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

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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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Cancer Mental Disorders Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Psychosocial and clinical assessment

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.

Primary outcomes

Anxiety and depression symptoms

Time frame: At the time of diagnosis or treatment initiation. Follow-up at 3 months: To assess the early evolution of symptoms. Follow-up at 6 months: To analyze the medium-term evolution.

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).

Study contacts

Contact information is provided by the study sponsor or research team.

Paula Dra. Jiménez Fonseca, MD-PhD

CONTACT

[email protected]

985106121 ext. 36582

Sponsors and collaborators

Lead sponsor

Fundación Sociedad Española de Oncologia Médica

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2027
First posted: Sep 11, 2025
Registry last updated: Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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