About this trial
To examine the trajectories of anxiety and depression symptoms over the course of oncological disease, and to assess potential predictors-sociodemographic (age, sex, marital status, employment status), clinical (tumor location, stage, treatment type, general health), psychological (coping strategies, quality of life, cognitive difficulties, fear of recurrence), and physical activity-and their association with support needs and utilization of psychosocial services.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed diagnosis of solid cancer (non-hematologic) at any stage.
Adult age (>18 years).
Candidate for perioperative systemic antineoplastic treatment or for advanced disease.
Willingness to participate in the study and sign the informed consent form, as appropriate, before initiating any study-specific procedures, in accordance with good clinical practice requirements and local regulations.
Disqualifiers
Presence of a pre-existing psychiatric or neurodegenerative disorder that impairs the patient's ability to participate in the study.
Presence of reading and writing difficulties that prevent the patient from completing the assessments.
Receipt of oncological treatment in the past 2 years for another cancer.
Trial population
Adult oncology patients diagnosed with solid (non-hematologic) cancer at any stage, aged 18 years or older, who are candidates for perioperative systemic antineoplastic treatment or have advanced disease.
Trial design
Cohort
Prospective
Treatments tested in this trial
Psychosocial and clinical assessment
Other interventionParticipants complete standardized self-report questionnaires and undergo medical record review at three time points (baseline, 3 months, and 6 months) to assess psychological symptoms (anxiety, depression, somatization), coping strategies, quality of life, cognitive difficulties, physical activity, nutrition, supportive care needs, and informed decision-making in the context of cancer treatment. No experimental treatment or therapy is administered.
Treatment groups
Trial outcomes
Primary outcomes
Anxiety and depression symptoms
The primary outcome of our study is psychological distress, specifically anxiety and depression symptoms, which will be measured using the Brief Symptom Inventory-18 (BSI-18). BSI-18 provides a single outcome measure for distress. The scoring ranges are as follows: 0-66 (low risk of depression and/or anxiety), 67-71 (intermediate risk), and \>71 (clinically significant distress).
Sponsors and contacts
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