The Effect of the Art-based Mandala Intervention on the Quality of Life of Cancer Patients Receiving Chemotherapy
ARQULA
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cancer
Started May 2022
Shorter than P25 for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2022
CompletedFirst Posted
Study publicly available on registry
April 25, 2022
CompletedStudy Start
First participant enrolled
May 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedJune 22, 2022
June 1, 2022
8 months
April 18, 2022
June 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
level of alexithymia
1 week
level of rumination
1 week
Study Arms (2)
Mandala Intervention
EXPERIMENTALTo the experimental group; Mandala practice will be done for 2 hours, once a week for 8 weeks.
Control
NO INTERVENTIONNo intervention will be applied to the control group
Interventions
To the experimental group; Mandala practice will be done for 2 hours, once a week for 8 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sultan Abdülhamid Training and Research Hospital
Üsküdar, Istanbul, 34660, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elif Yıldırım Ayaz, M.D.
Sultan Abdülhamid Training And Research Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 18, 2022
First Posted
April 25, 2022
Study Start
May 19, 2022
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
June 22, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share