Irish Research Council

Claire Kelly

Infections

Symptoms and General Pathology

Communicable Diseases

Head and Neck Neoplasms

Other Dietary Supplements

All Drugs and Chemicals

Amino Acids

Omega 3 Fatty Acid

Arginine

Experimental Group (immunomodulatory supplement STUDY)

immunomodulatory supplement

IMPACT (Nestle Healthcare Nutrition, Minnesota USA) an 'immune-enhancing' feed which contains supplemental L-arginine (1.25 78 g/L), dietary nucleotides (1.2 g/L) and omega-3 fatty acids in the form of 79 eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (EPA/DHA 1.7 g/L) 80 as its active ingredients.

IMPACT

Carmen Gomez Candela

The purpose of this study is to evaluate the effect of an immune formula , consumed 10 days before surgery , on the number and characteristics of postoperative infections for a period of 30 days in a group of oropharynx, hypopharynx , larynx and oral cavity squamous cell cancer patients, candidates for surgery.

68 subjects randomized into two study groups: 34 subjects consume the supplement of the study and 34 control consume the supplement IMPACT.

Intervention period will be 10 days before surgery . The consume amount is 400 ml/ day. The Subjects were stratified according to tumor location ( larynx and oral cavity and oropharynx, hypopharynx) and disease stage (early and advanced).

Comparison of Two Immunomodulatory Formulas on the Number of Postoperative Infections in Head & Neck Cancer Patients

Comparison of Two Immunomodulatory Formulas on the Number of Postoperative Infections in Oropharyngeal and Maxillofacial Cancer Patients Eligible Surgery

Vegenat, S.A.

Instituto de Investigación Hospital Universitario La Paz

Digestive System Diseases

Rare Diseases

Stomach Neoplasms

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Esophageal Diseases

Stomach Cancer

Esophageal Cancer

Pre-operative immunonutritrion, pre-operative glucose load, post-operative early immunonutrition

No immunonutrition, no glucose load, no early enteral immunonutrition

Preoperative 5 day oral Impact and early post-operative enteral Impact

Impact

Pre-operative glucose load: 800 ml of PreOp (Nutricia) 12 h before surgery; 400 ml of PreOp (Nutricia) 2 hours before surgery

Glucose load

Dan E Azagury, MD

The aim of this study is to demonstrate the influence of peri-operative nutrition on the post-operative complications, preservation of lean body mass and length of stay after gastrectomy or oesophagectomy.

Perioperative Nutrition in Upper Gastrointestinal (GI) Cancer Surgery

Perioperative Nutrition in Upper GI Cancer Surgery (Oesophagectomy or Gastrectomy)

Dan Azagury

Medecin adjoint du chef de service

Blood and Lymph Conditions

Immune System Diseases

Nervous System Diseases

Lymphoma

Leukemia

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Lymphosarcoma

A pediatric cancer-specific, clinic based, six-module interdisciplinary uncertainty intervention. Modules one through three target uncertainty prevention. Modules four through six target uncertainty responses for situations in which uncertainty cannot be prevented or avoided.

Sessions in this condition aim to provide education on cancer etiology, medical treatments, side effects, potential short- and long-term effects of treatment and resources that are often helpful to parents of children with cancer. Information presented will be based upon, "Young People with Cancer: A Handbook for Parents", a parent resource developed by the National Cancer Institute. Parents will also be provided with relevant educational brochures from COG. Each session will also include a structured set of questions that will facilitate discussion. All ESO interventionists will be trained in non-directive approaches including reflective listening. Content provided in the ESO sessions will offer valuable information to parents without providing the specific skills of the IMPACT.

• The intervention is 6 sessions lasting approximately 45 minutes reviewing ways to help prevent and respond to illness uncertainty. Sessions occur weekly at already scheduled clinic appointments. Interventions will be delivered by a trained interventionist.

This control is 6 sessions lasting approximately 45 minutes providing education on cancer etiology, medical treatments, side effects, potential short- and long-term effects of treatment and resources that are often helpful to parents of children with cancer. Sessions occur weekly at already scheduled clinic appointments. Interventions will be delivered by a trained interventionist.

Ahna LH Pai, PhD

The purpose of this study is to test the efficacy of a clinic-based intervention designed to reduce illness uncertainty for parents of children who have been recently diagnosed with cancer.

The proposed trial will test the efficacy of the parent-focused clinic-based Parent Uncertainty Management Intervention (PUMI) to improve the outcomes of children newly diagnosed with cancer and their parents. Participants will be randomly assigned to receive equivalent doses of either the PUMI or an Education/Support (ESO) group. Theoretically driven by Mishel's model of illness uncertainty, the PUMI will teach parents about uncertainty prevention and management through the use of medically-specific communication, information management, and problem-solving skills via in-clinic sessions and an online portal. Parents and children will complete measures online at baseline, 1-week, and 3-, 6-, and 12-month follow-ups.

Illness Management and Parental Adjustment to Cancer Treatment

A Clinic-Based Interdisciplinary Intervention for Parents of Children With Cancer

Due to the sensitive nature of the measures that provided information on the participants psychologically symptoms the final dataset will be stripped of identifiers prior to any release for sharing, we believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics due the relatively rare pediatric oncological diagnoses of the children in the study. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using the highest standards of practice; and (3) a commitment to destroying or returning the data after analyses are completed.

indicator of global psychological symptoms

Measure of caregiver post-traumatic stress symptoms

University of Oklahoma

Oklahoma State University

Dayton Children's Hospital

Children's Hospital Medical Center, Cincinnati

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Provision of 400 ml per day of high protein oral nutritional supplements

Provision of 400 ml per day of immunostimulating oral nutritional supplements

Administration of oral immunostimulating oral supplement

Administration of oral high-protein oral supplement

resource protein

Stanislaw Klek

Immunomodulating nutrition is supposed to reduce the number of complications and the legnth of the hospital stay during the postoperative period in patients after major gastrointestinal surgery. The aim of the study is to assess the clinical effect of immunomodulating oral nutrition in patients undergoing resection for gastrointestinal cancer in the group of well-nourished patients.

Between March 1, 2019, and December 31, 2020, a group of 300 well-nourished patients will be enrolled to the study and randomly assigned two one of two groups: A-high protein oral supplements (ONS) and B- immunomodulating ONS. The study is designed to test the hypothesis that immunonutrition and reduce the incidence of infectious complications after upper gastrointestinal surgery; the secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and hospital stay.

Preoperative High Protein vs Immunodiet in Surgical Cancer Patients

Preoperative Use of the High Protein ONS vs Immunoenhancing ONS in Gastrointestinal Cancer Patients Undergoing Surgery

Number and type of infectious complications

Number and type of surgical complications

Stanley Dudrick's Memorial Hospital

Head of the Unit

Nutritional and Metabolic Diseases

Malnutrition

Nutrition Disorders

study of immuno-modulating enteral nutrition

Impact (R) Enteral Nutrition

1500 calories every day :

-5 days before the begining of the chemoradiotherapy and until the last day of the treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Engaging Parents in Neuropsychological Rehabilitation for Childhood Cancer Survivors: The ImPACT Program - A Pilot Study	NCT05483166	Pediatric Cance... Cognitive Dysfu...	ImPACT	10 Years - 17 Years	Aarhus University Hospital
New Treatment Modalities for Localized Prostate Cancer	NCT05523856	Prostate Cancer	Active Surveill... Robot-Assisted ... Intensity-Modul... Real-time brach...	50 Years - 75 Years	Fundacion IMIM
Breast Surgery Recovery: The Clinical and Psychosocial Impact of THEYA Recovery Range	NCT02593890	Breast Cancer	THEYA Recovery ...	18 Years -	Theya
Engaging Parents in Neuropsychological Rehabilitation for Childhood Cancer Survivors: The ImPACT Program - A Pilot Study	NCT05483166	Pediatric Cance... Cognitive Dysfu...	ImPACT	10 Years - 17 Years	Aarhus University Hospital
Comparison of Two Immunomodulatory Formulas on the Number of Postoperative Infections in Head & Neck Cancer Patients	NCT02622880	Head and Neck N...	immunomodulator... IMPACT	18 Years -	Instituto de Investigación Hospital Universitario La Paz
Perioperative Nutrition in Upper Gastrointestinal (GI) Cancer Surgery	NCT00560846	Stomach Neoplas... Esophageal Neop...	Impact Glucose load	18 Years -	University Hospital, Geneva
Comparison of Two Immunomodulatory Formulas on the Number of Postoperative Infections in Head & Neck Cancer Patients	NCT02622880	Head and Neck N...	immunomodulator... IMPACT	18 Years -	Instituto de Investigación Hospital Universitario La Paz
Illness Management and Parental Adjustment to Cancer Treatment	NCT02505165	Solid Tumor Leukemia Lymphoma Brain Tumor	IMPACT ESO	0 Years - 18 Years	Children's Hospital Medical Center, Cincinnati
Preoperative High Protein vs Immunodiet in Surgical Cancer Patients	NCT03980704	General Surgery Cancer of Colon	IMPACT resource protei...	18 Years -	Stanley Dudrick's Memorial Hospital
Breast Surgery Recovery: The Clinical and Psychosocial Impact of THEYA Recovery Range	NCT02593890	Breast Cancer	THEYA Recovery ...	18 Years -	Theya
INEC Study: Immuno-modulating Enteral Nutrition in Cancer	NCT00333099	Malnutrition Esophageal Canc... Head and Neck C...	Impact (R) Ente... impact	18 Years -	University Hospital, Clermont-Ferrand

Spots Global Cancer Trial Database for impact

Every month we try and update this database with for impact cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for impact

Every month we try and update this database with for impact cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for impact cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.