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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFundación Sociedad Española de Oncologia Médica

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Adult oncology patients diagnosed with solid (non-hematologic) cancer at any stage, aged 18 years or older, who are candidates for perioperative systemic antineoplastic treatment or have advanced disease.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Psychosocial and clinical assessment

    Other intervention

    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.

Treatment groups

540 Participants
are divided into 2 treatment groups
Group A: Patients with baseline symptoms1 intervention
Group B: Patients without baseline symptoms1 intervention

Trial outcomes

Primary outcomes

1

Anxiety and depression symptoms

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).

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

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