CancerNCT07871734
Changes in Anxiety, Depression, Hopelessness, Spirituality, and Distress Levels Before and After Radiotherapy in Cancer Patients
An observational study of Cancer, run by Fatih Goksel at 1 site in Turkey (Türkiye).
Trial summary
This observational study evaluates changes in anxiety, depression, hopelessness, spirituality, and distress levels in adult cancer patients receiving radiotherapy. Participants complete standardized questionnaires immediately before the first radiotherapy session and again immediately after completion of the entire… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cancer
- What is being tested?
- radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 389 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2019to 31 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult cancer patients aged 18 to 85 years receiving radiotherapy at the Radiation Oncology Department of Ankara Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital. Participants are assessed immediately before the first radiotherapy session and immediately after completion of the entire radiotherapy course.
Who may be able to join
- Adults aged 18 to 85 years.
- Patients with a confirmed diagnosis of cancer.
- Patients receiving radiotherapy at the study center.
- Radiotherapy is ongoing at the time of the baseline assessment.
- Able and willing to complete the study questionnaires immediately before the first radiotherapy session and immediately after completion of the entire radiotherapy course.
- Willing to participate voluntarily in the study.
Who cannot join
- Age younger than 18 years or older than 85 years.
- Cognitive impairment that prevents completion of the study questionnaires or participation in the required assessment.
- Terminal-stage disease.
- Unwillingness to participate in the study.
- Failure to complete the post-radiotherapy assessment immediately after completion of the entire radiotherapy course.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, 06200
About this study
Official title: Evaluation of Changes in Anxiety, Depression, Hopelessness, Spirituality, and Distress Levels Before and After Radiotherapy in Cancer Patients
This observational study evaluates changes in anxiety, depression, hopelessness, spirituality, and distress levels in adult cancer patients receiving radiotherapy. Participants complete standardized questionnaires immediately before the first radiotherapy session and again immediately after completion of the entire radiotherapy course. The radiotherapy duration varies among patients but is approximately 5 weeks. The study aims to assess changes in psychological, emotional, and spiritual well-being during the course of radiotherapy.
- Conditions
- Cancer
- Being tested
- radiotherapy
- Keywords
- Radiotherapy, Spirituality, Depression, Anxiety, Distress, Hopelessness
- Medical subject headings
- Neoplasms, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiotherapyRadiation
Radiotherapy administered to adult cancer patients with an indication for radiotherapy. Patients were assessed immediately before the first radiotherapy session and after completion of the entire radiotherapy course, approximately 5 weeks later. The study evaluated changes in anxiety, depression, hopelessness, spirituality, and distress levels during the radiotherapy course.
| Study group | Role | What they receive |
|---|---|---|
| Cancer Patients Receiving Radiotherapy | Adult cancer patients receiving radiotherapy, assessed immediately before the first radiotherapy session and again after completion of the entire radiotherapy course, approximately 5 weeks later. Receives: Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Spirituality Score From Immediately Before to Immediately After Radiotherapy (Approximately 5 Weeks)
Change in spirituality level measured using the 27-item Spirituality Scale between the assessment performed immediately before the first radiotherapy session and the assessment performed immediately after completion of the entire radiotherapy course. The radiotherapy duration varies among patients but is approximately 5 weeks. The purpose is to evaluate whether spirituality changes during the course of radiotherapy. The total score ranges from 27 to 135, with higher scores indicating higher levels of spirituality.
Measured: From immediately before the first radiotherapy session to immediately after completion of the entire radiotherapy course. The radiotherapy duration varies among patients but is approximately 5 weeks.
Secondary outcomes (5)
Change in Distress Score From Immediately Before to Immediately After Radiotherapy (Approximately 5 Weeks)
Change in distress level measured using the Distress Thermometer and Problem List between the assessment performed immediately before the first radiotherapy session and the assessment performed immediately after completion of the entire radiotherapy course. The radiotherapy duration varies among patients but is approximately 5 weeks. The Distress Thermometer (DT) score ranges from 0 to 10, with higher scores indicating greater psychological distress.
Measured: From immediately before the first radiotherapy session to immediately after completion of the entire radiotherapy course. The radiotherapy duration varies among patients but is approximately 5 weeks.
Change in Coping Style Scores From Immediately Before to Immediately After Radiotherapy (Approximately 5 Weeks)
Change in coping style scores measured using the Coping Styles Scale (COPE) between the assessment performed immediately before the first radiotherapy session and the assessment performed immediately after completion of the entire radiotherapy course. The radiotherapy duration varies among patients but is approximately 5 weeks. The Coping Attitudes Assessment Scale-Revised (COPE-R) total score ranges from 40 to 160, with higher scores indicating a higher level of coping attitudes.
Measured: From immediately before the first radiotherapy session to immediately after completion of the entire radiotherapy course. The radiotherapy duration varies among patients but is approximately 5 weeks.
Change in Anxiety and Depression Scores From Immediately Before to Immediately After Radiotherapy (Approximately 5 Weeks)
Change in anxiety and depression levels measured using the Hospital Anxiety and Depression Scale (HADS) between the assessment performed immediately before the first radiotherapy session and the assessment performed immediately after completion of the entire radiotherapy course. The HADS consists of 14 items, with 7 items assessing anxiety and 7 items assessing depression. The radiotherapy duration varies among patients but is approximately 5 weeks. The Hospital Anxiety and Depression Scale (HADS) consists of two subscale scores, each ranging from 0 to 21. Higher scores indicate greater anxiety or depressive symptom severity, respectively.
Measured: From immediately before the first radiotherapy session to immediately after completion of the entire radiotherapy course. The radiotherapy duration varies among patients but is approximately 5 weeks.
Change in Depression Score From Immediately Before to Immediately After Radiotherapy (Approximately 5 Weeks)
Change in depression level measured using the Beck Depression Inventory between the assessment performed immediately before the first radiotherapy session and the assessment performed immediately after completion of the entire radiotherapy course. The radiotherapy duration varies among patients but is approximately 5 weeks. The Beck Depression Inventory (BDI) total score ranges from 0 to 63, with higher scores indicating more severe depressive symptoms.
Measured: From immediately before the first radiotherapy session to immediately after completion of the entire radiotherapy course. The radiotherapy duration varies among patients but is approximately 5 weeks.
Change in Anxiety Score From Immediately Before to Immediately After Radiotherapy (Approximately 5 Weeks)
Change in anxiety level measured using the Beck Anxiety Inventory between the assessment performed immediately before the first radiotherapy session and the assessment performed immediately after completion of the entire radiotherapy course. The radiotherapy duration varies among patients but is approximately 5 weeks. The Beck Anxiety Inventory (BAI) total score ranges from 0 to 63, with higher scores indicating greater anxiety.
Measured: From immediately before the first radiotherapy session to immediately after completion of the entire radiotherapy course. The radiotherapy duration varies among patients but is approximately 5 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Jul 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies 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
- 389 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Goksel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fatih Goksel, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871734
- Sponsor's protocol ID
- 2019-06/333
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Şirin T. Spirituality Scale: Development, Validity and Reliability. Journal of Turkish Studies. 2018;13(18):1283-1309. doi:10.7827/TurkishStudies.13996.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Changes in Anxiety, Depression, Hopelessness, Spirituality, and Distress Levels Before and After Radiotherapy in Cancer Patients
- ClinicalTrials.gov ID
- NCT07871734
- Acronym / sponsor ID
- 2019-06/333
- Conditions
- Cancer
- Keywords
- Radiotherapy, Spirituality, Depression, Anxiety, Distress, Hopelessness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 389 participants (actual)
- Lead sponsor
- Fatih GokselUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 13 Oct 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 observational study evaluates changes in anxiety, depression, hopelessness, spirituality, and distress levels in adult cancer patients receiving radiotherapy. Participants complete standardized questionnaires immediately before the first radiotherapy session and again immediately after completion of the entire radiotherapy course. The radiotherapy duration varies among patients but is approximately 5 weeks. The study aims to assess changes in psychological, emotional, and spiritual well-being during the course of radiotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer Patients Receiving Radiotherapy | – | Radiation: radiotherapyAdult cancer patients receiving radiotherapy, assessed immediately before the first radiotherapy session and again after completion of the entire radiotherapy course, approximately 5 weeks later. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult cancer patients aged 18 to 85 years receiving radiotherapy at the Radiation Oncology Department of Ankara Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital. Participants are assessed immediately before the first radiotherapy session and immediately after completion of the entire radiotherapy course.
Key inclusion criteria (6 listed)
- Adults aged 18 to 85 years.
- Patients with a confirmed diagnosis of cancer.
- Patients receiving radiotherapy at the study center.
- Radiotherapy is ongoing at the time of the baseline assessment.
- Able and willing to complete the study questionnaires immediately before the first radiotherapy session and immediately after completion of the entire radiotherapy course.
Key exclusion criteria (5 listed)
- Age younger than 18 years or older than 85 years.
- Cognitive impairment that prevents completion of the study questionnaires or participation in the required assessment.
- Terminal-stage disease.
- Unwillingness to participate in the study.
- Failure to complete the post-radiotherapy assessment immediately after completion of the entire radiotherapy course.
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 |
|---|---|---|
| radiotherapyRadiotherapy administered to adult cancer patients with an indication for radiotherapy. Patients were assessed immediately before the first radiotherapy session and after completion of the entire radiotherapy course, approximately 5 weeks later. The study evaluated changes in anxiety, depression, hopelessness, spirituality, and distress levels during the radiotherapy course. | Radiation | Cancer Patients Receiving Radiotherapy |
Primary outcome
Change in Spirituality Score From Immediately Before to Immediately After Radiotherapy (Approximately 5 Weeks)
Time frame: From immediately before the first radiotherapy session to immediately after completion of the entire radiotherapy course. The radiotherapy duration varies among patients but is approximately 5 weeks.
Change in spirituality level measured using the 27-item Spirituality Scale between the assessment performed immediately before the first radiotherapy session and the assessment performed immediately after completion of the entire radiotherapy course. The radiotherapy duration varies among patients but is approximately 5 weeks. The purpose is to evaluate whether spirituality changes during the course of radiotherapy. The total score ranges from 27 to 135, with higher scores indicating higher levels of spirituality.
5 secondary outcomes
Change in Distress Score From Immediately Before to Immediately After Radiotherapy (Approximately 5 Weeks)
Time frame: From immediately before the first radiotherapy session to immediately after completion of the entire radiotherapy course. The radiotherapy duration varies among patients but is approximately 5 weeks.
Change in Coping Style Scores From Immediately Before to Immediately After Radiotherapy (Approximately 5 Weeks)
Time frame: From immediately before the first radiotherapy session to immediately after completion of the entire radiotherapy course. The radiotherapy duration varies among patients but is approximately 5 weeks.
Change in Anxiety and Depression Scores From Immediately Before to Immediately After Radiotherapy (Approximately 5 Weeks)
Time frame: From immediately before the first radiotherapy session to immediately after completion of the entire radiotherapy course. The radiotherapy duration varies among patients but is approximately 5 weeks.
Change in Depression Score From Immediately Before to Immediately After Radiotherapy (Approximately 5 Weeks)
Time frame: From immediately before the first radiotherapy session to immediately after completion of the entire radiotherapy course. The radiotherapy duration varies among patients but is approximately 5 weeks.
Change in Anxiety Score From Immediately Before to Immediately After Radiotherapy (Approximately 5 Weeks)
Time frame: From immediately before the first radiotherapy session to immediately after completion of the entire radiotherapy course. The radiotherapy duration varies among patients but is approximately 5 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- BackgroundŞirin T. Spirituality Scale: Development, Validity and Reliability. Journal of Turkish Studies. 2018;13(18):1283-1309. doi:10.7827/TurkishStudies.13996.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Cancer, run by Fatih Goksel 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 16 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Spirituality Score From Immediately Before to Immediately After Radiotherapy (Approximately 5 Weeks) (time frame: From immediately before the first radiotherapy session to immediately after completion of the entire radiotherapy course. The radiotherapy duration varies among patients but is approximately 5 weeks.). 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 NCT07871734, which also lists 1 linked publication.
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 16 Oct 2026.