The Effect of the Art-based Mandala Intervention on the Quality of Life of Cancer Patients Receiving Chemotherapy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the effect of mandala application on fatigue, quality of life, rumination and alexithymia in cancer patients receiving chemotherapy.

Detailed Description
-----------------
A randomized controlled study on the effect of mandala application on cancer related fatigue, quality of life, rumination and alexithymia in cancer patients receiving chemotherapy has not been found in the literature. The aim of this study is to determine the effect of mandala application on fatigue, quality of life, rumination and alexithymia in cancer patients receiving chemotherapy.

Official Title
-----------------
The Effect of the Art-based Mandala Intervention on the Quality of Life of Cancer Patients Receiving Chemotherapy

Conditions
-----------------
Cancer, Chemotherapy Effect, Fatigue, Quality of Life, Rumination, Alexithymia

Intervention / Treatment
-----------------
* Behavioral: Art based mandala


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Conscious and no communication problems Being literate Having a cancer diagnosis Receiving chemotherapy treatment (planned to continue treatment for 8 more weeks) Willing to participate in our study voluntarily Exclusion Criteria: Not being willing to participate in the research Desire to leave the study at any time Deterioration of compliance with the working criteria during the time of the study, Those who do not participate in up to four mandala applications during the study period Those who cannot use a pen Those with a diagnosis of psychiatric and neurological disease Patients who are scheduled for drug intervention, radiotherapy, surgery other than chemotherapy within 8 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mandala Intervention<br>To the experimental group; Mandala practice will be done for 2 hours, once a week for 8 weeks. | Behavioral: Art based mandala<br>* To the experimental group; Mandala practice will be done for 2 hours, once a week for 8 weeks.<br>|
| No Intervention: Control<br>No intervention will be applied to the control group | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of quality of life | Level of quality of life as assessed by the Quality of Life Scale for the Treatment and Research of Cancer (min:0, max:100,with higher values indicating a higher functioning in functional scales and an increased presence of symptoms in symptom scales) | 1 week | 
| level of fatigue | level of fatigue assessed by the Piper Fatigue Scale (min:0, max, 100, higher values means higher fatigue) | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of alexithymia | level of alexithymia assessed by Toronto Alexythimia Scale (higher values means more alexithymic) | 1 week | 
| level of rumination | level of rumination assessed by ruminative thought scale (higher values means more ruminative thought) | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, Chemotherapy Effect, Fatigue, Quality of Life, Rumination, Alexithymia