- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07551817
The Effect of Art-Based Intervention on Fatigue, Anxiety, Perception of Nurse Presence, and Quality of Life in Patients With Hematological Cancers
April 22, 2026 updated by: Özlem Canbolat, Gazi University
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 Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ozlem Canbolat
- Phone Number: +90 312 216 26 86
- Email: ozlemcanbolat@gazi.edu.tr
Study Locations
-
-
Çankaya
-
Ankara, Çankaya, Turkey (Türkiye), 06560
- Gazi University
-
Contact:
- Ozlem Canbolat
- Phone Number: +90 312 216 26 86
- Email: ozlemcanbolat@gazi.edu.tr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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,
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
No application will be made to the control group.
|
|
|
Experimental: Application group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
0 st day (before intervention); 14 st day (after intervention) and 28 st day (after intervention).
|
|
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.
|
0 st day (before intervention); 14 st day (after intervention) and 28 st day (after intervention).
|
|
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.
|
0 st day (before intervention); 14 st day (after intervention) and 28 st day (after intervention).
|
|
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.
|
0 st day (before intervention); 14 st day (after intervention) and 28 st day (after intervention).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2026
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
April 6, 2026
First Submitted That Met QC Criteria
April 22, 2026
First Posted (Actual)
April 27, 2026
Study Record Updates
Last Update Posted (Actual)
April 27, 2026
Last Update Submitted That Met QC Criteria
April 22, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-77082166-302.08.01-1352660
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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