Comparative Evaluation of Psychological Stress and Anxiety Levels Before Biopsy, After Diagnosis, and During Treatment in Patients With Suspected Primary or Metastatic Bone or Soft Tissue Malignancy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Hospital Anxiety and Depression Scale Anxiety Subscale Score Across Three Assessment Points
研究概览
简要总结
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.
详细描述
BIOPSY-STRESS is a single-center, prospective observational cohort study conducted at Istanbul University, Istanbul Faculty of Medicine, Department of Orthopedics and Traumatology, in collaboration with the Department of Psychiatry. Approximately 100 eligible adults who are scheduled for clinically indicated biopsy because of a suspected solid tumor will be recruited consecutively.
Psychological assessments will be performed at three prespecified stages of routine clinical care: before biopsy, after the pathology result or diagnosis has been communicated to the participant, and at treatment initiation. The assessments will include the Hospital Anxiety and Depression Scale, the Perceived Stress Scale, and the Distress Thermometer.
Relevant demographic, clinical, and radiological information will be obtained from routine hospital records, the hospital information management system, the picture archiving and communication system, and patient files. Prespecified clinical variables will include age, sex, disease stage or extent, metastasis status, and treatment type. No additional biopsy, imaging examination, laboratory test, or other invasive procedure will be performed for research purposes. The study will not assign participants to a diagnostic or therapeutic intervention.
The primary objective is to compare within-participant changes in psychological stress and anxiety levels across the pre-biopsy, post-diagnosis, and treatment-initiation assessments. The secondary objective is to identify demographic and clinical factors associated with higher psychological stress or anxiety.
Participant characteristics and questionnaire scores will be summarized using appropriate descriptive statistics. Change across the three assessment points will be evaluated using repeated-measures analysis of variance when the relevant assumptions are satisfied or the Friedman test when those assumptions are not satisfied. Where appropriate, multivariable linear regression or linear mixed-effects models will be used to examine associations between psychological outcomes and prespecified demographic and clinical factors. Effect estimates and 95% confidence intervals will be reported.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Hospital Anxiety and Depression Scale Anxiety Subscale Score Across Three Assessment Points
时间窗: 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.
次要结局
- Hospital Anxiety and Depression Scale Depression 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.)
- Perceived Stress Scale Total 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.)
- Distress Thermometer 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.)
研究者
Serkan Bayram, MD
Associate Professor of Orthopedics and Traumatology
Istanbul University