Trajectories of Anxiety and Depression in Cancer Patients, Risk and Predictive Factors and Supportive Care; Prognostic Awareness and Shared Decision Making.
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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
Other trials for the same condition
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