Tracking anxiety and depression over time in adults with solid tumors
NEOPSYCO STUDY: Trajectories of Anxiety and Depression in Cancer Patients, Risk and Predictive Factors and Supportive Care; Prognostic Awareness and Shared Decision Making.
Fundación Sociedad Española de Oncologia Médica · NCT07168096
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 |
|---|---|
| Enrollment | 540 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación Sociedad Española de Oncologia Médica (other) |
| Locations | 18 sites (Santander, Cantabria and 17 other locations) |
| Trial ID | NCT07168096 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Santander, Cantabria and 17 other locations
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Depression, Cancer, Anxiety, anxiety, cancer, depression, quality of life, cognitive difficulties