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

Fundación Sociedad Española de Oncologia Médica

Status: Enrolling

Conditions: Cancer; Depression; Anxiety

Treatments: Other: Psychosocial and clinical assessment

Study type: Observational

Funder types: Other

Identifiers

NCT07168096

SEOM-NEOpsico-2024-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 540 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

540 participants in 2 patient groups

Patients with baseline symptoms

Description:

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

Treatment:

Other: Psychosocial and clinical assessment

Patients without baseline symptoms

Description:

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.

Treatment:

Other: Psychosocial and clinical assessment