Breast CancerNCT07367269
Effect of Mandala Coloring on Anxiety, Distress, and Comfort in Breast Cancer Patients Receiving Outpatient Chemotherapy
A study testing Mandala Coloring in people with Breast Cancer, run by Artvin Coruh University at 1 site in Turkey (Türkiye).
Trial summary
Breast cancer patients receiving chemotherapy often experience psychological distress, anxiety, and discomfort during treatment. Non-drug supportive methods may help improve patients' well-being during chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Mandala Coloring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Jan 2026to 20 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Being 18 years of age or older
- Having a diagnosis of breast cancer and receiving chemotherapy
- Having no communication problems
- Having no physical disability that would prevent mandala coloring
- Being willing to participate in the study
Who cannot join
- not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Artvin State Hospital
Artvin
Efe Hasdemir, MD, 5433750709, emreerkal@hotmail.de
About this study
Official title: The Effect of Mandala Coloring on Psychological Distress, Anxiety, and Comfort in Breast Cancer Patients Receiving Outpatient Chemotherapy
Breast cancer patients receiving chemotherapy often experience psychological distress, anxiety, and discomfort during treatment. Non-drug supportive methods may help improve patients' well-being during chemotherapy.
This study aims to evaluate whether mandala coloring during outpatient chemotherapy can reduce psychological distress and anxiety and improve comfort in breast cancer patients. Participants will be randomly assigned to either a mandala coloring group or a routine care group. Patients in the intervention group will color mandala patterns for 30 minutes during their chemotherapy session, while the control group will receive routine care only.
Psychological distress, anxiety, and comfort levels will be measured before and after the chemotherapy session in both groups. The results of this study may provide evidence for a simple and low-cost supportive intervention to improve the psychological well-being of breast cancer patients during chemotherapy.
Read the detailed description
Breast cancer is one of the most common malignancies among women and chemotherapy is a fundamental component of its treatment. However, chemotherapy is frequently associated with psychological distress, anxiety, and decreased comfort, which may negatively affect patients' quality of life and treatment adherence. Supportive non-pharmacological interventions that are easy to apply during chemotherapy are therefore needed.
Mandala coloring is a complementary approach that has been reported to reduce anxiety and psychological distress and improve well-being in patients with cancer. Nevertheless, evidence regarding its effectiveness during outpatient chemotherapy sessions remains limited. This study is designed to evaluate the effect of mandala coloring applied during outpatient chemotherapy on psychological distress, anxiety, and comfort in breast cancer patients.
This study is a randomized controlled experimental trial that will be conducted in the Chemotherapy Unit of Artvin State Hospital. A total of 60 breast cancer patients receiving outpatient chemotherapy will be recruited. Participants will be randomly assigned in a 1:1 ratio to either an intervention group (mandala coloring) or a control group (routine care). Block randomization with allocation concealment using sequentially numbered opaque sealed envelopes will be used.
Patients in the intervention group will perform mandala coloring for 30 minutes starting at the beginning of their chemotherapy session. They will be provided with mandala coloring books and colored pencils and will continue to receive routine medical care during the session. Patients in the control group will receive routine care only, without any coloring activity.
Psychological distress, anxiety, and comfort will be assessed before and after the chemotherapy session in both groups. Distress will be measured using the Distress Thermometer. Anxiety will be evaluated using the State Anxiety subscale of the State-Trait Anxiety Inventory. Comfort will be assessed using the General Comfort Scale. Pre-test and post-test measurements will be compared between groups to determine the effect of the mandala coloring intervention.
The findings of this study may contribute evidence for a simple, low-cost, and easily applicable supportive intervention to improve psychological well-being and comfort in breast cancer patients undergoing outpatient chemotherapy.
- Conditions
- Breast Cancer
- Being tested
- Mandala Coloring
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandala ColoringBehavioural
Mandala coloring activity performed for 30 minutes during outpatient chemotherapy using mandala coloring books and colored pencils.
| Study group | Role | What they receive |
|---|---|---|
| Mandala Coloring Group | Experimental | Participants will perform mandala coloring for 30 minutes during outpatient chemotherapy in addition to routine care. Receives: Behavioral: Mandala Coloring |
| Control group | No intervention | Participants will receive routine outpatient chemotherapy care without any additional activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological Distress
Psychological distress will be measured using the Distress Thermometer. Participants rate their level of distress on a scale from 0 (no distress) to 10 (extreme distress). Higher scores indicate greater psychological distress.
Measured: Before chemotherapy session and immediately after the chemotherapy session (single session).
Secondary outcomes (2)
Anxiety
Anxiety will be measured using the State Anxiety subscale of the State-Trait Anxiety Inventory (STAI-S). Scores range from 20 to 80, with higher scores indicating higher levels of anxiety.
Measured: Before chemotherapy session and immediately after the chemotherapy session (single session).
Comfort
Comfort will be measured using the General Comfort Scale. Scores range from 1 to 4, with higher scores indicating higher levels of comfort.
Measured: Before chemotherapy session and immediately after the chemotherapy session (single session).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start27 Jan 2026
- Primary completion20 Jan 2027 (estimated)
- Study completion20 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Artvin Coruh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EMRE ERKAL, Artvin Coruh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367269
- Sponsor's protocol ID
- MANDALA-BC-CHEMO-01
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
[1] Winters S, Martin C, Murphy D, Shokar NK. Breast Cancer Epidemiology, Prevention, and Screening. Prog Mol Biol Transl Sci 2017;151: 1-32. [2] El Masri J, Phadke S. Breast Cancer Epidemiology and Contemporary Breast Cancer Care: A Review of the Literature and Clinical Applications. Clin Obstet Gynecol 2022;65: 461-481. [3] Xiong X, Zheng LW, Ding Y, Chen YF, Cai YW, Wang LP, Huang L, Liu CC, Shao ZM, Yu KD. Breast cancer: pathogenesis and treatments. Signal Transduct Target Ther 2025;10: 49. [4] Wang J, Wu SG. Breast Cancer: An Overview of Current Therapeutic Strategies, Challenge, and Perspectives. Breast Cancer (Dove Med Press) 2023;15: 721-730. [5] Bourdeanu L, Liu EA. Systemic Treatment for Breast Cancer: Chemotherapy and Biotherapy Agents. Seminars in Oncology Nursing 2015;31: 156-162. [6] Phongnopakoon P, Kongvattananon P, Somprasert C. Nursing Outcomes of Patient's Comfort during Neoplastic Chemotherapy: An Integrative Review. The Bangkok Medical Journal 2018;14: 115. [7] Oh P-J, Cho J-R. Changes in fatigue, psychological distress, and quality of life after chemotherapy in women with breast cancer: a prospective study. Cancer nursing 2020;43: E54-E60. [8] Burrai F, Sguanci M, Petrucci G, De Marinis MG, Piredda M. Effectiveness of immersive virtual reality on anxiety, fatigue and pain in patients with cancer undergoing chemotherapy: A systematic review and meta-analysis. European Journal of Oncology Nursing 2023;64: 102340. [9] Hormozi M, Hashemi SM, Shahraki S. Investigating Relationship between Pre- and Post- Chemotherapy Cognitive Performance with Levels of Depression and Anxiety in Breast Cancer Patients: A Cross-Sectional Study. Asian Pac J Cancer Prev 2019;20: 3831-3837. [10] Guo Y-Q, Ju Q-M, You M, Liu Y, Yusuf A, Soon LK. Depression, anxiety and stress among metastatic breast cancer patients on chemotherapy in China. BMC nursing 2023;22: 33. [11] Li YC, Ma SC, Wang HH. Emotional Distress in Patients With Cancer: A Cross-Sectional Study. J Nurs Res 2
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mandala Coloring on Psychological Distress, Anxiety, and Comfort in Breast Cancer Patients Receiving Outpatient Chemotherapy
- ClinicalTrials.gov ID
- NCT07367269
- Acronym / sponsor ID
- MANDALA-BC-CHEMO-01
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Artvin Coruh UniversityUniversity, hospital or other
- Study start
- 27 Jan 2026 (actual)
- Primary completion
- 20 Jan 2027 (estimated)
- Study completion
- 20 Jan 2027 (estimated)
- First posted
- 26 Jan 2026 (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.
Breast cancer patients receiving chemotherapy often experience psychological distress, anxiety, and discomfort during treatment. Non-drug supportive methods may help improve patients' well-being during chemotherapy.
This study aims to evaluate whether mandala coloring during outpatient chemotherapy can reduce psychological distress and anxiety and improve comfort in breast cancer patients. Participants will be randomly assigned to either a mandala coloring group or a routine care group. Patients in the intervention group will color mandala patterns for 30 minutes during their chemotherapy session, while the control group will receive routine care only.
Psychological distress, anxiety, and comfort levels will be measured before and after the chemotherapy session in both groups. The results of this study may provide evidence for a simple and low-cost supportive intervention to improve the psychological well-being of breast cancer patients during chemotherapy.
Detailed description
Breast cancer is one of the most common malignancies among women and chemotherapy is a fundamental component of its treatment. However, chemotherapy is frequently associated with psychological distress, anxiety, and decreased comfort, which may negatively affect patients' quality of life and treatment adherence. Supportive non-pharmacological interventions that are easy to apply during chemotherapy are therefore needed.
Mandala coloring is a complementary approach that has been reported to reduce anxiety and psychological distress and improve well-being in patients with cancer. Nevertheless, evidence regarding its effectiveness during outpatient chemotherapy sessions remains limited. This study is designed to evaluate the effect of mandala coloring applied during outpatient chemotherapy on psychological distress, anxiety, and comfort in breast cancer patients.
This study is a randomized controlled experimental trial that will be conducted in the Chemotherapy Unit of Artvin State Hospital. A total of 60 breast cancer patients receiving outpatient chemotherapy will be recruited. Participants will be randomly assigned in a 1:1 ratio to either an intervention group (mandala coloring) or a control group (routine care). Block randomization with allocation concealment using sequentially numbered opaque sealed envelopes will be used.
Patients in the intervention group will perform mandala coloring for 30 minutes starting at the beginning of their chemotherapy session. They will be provided with mandala coloring books and colored pencils and will continue to receive routine medical care during the session. Patients in the control group will receive routine care only, without any coloring activity.
Psychological distress, anxiety, and comfort will be assessed before and after the chemotherapy session in both groups. Distress will be measured using the Distress Thermometer. Anxiety will be evaluated using the State Anxiety subscale of the State-Trait Anxiety Inventory. Comfort will be assessed using the General Comfort Scale. Pre-test and post-test measurements will be compared between groups to determine the effect of the mandala coloring intervention.
The findings of this study may contribute evidence for a simple, low-cost, and easily applicable supportive intervention to improve psychological well-being and comfort in breast cancer patients undergoing outpatient chemotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mandala Coloring Group | Experimental | Behavioral: Mandala ColoringParticipants will perform mandala coloring for 30 minutes during outpatient chemotherapy in addition to routine care. |
| Control group | No intervention | –Participants will receive routine outpatient chemotherapy care without any additional activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being 18 years of age or older
- Having a diagnosis of breast cancer and receiving chemotherapy
- Having no communication problems
- Having no physical disability that would prevent mandala coloring
- Being willing to participate in the study
Key exclusion criteria (1 listed)
- not meeting inclusion criteria
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 |
|---|---|---|
| Mandala ColoringMandala coloring activity performed for 30 minutes during outpatient chemotherapy using mandala coloring books and colored pencils. | Behavioural | Mandala Coloring Group |
Primary outcome
Psychological Distress
Time frame: Before chemotherapy session and immediately after the chemotherapy session (single session).
Psychological distress will be measured using the Distress Thermometer. Participants rate their level of distress on a scale from 0 (no distress) to 10 (extreme distress). Higher scores indicate greater psychological distress.
2 secondary outcomes
Anxiety
Time frame: Before chemotherapy session and immediately after the chemotherapy session (single session).
Comfort
Time frame: Before chemotherapy session and immediately after the chemotherapy session (single session).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Results publication[1] Winters S, Martin C, Murphy D, Shokar NK. Breast Cancer Epidemiology, Prevention, and Screening. Prog Mol Biol Transl Sci 2017;151: 1-32. [2] El Masri J, Phadke S. Breast Cancer Epidemiology and Contemporary Breast Cancer Care: A Review of the Literature and Clinical Applications. Clin Obstet Gynecol 2022;65: 461-481. [3] Xiong X, Zheng LW, Ding Y, Chen YF, Cai YW, Wang LP, Huang L, Liu CC, Shao ZM, Yu KD. Breast cancer: pathogenesis and treatments. Signal Transduct Target Ther 2025;10: 49. [4] Wang J, Wu SG. Breast Cancer: An Overview of Current Therapeutic Strategies, Challenge, and Perspectives. Breast Cancer (Dove Med Press) 2023;15: 721-730. [5] Bourdeanu L, Liu EA. Systemic Treatment for Breast Cancer: Chemotherapy and Biotherapy Agents. Seminars in Oncology Nursing 2015;31: 156-162. [6] Phongnopakoon P, Kongvattananon P, Somprasert C. Nursing Outcomes of Patient's Comfort during Neoplastic Chemotherapy: An Integrative Review. The Bangkok Medical Journal 2018;14: 115. [7] Oh P-J, Cho J-R. Changes in fatigue, psychological distress, and quality of life after chemotherapy in women with breast cancer: a prospective study. Cancer nursing 2020;43: E54-E60. [8] Burrai F, Sguanci M, Petrucci G, De Marinis MG, Piredda M. Effectiveness of immersive virtual reality on anxiety, fatigue and pain in patients with cancer undergoing chemotherapy: A systematic review and meta-analysis. European Journal of Oncology Nursing 2023;64: 102340. [9] Hormozi M, Hashemi SM, Shahraki S. Investigating Relationship between Pre- and Post- Chemotherapy Cognitive Performance with Levels of Depression and Anxiety in Breast Cancer Patients: A Cross-Sectional Study. Asian Pac J Cancer Prev 2019;20: 3831-3837. [10] Guo Y-Q, Ju Q-M, You M, Liu Y, Yusuf A, Soon LK. Depression, anxiety and stress among metastatic breast cancer patients on chemotherapy in China. BMC nursing 2023;22: 33. [11] Li YC, Ma SC, Wang HH. Emotional Distress in Patients With Cancer: A Cross-Sectional Study. J Nurs Res 2
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandala Coloring in people with Breast Cancer, run by Artvin Coruh University 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 5 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 3 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Efe Hasdemir Efe Hasdemir, MD (+90 5433750709, hasdemir52@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological Distress (time frame: Before chemotherapy session and immediately after the chemotherapy session (single session).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07367269, which also lists 1 linked publication.
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 3 Feb 2026.