About this trial
This prospective observational study will follow adults who are scheduled for a clinically indicated biopsy because of a suspected solid tumor involving bone or soft tissue. The period before biopsy, the disclosure of pathology results, and the start of treatment may be associated with changing levels of psychological stress and anxiety.
The purpose of the study is to compare psychological stress and anxiety in the same participants at three points in their care: before biopsy, after the pathology result or diagnosis is explained, and at treatment initiation. The investigators hypothesize that psychological questionnaire scores will differ across these three time points and may be associated with age, sex, disease stage, metastasis status, and treatment type.
Participants will complete the Hospital Anxiety and Depression Scale, Perceived Stress Scale, and Distress Thermometer. The study team will also collect relevant demographic and routine clinical information from medical records. The study will not assign any biopsy, diagnostic procedure, or treatment. All diagnostic and treatment decisions will be made by the treating clinical team as part of routine care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older.
Scheduled for biopsy because of a suspected solid tumor.
Able to understand and answer the study questionnaires.
Able and willing to provide written informed consent before study participation.
Disqualifiers
History of previous malignancy.
Current serious psychiatric disorder, including major depressive disorder or psychotic disorder.
Cognitive impairment or communication difficulty that prevents valid completion of the study questionnaires.
Severe general medical condition or need for emergency intervention that makes study participation inappropriate.
Trial population
Adults receiving care in the Department of Orthopedics and Traumatology at Istanbul University, Istanbul Faculty of Medicine, who are scheduled for biopsy because of a suspected solid tumor. Consecutive eligible participants will be recruited into a single prospective cohort and followed from before biopsy through pathology-result disclosure and treatment initiation.
Trial design
Cohort
Prospective
Treatments tested in this trial
Routine Diagnostic and Treatment Pathway
Other interventionObservational exposure of interest. Participants undergo clinically indicated biopsy, pathology-result disclosure, and treatment initiation according to routine clinical care. The study does not assign biopsy, imaging, surgery, systemic treatment, radiotherapy, or any other treatment. Research activities consist of psychological questionnaires and collection of routine demographic, clinical, and radiologic data at the prespecified assessment points.
Treatment groups
Trial outcomes
Primary outcomes
Hospital Anxiety and Depression Scale Anxiety Subscale Score Across Three Assessment Points
Participant-reported anxiety symptoms measured using the Hospital Anxiety and Depression Scale Anxiety subscale. Higher scores indicate greater anxiety symptom burden. Scores will be summarized at each assessment point, and within-participant differences across the three assessment points will be evaluated using prespecified repeated-measures methods.
Secondary outcomes
Hospital Anxiety and Depression Scale Depression Subscale Score Across Three Assessment Points
Participant-reported depressive symptoms measured using the Hospital Anxiety and Depression Scale Depression subscale. Higher scores indicate greater depressive symptom burden. Scores will be summarized at each assessment point, and within-participant differences across the three assessment points will be evaluated using prespecified repeated-measures methods.
Perceived Stress Scale Total Score Across Three Assessment Points
Participant-reported perceived stress measured using the Perceived Stress Scale total score. Higher scores indicate greater perceived stress. Scores will be summarized at each assessment point, and within-participant differences across the three assessment points will be evaluated using prespecified repeated-measures methods.
Distress Thermometer Score Across Three Assessment Points
Global psychological distress measured using the Distress Thermometer, scored from 0 to 10. Higher scores indicate greater distress. Scores will be summarized at each assessment point, and within-participant differences across the three assessment points will be evaluated using prespecified repeated-measures methods.
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