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

June 19, 2022 updated by: Elif Yıldırım Ayaz, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

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 Locations

  • Turkey
    • İstanbul
      • Üsküdar, İstanbul, Turkey, 34660
        • Recruiting
        • Sultan Abdulhamid Training and Research Hospital
        • Contact:

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mandala Intervention
To the experimental group; Mandala practice will be done for 2 hours, once a week for 8 weeks.
Behavioral: Art based mandala
To the experimental group; Mandala practice will be done for 2 hours, once a week for 8 weeks.
No Intervention: Control
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
Time Frame: 1 week
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
Time Frame: 1 week
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
Time Frame: 1 week
level of alexithymia assessed by Toronto Alexythimia Scale (higher values means more alexithymic)
1 week
level of rumination
Time Frame: 1 week
level of rumination assessed by ruminative thought scale (higher values means more ruminative thought)
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Investigators

  • Principal Investigator: Elif Yıldırım Ayaz, M.D., Sultan Abdulhamid Training and Research Hospital

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 (Actual)

May 19, 2022

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

April 18, 2022

First Submitted That Met QC Criteria

April 18, 2022

First Posted (Actual)

April 25, 2022

Study Record Updates

Last Update Posted (Actual)

June 22, 2022

Last Update Submitted That Met QC Criteria

June 19, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARQULA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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