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

Primary Purpose

Cancer, Chemotherapy Effect, Fatigue

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Art based mandala
Sponsored by
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer focused on measuring cancer, Chemotherapy Effect, Fatigue, Quality of Life, Rumination, Alexithymia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sultan Abdülhamid Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mandala Intervention

Control

Arm Description

To the experimental group; Mandala practice will be done for 2 hours, once a week for 8 weeks.

No intervention will be applied to the control group

Outcomes

Primary Outcome Measures

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)
level of fatigue
level of fatigue assessed by the Piper Fatigue Scale (min:0, max, 100, higher values means higher fatigue)

Secondary Outcome Measures

level of alexithymia
level of alexithymia assessed by Toronto Alexythimia Scale (higher values means more alexithymic)
level of rumination
level of rumination assessed by ruminative thought scale (higher values means more ruminative thought)

Full Information

First Posted
April 18, 2022
Last Updated
June 19, 2022
Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
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1. Study Identification

Unique Protocol Identification Number
NCT05344820
Brief Title
The Effect of the Art-based Mandala Intervention on the Quality of Life of Cancer Patients Receiving Chemotherapy
Acronym
ARQULA
Official Title
The Effect of the Art-based Mandala Intervention on the Quality of Life of Cancer Patients Receiving Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 19, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Chemotherapy Effect, Fatigue, Quality of Life, Rumination, Alexithymia
Keywords
cancer, Chemotherapy Effect, Fatigue, Quality of Life, Rumination, Alexithymia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mandala Intervention
Arm Type
Experimental
Arm Description
To the experimental group; Mandala practice will be done for 2 hours, once a week for 8 weeks.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention will be applied to the control group
Intervention Type
Behavioral
Intervention Name(s)
Art based mandala
Intervention Description
To the experimental group; Mandala practice will be done for 2 hours, once a week for 8 weeks.
Primary Outcome Measure Information:
Title
level of quality of life
Description
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)
Time Frame
1 week
Title
level of fatigue
Description
level of fatigue assessed by the Piper Fatigue Scale (min:0, max, 100, higher values means higher fatigue)
Time Frame
1 week
Secondary Outcome Measure Information:
Title
level of alexithymia
Description
level of alexithymia assessed by Toronto Alexythimia Scale (higher values means more alexithymic)
Time Frame
1 week
Title
level of rumination
Description
level of rumination assessed by ruminative thought scale (higher values means more ruminative thought)
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elif Yıldırım Ayaz, M.D.
Phone
+905325148300
Email
drelifyildirim@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif Yıldırım Ayaz, M.D.
Organizational Affiliation
Sultan Abdülhamid Training And Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sultan Abdülhamid Training and Research Hospital
City
Üsküdar
State/Province
İstanbul
ZIP/Postal Code
34660
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elif Yıldırım Ayaz, M.D.
Phone
05325148300
Email
drelifyildirim@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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