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

NCT07168096 | Recruiting

• 1 other identifier: SEOM-NEOpsico-2024-01
• Study Type: observational
• Target: 540
• Locations: 1 country
• Sites: 18

Brief 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.

Conditions

Depression; Cancer; Anxiety

Keywords

anxiety; cancer; depression; quality of life; cognitive difficulties

Outcome Measures

Primary Outcomes (1)

• 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).

  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.

Study Arms (2)

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

Other: Psychosocial and clinical assessment

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.

Other: Psychosocial and clinical assessment

Interventions

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.

Patients with baseline symptoms; Patients without baseline symptoms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Sociedad Española de Oncologia Médica: lead

Study Sites (18)

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

RECRUITING

Hospital General Universitario de Ciudad Real

Ciudad Real, Ciudad Real, 13005, Spain

RECRUITING

Hospital Universitario Virgen de la Luz

Cuenca, Cuenca, 16002, Spain

RECRUITING

Hospital General Universitario de Elche

Alicante, Elche, 03203, Spain

RECRUITING

Hospital Universitario del Sureste

Arganda, Madrid, 28500, Spain

RECRUITING

Hospital Universitario La Paz

Fuencarral-El Pardo, Madrid, 28046, Spain

RECRUITING

Hospital Universitario Fuenlabrada

Fuenlabrada, Madrid, 28942, Spain

RECRUITING

Hospital Universitario de La Princesa

Salamanca, Madrid, 28006, Spain

RECRUITING

Hospital Universitario Infanta Sofía

San Sebastián de los Reyes, Madrid, 28702, Spain

RECRUITING

Hospital Universitario Infanta Leonor

Vallecas, Madrid, 28031, Spain

RECRUITING

Hospital General Universitario Santa Lucía

Cartagena, Murcia, 30202, Spain

RECRUITING

Hospital General Universitario Morales Meseguer

Murcia, Murcia, 30008, Spain

RECRUITING

Hospital Universitario de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Complejo Hospitalario de Orense

Ourense, Orense, 32005, Spain

RECRUITING

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

RECRUITING

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Santa Cruz De Tenerife, 38320, Spain

RECRUITING

Hospital General Universitario de Valencia

Valencia, Valencia, 46014, Spain

RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, Zaragoza, 50009, Spain

RECRUITING

MeSH Terms

Conditions

Depression; Neoplasms; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Paula Dra. Jiménez Fonseca, MD-PhD

  Sociedad Española de Oncología Médica (SEOM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paula Dra. Jiménez Fonseca, MD-PhD

CONTACT

985106121; palucaji@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: September 11, 2025
• Study Start: September 12, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

ES (18)