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CompletedNCT07871734Updated Oct 16, 2026

Changes in Anxiety, Depression, Hopelessness, Spirituality, and Distress Levels Before and After Radiotherapy in Cancer Patients

An observational study in Cancer, sponsored by Fatih Goksel. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by Fatih Goksel · Observational

Updated Oct 16, 2026Primary outcomes revisedNewly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
389
Ages
18 Years to 85 Years
Sex
All
01

Study 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 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.

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Conditions studied

  • Cancer

Keywords

  • Radiotherapy
  • Spirituality
  • Depression
  • Anxiety
  • Distress
  • Hopelessness
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In context

Neoplasms

9,616 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.

This study's enrollment of 389 is above the median of 202 across 1,742 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

This is the only study on the registry with Fatih Goksel as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Adults aged 18 to 85 years.
  2. Patients with a confirmed diagnosis of cancer.
  3. Patients receiving radiotherapy at the study center.
  4. Radiotherapy is ongoing at the time of the baseline assessment.
  5. Able and willing to complete the study questionnaires immediately before the first radiotherapy session and immediately after completion of the entire radiotherapy course.
  6. Willing to participate voluntarily in the study.

Exclusion criteria

Exclusion Criteria:

  1. Age younger than 18 years or older than 85 years.
  2. Cognitive impairment that prevents completion of the study questionnaires or participation in the required assessment.
  3. Terminal-stage disease.
  4. Unwillingness to participate in the study.
  5. Failure to complete the post-radiotherapy assessment immediately after completion of the entire radiotherapy course.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
389 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Radiation: radiotherapy

Interventions

  • Radiationradiotherapy

    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.

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What researchers measure

Primary outcomes

  1. 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.

    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.

Secondary outcomes

  1. 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.

    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.

  2. 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.

    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.

  3. 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.

    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.

  4. 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.

    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.

  5. 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.

    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.

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Study locations

1 site
  • Ankara Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
    Ankara, 06200, Turkey (Türkiye)
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References and documents

Publications

  • Şirin T. Spirituality Scale: Development, Validity and Reliability. Journal of Turkish Studies. 2018;13(18):1283-1309. doi:10.7827/TurkishStudies.13996.

Individual participant data

Plan to share: No

09

Updates

2 registry updates since Sep 25, 2026
Also revised
primary outcomes
Registered
First appeared on the registry
Oct 13, 2026
Show all 2 updates
  1. Oct 16, 2026
    Primary outcomes Revised (1 change)
    + 1 other change: secondary outcomes
  2. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07871734
Lead sponsor
Fatih Goksel
Responsible party
Fatih Goksel (Associate Professor, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital) — Sponsor-investigator
First posted
Oct 13, 2026
Start date
Jul 1, 2019
Primary completion
Mar 31, 2020
Completion
Mar 31, 2020
Last update
Oct 16, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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