The Effect of Art-Based Intervention on Fatigue, Anxiety, Perception of Nurse Presence, and Quality of Life in Patients With Hematological Cancers

NCT07551817 | Not Yet Recruiting

• 1 other identifier: E-77082166-302.08.01-1352660
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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. 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

Hematological Cancer; Nurse Presence; Fatigue; Anxiety; Art-based Intervention; Quality of Life

Keywords

Art-based intervention; Hematological cancer; Nurse presence; Quality of life; Fatigue; Anxiety

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  0 st day (before intervention); 14 st day (after intervention) and 28 st day (after intervention).

Study Arms (2)

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.

Other: art-based intervention

Control Group

NO INTERVENTION

No application will be made to the control group.

Interventions

art-based intervention OTHER

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.

Application group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University

Ankara, Çankaya, 06560, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fatigue; Anxiety Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Ozlem Canbolat

CONTACT

+90 312 216 26 86; ozlemcanbolat@gazi.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 27, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

TU (1)