Receptive Music Therapy Effects on Anxiety, Depression, QoL, and EGF, IL-8, and NfL During the Breast Cancer Treatment.

Summary

The goal of this clinical study is to investigate whether receptive music therapy can help women with breast cancer by reducing anxiety and depression symptoms, improving quality of life, and influencing specific analytes in plasma, including epidermal growth factor (EGF), interleukin-8 (IL-8), and neurofilament light chain (NfL).

Main Questions the Study Aims to Answer:

GENERAL OBJECTIVE:

To investigate the effect of receptive music therapy on anxiety and depression symptoms, quality of life, and the levels of epidermal growth factor, interleukin-8, and neurofilament light chain in plasma during treatment in women with breast cancer.

SPECIFIC OBJECTIVES:

* To determine whether there is a correlation between the levels of epidermal growth factor, interleukin-8, and neurofilament light chain in plasma and the severity of anxiety and depression symptoms.
* To determine whether there is a correlation between the severity of anxiety and depression symptoms and quality of life.

Participants will be randomly assigned to either a music group or a control group.

The study will take place during the perioperative period and chemotherapy (in participants for whom chemotherapy will be indicated).

At two (perioperative) or three (+ chemotherapy) time points, participants will:

* Undergo assessments for anxiety, depression, and quality of life
* Provide blood samples for analytes analysis (EGF, IL-8, NfL)
* Receive music therapy sessions (for those in the intervention group)

The scientific contribution of this study lies in understanding the relationship between the application of receptive music therapy and the plasma levels of epidermal growth factor, interleukin-8, and neurofilament light chain in women with breast cancer during the perioperative period and chemotherapy, as well as its association with the occurrence of pronounced anxiety and depression symptoms related to the malignant process. This study represents the first application of such research in this patient population and serves as a foundation for the future implementation of receptive music therapy in the complementary treatment of breast cancer.

Conditions

• Breast Cancer Invasive
• Chemotherapy
• Breast Cancer Surgery
• Breast Cancer
• Positive Axillary Lymph Node

Interventions

OTHER

Music intervention

The protocol for the application of receptive music therapy in the intervention group will involve listening to music using a music playback device and headphones. Receptive music therapy will be applied twice daily for 30 minutes during the 3-day hospitalization period (in the morning and evening), and for 1 hour during the first three weeks of chemotherapy. The selection of music will be made by the researcher. Classical instrumental music pieces will be chosen based on musical components such as melody, harmony, tempo, rhythm, timbre, intensity, choice of instrument(s), and orchestration. Considering the study's hypothesis and objectives, which focus on inducing changes in symptoms of anxiety and depression under the influence of music therapy and consequently achieving relaxation in affected women, the music used will have a slow to moderate tempo (60-80 beats per minute), with continuous rhythmic patterns without significant tempo fluctuations and gentle melodic line development.

Sponsors & Collaborators

• Brigita Vilc

  lead OTHER

Principal Investigators

• Marina Šagud, PhD, MD · Clinical Hospital Centre Zagreb

• Goran Šimić, PhD, MD · Croatian Institute for Brain Research, University of Zagreb School of Medicine

• Ivan Milas, PhD, MD · University Hospital for Tumors, Sestre milosrdnice University Hospital Center Zagreb, Croatia

• Brigita Vilč, Master's Degree, PhD Candidate · University of Zagreb, Faculty of Education and Rehabilitation Sciences

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-01

Primary Completion

2025-09-15

Completion

2026-06-30

Countries

• Croatia

Study Locations