Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Arm A will engage in up to 4 aerobic sessions per week at 55% to 75% of the individually determined exercise capacity (VO2peak; determined from the cardiopulmonary exercise test (CPET) performed at baseline) for 16 weeks. This exercise prescription will be achieved through \~ 4 sessions / week. Men are provided with a heart rate monitor to help ensure they exercise in their target zone. At baseline \& week 16, all patients will complete: (1) lifestyle and quality-of-life questionnaires, (2) measurement of weight (3) collection of research fasting blood sample, (4) collection of urine sample, and (5) cardiorespiratory fitness testing. Archival biopsy tissue samples from before and after the intervention will also be requested.

Arm B will receive print material with physical activity guidance which includes general physical activity information (e.g., "Moving through Cancer - A Guide to Exercise for Cancer Survivors") at baseline, but no specific exercise program or goals. At the conclusion of the 16 weeks, subjects in this group will be provided with a heart rate monitor, an individualized aerobic exercise program based on their cardiorespiratory fitness test results, and opportunity to consult with study exercise physiologist (one-time).

Arm C is a non-randomized control group of men without cancer, which will receive all baseline and 16 week follow-up assessments (except tissue procurement) will engage in up to 4 aerobic sessions per week at 55% to 75% of the individually determined exercise capacity (VO2peak; determined from the cardiopulmonary exercise test performed at baseline) for 16 weeks. This exercise prescription will be achieved through \~ 4 sessions / week. Men are provided with a heart rate monitor to help ensure they exercise in their target zone. At baseline \& week 16, all patients will complete: (1) lifestyle and quality-of-life questionnaires, (2) measurement of weight (3) collection of research fasting blood sample, (4) collection of urine sample, and (5) cardiorespiratory fitness testing.

There is also a non-randomized observational component to the study where biospecimens and survey data will be collected and one CPET will be administered. Individuals who will be enrolled to this group include those who do not meet all eligibility criteria for the RCT, or those who do not wish to be in a RCT, but are interested to participate in some lifestyle research.

This open-label, two-arm randomized controlled trial (RCT) will investigate the effects of 16 weeks of structured aerobic training, relative to usual care (print material with physical activity guidance) in 76 men with histologically confirmed low-risk prostate adenocarcinoma on active surveillance. The only investigational therapeutic agent being tested in this trial is a behavioral intervention in the form of aerobic training.

Exercise

Exercise capacity test to assess peak oxygen consumption (VO2peak)

Cardiopulmonary Exercise Test (CPET)

June Chan, Sc.D.

This phase 2, open-label, dual-center, two-arm randomized controlled trial (RCT) investigates the effects of 16 weeks of structured aerobic training, relative to usual care (print material with physical activity guidance). Prostate genomic signatures represent the functional activity of all genes in the genome and are converted into genomic risk scores which correspond to the probability of a progression event (chance of having more aggressive disease). A structured exercise program may alter the genomic risk score and improve prediction of aggressive disease.

PRIMARY OBJECTIVE:

I. Determine the effect of remotely monitored, tailored aerobic training, compared to usual care (print material with physical activity guidance), on cardiopulmonary fitness in men on active surveillance for low-risk prostate cancer.

SECONDARY OBJECTIVES:

I. To determine the effect of aerobic training, compared with usual care, on prostate genomic signatures that predict risk of prostate cancer progression or aggressive disease; and messenger ribonucleic acid (mRNA) expression patterns in tumor and surrounding stromal (normal) tissue.

II. To determine the effect of aerobic training, compared with usual care, on patient-reported outcomes including active surveillance-specific anxiety, stress, \& adherence.

III. To procure blood, urine and paraffin embedded prostate tissue for future exploratory studies.

IV. To conduct correlative science examining associations between measures of cardiopulmonary fitness, clinical features, and biomarkers of prognosis.

V. To evaluate and compare circulating and urinary biomarkers (e.g., metabolomics, proteomics) among men in Arms A, B, and C.

OUTLINE: This study is a randomized controlled trial of 16-weeks aerobic exercise (home-based walking) versus (vs.) usual care among 64 men with prostate cancer on active surveillance. There is also a non-randomized observational component to the study where we will collect biospecimens, survey, data, and administer one cardiopulmonary exercise test (CPET).

ARM A: Patients undergo structured aerobic training comprising four treadmill walking sessions a week at 55% to 75% of the individually determined exercise capacity for 16 weeks. Men are provided with a heart rate monitor to help ensure they exercise in their target zone. At baseline \& week 16 (-7, +7 days), all patients complete: (1) lifestyle and quality-of-life questionnaires, (2) measurement of weight and waist circumference (3) collection of research fasting blood sample, (4) transrectal ultrasound-guided clinical biopsy, and (5) cardiorespiratory fitness testing. Archival tissue specimens from standard of care biopsies are also collected, pre/post intervention.

ARM B (USUAL CARE): Patients undergo usual care and are provided with general physical activity information ("Moving through Cancer-A Guide to Exercise for Cancer Survivors") at baseline. At the conclusion of the 16 weeks, subjects in this group will be provided with a free session with an exercise physiologist and an individualized aerobic exercise program based on their cardiorespiratory fitness test results. Archival tissue specimens from standard of care biopsies are also collected, pre/post intervention.

ARM C (NON-RANDOMIZED CONTROL GROUP): Control group of men without cancer, with a lower baseline fitness level (assessed as part of screening), who will receive all baseline and 16 week follow-up assessments (except tissue procurement), and the same intervention as Arm A. Subjects undergo structured aerobic training comprising four treadmill walking sessions a week at 55% to 75% of the individually determined exercise capacity for 16 weeks. Men are provided with a heart rate monitor to help ensure they exercise in their target zone. At baseline \& week 16 (-7, +7 days), all patients complete: (1) lifestyle and quality-of-life questionnaires, (2) measurement of weight and waist circumference (3) collection of research fasting blood sample, (4) cardiorespiratory fitness testing.

OBSERVATIONAL GROUP (NON-RANDOMIZED): Biospecimens, survey, data, and administer one CPET will be collected. Individuals who will be enrolled to this group include those who do not meet all eligibility criteria for the RCT, or those who do not wish to be in a RCT, but are interested to participate in some lifestyle research.

After completion of study, patients in Arms A \& B are followed up at 16 weeks, 12 months, and 24 months. Non-randomized participants (Arm C) are followed-up at 16 weeks, and Observational study participants are asked to complete surveys at 12 and 24 months.

Active Surveillance Exercise Clinical Trial

A Randomized Clinical Trial of Exercise vs. Usual Care Among Men Opting for Active Surveillance for Prostate Cancer

Change in cardiopulmonary fitness as indicated by V02max (from CPET) will be compared across each arm. All analyses will employ the intention-to-treat (ITT) approach. Every attempt will be made to complete the week 16 follow-up assessment on all patients.

Subject will complete the State Trait Anxiety Inventory (STAI) for Adults survey to assess general anxiety scores. The survey measures state and trait anxiety, with 20 questions, and each question can be scored as 1-4 points. Higher scores indicate greater anxiety and the score range is 20-80.

Subjects will complete the Memorial Anxiety Scale for Prostate Cancer (MAXPC) survey to assess specific prostate cancer anxiety. Higher scores indicate greater anxiety and the fear of cancer recurrence score ranges from 0 to 12.

Adherence is measured by the proportion of patients in each study group that remain on active surveillance after 12 months follow-up.

Adherence is measured by the proportion of patients in each study group that remain on active surveillance after 24 months follow-up.

Effect of aerobic training on mRNA expression patterns using the 1.4 million marker Affymetrix 1.0 Human Exon Array, in formalin-fixed paraffin-embedded (FFPE) prostate biopsy tissue taken before and after the intervention interval..

National Cancer Institute (NCI)

University of California, San Francisco

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Can people living with and beyond colorectal cancer make lifestyle changes with the support of health technology

Written instructions will be provided to participants, to include how to download supportive apps on smartphones. Participants will be asked to complete a 3 day food diary using an online platform (MyFood24) prior to attending a face to face consultation which will reinforce the participant's responsibilities. Participants will be assisted to set specific diet and lifestyle goals. 3 fortnightly follow ups will be arranged via 15 minute telephone consultations, three 24 hour dietary diaries will be completed via MyFood24 prior to each fortnightly digital consultation. Participants will be asked to measure their daily activity via a pedometer on their smart phones. Participants will be asked to complete the Godin leisure time questionnaire to assess changes in leisure time exercise.

Lifestyle changes with the support of health technology

Victoria Aubrey, BSc, MSc

Clare Shaw, BSc, PhD

The objective of this small study is to assess the feasibility of remotely delivering a diet and lifestyle intervention following treatment of CRC through telecommunications and digital technology. A DBCI will be implemented among a population of people living with and beyond CRC to help identify if patients find this an easy and achievable way to communicate with a Registered Dietitian. The information gained from this small scale feasibility will be used to help develop a larger study on supporting people with CRC to make a lifestyle change.

Fifty four percent of Colorectal cancer (CRC) cases are thought to be preventable, showing it has a strong correlation with lifestyle factors. A recent report by the World Cancer Research Fund and American Institute of Cancer Research (WCRF/AICR) on diet, physical activity (PA) and CRC reported numerous findings linking lifestyle with primary prevention of CRC. Approximately six out of ten people diagnosed with bowel cancer in England and Wales survive for 10-years or more and rates of survival have more than doubled in the last 40-years.

The term 'cancer survivors' denotes all people who are living with a diagnosis of cancer, and those who have recovered from the disease. The term is not universally accepted and survivors are increasingly being referred to as people 'living with and beyond cancer. This covers a wide variety of circumstances including people at diagnosis, during and post treatment, and those with recurrence therefore including people with potentially differing nutritional needs. People can be struggling with a poor nutritional intake due to treatment side effects or may need to optimise their nutritional status preoperatively or require advice post treatment for optimum recovery and rehabilitation. However, compared to the vast amount of research with respect to CRC incidence there is a paucity of research on diet and lifestyle factors influencing CRC recurrence and survival.

The second WCRF and AICR expert report in 2007 undertook a systematic literature review to assess the role of food, nutrition and PA in people diagnosed with cancer. The report included randomized control trials (RCTs) evaluating dietary interventions, however, there were no conclusions drawn. This was attributed to poor quality designs and varying intervention duration of the studies. The third WCRF and AICR expert report, in 2018, stated new evidence had accrued since the second report but primarily within breast cancer therefore a review of the evidence was undertaken in this group leaving a gap in the evidence base with regard to CRC.

The design of secondary prevention studies are based on expert conclusion with the third WCRF recommending survivors who have completed treatment should follow the general advice for cancer prevention. The current strongest primary prevention evidence is that CRC risk is decreased by being physically active in addition to a higher consumption of wholegrains, dietary fibre and dairy products. Risk is increased by the consumption of red and processed meat, more than two alcoholic drinks per day and being overweight or obese.

A recent review of the literature of lifestyle interventions in RCTs in people with CRC has identified 6 published studies (in preparation). The review identified that all current studies used a variety of dietary and physical activity interventions, data collection tools and inconsistent timing of interventions commencing from 6 months to 5 years post diagnosis. None of the published RCTs achieved changes in dietary intake and any small changes that occurred were not sustainable with participants reverting to their usual dietary habits.

One conclusion from the review was that no studies used appropriate methods to support behaviour change such as healthcare professionals trained in behaviour change techniques and methods of support, for example, digital technology. It has been demonstrated that such techniques would help support people to make lifestyle changes and from a research perspective can eliminate administration-intensive tasks, variation in interpretation and recording errors

Discussion with the PPI group of The Royal Marsden Hospital (NHS Foundation Trust) and Institute of Cancer Research provided a valuable insight into the variance in opinion as to when and how people could be asked to make lifestyle changes. The support provided by family members and / or carers was identified as a critical factor in supporting people to make lifestyle changes.

There has recently been an increased interest in the use of digital behaviour change interventions (DBCIs) and smartphone applications in the healthcare setting, including in the management of diet, PA and weight.

A recent systematic review of DBCIs amongst cancer survivors identified fifteen studies and concluded DBCIs can improve PA and Body Mass Index (BMI), in this patient group, with mixed results for improved dietary behaviours.

Lifestyle Changes Using Digital Technology in Colorectal Cancer

Can People Living With and Beyond Colorectal Cancer Make Lifestyle Changes With the Support of Health Technology

Mean percentage of CRC patients who have been able to engage with remote reviews through telecommunications and digital technology at the end of the 2 month intervention. This will be defined as patients that either have completed an online food diary or engaged with the dietitian over the telephone to set and monitor their diet and lifestyle changes.

The demographics including but not limited to age and gender of patients

Proportion of patients willing to take part in this study. This will be defined as those accepting to register to the study by completing the baseline three day food diary out of those approached to take part.

Specific barriers preventing the remote follow ups using telecommunications and digital technology for diet and lifestyle changes will be identified and their frequency and percentages will be reported. These will be recorded on an end of intervention evaluation form and the analysis will be mainly qualitative.

The number and duration of telephone calls between dietitian and participant will also be summarized.

Measure how much time is required to deliver the intervention by dietitians. The dietitian will log on a spread sheet time spent arranging appointments and interacting with participants in person and the telephone

The proportion of participants that had a change in their diet (defined as increased fibre and fruit and vegetables, decreased red meat, processed meat and alcohol) as assessed by comparing parameters from the baseline and end of intervention (at 2 months) three day food diary

Royal Marsden NHS Foundation Trust

Symptoms and General Pathology

Musculoskeletal Diseases

Skin and Connective Tissue Diseases

Nervous System Diseases

Immune System Diseases

Infections

Rare Diseases

Crohn Disease

Colitis

Colitis, Ulcerative

Inflammatory Bowel Diseases

Ulcer

Arthritis

Arthritis, Psoriatic

Sclerosis

Psoriasis

Multiple Sclerosis

Autoimmune Diseases

Arthritis, Rheumatoid

Spondylarthropathies

Joint Diseases

Demyelinating Autoimmune Diseases, CNS

Autoimmune Diseases of the Nervous System

Demyelinating Diseases

Skin Diseases

Skin Diseases, Papulosquamous

Gastroenteritis

Rheumatic Diseases

Collagen Diseases

Connective Tissue Diseases

Spondylitis

Spondylarthritis

Spinal Diseases

Bone Diseases

Chronic Graft Versus Host Disease

Spondylarthropathy

Participants from the "Diet, Cancer and Health" (DCH) cohort with no CID diagnosis at entry to the DCH study. The number of persons developing a CID (defined as at least one of the mentioned CIDs) during follow up (1993/1997 - 2018) and the number of persons not developing a CID will be investigated.

Based on the participants reporting of dietary habits in the Food Frequency Questionnaire (FFQ) from the DCH study, the exposure "intake of red and processed meat and fibres" will be investigated in both CID cases and non-cases.

Other exposure variables are "Lifestyle factors independently or combined" and are also obtained from the data in the DCH cohort.

The intention is to analyse exposure groups in tertiles: 1) Upper tertile (33.3% of the total sample) based on the ratio: meat/fibre intake is associated with higher risk of CID. 2) Low intake of fibre (defined as below the lower tertile \[33.3% of the total sample\]) and high intake of red and processed meat (defined as those above the upper tertile \[33.3% of the total sample\]) are independently associated with higher risk of CID, and their synergy (interaction between the factors meat and fibres) gives the highest risk outcome.

Intake of red and processed meat and fibres

Lifestyles factors are defined as: red and processed meat, vegetables, dietary fibre, cereals, gluten, legumes, red wine, dairy products, physical activity, smoking, total protein/fat, protein/fat from red and processed meat, glycemic index.

Lifestyle factors independently or combined

Vibeke Andersen, Prof

Chronic inflammatory diseases (CID) - including inflammatory bowel diseases (Crohn's disease and ulcerative colitis), rheumatic conditions (rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis), inflammatory skin diseases (psoriasis) and multiple sclerosis are diseases of the immune system that have some shared genetic and environmental predisposing factors, but still little is known on the effects of lifestyle as a prognostic factor on disease risk. This observational study will contribute to preexisting research on lifestyle factors by identifying diet factors associated with risk of developing CID, using prospective register data.

The study will use data from all of the 57,053 participants in the Danish cohort "Diet, Health and Cancer (DHC)" together with registry data. Blood samples, anthropometric measures and questionnaire data on diet and lifestyle were collected at the DHC study entry. The National Patient Registry (NPR) will be used to obtain to identify patients with CID during follow-up. Follow-up information on death and immigration will be collected in March 2018 from the Danish Civil Registration Register.

The outcome CID is defined as at least one of the following CIDs: Crohn's disease, ulcerative colitis, psoriasis/psoriatic arthritis, rheumatoid arthritis/ankylosing arthritis, or multiple sclerosis, during the follow-up period from 1993 to March 2018.

The primary hypothesis is that "the risk of CID will be significantly higher among those with a low fibre/high red and processed meat intake compared to those with a high fibre/low red and processed meat intake." Based on previous research on a shared etiology in CIDs a second hypothesis is that "the postulated causality between low fibre/high red and processed meat intake and risk of developing CID is applicable for each of the CID-diagnoses."

The core study is an open register-based cohort study. The study does not need approval from the local Ethics committee or Institutional Review Board by Danish law. The study was approved by the Danish Data Protection Agency (2012-58-0018) Study findings will be disseminated through peer-reviewed journals, patient associations and presentations at international conferences.

Material and methods:

The study design is a cohort study with prospective register data follow up. The Danish cohort "Diet, Health and Cancer" (DHC) will be used. The DHC Study is an ongoing Danish cohort study designed to investigate the relation between diet, lifestyle and disease risk. The cohort consists of 57,053 persons, recruited between December 1993 and May 1997. All the subjects (50 to 64 years of age) gave detailed information on diet (food frequency questionnaire) and other lifestyle data together with biological samples. Blood samples, anthropometric measures and questionnaire data on diet and lifestyle were collected at study entry. Data from the DHC cohort will be combined with Danish national registers (the National Patient Registry (NPR), the Danish Civil Registration Register, and The Danish National Prescription Registry).

Outcome measures and follow-up: The National Patient Registry (NPR) will be used to obtain to identify patients with CID during follow-up. The NPR contains data on all patients admitted to Danish hospitals since 1977. The register covers both inpatient and outpatient records and indicates the main medical reason for diagnostic procedures or treatment (since 1994 according to the tenth version of the International Classification of Diseases (ICD-10)). For this study there will be extracted data from NPR from 1993 to March 2018. The outcome CID is defined as at least one of the following diseases in the NPR; inflammatory bowel disease (IBD) (ICD10 codes: K50-K51), psoriasis/psoriatic arthritis (ICD10 codes: M073, M090, L40), rheumatoid arthritis/ankylosing arthritis (ICD10 codes: M059. M060, M069, M089, M459, M46), or multiple sclerosis (ICD10 codes: G35, G35.9), during the follow-up period. The Danish National Prescription Registry will be used to identify the most severe cases of the following diseases listed above, as it is expected that the patients have medication in relation to the diseases. Follow-up information on death and immigration will be collected in March 2018 from the Danish Civil Registration Register.

Exposure and possible confounders: Information on exposure is defined as high fibre intake and high red and processed meat intake and were collected at enrolment of the DHC cohort using questionnaires and interviews. In short, the food-frequency questionnaire, diet consumption was assessed in 12 categories of predefined responses, ranking from "never" to "eight times or more per day". The daily intake was then calculated by the software program FoodCalc. FoodCalc is a simple program to calculate intake of nutrients when given a list with amounts of different foods consumed and another list with contents of nutrients for the different foods. Both intake of dietary fibre and red meat and processed meat were measured as continues variable in g/day. Information on possible confounders will also be obtained from the questionnaire data at enrolment in relation to sex, age, BMI, smoking and other lifestyle factors and information on co-morbidity will be obtained from NPR.

Statistical analyses: The intention is to use data obtained from this prospective cohort study to explore the ability to predict risk of CID (Y=primary endpoint) and to explore whether diets low in fibre AND high in red and processed meat (X=assessed at baseline) are an informative prognostic factor on disease risk. Descriptive analyses for categorical variables will be presented as frequencies, and differences between CID cases and non-cases will be evaluated by Chi-square test. Continuous variables will be tabulated as medians (with quartiles, Q1 and Q3) and nonparametric tests on the equality of medians will be used to test for differences between groups. P-values below 0.05 will be considered statistically significant. Negative binomial regression will be applied to calculate incidence rates per 1000 patient years and incidence rate ratios (IRR) between exposures. To investigate the risk of and time to CID-diagnosis the Fine-Gray competing risk regression model will be applied, and thus competing risk of death will be taken into account while handling emigration as censoring, and reporting cumulative incidences and sub-hazard ratios (SHR) and the corresponding p-values for CID associated with specified food substitutions. Regressions will be carried out as both crude regression, only including the exposure, and adjusted for age, sex, lifestyle factors and selected comorbidities. Analyses will be conducted using Stata.

To test if the hypothesized causality between diet factors and development of CID is applicable for all of the CIDs there will be conducted subanalyses on each of the CID-diagnoses. Sensitivity analyses will be conducted on data from the Danish National Prescription Registry to evaluate the validity of the CID diagnoses, as it is expected that they get treatment in relation to the diseases. Data on medication and treatment of each diagnosis will be analysed separately.

Chronic Inflammatory Disease, Lifestyle and Risk of Disease

Intake of Dietary Fibre, Red and Processed Meat and Risk of Late-Onset Chronic Inflammatory Diseases: A Prospective Danish Study on the "Diet, Cancer and Health" Cohort

* Crohn's disease (yes/no)
* Ulcerative colitis (yes/no)
* Rheumatoid arthritis (yes/no)
* Axial spondyloarthritis (yes/no)
* Psoriatic arthritis (yes/no)
* Psoriasis (yes/no)
* Multiple sclerosis (yes/no)

Hospital of Southern Jutland

Odense Patient Data Explorative Network

University of Aarhus

Danish Cancer Society

University of Southern Denmark

Professor

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Cases (incident patients with a diagnosis of primary sarcoma and histologically confirmed by an expert pathologist of the RRePS or ResOs networks in the 15 districts of France participating to this study) Environmental, occupational and lifestyle-related exposures

Subjects never diagnosed with a primary sarcoma and individually-matched by sex, age (5-years group), and districts of residence and randomly selected from electoral list.

Environmental, occupational and lifestyle-related exposures

A standardized questionnaire will be administered by a trained interviewer in order to gather information about occupational and residential history, demographic and socioeconomic characteristics and lifestyle factors. At the end of the interview, a saliva sample will be systematically proposed

Environmental, occupational and lifestyle-related exposures

Aude Lacourt, PhD

Brice Amadéo, PhD

Loïc CHAIGNEAU

Antoine ITALIANO

Thierry FABRE

Corinne DELCAMBRE LAIR

Nicolas PENEL

Carlos MAYNOU

Fabrice FIORENZA

Valérie LEBRUN-LY

Jean-Yves BLAY

Isabelle RAY-COQUARD

Didier CUPISSOL

François GOUIN

Emmanuelle BOMPAS

Jean-Emmanuel Kurtz

Antonio DI MARCO

Axel LE CESNE

Gilles MISSENARD

Introduction: Sarcomas are rare tumors of connective tissue. The exact overall incidence of sarcomas is unknown due to diagnostic difficulties and the various histological subtypes (over 80 subtypes). However, the apparent increasing incidence of sarcomas suggests environmental causes such as pesticides. Except for some specific factors (i.e. ionizing radiation, vinyl chloride, dioxin, and genetic predispositions) the scientific knowledge on the aetiology of sarcomas is sparse and inconsistent. France is a particularly appropriate country to set up a study investigating the causes of sarcoma occurrence due to the French organization in treatment and care of sarcoma patients, which is highly structured and revolved around national expert networks. The main objective of the ETIOSARC project is to study the role of lifestyle, environmental and occupational factors in the occurrence of sarcomas among adults from a multicentric population-based case-control study.

Methods and analysis: Cases will be all incident cases (older than 18 years old) identified in 15 districts of France covered by a cancer registry and/or a reference center in sarcoma's patient care over a three-year period with an inclusion start date ranging from the 1st October 2018 to the 1st January 2020 and histologically confirmed by a second review of the diagnosis. Two controls will be individually-matched by sex, age (5-years group), and districts of residence and randomly selected from electoral list. A standardized questionnaire will be administered by a trained interviewer in order to gather information about occupational and residential history, demographic and socioeconomic characteristics and lifestyle factors. At the end of the interview, a saliva sample will be systematically proposed.

This study will permit to validate or not already suspected risk factors for sarcomas such as phenoxyherbicides, chlorophenol and to generate new hypothesis to increase our understanding about the genetic and environmental contributions in the carcinogenicity process.

The main objective of the ETIOSARC study is to assess the role of lifestyle, environmental and occupational factors in the occurrence of sarcomas among adults from a multicenter population-based case-control study.

Specific objectives are:

* To identify environmental risk factors for sarcomas as a whole and for the most frequent subtypes;
* To investigate the interactions between gene polymorphisms and environmental exposures in sarcoma susceptibility;
* To assess whether some specific genetic characteristics of sarcoma' tumors are associated with environmental exposures; We will also explore the feasibility of classifying sarcomas by genetics types (simple vs complex genomic profile) as part of the objective of identifying environmental risk factors.

Study design

The ETIOSARC study is a prospective multicenter population-based case-control study. This study is restricted to French geographical areas (further called districts) that meet at least one of these four criteria:

* Criteria 1: Districts covered by both a general cancer registry and a French Sarcoma Group (GSF-GETO) expert center from either the network of reference for soft-tissue sarcoma pathology (RRePS), the network of reference for bone sarcoma pathology (ResOs) or the clinical sarcoma network (NetSarc);
* Criteria 2: Districts including a coordinator center of any of the RRePS / NetSarc networks;
* Criteria 3: Districts covered by a general cancer registry that is expected to register more than 50 cases per year;
* Criteria 4: Districts adjacent to districts meeting criteria 1 and covered by a general cancer registry.

In total, 15 districts meet one of the four criteria, which represent approximatively 24% of the French population (2015 estimations from the national institute of statistics and economic studies, Insee). Nine districts meet criteria 1 (Gironde, Hérault, Haute-Vienne, Loire Atlantique, Calvados, Nord, Bas-Rhin and Doubs, Poitou-Charentes), two districts meet criteria 2 (Rhône and Val-de-Marne); two districts meet criteria 3 (Isère and Haut-Rhin) et two districts meet criteria 4 (Manche, Vendée).

Study population

Cases recruitment modalities

Patients will be recruited by specifically trained clinical research associate (CRA). In districts where a general cancer registry is active, the process of identifying incident sarcoma patients is well defined, which warrants the efficiency and exhaustiveness of the recruitment. However, poor survival for some cancer cases will not allow to rely on routine inclusion procedure and the registries will implement a rapid case ascertainment procedure to minimize the delay between diagnosis and enrollment and interview. Cases will be identified from pathology laboratories and multidisciplinary sarcoma tumor board (including sarcoma, gynecological, digestive, skin and bone tumor board). CRA will regularly contact laboratories and hospitals (within a three months window) to identify newly diagnosed sarcoma cases and to collect associated reports. The CRA will retrieve the clinical file in order to check inclusion and non inclusion criteria and to collect names and addresses of eligible patients and their physicians. Then, the CRA will contact the case's physicians in order to gather their clinical advice to include their patients in the study. In case of agreement, the CRA will contact the patients and ask them to participate. In case of oral agreement, he/she will arrange an interview to collect written consent and administer detailed questionnaire.

In Rhône and Val de Marne where no general cancer registry exists, the process of identifying incident sarcoma patients will largely rely on the existence of a RRePS/ResOS/NetSarc coordination center to facilitate the identification of new cases.

Regardless of the district, the diagnosis of all included cases will be systematically ascertained by an expert pathologist within the RRePS and ResOs networks following a standard procedure.

On a regular basis (at least once a month), the list of incident cases included in the RRePS/ResOS/NetSarc networks will be extracted from the shared databases. The list of cases identified by registries will be merged with the list of cases included in the RRePS/ResOS/NetSarc networks by the pathology sample reference number in order to collect diagnosis confirmation and to identify new but missed incident cases.

Controls selection

The selection of controls and the recruitment of cases will take place simultaneously. Every time a case will be diagnosed and identified, two controls will be randomly selected at that time from the electoral rolls of the same district as the case district of residence. For each case, a list of 20 potential controls with the same age (within a 5-year age group) and sex as the cases will be constituted in order to account for potential refusal. Calls to contact potential controls will be centralized and will be made by an investigator specifically trained to better understand the objectives of the study. First, this investigator will try to retrieve the phone number of the first potential control on the list and will contact him/her in order to gather his/her agreement to participate in this study. After five calls made at different schedules (e.g. in the evening on weekdays), if the potential control couldn't be reached, the investigator will send an information letter containing a reply coupon indicating phone number and schedule at which the person could be reach. If the reply coupon is not returned, or after 10 calls made at the phone number and the schedule indicated on the reply coupon, the first potential control will be considered as unreachable and then, the same procedure will be applied for the second potential controls on the list and so on until two controls per case agreed to participate to the study.

For each control agreeing to participate, an appointment will be made to collect written consent and to administer detailed questionnaire by a CRA.

All participants will give their informed written consent to participation, in line with French ethical guidelines.

Data collection

Data will be collected from self-questionnaire supplemented by a specific questionnaire. The self-questionnaire will permit to gather the complete occupational history (for each job held for at least 6 months) and residential history (for each place occupied for at least 6 months). During a face-to-face interview, the trained interviewer will check (complete if necessary) and supplement the self-administered questionnaire by a specific questionnaire with questions about demographic and socioeconomic characteristics, occupations of spouse and parents, leisure-time activities, reproduction, medical history, family history of cancer, diet, lifestyle factors such as tobacco smoking and alcohol consumption. The specific questionnaire will also collect additional occupational and residential information such as work tasks, work places, materials handled for each job held for at least 6 months and description of the environment of each residence places.

At the end of the interview, subjects (both cases and controls) will be invited to provide a saliva sample in order to obtain germline DNA.

In case of refusal to participate and if the subject agreed, data on demographic and socioeconomic characteristics will be collected in order to assess the potential selection bias that might occur due to the specific profile of non-respondent subjects.

Biological sampling and storage

Each participant will be asked to provide a salivary sample in order to obtain germline DNA. Salivary samples will be collected by the subjects themselves under instructions from the CRA, using DNA Genotek Oragene 575 collection kit. After collection, samples will be sent at the Biological Resources Center of the Bordeaux hospital university center "Bordeaux Biothèque Santé" for storage.

Determination of the sample size

Since our definition of environmental exposures is very broad, the sample size calculation has been based on various scenarios of exposure prevalence, from 5% (relevant for domestic, environmental but also some occupational exposures such as farmer in the general population) to 20% (relevant for some occupational exposures such as fibers). For a total sample size of 2000 cases and a 1:2 individually-matched design, considering a statistical power of 80% at a significance level of 5%, the minimum detectable odds ratio will be 1.39 and 1.21 under a exposure prevalence of 5% and 20%, respectively. Considering sub-types analyses, the four main histological types are GIST, liposarcoma, leiomyosarcoma and unclassified sarcoma, which account for 18%, 15%, 11% and 16% of sarcomas, respectively. Considering a sample size of 300 cases, the minimum detectable odds ratio will be 2.21 and 1.61 under an exposure prevalence of 5% and 20%, respectively. Typically in environmental epidemiology, the relative increases in disease risks due to environmental exposures are usually low around 1.5, thus, it is essential to recruit a minimum of 2000 cases in order to be able to perform sub-type analyses.

Statistical analysis

Relationship between case/control status and each exposure variable and 95% confidence intervals will be individually estimated using conditional logistic regression models. If necessary, a multilevel logistic model will be implemented in order to take into account the data variability due to the multicenter design and the various CRA that will administer the questionnaires.

Stratified histological sub-types analyses are also planned. Moreover, since sarcomas may be classified into four groups on a molecular basis (i.e. sarcomas with recurrent translocation, sarcomas with specific activating or inactivating mutations, sarcomas with MDM2 amplifications, and sarcomas with a complex genomic profile), the feasibility of classifying sarcomas by genetic types instead of by histological subtypes for the objective of identifying environmental risk factors will be explore. The underlying hypothesis is that the aetiology among these four molecular groups may be homogeneous.

Methods for coordinating the project and for quality control

This study is organized around three different centers or committees: a national coordination center, a steering committee, and local centers.

The national coordination center will be in charge of running routine operations, assisting participating local centers, guaranteeing the quality of the data collection, centralizing data, supervising the data coding and exposure assessment.

The steering committee's principal role will be to establish research priorities based on the availability of the data and the current scientific knowledge.

Local centers will be in charge of determining identification sources of cases in their districts and of collecting data. They will also transmit the collected data to the national coordination center.

Standardized procedures are written in a procedure manual to guarantee the quality of the collected data. Besides, a completion guide of the standardized questionnaire has been developed to assist CRA during interviews. A data manager will ensure that the study is conducted in compliance with the protocol. On a regular basis and as frequently as necessary, he/she will assess the quality of the collected data using several indicators: the average time spent by the CRA at the subject's home, the degree of completeness of the questionnaires by CRA, the ratio of included cases to expected cases, the average elapsed time between the identification of a case and the interview, the average elapsed time between case and control interviews, etc.

All collected data will be centralized in a single location, the University of Bordeaux (CREDIM, centre de Recherche et de Développement en Informatique Médicale).

Each participant will be asked to provide a salivary sample in order to obtain germline DNA. Salivary samples will be collected by the subjects themselves under instructions from the CRA, using DNA Genotek Oragene 575 collection kit. After collection, samples will be sent at the Biological Resources Center of the Bordeaux hospital university center "Bordeaux Biothèque Santé" for storage.

Etiosarc: Environmental Aetiology of Sarcomas From a Multicenter French Population-based Case-control Study Among Adults

Etiosarc: Study of the Environmental Aetiology (Environment, Occupations and Lifestyle) of Sarcomas (Soft Tissue, Visceral and Bone) From a Multicenter French Population-based Case-control Study Among Adults.

Anonymized individual participant data for both cases and controls will be made available under request to the principal investigator

The relationship between case/control status and each exposure variable will be estimated by odds ratios and their 95% confidence intervals using conditional logistic regression models.

Institut National de la Santé Et de la Recherche Médicale, France

Nutritional and Metabolic Diseases

Obesity

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

6 months after surgical treatment, women in the experimental group will attend a counseling program to promote healthy eating and physical activity.

Control group will receive usual care (verbal nutritional counseling after surgical treatment, at discharge).

A behavior change program with 4 monthly 90-min sessions about healthy eating and physical activity.

Intervention group

Gabriela V Chaves, PhD

The objective of the present study is to implement and evaluate the effect of a counseling program to promote healthy eating and practice of physical activity in the nutritional status, quality of life and prognosis of women Type I (endometrioid) endometrial cancer.

Endometrial cancer (EC) is the fifth most commonly diagnosed malignant neoplasm among women worldwide. The incidence of EC is higher in high-income countries, but it has been increasing in low- and middle-income countries.

The main risk factors for EC include the presence of comorbidities, such as diabetes mellitus and hypertension, as well as conditions associated with prolonged exposure to estrogens. Obesity is recognized as a major risk factor for many cancers, including EC. Multiple mechanisms related to obesity are probably involved in the carcinogenesis of EC. Among obese women in the postmenopausal period, there is an increase of bioavailable circulating estrogens. These estrogens come from the aromatization of androgens in adipose tissue and from increased circulating estrogens secondary to the reduced synthesis of sex hormone binding globulin (SHBG) in the liver. Insulin resistance, hyperinsulinemia, increased secretion of adipocytokines and pro-inflammatory cytokines may also play a role in the carcinogenesis of EC.

Although the incidence of EC is remarkable, insufficient data has addressed the impact of obesity on EC outcomes. Since about 70% of women diagnosed with endometriod EC are obese, the consequences of obesity-related diseases should be taken into account in order to implement strategies to improve survival outcomes among these women.

Sedentary lifestyle and physical inactivity also seem to be relevant, and have been identified as predictors of poor prognosis in patients with different types of cancer. However, the role of lifestyle (including eating and social habits and physical activity) on endometrial cancer prognosis has not been assessed prospectively yet. Studies assessing nutritional status and lifestyle before and after EC diagnosis may elucidate whether and when these factors influence clinical outcomes, including long-term survival.

Effect of a Lifestyle Intervention on Nutritional Status and Prognosis of Endometrial Cancer Survivors

Change in quality of life assessed by the Quality of Life-30 (QL30) questionaire of the European Organisation for Research and Treatment of Cancer (EORCT) before and 6, 12, 24, 26, 48 and 60 months after surgery.

Change in handgrip strength before and 6, 12, 24, 26, 48 and 60 months after surgery.

change in functional capacity assessed by 30 second stand chair test before and 6, 12, 24, 26, 48 and 60 months after surgery

change in functional capacity assessed by Timed Get Up and Go test before and 6, 12, 24, 26, 48 and 60 months after surgery

change in functional capacity assessed by 6 minute walk test before and 6, 12, 24, 26, 48 and 60 months after surgery

change in physical activity behaviour assessed by The International Physical Activity Questionnaire (IPAQ) before and 6, 12, 24, 26, 48 and 60 months after surgery

change in food intake pattern assessed by Food Frequency questionaire before and 6, 12, 24, 26, 48 and 60 months after surgery

change in body composition assessed by bioelectrical impedance before and 6, 12, 24, 26, 48 and 60 months after surgery

change in weight before and 6, 12, 24, 26, 48 and 60 months after surgery

change in body mass index before and 6, 12, 24, 26, 48 and 60 months after surgery

change in waist circumference before and 6, 12, 24, 26, 48 and 60 months after surgery

change in hip circumference before and 6, 12, 24, 26, 48 and 60 months after surgery

Brazilian National Cancer Institute

PhD, researcher

Behaviors and Mental Disorders

Malnutrition

Alcohol Drinking

Postoperative Complications

Urologic Neoplasms

Urologic Diseases

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Ethanol

Intervention: Patients allocated to the intervention group receive weekly counselling sessions in 6 weeks as an integrated prehabilitation program tailored to meet the individual patient's need for risk reduction at surgery. It is introduced via the surgical 'Engage in the process of change'. The smoking and alcohol cessation intervention follows the Gold Standard Programme and patients in the intervention group are introduced to a standardized exercise training programme taking individualized needs into account. Nutritional support is also individualized.

Treatment as ususal covers shorter interventions, e.g. advice, brief counselling, and handing out the national folders on smoking and alcohol and surgery. Patients are ensured that they are free to access support to lifestyle changes in the community.

Patients screened positive for minimun 1 SNAP factor will be offered enrollment in the study and have an individualized plan for the prehabilitation intervention.

Prehabilitation

Hanne Tønnesen, Professor MD

Susanne V Lauridsen, PhD

Hanne Tonnesen, Professor MD

Despite knowledge about the effect of preventive measures in lifestyle, smoking,nutrition, alcohol and physical activity (SNAP), there is a lack of systematic assessment of the overall lifestyle of the patient before surgery and knowledge about how lifestyle interventions can be organized in connection with cancer surgery. The intention with prehabilitation is to optimize the individual's risk factors and personal burdens that can affect the clinical and patient reported outcomes after surgery. The aim of this study is to evaluate the efficacy of intensive SNAP interventions compared to treatment as usual (TAU) in ptt undergoing urological cancer surgery on surgical risk reduction.

The project contains three clinical intervention studies, in total including 100 urological cancer patients screened positive for at least 1 SNAP factor:

I. Efficacy and preferences of intensive SNAP-Interventions among patients with at least one SNAP factor and undertaking neo-adjuvant chemotherapy before radical cystectomy. A randomised controlled trial with nested interviews (42 patients).

II. Implementation and preferences of intensive SNAP-Interventions among patients with kidney cancer undergoing nephrectomy/partial nephrectomy. An implementation feasibility study including interviews (20 patients).

III. Reach out and effect as well as preferences of perioperative intensive smoking cessation intervention via the municipality clinic compared to the surgical department among smokers with non-invasive bladder cancer treated with Trans-Urethral Resection of the Bladder (TUR-B). A randomised controlled trial with nested interviews (38 patients).

The intervention groups receive minimum five educational sessions tailored to individual needs over six weeks perioperatively. The control groups receive standard care.

Randomised Controlled Trials, Implementation feasibilty trial, Interviews nested

Outcome assessors will not know if patients were allocated to intervention or control group

STRONG for Surgery & Strong for Life - Against All Odds: Intensive Prehabilitation for Risk Reduction in Cancer Surgery

STRONG for Surgery & Strong for Life - Against All Odds: Intensive Prehabilitation Including Smoking, Nutrition, Alcohol and Physical Activity for Risk Reduction in Cancer Surgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Active Surveillance Exercise Clinical Trial	NCT02435472	Localized Prost... Active Surveill...	Exercise Cardiopulmonary...	18 Years -	University of California, San Francisco
Active Surveillance Exercise Clinical Trial	NCT02435472	Localized Prost... Active Surveill...	Exercise Cardiopulmonary...	18 Years -	University of California, San Francisco
Lifestyle Changes Using Digital Technology in Colorectal Cancer	NCT03849352	Life Style Colo-rectal Can...	Lifestyle chang...	18 Years -	Royal Marsden NHS Foundation Trust
Chronic Inflammatory Disease, Lifestyle and Risk of Disease	NCT03456206	Autoimmune Dise... Inflammatory Bo... Crohn Disease (... Ulcerative Coli... Arthritis, Rheu... Spondylarthropa... Arthritis, Psor... Psoriasis (PsO) Multiple Sclero...	Intake of red a... Lifestyle facto...	50 Years - 64 Years	University of Southern Denmark
Active Surveillance Exercise Clinical Trial	NCT02435472	Localized Prost... Active Surveill...	Exercise Cardiopulmonary...	18 Years -	University of California, San Francisco
Etiosarc: Environmental Aetiology of Sarcomas From a Multicenter French Population-based Case-control Study Among Adults	NCT03670927	Sarcoma Environmental E... Occupational Ex... Life Style	Environmental, ...	18 Years -	Institut National de la Santé Et de la Recherche Médicale, France
Effect of a Lifestyle Intervention on Nutritional Status and Prognosis of Endometrial Cancer Survivors	NCT03095664	Endometrium Can... Life Style Obesity	Intervention gr...	20 Years - 69 Years	Brazilian National Cancer Institute
Chronic Inflammatory Disease, Lifestyle and Risk of Disease	NCT03456206	Autoimmune Dise... Inflammatory Bo... Crohn Disease (... Ulcerative Coli... Arthritis, Rheu... Spondylarthropa... Arthritis, Psor... Psoriasis (PsO) Multiple Sclero...	Intake of red a... Lifestyle facto...	50 Years - 64 Years	University of Southern Denmark
STRONG for Surgery & Strong for Life - Against All Odds: Intensive Prehabilitation for Risk Reduction in Cancer Surgery	NCT04088968	Risk Reduction Urological Canc... Surgery Life Style	Prehabilitation	18 Years - 100 Years	Bispebjerg Hospital

Spots Global Cancer Trial Database for life style

Every month we try and update this database with for life style 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 life style

Every month we try and update this database with for life style 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 life style 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.