CancerARQULANCT05344820
The Effect of the Art-based Mandala Intervention on the Quality of Life of Cancer Patients Receiving Chemotherapy
A study testing Art based mandala in people with Cancer and Chemotherapy Effect, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Chemotherapy Effect, Fatigue
- What is being tested?
- Art based mandala
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 May 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sultan Abdülhamid Training and Research Hospital
Üsküdar, Istanbul, 34660
Elif Yıldırım Ayaz, M.D., 05325148300, drelifyildirim@hotmail.com
About this study
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.
Read the 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.
- Conditions
- Cancer, Chemotherapy Effect, Fatigue, Quality of Life, Rumination, Alexithymia
- Being tested
- Art based mandala
- Keywords
- cancer, Chemotherapy Effect, Fatigue, Quality of Life, Rumination, Alexithymia
- Medical subject headings
- Neoplasms, Fatigue, Rumination Syndrome, Affective Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art based mandalaBehavioural
To the experimental group; Mandala practice will be done for 2 hours, once a week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Mandala Intervention | Experimental | To the experimental group; Mandala practice will be done for 2 hours, once a week for 8 weeks. Receives: Behavioral: Art based mandala |
| Control | No intervention | No intervention will be applied to the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 week
level of fatigue
level of fatigue assessed by the Piper Fatigue Scale (min:0, max, 100, higher values means higher fatigue)
Measured: 1 week
Secondary outcomes (2)
level of alexithymia
level of alexithymia assessed by Toronto Alexythimia Scale (higher values means more alexithymic)
Measured: 1 week
level of rumination
level of rumination assessed by ruminative thought scale (higher values means more ruminative thought)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start19 May 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Yıldırım Ayaz, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Investigators
- Elif Yıldırım Ayaz, M.D., Principal investigator, Sultan Abdülhamid Training And Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344820
- Sponsor's protocol ID
- ARQULA
- Acronym
- ARQULA
- Status last verified
- Jun 2022
- First submitted
- 18 Apr 2022
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Art-based Mandala Intervention on the Quality of Life of Cancer Patients Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT05344820
- Acronym / sponsor ID
- ARQULA / ARQULA
- Conditions
- Cancer, Chemotherapy Effect, Fatigue, Quality of Life, Rumination, Alexithymia
- Keywords
- cancer, Chemotherapy Effect, Fatigue, Quality of Life, Rumination, Alexithymia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 19 May 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mandala Intervention | Experimental | Behavioral: Art based mandalaTo the experimental group; Mandala practice will be done for 2 hours, once a week for 8 weeks. |
| Control | No intervention | –No intervention will be applied to the control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Art based mandalaTo the experimental group; Mandala practice will be done for 2 hours, once a week for 8 weeks. | Behavioural | Mandala Intervention |
Primary outcome
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)
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)
2 secondary outcomes
level of alexithymia
Time frame: 1 week
level of rumination
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elif Yıldırım Ayaz, M.D. principal investigator
Sultan Abdülhamid Training And Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Art based mandala in people with Cancer and Chemotherapy Effect, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elif Yıldırım Ayaz, M.D. (+905325148300, drelifyildirim@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of quality of life (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.