Stress and Anxiety Before Biopsy, After Biopsy Results, and During Treatment in Patients With Suspected Bone or Soft Tissue Cancer
Recruiting · NCT07727434 · Observational (researchers observe without assigning treatment) · Lead sponsor: Istanbul University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
1 location listed.
- Istanbul University, Istanbul Faculty of Medicine, Department of Orthopedics and Traumatology - Istanbul, Turkey (Türkiye)