Bone NeoplasmsBIOPSY-STRESSNCT07727434
Stress and Anxiety Before Biopsy, After Biopsy Results, and During Treatment in Patients With Suspected Bone or Soft Tissue Cancer
An observational study of Bone Neoplasms and Soft Tissue Neoplasms, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Neoplasms, Soft Tissue Neoplasms, Anxiety
- What is being tested?
- Routine Diagnostic and Treatment Pathway
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2026to 20 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University, Istanbul Faculty of Medicine, Department of Orthopedics and Traumatology
Istanbul, 34093
Serkan Bayram, M.D., +90 535 384 1408, dr.serkanbayram89@gmail.com
İsmail Tarık Atasoy, M.D., +90 534 632 0870, tarikatasoy96@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Bone Neoplasms, Soft Tissue Neoplasms, Anxiety, Stress, Psychological
- Being tested
- Routine Diagnostic and Treatment Pathway
- 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
- Medical subject headings
- Bone Neoplasms, Soft Tissue Neoplasms, Anxiety Disorders, Stress, Psychological, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Diagnostic and Treatment PathwayOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Routine Diagnostic and Treatment Pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Participant-reported depressive symptoms measured using the Hospital Anxiety and Depression Scale Depression subscale. Higher scores indicate greater depressive 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.
Measured: 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
Participant-reported perceived stress measured using the Perceived Stress Scale total score. Higher scores indicate greater perceived stress. 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.
Measured: 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
Global psychological distress measured using the Distress Thermometer, scored from 0 to 10. Higher scores indicate greater distress. 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start20 Jul 2026
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Bone NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serkan Bayram, MD, Istanbul University
- Investigators
- Serkan Bayram, M.D., Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727434
- Sponsor's protocol ID
- 2025/2101
- Acronym
- BIOPSY-STRESS
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly or with external researchers. To safeguard participant confidentiality and comply with applicable ethical and legal data-protection requirements, including the Turkish Personal Data Protection Law (KVKK), study findings will be disseminated only in aggregate, non-identifiable form through peer-reviewed publications and scientific presentations.
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.
PubMed 25160838Ozalp 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.
PubMed 16909427Jacobsen 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.
PubMed 15726544Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Zigmond 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.
PubMed 6880820
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07727434
- Acronym / sponsor ID
- BIOPSY-STRESS / 2025/2101
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Jan 2027 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults Undergoing Biopsy for Suspected Primary or Metastatic Bone or Soft Tissue Malignancy | – | Other: Routine Diagnostic and Treatment PathwaySingle 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine Diagnostic and Treatment PathwayObservational 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. | Other | Adults Undergoing Biopsy for Suspected Primary or Metastatic Bone or Soft Tissue Malignancy |
Primary outcome
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.
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.
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Background: PubMed 25160838Donovan 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.
- Background: PubMed 16909427Ozalp 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.
- Background: PubMed 15726544Jacobsen 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.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Background: PubMed 6880820Zigmond 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly or with external researchers. To safeguard participant confidentiality and comply with applicable ethical and legal data-protection requirements, including the Turkish Personal Data Protection Law (KVKK), study findings will be disseminated only in aggregate, non-identifiable form through peer-reviewed publications and scientific presentations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Serkan Bayram, M.D. principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Neoplasms and Soft Tissue Neoplasms, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Serkan Bayram, M.D. (+90 535 384 1408, dr.serkanbayram89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07727434, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.