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

NCT07727434 | Recruiting

• 1 other identifier: 2025/2101
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bone Neoplasms; Soft Tissue Neoplasms; Anxiety; Stress, Psychological

Keywords

Orthopedic oncology; Biopsy; Solid tumor; Bone tumor; Soft tissue tumor; Cancer diagnosis; Pathology result disclosure; Treatment initiation; Psychological distress; Anxiety; Depression; Hospital Anxiety and Depression Scale; Perceived Stress Scale; Distress Thermometer

Outcome Measures

Primary Outcomes (1)

• Hospital Anxiety and Depression Scale Anxiety Subscale Score Across Three Assessment Points

  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.

  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 Outcomes (3)

• 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.

Study Arms (1)

Adults Undergoing Biopsy for Suspected Primary or Metastatic Bone or Soft Tissue Malignancy

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.

Other: Routine Diagnostic and Treatment Pathway

Interventions

Routine Diagnostic and Treatment Pathway OTHER

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.

Adults Undergoing Biopsy for Suspected Primary or Metastatic Bone or Soft Tissue Malignancy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults receiving care in the Department of Orthopedics and Traumatology at Istanbul University, Istanbul Faculty of Medicine, who are scheduled for biopsy because of a suspected solid tumor. Consecutive eligible participants will be recruited into a single prospective cohort and followed from before biopsy through pathology-result disclosure and treatment initiation.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University, Istanbul Faculty of Medicine, Department of Orthopedics and Traumatology

Istanbul, 34093, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Bone Neoplasms; Soft Tissue Neoplasms; Anxiety Disorders; Stress, Psychological; Depression

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Serkan Bayram, M.D.

  Istanbul University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Serkan Bayram, M.D.

CONTACT

+90 535 384 1408; dr.serkanbayram89@gmail.com

Irmak Polat, M.D.

CONTACT

+90 543 773 1949; irmak.polat@istanbul.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Orthopedics and Traumatology

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 27, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): January 20, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)