Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Psychological and quality of life questionnaires

Questionnaires administration

FFMQ is a 39-item measure consisting of five subscales (observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience).

Five Facet Mindfulness Questionnaire (FFMQ)

The LMS Tis a 21-item questionnaire, assessing four domains associated with mindful thinking: novelty-seeking, engagement, novelty producing, and flexibility.

Langer Mindfulness Scale (LMS)

The CFS is 12-item self-report test assessing awareness.

Cognitive Flexibility Scale (CFS)

The LOT is a 10-item, self-administered scale assessing generalized expectancies for positive versus negative outcomes.

Life Orientation Test (LOT)

The MLS is a 6-item questionnaire that includes 3 factors : chance, powerful others, and internality.

Mini Locus of Control test (MLS)

The HADS is a 14-items rated on a four-point Likert scale. The questionnaire was designed to screen for the presence and severity of depression (HADS-D) and anxiety (HADS-A) in people with a physical symptomatology

Hospital Anxiety and Depression Scale (HADS)

The PSS is 14-item self-report tool commonly used to provide a global measure of perceived stress in daily life.

Perceived Stress Scale (PSS)

The TSA is a 20-item scale that evaluates the three components of alexithymia: difficulty to identify feelings and distinguish between feelings and bodily sensations of emotional arousal difficulty, describing feelings to others, and a cognitive style that is literal, utilitarian, and externally oriented.

Toronto Alexithymia Scale (TAS)

Annalisa Maroli, PhD

Francesca De Lucia, MD

Antonino Spinelli, MD, PhD

This is an observation pilot trial aimed to study to the association between mindfulness and other psychological factors, including both protective and risk factors, with recovery of functional ability following colorectal cancer surgery.

Preliminary evidence suggests that there are multiple variables that may influence the functional recovery following colorectal cancer surgery, some of which deal with the psychological domain. Distress and depression can negatively affect the perceptions of functional ability, while resilience and effective coping styles promote a better psychological adaptation to challenging situations. Furthermore, psychosocial prehabilitation and interventions have been proposed as a feasible and cost-effective way to positively influence the recovery after surgery in association with the Enhanced Recovery After Surgery (ERAS) protocol.

In particular, mindfulness is proved to be associated with higher quality of life in different medical conditions, including oncological patients and has been also associated with improved clinical outcomes.

The aim of the study is to investigate the association of mindfulness and other psychological predictors with functional and quality of life outcomes in patients undergoing colorectal surgery for oncological condition.

Psychological Predictors in Colorectal Cancer Surgery Recovery

Psychological Predictors of Post-surgical Recovery in Colorectal Cancer Patients: a Pilot Cohort Study

Length of stay calculated in days from the day of surgery until the day of discharge

Quality of Life will be assessed by using the European Organization for Research and Treatment of Cancer Quality of Life core Questionnaire (EORTC-QLQ-C30) and the European Organisation for Research and Treatment of Cancer Quality of life Questionnaire ColoRectal specific module (EORTC-QLQ-CR29)

Quality of Life will be assessed by using the European Organization for Research and Treatment of Cancer quality of Life core Questionnaire (EORTC-QLQ-C30) and the European Organisation for Research and Treatment of Cancer Quality of life Questionnaire ColoRectal specific module (EORTC-QLQ-CR29)

Istituto Clinico Humanitas

Nervous System Diseases

Behaviors and Mental Disorders

Brain Neoplasms

Head and Neck Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Quality of Life

about 80 patients with at least a 5 year follow up with head and neck, skull base and brain tumors and no evidence of progressive disease.

100 patients with histological and/or radiological diagnosis of head and neck tumors enrolled at baseline

Enrolled people will be requested to fill in questionnaires. Cohort A affected by head and neck cancer: SF-12, EORTC QLQ-C30, EORTC QLQ-H\&N43, HADS, Brief COPE, BRCS.

Cohort A affected by skull base/brain cancer: SF-12, EORTC QLQ-BN20, HADS, Brief COPE, BRCS.

Cohort B will receive: EORTC QLQ-C30, BRCS, PROFFIT, SF-12, EORTC QLQ-H\&N43.

questionnaires administration

Anna Maria Camarda

Cristina Bono

Cristina Bono, MSc

The Quality of Life of patients treated with hadrontherapy is still limited. Two cohorts are established, they will be receiving specific standardized questionnaires to be evalutaed in their results.

Since 2011, CNAO has been treating patients suffering from solid tumors with particle therapy (both protons and carbon ions). Hadrontherapy improves outcome of radioresistant tumors which normally do not benefit from conventional radiotherapy. The treated population is highly heterogenous in term of tumor site, histotype, treatment fields and doses however its common anatomical origin justifies a unified approach in evaluating a QoL in this setting. QoL of patients suffering from these tumors have been poorly investigated and there are still few studies on patient reported outcomes (PROs) and QoL following hadrontherapy. In this context, therefore, there is a need to generate data by designing distinct cohort studies, conceived within a single protocol, that will gather quality of life data by means of standardized questionnaires of patients along their oncological history. Thanks to this protocol design, the investigator will be facilitated, in the future, in adding new cohorts pending a study protocol amendment and ethical approval.

HRQoL in Patients With Solid Tumors Treated With Hadrontherapy

Health Related Quality of Life (HRQoL) in Patients With Solid Tumors Treated With Hadrontherapy (HadroQoL).

quality of life in subjects treated with curative hadrontherapy investigated by global score according to SF12 and compared to healthy population

quality of life in subjects treated with curative hadrontherapy investigated by global score according to EORTC QLQ-C30

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Psychological Predictors in Colorectal Cancer Surgery Recovery	NCT03781193	Colorectal Canc...	Questionnaires ... Five Facet Mind... Langer Mindfuln... Cognitive Flexi... Life Orientatio... Mini Locus of C... Hospital Anxiet... Perceived Stres... Toronto Alexith...	18 Years -	Istituto Clinico Humanitas
Psychological Predictors in Colorectal Cancer Surgery Recovery	NCT03781193	Colorectal Canc...	Questionnaires ... Five Facet Mind... Langer Mindfuln... Cognitive Flexi... Life Orientatio... Mini Locus of C... Hospital Anxiet... Perceived Stres... Toronto Alexith...	18 Years -	Istituto Clinico Humanitas
HRQoL in Patients With Solid Tumors Treated With Hadrontherapy	NCT05947149	Head and Neck C... Skull Base--Can... Brain Cancer	questionnaires ...	18 Years -	CNAO National Center of Oncological Hadrontherapy

Spots Global Cancer Trial Database for questionnaires administration