Clinical trial NCT04396093: Analysis Of The Anxiety-Depressive Pattern, Quality Of Life And Assessment Of Personality in Patients With Pancreatic Ductal Adenocarcinoma (PACT24)
Official title: Analysis of Anxiety-depressive Patterns, Quality of Life and Personality Assessment in Patients With Pancreatic Cancer: Outcome of Adaptation to Disease and Clinical Treatments
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreas Adenocarcinoma
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with a confirmed diagnosis of pancreatic ductal adenocarcinoma (resectable, borderline resectable, locally advanced or metastatic)

Brief summary: The aim of this study is the evaluation of psychological aspects, such as anxiety-depressive patterns, quality of life, personality and other psychopathological syndromes of patients who receive a diagnosis of pancreatic cancer and who face chemotherapy treatment, radio-chemotherapy or surgery

Detailed description: Pancreatic cancer is an aggressive disease whose prognosis is generally unfavorable: less than 20% of patients results eligible for resection treatment with potentially curative purposes and only in 2019 in Italy 13,500 new cases were estimated. It represents one of the poorest prognosis with 8.1% survival at 5 years and 3% at 10 years.

Its treatments can have a negative effect on the quality of life linked to the health of patients (HRQoL). Over the past 20 years, the quality of life assessment has become an important component of evaluating new therapeutic approaches, providing indications on the patient's perception of the benefits of the treatments to which he undergoes. Therefore, an accurate assessment of HRQoL using valid and standardized tools is crucial to highlight the costs and benefits of the different therapeutic options and the clinical utility of the data.

Description of the intervention (schedule of visits):

Visit 1 (screening). Patients will be informed about the study. Once patients agree with the inclusion in the study the investigators will evaluate the inclusion and exclusion criteria. Those patients who meet all the inclusion criteria and none of the exclusion criteria will be finally included in the study. In this visit, patients, tumor-related variables, and general patients' features will be recorded, and all questionnaires will be administered EORTC QLQ 30, EORTC- PAN 26, HADS, Millon Clinical Multiaxial Inventory).

Enrolled patients will make a first psychological visit within one month of the initial diagnosis and before starting active medical treatment (chemotherapy, radiochemotherapy, surgery). During this visit, they will be asked to complete questionnaires aimed at assessing the quality of life (EORCT QLQ 30, EORCT PAN26) of the anxiety-depressant aspects related to the disease (HADS) and of the personological functioning (MCMI-III) to proceed psychological evaluation.

During the visit 2 (2-3 months after the first dose of planned chemotherapy and following an instrumental re-evaluation), the quality of life and the anxiety-depression symptoms related to the disease will be re-evaluated (EORCT QLQ 30, EORCT PAN26; HADS)

The researcher will record in a dedicated database all patient information, such as:

* Personal data (gender, age, schooling)
* Onset and related timing of anxiety disorders or mood before the disease onset
* Psychological or psychiatric visits before the disease onset
* Psychotropic drugs use/abuse
* Psychotherapeutic or psychological path in progress
* Family, social, religious /spiritual resources
* Eligibility for surgery
* Stage of illness
* Clinical treatment (type of chemotherapy, radiochemotherapy)
* Therapeutic result (response, progression stability)
* Any serious adverse events (SAE).

The same variables recorded at Visit 1 will be checked again.

Power size calculation:

The number of patients was calculated taking into account the main outcome. Assuming a positive correlation coefficient of 0.3 (effect size) between the change in anxiety depression levels and self-perceived quality of life, an 85% power, a 5% significance level and a drop-out percentage / missing data equal to 30%, it is estimated a sample size of 75 patients.

Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years
* Patients candidated to receive an active treatment (surgery, chemiotherapy, chemio-radiation)
* Patients able to sign the informed consent.

Exclusion Criteria:

* • Patients with a school education level less than 8 years, since the complexity of submitted questionnaires.

Primary outcomes:
measure: Analysis of the anxiety and depression in patients who face active cancer treatment (chemotherapy, radiotherapy, surgery)
timeFrame: 12 weeks after the diagnosis
measure: Analysis of the quality of life in patients who face active cancer treatment (chemotherapy, radiotherapy, surgery)
timeFrame: 12 weeks after the diagnosis
Secondary outcomes:
measure: The influence of patient personality on chemioterapic treatment response
timeFrame: 12 weeks after the diagnosis
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS S Raffaele
Study officials:
affiliation: IRCCS San Raffaele
name: Michele Reni, MD
role: PRINCIPAL_INVESTIGATOR
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