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

Official title

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

Overview

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.

Detailed description

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.

Study data will be collected prospectively and stored in coded form with access restricted to authorized study personnel. Participation involves only questionnaires and collection of routine clinical information. Possible research-related burdens include temporary emotional discomfort and fatigue while completing the questionnaires. Participants may pause questionnaire completion or withdraw from the study. Participants with marked anxiety or depressive symptoms, or those who report suicidal ideation, will be referred for same-day psychiatric evaluation in accordance with the study safety plan.

Interventions

• Other 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.

Primary outcome measures

• Hospital Anxiety and Depression Scale Anxiety Subscale Score Across Three Assessment Points [Time frame: 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.]

Secondary outcome measures (3)

• Hospital Anxiety and Depression Scale Depression Subscale Score Across Three Assessment Points [Time frame: 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 [Time frame: 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 [Time frame: 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Turkey (Türkiye) · 1 center

• Istanbul University, Istanbul Faculty of Medicine, Department of Orthopedics and Traumatol — Istanbul

Publications

• Donovan KA, Grassi L, McGinty HL, Jacobsen PB. Validation of the distress thermometer worldwide: state of the science. Psychooncology. 2014 Mar;23(3):241-50. doi: 10.1002/pon.3430. Epub 2013 Nov 11. PMID 25160838
• Ozalp E, Cankurtaran ES, Soygur H, Geyik PO, Jacobsen PB. Screening for psychological distress in Turkish cancer patients. Psychooncology. 2007 Apr;16(4):304-11. doi: 10.1002/pon.1059. PMID 16909427
• Jacobsen PB, Donovan KA, Trask PC, Fleishman SB, Zabora J, Baker F, Holland JC. Screening for psychologic distress in ambulatory cancer patients. Cancer. 2005 Apr 1;103(7):1494-502. doi: 10.1002/cncr.20940. PMID 15726544
• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available. PMID 6668417
• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x. PMID 6880820

Identifiers

NCT: NCT07727434 · 2025/2101

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗