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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07168096
Enrollment
540
Registered
2025-09-11
Start date
2024-09-12
Completion date
2027-12-31
Last updated
2025-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Cancer, Depression

Keywords

anxiety, cancer, depression, quality of life, cognitive difficulties

Brief 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.

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

OTHERPsychosocial 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.

Sponsors

Fundación Sociedad Española de Oncologia Médica
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Anxiety and depression symptomsAt 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).

Countries

Spain

Contacts

Primary ContactPaula Dra. Jiménez Fonseca, MD-PhD
palucaji@hotmail.com985106121

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026