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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: art-based intervention
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gazi University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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