Trajectories of Anxiety and Depression in Cancer Patients, Risk and Predictive Factors and Supportive Care; Prognostic Awareness and Shared Decision Making.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

540 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-12

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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The study population consists of consecutive oncology patients recruited across multiple centers, with data collection occurring at baseline (diagnosis or treatment initiation) and at 3-month and 6-month follow-up time points.

Conditions

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Depression Cancer Anxiety

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with baseline symptoms

Patients presenting symptoms of anxiety and/or depression at the time of study inclusion. These patients will be followed to evaluate the evolution of symptoms and the impact of clinical and psychosocial variables over time

Psychosocial and clinical assessment

Intervention Type OTHER

Participants 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.

Patients without baseline symptoms

Patients without symptoms of anxiety or depression at the time of study inclusion. These participants serve as a comparison group to explore predictors of psychological distress trajectories and use of supportive care resources.

Psychosocial and clinical assessment

Intervention Type OTHER

Participants 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.

Interventions

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Psychosocial and clinical assessment

Participants 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No