Trajectories of Anxiety and Depression in Cancer Patients, Risk and Predictive Factors and Supportive Care; Prognostic Awareness and Shared Decision Making.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Psychosocial and clinical assessment.
- Who it may be relevant to
- Registry conditions: Depression, Cancer, Anxiety. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Overview
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.
Detailed description
The study population consists of consecutive oncology patients recruited across multiple centers, with data collection occurring at baseline (diagnosis or treatment initiation) and at 3-month and 6-month follow-up time points.
Interventions
- Other 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.
Primary outcome measures
- Anxiety and depression symptoms [Time frame: 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.]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 18 centers
- Hospital Universitario Marqués de Valdecilla — Santander
- Hospital General Universitario de Ciudad Real — Ciudad Real
- Hospital Universitario Virgen de la Luz — Cuenca
- Hospital General Universitario de Elche — Alicante
- Hospital Universitario del Sureste — Arganda
- Hospital Universitario La Paz — Fuencarral-El Pardo
- Hospital Universitario Fuenlabrada — Fuenlabrada
- Hospital Universitario de La Princesa — Salamanca
- … and 10 more centers
Identifiers
NCT: NCT07168096 · SEOM-NEOpsico-2024-01