Neoplasms

All Conditions

Rare Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

Patients with neuroendocrine tumors will be given access to an application that monitors distress, anxiety, depression, self-perceived burden, and resilience at regular intervals for 3 months lasting for 24 months.

Shen Lin, Professor

Shen Lin, professor

This is a psychosocial screening application to usual care in a cohort of neuroendocrine tumor patients. The application involves monitoring using the NCCN Distress Thermometer(DT), Hospital Anxiety and Depression Scale(HADS), Self-Perceived Burden Scale(SPBS) and Connor-Davidson Resilience Scale(CD-RISC). These assessments will be completed at baseline, 3 months, 6 months, 12 months and 24 months. Patients will have the option of filling out questionnaires more frequently if desired.

Psychosocial Screening for Neuroendocrine Tumor Patients

Peking University

MD, Professor, Chief of Department of GI Oncology, Peking University Cancer Hospital

Behaviors and Mental Disorders

Quality of Life

Enrolled patients will be asked to complete a subset of the PRO-CTCAE items based on cancer type, and the following instruments used as anchors to measure psychometric properties:

* the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life disease-specific module, if a linguistically validated Italian version exists, or the General QLQ-C30, if the Italian version is not available.
* the Hospital Anxiety and Depression Scale (HADS)
* The Patients' Global Impression of Change (PGIC) Scale.

PRO-CTCAE items

Francesco Perrone, MD, PhD

Domenico Galetta, MD

Saverio Cinieri, MD

Alberto Sobrero, MD

Lucia Del Mastro, MD

Emiliano Tamburini, MD

Silvana Leo, MD

Ugo De Giorgi, MD, PhD

Ugo De giorgi, MD

Vincenzo Adamo, MD

Carla Ida Ripamonti, MD

Alice Bergamini, MD

Silvia Della Torre, MD

Sara Di Bella, MD

Sandro Pignata, MD, PhD

Alessandro Morabito, MD

Michele Orditura, MD

Antonio Pizzolorusso, MD

Vincenzo Montesarchio, MD

Vittorina Zagonel, MD

Marcello Tiseo, MD

Camillo Porta, MD

Luigi Cavanna, MD

Patrizia Vici, MD

Antonella Savarese, MD

Salvatore Pisconti, MD

Stefania Gori, MD

The aim of this study is to complete the validation process by testing the remaining two psychometric properties (validity and responsiveness) of the Italian version of the PRO-CTCAE in a large group of patients. In particular, for the first time this study will validate the tool for individual types of cancer and will provide information on psychometric properties based on the type of treatment used in clinical practice.

This is a prospective observational study, conducted in Italian cancer centers located Nationwide.

The investigators plan to consider for validation 21tumor sites, which correspond to the conditions for which a specific EORTC module has been produced, plus all remaining cancer types classified as "other setting".

The study will take place during two planned visits, one the first the day of enrollment, the second after 3-6 weeks. Enrolled patients will be asked to complete a subset of the PRO-CTCAE items based on cancer type, and the following instruments used as anchors to measure psychometric properties:

* EORTC Quality of Life disease-specific module, if a linguistically validated Italian version exists, or the General QLQ-C30, if the Italian version is not available.
* the Hospital Anxiety and Depression Scale (HADS)
* The Patients' Global Impression of Change (PGIC) Scale

Validation of the Italian Version of the PRO-CTCAE

VIP: Validation of the Italian Version of the Patient-Reported Outcomes - Common Terminology Criteria for Adverse Events (PRO-CTCAE): A Prospective Multicenter Observational Study on Different Cancer Types

Evaluation of the validity (degree to which an instrument accurately measures the underlying phenomenon) of single items of the PRO-CTCAE, Italian version, for each of the type of cancer considered

Evaluation of responsiveness (ability of an instrument to show a change when there has been a change in the phenomenon) of single items of the PRO-CTCAE for each of the types of cancer considered.

Evaluate any differences in psychometric measures according to:

* type of cancer (breast, lung, liver ...)
* type of treatment (chemotherapy, hormone therapy, immunotherapy, ...)

National Cancer Institute, Naples

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Psychosocial Screening for Neuroendocrine Tumor Patients	NCT03372356	Neuroendocrine ...		18 Years -	Peking University
Validation of the Italian Version of the PRO-CTCAE	NCT04416672	Malignant Neopl...	PRO-CTCAE items	18 Years -	National Cancer Institute, Naples

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Spots Global Cancer Trial Database for hads

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