The Effect of a Music-Assisted Mandala Intervention on Psychological Well-being and Quality of Life in Cancer Patients Undergoing Chemotherapy

NCT07752667 | Completed

• 1 other identifier: IstanbulMU14
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Cancer is one of the most significant global health issues of our time. Chemotherapy, one of the methods used to treat cancer, not only treats the disease but also causes numerous physiological and psychological side effects that adversely affect quality of life. It has been reported that treatment adherence problems are more common in patients with a high symptom burden associated with these side effects. For this reason, it is crucial that patients have achieved psychological adaptation to their condition and treatment in order for the treatment to be effective, to ensure that toxicity is kept under control, and to ensure that the course of the disease progresses favourably. In cases of illness and failure to adhere to treatment, this can lead to unnecessary visits to the doctor, visits to A\&E, hospitalisation, and an increase in the use of healthcare services and associated costs; it may also result in the development of treatment resistance, an increased burden on patients and carers, disease progression, and even death. Various non-pharmacological approaches, such as exercise, expressing emotions and art therapy, can be used to ensure the patient's adherence to treatment. It has been reported that mandala practice, a form of art therapy, reduces anxiety, fatigue, insomnia and stress. In light of this information, the aim of this study is to assess the effect of mandala practice on psychological adjustment to the disease and treatment, and on quality of life, in cancer patients undergoing chemotherapy.

Conditions

Cancer; Mandala; Quality of Life (QOL); Chemotherapy; Psychological Well-being

Keywords

Cancer; Music; Chemotherapy; Psychological Well-being; Quality of life (QOL); Mandala

Outcome Measures

Primary Outcomes (2)

• Change in the Psychological Impact of Cancer Score, as Measured by the Psychological Impact of Cancer Scale, Compared with the Baseline Value.

  The psychological impact of cancer will be assessed using the Psychological Impact of Cancer Scale. Higher scores indicate a better psychological impact.

  Baseline, Week 4, and Week 8.

• Change in patients' quality of life scores, as measured by the EORTC QLQ-C30, compared with baseline

  Patients' quality of life will be assessed using the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire) scale. Higher scores indicate a higher quality of life.

  Baseline, Week 4, and Week 8

Study Arms (2)

Control

NO INTERVENTION

The control group will complete the Patient Information Form, the EORTC QLQ-C30 and the Psychological Impact of Cancer Scale; no specific intervention will be carried out, and the clinic's standard protocol will be followed.

Mandala Group

EXPERIMENTAL

After watching an instructional video on how to carry out the mandala activity, the patient will complete their first mandala colouring session during the treatment. The patient and their family will then be sent home with a mandala colouring book and coloured pencils to carry out the mandala activity on a weekly basis. The experimental group will repeat the mandala activity once a week for 8 weeks as part of their chemotherapy treatment, with each session lasting 60-90 minutes (a different mandala will be provided each week). They will be able to choose any design and colour they wish from the mandala book. Patients will be advised to listen to classical music during the activity. Patients will be contacted by telephone on a weekly basis to check whether they have carried out the mandala session.

Behavioral: Mandala

Interventions

Mandala BEHAVIORAL

Arm Description: After watching an instructional video on how to carry out the mandala activity, the patient will complete their first mandala colouring session during the treatment. The patient and their family will then be sent home with a mandala colouring book and coloured pencils to carry out the mandala activity on a weekly basis. The experimental group will repeat the mandala activity once a week for 8 weeks as part of their chemotherapy treatment, with each session lasting 60-90 minutes (a different mandala will be provided each week). They will be able to choose any design and colour they wish from the mandala book. Patients will be advised to listen to classical music during the activity. Patients will be contacted by telephone on a weekly basis to check whether they have carried out the mandala session.

Mandala Group

Eligibility Criteria

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

You may qualify if:

• patients who have been diagnosed with cancer,
• aged 18 or over,
• receiving chemotherapy for the first time,
• able to hold a pen,
• agreed to take part in the study

You may not qualify if:

• Decline to participate in the study or do not provide written informed consent.
• Have physical conditions that would prevent participation in the mandala intervention (e.g., severe pain, severe nausea, or severe vomiting).
• Have mental health conditions or cognitive impairment that limit their ability to communicate or participate in the intervention.
• Experience fatigue primarily due to causes other than chemotherapy (e.g., severe anemia with hemoglobin \< 9 g/dL).
• Are unable to hold or use a pen to complete the mandala activity.

Sponsors & Collaborators

• Istanbul Medeniyet University: lead
• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization: collaborator

Study Sites (1)

Cemil Ta

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neoplasms; Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Design

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

Model Details: Following the explanation of the study, patients who gave their verbal and written consent to participate were divided into two groups-the experimental group and the control group-using a randomisation checklist prepared prior to the study. Whilst the intervention group underwent the mandala therapy, the control group was treated according to the clinic's standard protocol.

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: August 7, 2026
• Study Start: December 30, 2024
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: August 7, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)