Stress and Anxiety Before Biopsy, After Biopsy Results, and During Treatment in Patients With Suspected Bone or Soft Tissue Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

Routine Diagnostic and Treatment Pathway: Observational 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.

Study summary

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

Primary outcome measure(s)

• Hospital Anxiety and Depression Scale Anxiety Subscale Score Across Three Assessment Points — Within 7 days before biopsy; within 7 days after pathology-result disclosure; and within 7 days before or on the day of treatment initiation, before the first planned treatment.
  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.

Trial sites (1)

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