CancerNCT07861451
Islamic Spiritual Care Versus Psychological Support in Radiotherapy
A study testing IHSAN Model-based Islamic Spiritual Care and CBT-based Psychological Support in people with Cancer, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study evaluated the effects of IHSAN Model-based Islamic spiritual care compared with cognitive behavioral therapy (CBT)-based psychological support and routine care in Muslim patients with cancer receiving radiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cancer
- What is being tested?
- IHSAN Model-based Islamic Spiritual Care and CBT-based Psychological Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Sep 2020to 28 Feb 2021
- Phase
- Interventional
- 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
Who may be able to join
- Patients aged 18 to 85 years.
- Outpatients receiving radiotherapy at the Radiation Oncology Clinic.
- Patients who voluntarily agreed to participate in the study.
Who cannot join
- Patients with cognitive impairment severe enough to interfere with detailed psychiatric interviewing or questionnaire administration.
- Patients in the terminal stage of illness.
- Individuals who did not wish to participate in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara, Ankara, 06200
About this study
Official title: Islamic Spiritual Care Versus Psychological Support in Turkish Muslim Patients Undergoing Radiotherapy: A Randomized Controlled Study
This study evaluated the effects of IHSAN Model-based Islamic spiritual care compared with cognitive behavioral therapy (CBT)-based psychological support and routine care in Muslim patients with cancer receiving radiotherapy. A total of 137 patients were initially recruited, and 17 were subsequently excluded because they did not continue participation or did not complete the required study questionnaires. The remaining 120 participants were allocated by drawing lots to three groups: Spiritual Support, Psychological Support, or Control, with 40 participants in each group. Anxiety, depressive symptoms, psychological distress, and spirituality were assessed before and after the intervention. The study examined whether changes in these outcomes differed among the three groups.
Read the detailed description
This three-arm randomized controlled study was conducted among outpatients receiving radiotherapy at a Radiation Oncology Clinic. Eligible participants were patients aged 18 to 65 years who were receiving radiotherapy and voluntarily agreed to participate. Patients outside the specified age range, those with cognitive impairment severe enough to interfere with detailed psychiatric interviewing or questionnaire administration, patients in the terminal stage of illness, and individuals who did not wish to participate were not eligible for inclusion.
A total of 137 patients were initially recruited. Seventeen patients subsequently did not continue participation or did not complete the required study questionnaires and were excluded from the final study sample. The remaining 120 participants were allocated by drawing lots to the Spiritual Support, Psychological Support, or Control group, with 40 participants in each group.
The Spiritual Support group received individual Islamic spiritual care based on the IHSAN Model. The Psychological Support group received individual CBT-based psychological support. The Control group continued routine radiotherapy care without either study intervention. The interventions were delivered individually during the radiotherapy treatment period.
The study evaluated anxiety, depressive symptoms, psychological distress, and spirituality before and after the intervention using the Hospital Anxiety and Depression Scale anxiety and depression subscales (HADS-A and HADS-D), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Spirituality Scale (SS), and Distress Thermometer (DT). The primary analyses examined changes over time and differences among the three study groups.
The study received ethical approval from the Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital Clinical Research Ethics Committee on September 23, 2020 (Approval No. 2020-09/823). Written informed consent was obtained from all participants. The study was not preregistered.
- Conditions
- Cancer
- Being tested
- IHSAN Model-based Islamic Spiritual Care, CBT-based Psychological Support
- Keywords
- Radiotherapy, Islamic spiritual care, IHSAN Model, Anxiety, Depression, Psychological distress, Spirituality
- Medical subject headings
- Neoplasms, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IHSAN Model-based Islamic Spiritual CareBehavioural
Individual Islamic spiritual care based on the IHSAN Model. Sessions were held once a week during the radiotherapy treatment period, with an average of approximately seven sessions (range = 5-11), and each session lasted approximately 60 minutes.
CBT-based Psychological SupportBehavioural
Individual cognitive behavioral therapy (CBT)-based psychological support delivered during the radiotherapy treatment period. Sessions were held once a week, with an average of approximately seven sessions (range = 4-11), and each session lasted approximately 40 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Spiritual Support | Experimental | Participants received individual Islamic spiritual care based on the IHSAN Model during the radiotherapy treatment period. Sessions were held once a week, with an average of approximately seven sessions (range = 5-11). Receives: Behavioral: IHSAN Model-based Islamic Spiritual Care |
| Psychological Support | Active comparator | Participants received individual CBT-based psychological support during the radiotherapy treatment period. Sessions were held once a week, with an average of approximately seven sessions (range = 4-11), and each session lasted approximately 40 minutes. Receives: Behavioral: CBT-based Psychological Support |
| Control | No intervention | Participants continued routine radiotherapy care and did not receive the study-specific Islamic spiritual care or CBT-based psychological support interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) Score
Anxiety symptoms measured using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). The subscale consists of 7 items, with total scores ranging from 0 to 21; higher scores indicate greater anxiety symptoms.
Measured: Baseline (before the first radiotherapy session) and at the end of radiotherapy (approximately 5 weeks after baseline).
Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D) Score
Depressive symptoms measured using the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D). The subscale consists of 7 items, with total scores ranging from 0 to 21; higher scores indicate greater depressive symptoms.
Measured: Baseline (before the first radiotherapy session) and at the end of radiotherapy (approximately 5 weeks after baseline).
Beck Depression Inventory (BDI) Score
Depressive symptom severity measured using the 21-item Beck Depression Inventory (BDI). Each item is scored from 0 to 3, with total scores ranging from 0 to 63; higher scores indicate greater depressive symptom severity.
Measured: Baseline (before the first radiotherapy session) and at the end of radiotherapy (approximately 5 weeks after baseline).
Beck Anxiety Inventory (BAI) Score
Anxiety symptom severity measured using the 21-item Beck Anxiety Inventory (BAI). Each item is scored from 0 to 3, with total scores ranging from 0 to 63; higher scores indicate greater anxiety symptom severity.
Measured: Baseline (before the first radiotherapy session) and at the end of radiotherapy (approximately 5 weeks after baseline).
Spirituality Scale (SS) Score
Spirituality measured using the 27-item Spirituality Scale (SS) developed by Şirin (2018a). The scale uses a five-point Likert response format and yields total scores ranging from 27 to 135, with higher scores indicating greater spirituality.
Measured: Baseline (before the first radiotherapy session) and at the end of radiotherapy (approximately 5 weeks after baseline).
Distress Thermometer (DT) Score
Psychological distress measured using the Distress Thermometer (DT), a single-item visual analog screening measure scored from 0 to 10; higher scores indicate greater psychological distress.
Measured: Baseline (before the first radiotherapy session) and at the end of radiotherapy (approximately 5 weeks after baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start28 Sep 2020
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three parallel study groups were used: IHSAN Model-based Islamic spiritual care, CBT-based psychological support, and routine radiotherapy care.
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Goksel, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Investigators
- Fatih Göksel, MD, Principal investigator, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861451
- Sponsor's protocol ID
- 2020-09/823
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 6 Oct 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 with other researchers because the dataset contains sensitive clinical information and is subject to medical confidentiality, participant privacy, and applicable ethical and institutional requirements.
Publications
Şirin, T. (2018). Manevi danışmanlıkta İHSAN modeli. İstanbul, Türkiye: Kaknüs Yayınları.
Sirin T, Goksel F. Investigation of the Spiritual Care Effects on Anxiety, Depression, Psychological Distress and Spiritual Levels of Turkish Muslim Radiotherapy Patients. J Relig Health. 2021 Aug;60(4):2484-2502. doi: 10.1007/s10943-020-01117-1. Epub 2020 Oct 31.
PubMed 33128709
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Islamic Spiritual Care Versus Psychological Support in Turkish Muslim Patients Undergoing Radiotherapy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07861451
- Acronym / sponsor ID
- 2020-09/823
- Conditions
- Cancer
- Keywords
- Radiotherapy, Islamic spiritual care, IHSAN Model, Anxiety, Depression, Psychological distress, Spirituality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 6 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 study evaluated the effects of IHSAN Model-based Islamic spiritual care compared with cognitive behavioral therapy (CBT)-based psychological support and routine care in Muslim patients with cancer receiving radiotherapy. A total of 137 patients were initially recruited, and 17 were subsequently excluded because they did not continue participation or did not complete the required study questionnaires. The remaining 120 participants were allocated by drawing lots to three groups: Spiritual Support, Psychological Support, or Control, with 40 participants in each group. Anxiety, depressive symptoms, psychological distress, and spirituality were assessed before and after the intervention. The study examined whether changes in these outcomes differed among the three groups.
Detailed description
This three-arm randomized controlled study was conducted among outpatients receiving radiotherapy at a Radiation Oncology Clinic. Eligible participants were patients aged 18 to 65 years who were receiving radiotherapy and voluntarily agreed to participate. Patients outside the specified age range, those with cognitive impairment severe enough to interfere with detailed psychiatric interviewing or questionnaire administration, patients in the terminal stage of illness, and individuals who did not wish to participate were not eligible for inclusion.
A total of 137 patients were initially recruited. Seventeen patients subsequently did not continue participation or did not complete the required study questionnaires and were excluded from the final study sample. The remaining 120 participants were allocated by drawing lots to the Spiritual Support, Psychological Support, or Control group, with 40 participants in each group.
The Spiritual Support group received individual Islamic spiritual care based on the IHSAN Model. The Psychological Support group received individual CBT-based psychological support. The Control group continued routine radiotherapy care without either study intervention. The interventions were delivered individually during the radiotherapy treatment period.
The study evaluated anxiety, depressive symptoms, psychological distress, and spirituality before and after the intervention using the Hospital Anxiety and Depression Scale anxiety and depression subscales (HADS-A and HADS-D), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Spirituality Scale (SS), and Distress Thermometer (DT). The primary analyses examined changes over time and differences among the three study groups.
The study received ethical approval from the Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital Clinical Research Ethics Committee on September 23, 2020 (Approval No. 2020-09/823). Written informed consent was obtained from all participants. The study was not preregistered.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three parallel study groups were used: IHSAN Model-based Islamic spiritual care, CBT-based psychological support, and routine radiotherapy care.
| Arm | Type | Receives |
|---|---|---|
| Spiritual Support | Experimental | Behavioral: IHSAN Model-based Islamic Spiritual CareParticipants received individual Islamic spiritual care based on the IHSAN Model during the radiotherapy treatment period. Sessions were held once a week, with an average of approximately seven sessions (range = 5-11). |
| Psychological Support | Active comparator | Behavioral: CBT-based Psychological SupportParticipants received individual CBT-based psychological support during the radiotherapy treatment period. Sessions were held once a week, with an average of approximately seven sessions (range = 4-11), and each session lasted approximately 40 minutes. |
| Control | No intervention | –Participants continued routine radiotherapy care and did not receive the study-specific Islamic spiritual care or CBT-based psychological support interventions. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 to 85 years.
- Outpatients receiving radiotherapy at the Radiation Oncology Clinic.
- Patients who voluntarily agreed to participate in the study.
Key exclusion criteria (3 listed)
- Patients with cognitive impairment severe enough to interfere with detailed psychiatric interviewing or questionnaire administration.
- Patients in the terminal stage of illness.
- Individuals who did not wish to participate in the study.
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 |
|---|---|---|
| IHSAN Model-based Islamic Spiritual CareIndividual Islamic spiritual care based on the IHSAN Model. Sessions were held once a week during the radiotherapy treatment period, with an average of approximately seven sessions (range = 5-11), and each session lasted approximately 60 minutes. | Behavioural | Spiritual Support |
| CBT-based Psychological SupportIndividual cognitive behavioral therapy (CBT)-based psychological support delivered during the radiotherapy treatment period. Sessions were held once a week, with an average of approximately seven sessions (range = 4-11), and each session lasted approximately 40 minutes. | Behavioural | Psychological Support |
Primary outcome
Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) Score
Time frame: Baseline (before the first radiotherapy session) and at the end of radiotherapy (approximately 5 weeks after baseline).
Anxiety symptoms measured using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). The subscale consists of 7 items, with total scores ranging from 0 to 21; higher scores indicate greater anxiety symptoms.
Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D) Score
Time frame: Baseline (before the first radiotherapy session) and at the end of radiotherapy (approximately 5 weeks after baseline).
Depressive symptoms measured using the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D). The subscale consists of 7 items, with total scores ranging from 0 to 21; higher scores indicate greater depressive symptoms.
Beck Depression Inventory (BDI) Score
Time frame: Baseline (before the first radiotherapy session) and at the end of radiotherapy (approximately 5 weeks after baseline).
Depressive symptom severity measured using the 21-item Beck Depression Inventory (BDI). Each item is scored from 0 to 3, with total scores ranging from 0 to 63; higher scores indicate greater depressive symptom severity.
Beck Anxiety Inventory (BAI) Score
Time frame: Baseline (before the first radiotherapy session) and at the end of radiotherapy (approximately 5 weeks after baseline).
Anxiety symptom severity measured using the 21-item Beck Anxiety Inventory (BAI). Each item is scored from 0 to 3, with total scores ranging from 0 to 63; higher scores indicate greater anxiety symptom severity.
Spirituality Scale (SS) Score
Time frame: Baseline (before the first radiotherapy session) and at the end of radiotherapy (approximately 5 weeks after baseline).
Spirituality measured using the 27-item Spirituality Scale (SS) developed by Şirin (2018a). The scale uses a five-point Likert response format and yields total scores ranging from 27 to 135, with higher scores indicating greater spirituality.
Distress Thermometer (DT) Score
Time frame: Baseline (before the first radiotherapy session) and at the end of radiotherapy (approximately 5 weeks after baseline).
Psychological distress measured using the Distress Thermometer (DT), a single-item visual analog screening measure scored from 0 to 10; higher scores indicate greater psychological distress.
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 6 Oct 2026.
- BackgroundŞirin, T. (2018). Manevi danışmanlıkta İHSAN modeli. İstanbul, Türkiye: Kaknüs Yayınları.
- Background: PubMed 33128709Sirin T, Goksel F. Investigation of the Spiritual Care Effects on Anxiety, Depression, Psychological Distress and Spiritual Levels of Turkish Muslim Radiotherapy Patients. J Relig Health. 2021 Aug;60(4):2484-2502. doi: 10.1007/s10943-020-01117-1. Epub 2020 Oct 31.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers because the dataset contains sensitive clinical information and is subject to medical confidentiality, participant privacy, and applicable ethical and institutional requirements.
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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.
Fatih Göksel, MD principal investigator
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IHSAN Model-based Islamic Spiritual Care and CBT-based Psychological Support in people with Cancer, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital 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 3 inclusion and 3 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 6 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?
Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) Score (time frame: Baseline (before the first radiotherapy session) and at the end of radiotherapy (approximately 5 weeks after baseline).). The study lists 6 primary outcomes in all. 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 NCT07861451, which also lists 2 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 6 Oct 2026.