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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 540 (estimated) |
| Sponsor | Fundación Sociedad Española de Oncologia Médica Academic / other |
| Locations | 18 sites (Santander, Cantabria and 17 other locations) |
| Status | Recruiting |
| Started | September 12, 2024 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | September 11, 2025 |
| Trial ID | NCT07168096 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
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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
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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
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.