Effect of Mandala Coloring on Anxiety, Distress, and Comfort in Breast Cancer Patients Receiving Outpatient Chemotherapy

NCT07367269 | Recruiting

• 1 other identifier: MANDALA-BC-CHEMO-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Before chemotherapy session and immediately after the chemotherapy session (single session).

Secondary Outcomes (2)

• Anxiety

  Before chemotherapy session and immediately after the chemotherapy session (single session).

• Comfort

  Before chemotherapy session and immediately after the chemotherapy session (single session).

Study Arms (2)

Mandala Coloring Group

EXPERIMENTAL

Participants will perform mandala coloring for 30 minutes during outpatient chemotherapy in addition to routine care.

Behavioral: Mandala Coloring

Control group

NO INTERVENTION

Participants will receive routine outpatient chemotherapy care without any additional activity.

Interventions

Mandala Coloring BEHAVIORAL

Mandala coloring activity performed for 30 minutes during outpatient chemotherapy using mandala coloring books and colored pencils.

Mandala Coloring Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Artvin Coruh University: lead

Study Sites (1)

Artvin State Hospital

Artvin, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• [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

  RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Efe Hasdemir Efe Hasdemir, MD

CONTACT

+90 5433750709; hasdemir52@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: January 26, 2026
• Study Start: January 27, 2026
• Primary Completion (Estimated): January 20, 2027
• Study Completion (Estimated): January 20, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)