Nancy A. Potischman, Ph.D.

Information about Americans food choices and opinions helps researchers and law makers to develop policies and programs to promote health. For this reason, it is important to be able to collect good quality information about how people think about food. This project will compare different ways of collecting information about food from adults.

Objectives:

-To compare different ways of collecting information about food choices and opinions from adults.

Eligibility:

* Individuals between the ages of 20 and 70, recruited from a database of volunteers who wish to participate in research studies.
* Volunteers must have high-speed Internet access.
* Individuals who have previously been involved in a research study will be excluded.

Design:

-Participants will come to a research study center for three consecutive meals (approximately 45 minutes per meal). On the following day, participants will return to the study center for an interview about their food choices and opinions (approximately 45 minutes).

National Cancer Institute Food Study

National Cancer Institute (NCI) Food Study

Measured exact intake of foods will be compared to reported intake by the participant. Two different reporting systems will be compared with truth.

National Cancer Institute (NCI)

Symptoms and General Pathology

All Conditions

Substance Related Disorders

Behaviors and Mental Disorders

Nervous System Diseases

Rare Diseases

Chronic Pain

Pain

Opioid-Related Disorders

Neurologic Manifestations

Narcotic-Related Disorders

Substance-Related Disorders

Chemically-Induced Disorders

Mental Disorders

Psychotic Disorders

Quality of Life

Chronic Graft Versus Host Disease

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics, Opioid

Patients with chronic non-cancer pain referred to secondary and tertiary care

ASI-SR

Pernilla Åsenlöf, Profesor

The Swedish version of ASI-SR has shown good feasibility in assessment of addiction patients functioning compare to long and time-consuming ASI, which is upp to date golden standard in Sweden. This study investigate if ASI-SR is suitable instrument for the assessment of the chronic pain patient addicted to opioids. The validation process is designed according to the COSMIN guidelines.

Preliminary results are expected by December 2022.

The use of opioids in treatment of chronic non- cancer pain (CNCP) has increased during the past decades in most parts of the western world. Use of prescription opioids can lead to problematic opioid use which can be life-threatening with significant morbidity and mortality. Studies have found that 21-29% of CNCP patients receiving chronic opioid therapy (COT) ( receiving opioids for \> 90 days) have problematic opioid use. Individuals with chronic pain and co-occurring substance use disorders and/or mental health disorders, have increased risk for problematic use of prescribed opioids.

Several screening instruments and strategies have been introduced in recent years for identifying patients not suitable for opioid therapy. Even so, there is no single test or instrument that can reliably identify those patients at risk for developing problematic opioid use or opioid use disorder if opioid therapy is initiated, or identify those who need increased monitoring during treatment.

Addiction Severity Index (ASI) is a standardized semi-structured interview used for assessing severity and need of treatment in seven functional domains associated to substance use disorders; physical health, employment/support status, alcohol use, drug use, legal status, family/social functioning and psychiatric health. The ASI was developed in the US. by McLellan and colleagues and is widely used all over the world, both in research and for clinical assessment and treatment evaluations . The ASI could be a useful instrument for a multidimensional assessment of patients with chronic non-cancer where opioid treatment is considered, and it could also be used for evaluation of ongoing opioid therapy . However, the ASI interview is a time consuming instrument. To conduct an interview takes between 45-60 minutes and is followed by 20-25 minutes of administrative work. In the year of 2000 Rosen et al tested a short self-report form based the items used to calculate the ASI composite scores that asses current function and problem severity. This questionnaire was translated by our research group and tested on a sample of individuals referred to the Addiction clinic at Uppsala University Hospital. The study suggested that a self-administered questionnaire based on the subscales of the ASI composite scores is a feasible alternative to the ASI interview for assessing patient functioning in the different domains and screen for current problematic alcohol- or drug use .

A validated screening tool that provides both an effective method of assessing patients and identifying problems in several different life domains, and identify substance use related problems if they should arise, would be beneficial in clinical practice when deciding what treatment to offer. Such an instrument could potentially decrease the risk of iatrogenic opioid use disorder.

Purpose and aims The main objective with this study is to test the psychometric properties of the ASI-SR in a population of CNCP patients. 'Secondary aim is to describe differences between subjects treated within the substitution therapy program and those who are treated within the pain clinic.

Method:

Sample Participants for this study will be recruited from outpatient pain clinic and addiction clinic at Uppsala University Hospital, and Linköping University Hospital Sweden. Eligible for participation are persons \>18-65 years of age with current CNCP and ongoing treatment at the facilities. Estimated number of participant needed is about 200.

Exclusion criteria are severe cognitive impairment, illiterate in Swedish, and inability to give informed consent.

Procedures Eligible participants will be approached and asked if they can consider to participate in the study by clinical staff at the facilities. If they accept, they will receive an e-mail with a link to the questionnaires and to written information about the study. If they decide to participate they will give informed consent by signing a digital consent form. A digital battery of questionnaires containing the ASI-SR and a validity battery will then be provided to the participants to fill out. The validity battery will consist of self-report forms. To participants that do not respond to the questionnaires and have not declined participation, reminders will be sent out by text-messages, e-mail and mail. Four days after the participants have completed the questionnaires they will receive an e-mail with a link the ASI-SR form to fill out once more to test re-test reliability.

Participants that do not want to or do not have access to the digitalized versions of the questionnaires will be offered to fill out paper versions of the questionnaires sent to them by mail.

Measures ASI-SR is a 38 question self-administered form based on the items used to calculate the ASI's composite scores, measuring current problems and severity in seven domains . The CS ranges from 0 to 1 where 0 indicates no problems.

The validity battery consist of self-administered questionnaires that correspond to six out of seven of the ASI-SR's domains. These questionnaires will be used as concurrent validity measures for all the ASI-SR composite scores (CS) except the CS for legal situation. The participants will fill out questions about current pain intensity and pain interference, the Rand 36 for multidimensional health related quality of life , pain related disability Pain Disability Index (PDI) and Sheehan Disability Scale (SDS) which measures disability across domains of work/school, social life, and family life/home responsibilities . The Alcohol Use Disorder Identification Test (AUDIT) will be used for assessment of problematic alcohol use and the Drug Use Disorder Identification Test (DUDIT) for assessment of problematic illicit drug use . PHQ9 will assess depressive symptoms and the GAD 7 will be used for assessment of anxiety symptoms . Patient global impression of change (P-GIC) will be used to evaluate if the participants experienced any changes in global health between test-retest of the ASI-SR. P-GIC is gold standard for measuring change in CNCP patients .

Statistics Statistical analyses will be done using SPSS (Version 23, IBM SPSS Statistics for Windows, Armonk, NY: IBM Corp). Calculation of the CS follow standard procedure . Consistency of CS between the interview and the self-report will be evaluated on the individual basis by interclass correlation analysis (ICC) and at group level with paired t-test or Wilcoxon signed rank test if data is not normally distributed. ICC coefficient is considered to be poor if it is less than 0.40, fair between 0.40-0.59 , good between 0.60-0.70 and excellent between 0.75-1.00 .

Reliability and internal consistency will be evaluated using Cronbach's α. The α coefficient is considered acceptable if it is above 0.70 .

The concurrent validity of each score will be assessed with suitable correlation analyses between the ASI-SR composite score(s) and the external validity measure(s).

To assess discriminant validity of the ASI-SR composite scores and external validity measures, an intercorrelation matrix between ASI-SR composite scores, and composite scores and external measures will be computed.

For evaluating factor structure principal component analyses (PCA) will be used.

Relevance for the field Opioid therapy for chronic non-cancer pain has emerged as a problematic treatment and the evidence is scarce for its effectiveness . However, there are some individuals that seem to benefit from opioid therapy and most guidelines propose an individual approach to management, beginning with a comprehensive patient evaluation, focusing on factors that may indicate potential substance use disorder. When opioids are used, clinicians should closely monitor patients for loss of response, adverse effects or aberrant behavior, and assess treatment outcome . There is a need for a multi-dimensional instrument that can assess problems related to increased risk for developing problematic opioid use, i.e. opioid use disorder, psychiatric co-morbidity and social problems. The ASI-SR could be an effective way of screening for current problems in different life domains and to monitor and evaluate ongoing treatment and identify problems if they would arise. Additional measures include urine or saliva drug testing, prescription practice, opioid treatment agreements, and universal precautions in conjunction with opioid therapy.

Ethical considerations The study will be sent to the Regional Ethical Review Board in Uppsala. Participants will be anonymous and all data will be coded before processed.

Validation of the ASI-SR Form in a Population of Chronic Non-cancer Pain Patients

ASI-SR Form as a Standardized Instrument for Healthcare Management of Chronic Non-cancer Pain Patients

Age, sex, educational level, occupational status etc For evaluating factor structure principal component analyses (PCA) will be used.

The main objective with this study is to test the psychometric properties of the ASI-SR in a population of CNCP patients.Consistency of CS between the interview and the self-report will be evaluated on the individual basis by interclass correlation analysis (ICC) and at group level with paired t-test or Wilcoxon signed rank test if data is not normally distributed. ICC coefficient is considered to be poor if it is less than 0.40, fair between 0.40-0.59 , good between 0.60-0.70 and excellent between 0.75-1.00.

7-grade scale (-3-+3)where the lowest points indicate negative and highest points indicate positive change.

Second test ASI-SR for reproducibility( 0,1 answer /scores in different categories)

Generalised Anxiety Disorder 7-item scale (0-21) The higher the score the higher severity of the anxiety disorder, cut-off 10.

Quality of life instrument of International Resource Center for Health Care considering both physical and mental health aspects. Scores 0-100. The Higher score the better quality of life in different segments of well-being, function or quality of life.

7-question score system for different pain groups,(0-70). The higher the index the greater the persons disability due to the pain.

Scoring system, (0-40)where increase of the points reflects increased risk of problematic alcohol use.

Scoring system,(0-44) where increase of the points reflects increased probability of drug abuse syndrome.

Depression Assesment scoring system, (0-15) where \<4 is no need of depression treatment, and \>15 identifies need of pharmacologic or other depression treatment

Uppsala University Hospital

Uppsala University

EUonQoL-Kit questionnaire specifically designed and administered to patients undergoing/having recently completed curative treatment for early-stage cancers OR undergoing/having recently completed non-curative treatment for advanced or metastatic cancers, including disease controlling/life prolonging tumour-directed treatment.

EUonQoL-Kit questionnaire specifically designed and administered to people being disease-free without evidence of active cancer, and at least one year off active treatment (with the exception of long-term adjuvant hormonotherapy).

EUonQoL-Kit questionnaire specifically designed and administered to patients with advanced cancers with projected prognosis \<12 months and Eastern Cooperative Oncology Group (ECOG) ≥2 OR referred to a specialist palliative care team for symptom control, OR receiving non-curative systemic treatment or radiotherapy purely for symptom control.

Electronic questionnaire to be administered to patients in active treatment.

Administration of the EUonQoL-Kit - Active Treatment questionnaire

Electronic questionnaire to be administered to cancer survivors.

Administration of the EUonQoL-Kit - Survivors questionnaire

Electronic questionnaire to be administered to patients in palliative care.

Administration of the EUonQoL-Kit - Palliative Care questionnaire

Cinzia Brunelli, PhD

Ivaylo Petrov, Mr

Maria Krini, Ms

Helle Pappot, Prof

Vahur Valvere, Dr

Robert Marie, DR

Anne Brédart, Dr

Maria A Franzoi, Dr

Ekaterina Kldiashvili, Prof

Volker Arndt, Prof

Theres Fey, Dr

Orsolya Horvath, Dr

Alessandro Rizzo, Dr

Gabriella Pravettoni, Prof

Audrius Dulskas, Dr

Vadim Pagonet, DR

Lonneke van de Poll, Prof

Marianne Grønlie Guren, Prof

Maria Litwiniuk, Prof

Iwona Lugowska

Tudor Ciuleanu, Prof

Milana Mitric Askovic, Dr

Michal Chovanec, Prof

Maria Vieito, Dr

Ana Carneiro, Dr

Mahmut Gumus, Prof

Alexandra Gilbert, Dr

The improvement or preservation of quality of life (QoL) is one of the three pillars of the European Union (EU) Mission on Cancer, which underpins the needs of patients from cancer diagnosis throughout treatment, survivorship, and advanced terminal stages. Clinical studies and real-world data show that the use of Patient Reported Outcome Measures (PROMs) for QoL assessment in routine oncology practice has positive effects on patient wellbeing and healthcare resource utilization. However, full implementation of PROMs is not yet part of standard of care and is not adequately considered in cancer policies and programs.

A comprehensive tool incorporating the perspective of patients at different stages of the disease trajectory and widely applicable across Europe is still lacking.

The European Oncology Quality of Life Toolkit (EUonQoL-Kit) is a unified patient-centred tool for the assessment of QoL, developed from preferences and priorities of people with past or current cancer experience. The EUonQoL-Kit includes three electronic questionnaires, specifically designed for different disease phases (patients in active treatment, survivors, and patients in palliative care), available in both static and dynamic (Computer Adaptive Testing, CAT) versions and in several European languages.

This is a multicentre observational study, with the following aims:

* The primary aim is to perform the psychometric validation of the EUonQoL-Kit.
* Secondary aims are to assess its acceptability, to validate the static and dynamic versions against each other, and to provide estimates of QoL across European countries.

The EUonQoL-Kit will be administered to a sample of patients from 45 European cancer centres. The sample will include patients in active treatment (group A), survivors (group B), and patients in Palliative Care (group C).

Each centre will recruit 100 patients (40 from group A, 30 from group B, 30 from group C), for an overall sample size of 4,500 patients (at least 4,000 patients are assumed to be enrolled, due to an expected lower recruitment rate of 10-15%). Three sub-samples of patients (each corresponding to 10% of the total sample for each centre) will fill in an additional questionnaire:

* FACT-G (Functional Assessment of Cancer Therapy - General) and EQ-5D-5L (5-level European Quality of Life Five Dimension), to test concurrent validity.
* Live-CAT version, to validate the static and dynamic versions against each other.
* EUonQoL-Kit, at least 1 hour after the first completion, to assess test-retest reliability.

Several patient-reported questionnaires have been developed and validated to measure quality of life (QoL) of cancer patients. However, a comprehensive tool, developed in close collaboration with people who have experienced cancer, widely applicable across Europe and tailored to the health status of the individual patient, is lacking. Such a tool will be important for incorporating the patient's perspective into the evaluation of policies and programs addressing cancer at the European level.

The European Oncology Quality of Life Toolkit (EUonQoL-Kit) is a unified patient-centred tool for the assessment of QoL based on preferences of cancer patients and survivors. It is developed from a patient perspective, administered digitally, available in the languages of the European Union (EU) 27 and several associated countries, and applicable in future surveys to contribute to the EU's mission on cancer. It includes three static questionnaires specifically developed for different disease phases (patients in active treatment, survivors, and patients in palliative care), and three dynamic versions of the same questionnaires based on Item Response Theory (IRT) and Computer Adaptive Testing (CAT).

This is an observational study aimed to perform the psychometric validation of the EUonQoL-Kit through its first large scale application in a pan European pilot survey.

The EUonQoL-Kit will be tested in a sample of cancer patients and survivors from 45 oncological centres located in 33 European countries. The sample will include patients in active treatment (group A), survivors (group B), and patients in Palliative Care (group C). Each centre will recruit a sample of 100 participants (40 from group A, 30 from group B, 30 from group C), stratified for primary diagnosis: lung cancer, breast cancer, colorectal cancer, haematological malignancies, prostate cancer, others.

In each centre, data collection will be performed in pre-identified outpatient clinics and inpatient wards. Participation in the study will be offered to eligible patients until the pre-defined sample size is reached.

All patients in the sample will fill in the EUonQoL-Kit. Additionally, three subgroups of patients will be proposed to fill in the following additional questionnaires:

* FACT-G and EQ-5D-5L, to evaluate concurrent validity ("concurrent validity" sub-sample: 10% of the overall sample, stratified for the three disease conditions: A, B, and C).
* Live CAT version of the EUonQoL-Kit, to validate the static and dynamic versions against each other ("live CAT" sub-sample: 10% of the overall sample, stratified for the three disease conditions).
* EUonQoL-Kit, a second time, (at least 1 hour after the first administration), to assess test-retest reliability ("test-retest" sub-sample: 10% of the overall sample, stratified for the three disease conditions).

The development of the EUonQoL-Kit has involved multiple stakeholder groups, also including patients, through different steps:

* Systematic search, collection, and analysis of existing validated QoL tools, metrics, item banks in databases to identify QoL dimensions not adequately covered by existing tools.
* A mixed-method study including patient interviews, a Delphi survey with patients and healthcare providers, aimed at collecting patient priorities and preferences on QoL dimensions, followed by a usability testing of a preliminary version of the EUonQoL-Kit.
* Development of the EUonQoL-Kit, including three static questionnaires specifically developed for patients in active treatment, survivors and in palliative care, and three dynamic versions of the same questionnaires. The final version of the six questionnaires will be submitted as an amendment to the current protocol when available.
* Translation and cultural adaptation of the EUonQoL-Kit across European countries.

The CAT version of the EUonQoL-Kit requires an item bank containing IRT-calibrated items (questions) and an algorithm for selecting the most relevant item to ask, based on the previous answers. Such dynamic system ensures that each patient is asked the most relevant and informative items.

CAT/IRT-based technology will be implemented as:

* Short forms within the EUonQoL-Kit static version. Three static versions will be designed to secure the optimal fit between items and patient groups.
* Live CAT, within the EUonQoL-Kit dynamic version. Each item is selected based on the previous answers, while the patient completes the questionnaire.

The final EUonQoL-kit will include both traditional and CAT/IRT-based items.

The overall sample size is planned to be 4,500 patients. Expecting a lower recruitment rate of 10-15%, at least 4,000 patients will be enrolled, a number suitable for data analyses.

Scientifically sound recommendations on statistical power/sample size in validation studies are lacking and minimum rule-of-thumb requirements are provided. The highest number of participants recommended for exploratory and confirmatory factor analyses (EFA \& CFA) is 1,000; thus, the sample size by subgroup mentioned above is appropriate to evaluate construct validity.

Analyses of the primary aim will include:

* EFA \& CFA to assess structural validity. The sample will be divided into two random sub-samples, stratified by disease stage and country. The first sub-sample will be used to perform EFA, and the model obtained will be confirmed by CFA in the second sub-sample. Goodness-of-fit will be measured by the Root Mean Square Error of Approximation, Comparative Fit Index, and Tucker-Lewis Index.
* Distribution of scale scores, examined by calculating the observed range, floor and ceiling effects, and statistics of central tendency and dispersion.
* Reliability in terms of internal consistency (estimated with Cronbach's alpha coefficient of multi-item scales) and reproducibility (agreement between the two administrations of EUonQoL-Kit estimated with the Intra-class Correlation Coefficient).
* Concurrent validity, assessed by the multi-trait multimethod matrix between the EUonQoL-Kit and the FACT-G/EQ-5D-5L questionnaires.
* Construct validity based on hypotheses-testing, assessed through the patterns of EUonQoL-Kit scores across known groups defined by variables such as disease stage, treatment, and Eastern Cooperative Oncology Group performance status. Mean differences among groups will be tested with ANOVA, and the magnitude of the difference between them will be estimated by Effect Size coefficient: \> 0.8 high, 0.5 moderate, and 0.2 low.
* Test of Differential Item Functioning, used to assess item equivalence.

Analyses of the secondary aims will include:

* Assessment of acceptability and respondent burden, based on the response rate and percentage of missing items, as well as the time needed to complete the questionnaire.
* Validation of the static and dynamic versions of the EUonQoL-Kit against each other, performed by 1) comparing scores obtained with the static and dynamic versions to test if they produce interchangeable results; and 2) assessing whether the items selected for the static versions should be adjusted to obtain optimal assessment.
* To analyse QoL inequalities across clusters of populations, countries, and healthcare systems, multi-level regression models will be applied across three levels: individual, cancer centre and country. It will also be explored whether the magnitude of subgroup differences (e.g., for age or education) varies across countries.
* Analysis of QoL disparities across different patient groups will include gender, ethnicity, religion, geographical area, psychological and socio-economic factors, and education level.

Data collected include personal information belonging to special categories, like health-related data, origins, lifestyles etc. Legal basis to collect and process information is the data subject consent, which is necessary to take part in this study. A data protection expert will assess the impact on data protection throughout the duration of the study. Patient registration and CRF data collection will be centralized through the CRF.net platform, developed and owned by Istituto Nazionale Tumori, IRCCS - Fondazione G. Pascale, Napoli (INT-NA) and released with the GPL v3 license. Data will be stored by INT-NA on cloud services provided by Telecom Italia S.p.A. and located in Acilia (Italy).

Patient-reported data associated to QR codes will be collected by an ad hoc mobile app developed by Clinical Research Technology (CRT), Salerno (Italy).

The CAT version of EUonQoL-Kit will be administered through the integration of a CAT engine provided by the European Organization for Research and Treatment of Cancer (EORTC), sited in Bruxelles (Belgium).

Data processing is managed by:

* Istituto Nazionale Tumori, IRCCS - Milan (INT): INT serves as the data controller.
* Istituto Nazionale Tumori, IRCCS - Fondazione G. Pascale, Napoli (INT-NA). INT-NA will be appointed as data processor under article 28 GDPR and will be responsible for patient enrolment, questionnaire assignment through the generation of a QR code, clinician reported data collection through the electronic Case Report Form (eCRF), management of the interface with the CAT engine and with the mobile app for the administration of EUonQoL-kit items.
* CRT: based on a QR code provided by CRF.net platform, the mobile app administers specific QoL questionnaires for specific subgroup of patients. For each item administered, the app will directly transfer the answer to the platform, without recording/storing any content. Such a procedure avoids any possibility to link contents to patients' IDs.
* EORTC: in case of the dynamic EUonQoL-Kit administration, EORTC CAT will be appointed as data processor under article 28 GDPR and will get access to each pseudonymized answer as provided by the CRF.net platform. The EORTC CAT will delete any content once the questionnaire has been submitted including scores sent to the CRF.net platform.

The CRF.net platform is accessible online by investigators and data managers through username and password and is protected through encrypted data certified by SSL certificates and HTTPS protocols. For each registered patient, the CRF.net platform generates a Quick Response (QR) code that will be scanned with the tablet to allow the patient to complete the questionnaires.

The interface of the platforms allows data review and cleaning in the central archive directly (with a limited and controlled access of data-managers and investigators). Each operation done in the archive database is registered through track-change.

Each participating centre will receive tablet devices from the sponsor to get access to the CRF.net platform and collect data directly from patients. Results will be shared as open data in a completely anonymous and aggregated form. After 5 years since data collection, all personal information related to the study, including informed consents, will be anonymized/destroyed according to the delay stated by the Ethics Code on data processing for statistics or scientific research purposes issued by the Italian Data Protection Authority under article 20, par. 4, LD 101/2018.

Patients could exercise their rights by submitting requests to the staff identified in the private information. All centres have appointed a data protection officer under the General Data Protection Regulation (GDPR) and an internal data breach policy.

This study was designed and shall be implemented and reported in accordance with national and European legal and ethical requirements. Moreover, the survey will follow the ethical principles laid down in the Declaration of Helsinki and the ethical principles of observational research on potentially fragile patients.

The protocol, Informative Sheet, and Informed Consent Form must be reviewed and approved by ethics committees of each centre involved. No study procedure can be performed before the written informed consent has been provided.

Validation of the European Oncology Quality of Life Toolkit

Validation of the European Oncology Quality of Life Toolkit. A European Pilot Survey.

Exploratory and confirmatory factor analyses, distribution of the scales' scores, reliability in terms of internal consistency and reproducibility, concurrent and construct validity, differential item functioning.

Acceptability of the EUonQoL-Kit and reasons for refusal, including patient burden in filling in the questionnaire

Comparison of the scores obtained with the static and dynamic versions to test if they produce similar, interchangeable results; assessment to test whether the items selected for the static version and the related CAT-settings should be adjusted to obtain optimal assessment.

Analysis of the QoL scores (dependent variable) according to individual-level variables as well as country/health system level variables (independent variables)

Assessment of QoL disparities across different patient groups (by gender, ethnicity, religion, area, psychological and socio-economic factors, and education level)

Gustave Roussy, Cancer Campus, Grand Paris

DEUTSCHES KREBSFORSCHUNGSZENTRUM HEIDELBERG (German Cancer Research Center)

Oslo universitetssykehus HF

The Netherlands Cancer Institute

Hospital del Mar Research Institute

Istituto Europeo di Oncologia

European Organisation for Research and Treatment of Cancer - EORTC

UNICANCER

EAPC

Institut Curie

EUROPEAN CANCER ORGANISATION

DIGICORE/IFO

Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

Alleanza Contro il Cancro

Istituti Fisioterapici Ospitalieri

STICHTING NEDERLANDS INSTITUUT VOOR ONDERZOEK VAN DE GEZONDHEIDSZORG

University of Milan

SporeData OÜ

ORGANISATION OF EUROPEAN CANCER INSTITUTES

FEDERAZIONE ITALIANA DELLE ASSOCIAZIONI DI VOLONTARIATO IN ONCOLOGIA

Medical University Innsbruck

SDRUZHENIE ASOTSIATSIA NA PATSIENTITE SONKOLOGICHNI ZABOLYAVANIA I PRIYATELI

FEDERATIA ASOCIATIILOR BOLNAVILOR DE CANCER

University of Leeds

The Leeds Teaching Hospitals NHS Trust

Region Hovedstaden (Bispebjerg Hospital & Rigshospitalet)

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Neoplasms

Digestive System Diseases

Ear, Nose, and Throat Diseases

Mouth and Tooth Diseases

Esophageal Neoplasms

Deglutition Disorders

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Pharyngeal Diseases

Otorhinolaryngologic Diseases

Esophageal Cancer

Patients with oesophageal cancer and dysphagia

Validation of different dysphagia scores

This study validates 3 well known dysphagia scores for dysphagia due to malignancies of the oesophagus and gastro-oesophageal junction and to the Swedish language.

In the present study, our aim was to firstly, validate 3 commonly used scales for use in patients with dysphagia due to malignancy, and secondly, to validate them in the Swedish language. The 3 scales were: The Watson dysphagia scale, which was developed in studies on surgical treatment of reflux disease. It consists of questions about food with 9 different viscosity and solidity and the patient answer if they have problems with a specific food: never, sometimes or always when ingesting this. The scores are added and provides a range of 0-45 where 45 is the worst possible dysphagia. The Ogilvie score is a 5-graded scale 0-4 where 4 is total inability to swallow. The Goldschmid score is graded from 0-5 where 0 is inability to swallow and 5 is normal function. QoL was measured with validated instruments originating from the European Organization for Research and Treatment of Cancer (EORTC), which has a generic instrument that measures global QoL in patients with cancer (QLQ-C30) and a more symptom-specific instrument that is developed for cancer in the oesophagus and stomach (QLQ-OG25). These are well known, validated instruments that also have normal reference values for the healthy population. The symptom specific instrument QLQ-OG25 includes a dysphagia module consisting of 3 questions which is validated to malignant disease and food intake with the help of expert groups and deep interviews with patients.

Validation of Instruments Used for Assessment of Dysphagia in Patients With Esophageal Cancer

Sahlgrenska University Hospital, Sweden

The Göteborg Medical Society, Sweden

Vastra Gotaland Region

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

VATS lobectomy

Andrea Imperatori, MD

A five classes (A-E) aggregate risk score predicting 90-day mortality after video-assisted thoracoscopic lobectomy for lung cancer, including as independent factors male sex (3 points), carbon monoxide lung diffusion capacity \<60% (1 point) and operative time \>150 minutes (1 point), has been recently published. This study aims to assess the effectiveness and reliability of this risk model in a large, independent cohort of patients, in order to confirm its generalizability.

From the Italian VATS Group Database, we selected patients who underwent video-assisted thoracoscopic lobectomy for non-small cell lung cancer. We calculated the aggregate risk score and the corresponding class of 90-day mortality risk for each patient. The correlation between risk classes and mortality rates was tested by Spearman's rho-test. Model calibration was evaluated by Hosmer-Lemeshow goodness-of-fit test.

Assessment of the 90-day Mortality Risk Score After VATS Lobectomy

Assessment of the 90-day Mortality Risk Score After Video-assisted Thoracoscopic Lobectomy in the Italian VATS Group Cohort

Università degli Studi dell'Insubria

Principal Investigator - Clinician at Center for Thoracic Surgery - School of Medicine and Surgery - University of Insubria - Varese

Cancer Pain

Parmanand Jain, MD

charushree E jibhkate, Junior resident

This study aims at finding degree of adherence of patients to their chronic pain medication prescriptions containing opioid e.g. Morphine, using Morisky Medication Adherence Scale 8, self- reported questionnaire. Also relationship of various demographic, disease related and opioid related factors to medication adherence.

After institutional review board approval, a Pilot study including 30 patients will be conducted to validate Morisky Medication Adherence Scale 8 to validate the questionnaire for cross cultural variation. The data collected will be analyzed and result will be submitted to institutional review board for approval to conduct the parent study. Following the above approval, all adult patients , more than 18 yrs. of age, who are on a strong opioid for their chronic cancer pain, taken prescription from pain clinic at least once in past, who are able to understand and communicate Hindi will be invited to participate in the study. Each patient will be verbally asked about their medication and same will be confirmed by their previous medical records. An informed written consent will be obtained. Data will be collected by PI or co-investigator after obtaining written consent at Pain clinic(general and private) of Tata Memorial Hospital. Fund for purchasing the copyright to use the Hindi translation of Morisky Medication Adherence Scale 8, was provided by the department of Anesthesia Account, Tata Memorial Hospital, after due permission obtained from, Director Tata Memorial Center and Head of the department of Anesthesiology, critical care and pain, Tata Memorial Center. The precise scoring and permission to use the Hindi translation of the scale has been obtained from the developer. For income we will be considering private and general category of the patients respectively.Data will be analyzed using International Business machines software package for statistical analysis version 20.0.Pilot study data will be analyzed applying tests as internal consistency (Cronbach's alfa), Test retest variability and factor analysis.For parent study in the uni-variate analysis all variables listed above will consecutively tested for significant associations with ''good adherence'' as the outcome variable. Chi-square tests and Student's t-tests will used for categorical and continuous variables, respectively. All variables will be unconditionally entered into a binary logistic multi variate analysis. All p values #0.05 will regarded as statistically significant.

Validation and Assessment of Patient Adherence to Opioids for Cancer Pain Using MMAS 8 Pain Clinic

Validation and Assessment of Patient Adherence to Opioids for Cancer Pain Using MMAS 8 Questionnaire in Pain Clinic

to do a pilot study comprising of 30 patients for cross cultural validation of Morisky medication adherence questionnaire , if it gets validated then assessment of adherence of patients suffering from chronic cancer pain to opioids.

Tata Memorial Centre

Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Aggression

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Participants assigned to the control arm will receive usual care, including whatever information materials are provided to them by their urologist.

Participants assigned to the intervention will receive Decision Support Intervention in the form of a decision aid plus health coaching. The decision aid (delivered by internet and as a Portable Document Format (PDF) document) provides participants with a report on options and outcomes as described in the literature; along with more tailored risk information. The tailored risk information will include their estimated risk of harboring more aggressive prostate cancer based on their clinical/pathologic features (i.e., "My Clinical Risk"). The DSI was developed and piloted at UCSF according to the International Patient Decision Aid Standards (see http://ipdas.ohri.ca/) (IRS# 14-13332), and incorporates tailored risk models developed and validated.

A question list (QL) that includes areas of patient concern are created by the health coach for use by the patient and the urologist at their first consultation visit where they discuss the extent of their cancer and consider treatment options. The coach uses the Prostate Cancer SCOPED model to complete a "Prostate Cancer SCOPED Model Form". The SCOPED model uses concepts such as the situation, choices (treatment), objectives (personal goals and priorities), people (involved in supporting a treatment decision), evaluation and decisions (clarifying which choice is best and next steps).

Decision Support Intervention (DSI)

Peter R Carroll, MD, MPH

This clinical trial evaluates the use of novel decision support educational materials and services using health coaches. The study includes men newly diagnosed with low-risk prostate cancer. A 160 men will be recruited. Half of the men will receive a call from a health coach before their initial consultation visit with their urologist to review their treatment concerns and questions. The other half will receive usual care provided by the urologist, such as educational materials and services provided by the urologist.

A critical public health need exists for improved prognostic tools to distinguish aggressive from slow growing prostate cancer at diagnosis, and for better support systems to guide patients in decision-making regarding management options.

Decision support interventions that are tailored to specific clinical conditions are known to have increased patient self-efficacy, knowledge, question-asking, and satisfaction; and decreased decisional conflict, regret, anxiety, and distress.

To reduce the risk of over-treatment, our team has developed individual risk prediction models that we have now integrated into our decision support intervention (DSI).

Delivering such decision support intervention should increase patient knowledge and question-asking by the patient to their doctor.

The decision support intervention can be delivered by telephone and or the Internet.

This is a site-randomized, cluster-crossover clinical trial of a decision support intervention (DSI) vs. usual care, among men with low prognostic risk prostate cancer, to assess differences in informed decision making (i.e., knowledge), anxiety, and decision quality and self-efficacy.

Pioneering Advances in Care and Education (PACE)

Development, Validation, and Dissemination of an Integrated Risk Prediction Model and Decision Aid to Discern Aggressive Versus Indolent Prostate Cancer

De-identified individual participant data for all primary and secondary outcome measures will be made available through a formal data request

The DQI measures patient Knowledge, Concordance, and Decision process. For each fact about prostate cancer item, a correct response = 1 point. Missing responses=0 points. Total score is calculated for all patients who complete at least half of the items and scaled from 0-100%, with higher scores indicating greater knowledge. Patients rate their goals and concerns on an 11-point importance scale from 0 (not important at all) to 10 (extremely important). These questions + one question about patient's treatment preference can be used to calculate a concordance score. Patients are asked about whether they were offered a choice, how much pros and cons were discussed, and whether the health care provider asked for their preferences. Participants get 1 point for a response of "yes" / "a lot/some.", total points are summed, then divided by total number of items for a decision making process score from 0-100%. Higher scores indicate a more shared decision making process.

The MAX-PC is an 18-item questionnaire with a 4-point Likert-type scale asking how frequently certain "comments made by men about prostate cancer" were true of the respondent (Roth et al., 2003). Each item is scored from 0 to 4 with anchors ranging from "Not at all" to "Often." The scale can be scored in its entirety by summing all the items or summary scores can be grouped into Prostate Cancer Anxiety (11 items), Prostate-specific antigen (PSA) Anxiety (3 items), or Fear of Re-occurrence (4 items).

The DSE measures self-confidence or belief in one's ability to make informed decisions and participate in shared decision making with health professionals. It is a 11-item instrument with a five-point response scale ranging from 0 (not at all confident) to 4 (very confident).

CentraCare Adult & Pediatric Urology

Lancaster Urology

San Francisco Veterans Affairs Medical Center

Palo Alto Medical Foundation

University of California, San Francisco

Subjects with lung cancer detected by a computed tomography (CT)-scan and referred to a positron emission tomography (PET)/CT-scan are included. The diagnosis of lung cancer is confirmed by means of an pathological biopsy or by a medical doctor specialized in oncology with respect to radiological or clinical data.

Intervention: a fasted venous blood sample is taken before PET-scan

The control group consists of subjects who were referred to the department Nuclear Medicine for an examination of the heart. This control group represents the average population, consists of healthy subjects and patients with non-cancer diseases and who did not undergo a PET/CT-scan.

Intervention: fasted venous blood sample

Collection of a venous blood sample to investigate metabolic changes in blood

Venous blood sample

Michiel J Thomeer, MD, PhD

Lung cancer is the most common cancer in men and the fourth most common cancer in women worldwide. Until today no effective method permits the early detection of lung cancer. Consequently, lung cancer is often diagnosed owing to symptoms of advanced disease. To address this problem, detection methods with an improved sensitivity and specificity are urgently needed.

Over the past decade, accumulating evidence shows that the metabolism of cancer cells differs from that of normal cells. More specifically, the entire metabolism of cancer cells is reorganized or reprogrammed to increase anabolic reactions that induce cell growth and survival. Metabolic reprogramming during the development of cancer is driven by aberrant signaling pathways due to the activation of oncogenes and the loss of tumor suppressor genes. Furthermore, the microenvironment of the tumor plays a role in metabolic reprogramming. The altered cancer metabolism is characterized by an increased glycolysis, the production of lactate and the biosynthesis of macromolecules, such as proteins, lipids and nucleotides. Cancer cells have a high glycolytic rate and eliminate most of the glucose-derived carbon as lactate rather than oxidizing it completely via oxidative phosphorylation, a phenomenon known as the Warburg effect. The breakdown of glucose and other nutrients leads to a high energy production and provides the Krebs cycle with intermediates, which consequently are allocated to metabolic pathways that support biosynthesis. Metabolites are the end products of cellular metabolism and are therefore closely related to the observed phenotype. Disturbances in biochemical pathways which occur during the development of cancer consequently provoke changes in the metabolic phenotype. As a result, low-molecular weight metabolites are very attractive biomarkers for different cancer types. Nuclear magnetic resonance (NMR) spectroscopy enables the identification and quantitative analysis of complex mixtures of metabolites, as in plasma and serum, without an extended sample preparation.

The present study aims to determine the metabolic phenotype of lung cancer by means of proton (1H)-NMR spectroscopy. Once the phenotype determined (training cohort), this has to be validated by an independent cohort.

Subjects Subjects with lung cancer detected by a computed tomography (CT)-scan and referred to a positron emission tomography (PET)/CT-scan are included. The diagnosis of lung cancer is confirmed by means of an pathological biopsy or by a medical doctor specialized in oncology with respect to radiological or clinical data. The control group consists of subjects who were referred to the department Nuclear Medicine for an examination of the heart. This control group represents the average population, consists of healthy subjects and patients with non-cancer diseases and did not undergo a PET/CT-scan. Exclusion criteria are as follows: (1) not fasted for at least 6 hours, (2) poorly controlled diabetes (fasting plasma glucose concentration ≥ 200 mg/dl) in cancer patients, (3) medication intake at the day of blood sampling and (4) treatment or history of cancer in the preceding 5 years.

The training cohort consists of 80 subject with lung cancer and 80 controls. The validation cohort consist of 250 subject with lung cancer and 250 controls.

Blood sampling and processing Fasting venous blood samples (BD Vacutainer® LH 17 I.U. 10 ml tube) are collected and stored at 4°C within 5 to 10 minutes. Around 8 hours after blood collection, blood samples are transported on crushed ice to the central laboratory and centrifuged at room temperature (swinging bucket centrifuge, 1600 g, 15 minutes). Subsequently, 4 plasma aliquots of 500 µl are transferred into sterile cryovials and stored at -80°C until examination within 6 months. When subjects give permission to store their biological material, 3 aliquots are stored at the University Biobank Limburg (UBiLim) for biomedical research purposes.

Prior to NMR analysis, plasma aliquots are thawed and homogenized using a vortex mixer. After centrifugation at 13000 g for 4 minutes at 4°C (fixed rotor Eppendorf centrifuge 5415 R, Hamburg, Germany), plasma aliquots are diluted in deuterium oxide (D2O, 99.9%, Cambridge Isotope Laboratories Inc, Andover, USA) containing 180 µg/µl trimethylsilyl-2,2,3,3-tetradeuteropropionic acid (TSP, 98%, Cambridge Isotope Laboratories Inc, Andover, USA) as a chemical shift reference. Finally, the prepared plasma samples are transferred into a 5 mm NMR tube and analyzed.

1H-NMR analyses and assignment of present resonances The 1H-NMR spectra are recorded on a 400 Megahertz (MHz) NMR spectrometer (Varian/Agilent, Nuclear Magnetic Resonance Instruments, Palo Alto, California, USA) with a magnetic field strength of 9.4 Tesla at 294 K. Slightly T2- weighted spectra are acquired using a Carr-Purcell-Meiboom-Gill (CPMG) pulse sequence to attenuate signals of macromolecules, such as proteins and polysaccharides. Additionally, water suppression is performed in order to allow optimal detection and quantification of low-molecular weight metabolites. The 1H-NMR spectra are phased manually, baseline corrected and referenced to the TSP resonance at 0.015 parts per million (ppm). The assignment of the present 1H-NMR resonances occurs by means of spiking experiments. A reference plasma sample is alternately spiked with 34 known metabolites with a concentration of 1 mg compound per 100 µl plasma. The obtained chemical shifts are double checked with Chenomx NMR suite software (Version 7.5, Chenomx Inc., Edmonton, Alberta, Canada). Finally, 1H-NMR spectra are divided in 112 spectral regions, which are integrated and normalized relative to the total integrated area of all spectral regions, irrespective of the remaining water, TSP, fructose and glucose resonances. The end result corresponds to 110 normalized integration regions (all integration regions except those of water and TSP).

Statistical analysis At first, the integration values of all 110 spectral regions are analyzed by means of a student t-test with correction for multiple testing by Benjamini-Hochberg to identify those which differ significantly between lung cancer patients and controls (IBM SPSS Version 20.0, Chicago, Illinois, USA). Secondly, multivariate statistical analyses are performed using SIMCA-P+ (Version 12.0, Umetrics, Umea, Sweden) to investigate whether the metabolic composition of blood plasma allows to discriminate between lung cancer patients and controls. An unsupervised principal component analysis (PCA) was performed to identify intrinsic clusters and outliers within the dataset. After the removal of outliers (detected by a Hotelling's T2 range plot), an orthogonal partial least squares discriminant analysis (OPLS-DA), an extension of partial least squares discriminant analysis (PLS-DA) with an integrated orthogonal signal correction filter, is performed to remove variability not relevant to class separation. The predicted classification is expressed as specificity (the percentage of controls that are actually classified as controls) and sensitivity (the percentage of lung cancer patients that are actually classified as lung cancer patients). The outcome of using the integration values of the significantly different spectral regions, obtained by the student t-test with correction for multiple testing by Benjamini-Hochberg, is compared to the outcome in which the integration values of all 110 spectral regions were used.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
National Cancer Institute Food Study	NCT00978406	Validation Stud... Diet Surveys Nutritional Ass... Epidemiology Methodologic St...		20 Years - 70 Years	National Institutes of Health Clinical Center (CC)
Validation of the ASI-SR Form in a Population of Chronic Non-cancer Pain Patients	NCT04998734	Chronic Pain Opioid-use Diso... Quality of Life Risk Reduction Assessment, Sel...	ASI-SR	18 Years - 65 Years	Uppsala University
Validation of the ASI-SR Form in a Population of Chronic Non-cancer Pain Patients	NCT04998734	Chronic Pain Opioid-use Diso... Quality of Life Risk Reduction Assessment, Sel...	ASI-SR	18 Years - 65 Years	Uppsala University
Validation of the European Oncology Quality of Life Toolkit	NCT05947903	Cancer Survivorship Palliative Care	Administration ... Administration ... Administration ...	18 Years -	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Validation of Instruments Used for Assessment of Dysphagia in Patients With Esophageal Cancer	NCT03066167	Dysphagia, Esop... Esophageal Canc...	Validation of d...	-	Vastra Gotaland Region
Assessment of the 90-day Mortality Risk Score After VATS Lobectomy	NCT04799509	Lung Cancer Surgery--Compli... Morality	VATS lobectomy	-	Università degli Studi dell'Insubria
Validation and Assessment of Patient Adherence to Opioids for Cancer Pain Using MMAS 8 Pain Clinic	NCT02804477	Chronic Cancer ...		18 Years - 80 Years	Tata Memorial Centre
Validation of the European Oncology Quality of Life Toolkit	NCT05947903	Cancer Survivorship Palliative Care	Administration ... Administration ... Administration ...	18 Years -	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Pioneering Advances in Care and Education (PACE)	NCT03397160	Decision Suppor... Prostate Cancer	Decision Suppor...	18 Years -	University of California, San Francisco
LC-NMR Study Biomarkers to Detect Lung Cancer	NCT02024113	Lung Cancer	Venous blood sa...	18 Years -	Hasselt University
Validation of Instruments Used for Assessment of Dysphagia in Patients With Esophageal Cancer	NCT03066167	Dysphagia, Esop... Esophageal Canc...	Validation of d...	-	Vastra Gotaland Region
Decision Support Tools for Men With Prostate Cancer- Clinical & Lifestyle Model	NCT02451345	Prostate Cancer	Personalized ri...	18 Years -	University of California, San Francisco

Spots Global Cancer Trial Database for validation

Every month we try and update this database with for validation 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 validation

Every month we try and update this database with for validation 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 validation 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.