RecruitingNCT07168096

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.


Sponsor

Fundación Sociedad Española de Oncologia Médica

Enrollment

540 participants

Start Date

Sep 12, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria3

  • 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.

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.


Locations(18)

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Hospital General Universitario de Ciudad Real

Ciudad Real, Ciudad Real, Spain

Hospital Universitario Virgen de la Luz

Cuenca, Cuenca, Spain

Hospital General Universitario de Elche

Alicante, Elche, Spain

Hospital Universitario del Sureste

Arganda, Madrid, Spain

Hospital Universitario La Paz

Fuencarral-El Pardo, Madrid, Spain

Hospital Universitario Fuenlabrada

Fuenlabrada, Madrid, Spain

Hospital Universitario de La Princesa

Salamanca, Madrid, Spain

Hospital Universitario Infanta Sofía

San Sebastián de los Reyes, Madrid, Spain

Hospital Universitario Infanta Leonor

Vallecas, Madrid, Spain

Hospital General Universitario Santa Lucía

Cartagena, Murcia, Spain

Hospital General Universitario Morales Meseguer

Murcia, Murcia, Spain

Hospital Universitario de Navarra

Pamplona, Navarre, Spain

Complejo Hospitalario de Orense

Ourense, Orense, Spain

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Santa Cruz De Tenerife, Spain

Hospital General Universitario de Valencia

Valencia, Valencia, Spain

Hospital Universitario Miguel Servet

Zaragoza, Zaragoza, Spain

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NCT07168096


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