Clinical trial Recruiting at 18 sites Observational Ages 18 and up

Tracking anxiety and depression over time in adults with solid tumors

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

Run by Fundación Sociedad Española de Oncologia Médica · NCT07168096 · Data updated 2026-11-12

This project will try to track anxiety and depression over six months in adults with solid tumors to see which medical, social, and psychological factors predict who needs extra support.

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Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment540 (estimated)
SponsorFundación Sociedad Española de Oncologia Médica
Academic / other
Locations18 sites (Santander, Cantabria and 17 other locations)
StatusRecruiting
StartedSeptember 12, 2024
Main results expectedDecember 2027
Study endsDecember 2027
Registry record updatedSeptember 11, 2025
Trial IDNCT07168096 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (over 18) with a histologically confirmed solid tumor who are candidates for perioperative systemic antineoplastic treatment or have advanced disease, can read and write, and can provide informed consent.

Probably not a fit

Patients with pre-existing psychiatric or neurodegenerative disorders that prevent participation, those treated for another cancer within the past 2 years, people with hematologic cancers, or those unable to complete assessments are unlikely to gain direct benefit from this study's predictive findings.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Consecutive adult patients with histologically confirmed solid tumors will be recruited at multiple Spanish hospitals and enrolled at diagnosis or treatment start, with follow-up visits at 3 and 6 months. The study collects sociodemographic, clinical (tumor site, stage, treatments, general health), psychological (coping, quality of life, cognitive complaints, fear of recurrence), physical activity, and supportive-care utilization data. Researchers will map trajectories of anxiety and depression symptoms over time and model which factors predict worsening, improvement, or persistence of symptoms. The observational design means participants receive usual oncologic care while contributing questionnaire and clinical data for analysis.

Why it matters

Potential benefit: If successful, the findings could help clinicians identify patients at higher risk of persistent anxiety or depression so they can be offered psychosocial support earlier.

How similar studies have gone: Previous longitudinal oncology studies have shown variable anxiety and depression trajectories and have identified predictors such as coping style and physical activity, so this approach builds on existing evidence though prospective multi-center data remain relatively limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Hospital Universitario Marqués de Valdecilla
    Santander, Cantabria, Spain
    Recruiting
  • Hospital General Universitario de Ciudad Real
    Ciudad Real, Ciudad Real, Spain
    Recruiting
  • Hospital Universitario Virgen de la Luz
    Cuenca, Cuenca, Spain
    Recruiting
  • Hospital General Universitario de Elche
    Alicante, Elche, Spain
    Recruiting
  • Hospital Universitario del Sureste
    Arganda, Madrid, Spain
    Recruiting
  • Hospital Universitario La Paz
    Fuencarral-El Pardo, Madrid, Spain
    Recruiting
Show 12 more locations
  • Hospital Universitario Fuenlabrada
    Fuenlabrada, Madrid, Spain
    Recruiting
  • Hospital Universitario de La Princesa
    Salamanca, Madrid, Spain
    Recruiting
  • Hospital Universitario Infanta Sofía
    San Sebastián de los Reyes, Madrid, Spain
    Recruiting
  • Hospital Universitario Infanta Leonor
    Vallecas, Madrid, Spain
    Recruiting
  • Hospital General Universitario Santa Lucía
    Cartagena, Murcia, Spain
    Recruiting
  • Hospital General Universitario Morales Meseguer
    Murcia, Murcia, Spain
    Recruiting
  • Hospital Universitario de Navarra
    Pamplona, Navarre, Spain
    Recruiting
  • Complejo Hospitalario de Orense
    Ourense, Orense, Spain
    Recruiting
  • Hospital Universitario Central de Asturias
    Oviedo, Principality of Asturias, Spain
    Recruiting
  • Hospital Universitario de Canarias
    Santa Cruz de Tenerife, Santa Cruz De Tenerife, Spain
    Recruiting
  • Hospital General Universitario de Valencia
    Valencia, Valencia, Spain
    Recruiting
  • Hospital Universitario Miguel Servet
    Zaragoza, Zaragoza, Spain
    Recruiting

Study contacts

  • Principal investigator: Paula Dra. Jiménez Fonseca, MD-PhD — Sociedad Española de Oncología Médica (SEOM)
  • Study coordinator: Paula Dra. Jiménez Fonseca, MD-PhD
  • Email: palucaji@hotmail.com
  • Phone: 985106121

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.