Ireland
--:--IST
Recruiting Observational

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

NCT07168096 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2024-09-12
Last updated
2025-09-11

Condition(s) studied

DepressionCancerAnxiety

Investigational drug(s) / intervention(s)

Psychosocial and clinical assessment

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.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Anxiety and depression symptoms — 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).

Trial sites (18)

FacilityCityRegionStatus
Hospital Universitario Marqués de Valdecilla Santander Cantabria Recruiting
Hospital General Universitario de Ciudad Real Ciudad Real Ciudad Real Recruiting
Hospital Universitario Virgen de la Luz Cuenca Cuenca Recruiting
Hospital General Universitario de Elche Alicante Elche Recruiting
Hospital Universitario del Sureste Arganda Madrid Recruiting
Hospital Universitario La Paz Fuencarral-El Pardo Madrid Recruiting
Hospital Universitario Fuenlabrada Fuenlabrada Madrid Recruiting
Hospital Universitario de La Princesa Salamanca Madrid Recruiting
Hospital Universitario Infanta Sofía San Sebastián de los Reyes Madrid Recruiting
Hospital Universitario Infanta Leonor Vallecas Madrid Recruiting
Hospital General Universitario Santa Lucía Cartagena Murcia Recruiting
Hospital General Universitario Morales Meseguer Murcia Murcia Recruiting
Hospital Universitario de Navarra Pamplona Navarre Recruiting
Complejo Hospitalario de Orense Ourense Orense Recruiting
Hospital Universitario Central de Asturias Oviedo Principality of Asturias Recruiting
Hospital Universitario de Canarias Santa Cruz de Tenerife Santa Cruz De Tenerife Recruiting
Hospital General Universitario de Valencia Valencia Valencia Recruiting
Hospital Universitario Miguel Servet Zaragoza Zaragoza Recruiting

More Fundación Sociedad Española de Oncologia Médica trials in Spain

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07168096 on ClinicalTrials.gov ↗ ← All trials in Spain