Clinical trial · Observational
Stress and Anxiety Before Biopsy, After Biopsy Results, and During Treatment in Patients With Suspected Bone or Soft Tissue Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Bone Neoplasms | Bone Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Soft Tissue Neoplasms | Soft Tissue Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Stress, Psychological | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Routine Diagnostic and Treatment Pathway | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Adults Undergoing Biopsy for Suspected Primary or Metastatic Bone or Soft Tissue Malignancy
- description
- Single prospective cohort of adults undergoing clinically indicated biopsy for a suspected solid tumor involving bone or soft tissue. Participants are assessed before biopsy, after pathology-result disclosure, and at treatment initiation. No diagnostic or therapeutic intervention is assigned by the study.
- interventionNames
- Other: Routine Diagnostic and Treatment Pathway
Primary outcomes (1)
- measure
- Hospital Anxiety and Depression Scale Anxiety Subscale Score Across Three Assessment Points
- timeFrame
- 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.
- description
- 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 (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (5)
- BACKGROUNDDonovan 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
- BACKGROUNDOzalp 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
- BACKGROUNDJacobsen 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
- BACKGROUNDCohen 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
- BACKGROUNDZigmond 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