Art-based InterventionNCT07551817
The Effect of Art-Based Intervention on Fatigue, Anxiety, Perception of Nurse Presence, and Quality of Life in Patients With Hematological Cancers
A study testing art-based intervention in people with Art-based Intervention and Hematological Cancer, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
This study will be conducted in a randomized controlled experimental design to examine The effect of art-based intervention on fatigue, anxiety, perception of nurse presence, and quality of life in patients with hematological cancer. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Art-based Intervention, Hematological Cancer, Nurse Presence
- What is being tested?
- art-based intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2026to 31 Dec 2026
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between 18 and 65 years of age
- Speaking and understanding Turkish
- Being literate
- Having a diagnosis of hematological cancer,
- Receiving chemotherapy in an inpatient ward,
- Not having a psychiatric diagnosis,
- Having an ECOG score of 1 or 2,
Who cannot join
- Having vision loss and hearing loss,
- Having an ECOG score of 3 or 4
- Patients who wanted to leave the study
- Failure to attend at least two sessions of art therapy.
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
Gazi University
Ankara, Çankaya, 06560
Ozlem Canbolat, +90 312 216 26 86, ozlemcanbolat@gazi.edu.tr
About this study
This study will be conducted in a randomized controlled experimental design to examine The effect of art-based intervention on fatigue, anxiety, perception of nurse presence, and quality of life in patients with hematological cancer. The study will be conducted with 52 patients (26 intervention, 26 control groups) treated in the Hematology department of a training and research hospital between May 2025 and October 2026. Art-based intervention will be applied to the intervention group for 2 week (3 sessions per week), No application will be made to the control group. The data collection tools in the study are the Patient Identifier Information Form, Cancer Fatigue Scale, Functional Assessment of Cancer Therapy-General Scale (FACT-G), Hospital Anxiety and Depression Scale (HADS), and Nurse Presence Scale (PONS).
- Conditions
- Art-based Intervention, Hematological Cancer, Nurse Presence, Quality of Life, Fatigue, Anxiety
- Being tested
- art-based intervention
- Keywords
- Art-based intervention, Hematological cancer, Nurse presence, Quality of life, Fatigue, Anxiety
- Medical subject headings
- Fatigue, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
art-based interventionOther
The Art-Based Intervention program will be implemented in 3 sessions per week, for a total of 6 sessions. Before starting the Art-Based Intervention program, the researcher will provide information about the purpose of the activity and the tools to be used. Each session will have a theme, and the session will be conducted according to the instructions given to the patient within the framework of this theme. Before each session, the theme specific to that day will be explained to the patients. Sessions will last approximately 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Application group | Experimental | After the purpose of the study and the method of application are explained to the intensive care patients, the "Patient Identifier Information Form", "Cancer Fatigue Scale", "Functional Assessment of Cancer Therapy-General Scale (FACT-G)", "Hospital Anxiety and Depression Scale (HADS)", and "Nurse Presence Scale (PONS)" will be applied. A total of 2 week (3 sessions per week) of art-based intervention will be applied . The measurements will be repeated afterwards. Receives: Other: art-based intervention |
| Control Group | No intervention | No application will be made to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Assessment of Cancer Therapy-General Scale (FACT-G)
It is a system based on health-related quality of life measurements. FACT-G consists of four sub-dimensions and 27 items: physical condition, social life and family condition, emotional condition, and activity status. The sub-dimension scores of the 27-item, five-point Likert-type scale are evaluated as follows: none: 0, very little: 1, somewhat: 2, quite: 3, very much: 4. The score ranges are 0 to 28, 0 to 28, 0 to 24, and 0 to 28 for the physical condition, social life and family condition, emotional condition, and activity status subscales, respectively. The maximum total score that can be obtained from the scale is 108, and the minimum score is 0.
Measured: 0 st day (before intervention); 14 st day (after intervention) and 28 st day (after intervention).
Cancer Fatigue Scale
This 5-point Likert-type scale consists of three sub-sections: physical, emotional, and cognitive, totaling 15 items. The highest possible score is 28 for the physical dimension, 16 for the emotional dimension, and 16 for the cognitive dimension, for a total of 60 points.
Measured: 0 st day (before intervention); 14 st day (after intervention) and 28 st day (after intervention).
Hospital Anxiety and Depression Scale (HADS)
Designed to assess patients' mental health and take necessary precautions. It is a 14-item, 4-point Likert-type scale. Each item has a different score. Items 1, 3, 5, 6, 8, 10, 11, and 13 show decreasing severity and are scored as 3, 2, 1, 0; items 2, 4, 7, 9, 12, and 14 are scored as 0, 1, 2, 3. For anxiety, patients scoring between 0-10 are interpreted as having no anxiety, and those scoring 11 and above are interpreted as having anxiety. For depression, patients scoring between 0-7 are interpreted as having no depression, and those scoring 8 and above are interpreted as having depression.
Measured: 0 st day (before intervention); 14 st day (after intervention) and 28 st day (after intervention).
Nurse Presence Scale
The scale measures nurse presence with 26 items and patient satisfaction with the last two items. Each item is scored as follows: never (1 point), rarely (2 points), sometimes (3 points), frequently (4 points), and always (5 points). An increase in the score indicates that the nurse's presence and the behaviors she provides are increasing, and patients perceive this positively.
Measured: 0 st day (before intervention); 14 st day (after intervention) and 28 st day (after intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Art-based InterventionStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem Canbolat, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551817
- Sponsor's protocol ID
- E-77082166-302.08.01-1352660
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Art-Based Intervention on Fatigue, Anxiety, Perception of Nurse Presence, and Quality of Life in Patients With Hematological Cancers
- ClinicalTrials.gov ID
- NCT07551817
- Acronym / sponsor ID
- E-77082166-302.08.01-1352660
- Conditions
- Art-based Intervention, Hematological Cancer, Nurse Presence, Quality of Life, Fatigue, Anxiety
- Keywords
- Art-based intervention, Hematological cancer, Nurse presence, Quality of life, Fatigue, Anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Apr 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 will be conducted in a randomized controlled experimental design to examine The effect of art-based intervention on fatigue, anxiety, perception of nurse presence, and quality of life in patients with hematological cancer. The study will be conducted with 52 patients (26 intervention, 26 control groups) treated in the Hematology department of a training and research hospital between May 2025 and October 2026. Art-based intervention will be applied to the intervention group for 2 week (3 sessions per week), No application will be made to the control group. The data collection tools in the study are the Patient Identifier Information Form, Cancer Fatigue Scale, Functional Assessment of Cancer Therapy-General Scale (FACT-G), Hospital Anxiety and Depression Scale (HADS), and Nurse Presence Scale (PONS).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Application group | Experimental | Other: art-based interventionAfter the purpose of the study and the method of application are explained to the intensive care patients, the "Patient Identifier Information Form", "Cancer Fatigue Scale", "Functional Assessment of Cancer Therapy-General Scale (FACT-G)", "Hospital Anxiety and Depression Scale (HADS)", and "Nurse Presence Scale (PONS)" will be applied. A total of 2 week (3 sessions per week) of art-based intervention will be applied . The measurements will be repeated afterwards. |
| Control Group | No intervention | –No application will be made to the control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Being between 18 and 65 years of age
- Speaking and understanding Turkish
- Being literate
- Having a diagnosis of hematological cancer,
- Receiving chemotherapy in an inpatient ward,
Key exclusion criteria (4 listed)
- Having vision loss and hearing loss,
- Having an ECOG score of 3 or 4
- Patients who wanted to leave the study
- Failure to attend at least two sessions of art therapy.
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 |
|---|---|---|
| art-based interventionThe Art-Based Intervention program will be implemented in 3 sessions per week, for a total of 6 sessions. Before starting the Art-Based Intervention program, the researcher will provide information about the purpose of the activity and the tools to be used. Each session will have a theme, and the session will be conducted according to the instructions given to the patient within the framework of this theme. Before each session, the theme specific to that day will be explained to the patients. Sessions will last approximately 45 minutes. | Other | Application group |
Primary outcome
Functional Assessment of Cancer Therapy-General Scale (FACT-G)
Time frame: 0 st day (before intervention); 14 st day (after intervention) and 28 st day (after intervention).
It is a system based on health-related quality of life measurements. FACT-G consists of four sub-dimensions and 27 items: physical condition, social life and family condition, emotional condition, and activity status. The sub-dimension scores of the 27-item, five-point Likert-type scale are evaluated as follows: none: 0, very little: 1, somewhat: 2, quite: 3, very much: 4. The score ranges are 0 to 28, 0 to 28, 0 to 24, and 0 to 28 for the physical condition, social life and family condition, emotional condition, and activity status subscales, respectively. The maximum total score that can be obtained from the scale is 108, and the minimum score is 0.
Cancer Fatigue Scale
Time frame: 0 st day (before intervention); 14 st day (after intervention) and 28 st day (after intervention).
This 5-point Likert-type scale consists of three sub-sections: physical, emotional, and cognitive, totaling 15 items. The highest possible score is 28 for the physical dimension, 16 for the emotional dimension, and 16 for the cognitive dimension, for a total of 60 points.
Hospital Anxiety and Depression Scale (HADS)
Time frame: 0 st day (before intervention); 14 st day (after intervention) and 28 st day (after intervention).
Designed to assess patients' mental health and take necessary precautions. It is a 14-item, 4-point Likert-type scale. Each item has a different score. Items 1, 3, 5, 6, 8, 10, 11, and 13 show decreasing severity and are scored as 3, 2, 1, 0; items 2, 4, 7, 9, 12, and 14 are scored as 0, 1, 2, 3. For anxiety, patients scoring between 0-10 are interpreted as having no anxiety, and those scoring 11 and above are interpreted as having anxiety. For depression, patients scoring between 0-7 are interpreted as having no depression, and those scoring 8 and above are interpreted as having depression.
Nurse Presence Scale
Time frame: 0 st day (before intervention); 14 st day (after intervention) and 28 st day (after intervention).
The scale measures nurse presence with 26 items and patient satisfaction with the last two items. Each item is scored as follows: never (1 point), rarely (2 points), sometimes (3 points), frequently (4 points), and always (5 points). An increase in the score indicates that the nurse's presence and the behaviors she provides are increasing, and patients perceive this positively.
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 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing art-based intervention in people with Art-based Intervention and Hematological Cancer, run by Gazi 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 7 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: opening soon, as of the sponsor's last update on 27 Apr 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 Ozlem Canbolat (+90 312 216 26 86, ozlemcanbolat@gazi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Assessment of Cancer Therapy-General Scale (FACT-G) (time frame: 0 st day (before intervention); 14 st day (after intervention) and 28 st day (after intervention).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2026.