MUSIC
INTERVENTIONS ON CANCER-RELATED FATIGUE DURING CHEMOTHERAPY: MUSIC FOR
ALLEVIATING SYMPTOMS (MUSAS) TRIAL RATIONALE AND PROTOCOL
INTERVENÇÕES
MUSICAIS NA FADIGA RELACIONADA AO CÂNCER NA QUIMIOTERAPIA: RACIOCÍNIO E
PROTOCOLO DO ESTUDO MÚSICA NO ALÍVIO DE SINTOMAS (MUSAS)
Camila
Siqueira Gouvêa Acosta Gonçalves
Paula Karina
Hembecker
Thais Abreu de
Almeida
Willian
Felipe Hadiak Amalio de Souza
Percy
Nohama
Audrey
Tieko Tsunoda
ABSTRACT
Background: Cancer-related
fatigue is the most reported symptom of cancer treatment, especially
chemotherapy, and is associated with psychological symptoms.
Non-pharmacological interventions are recommended for symptom management,
including music-based interventions. Methods: The proposed Music for
Alleviating Symptoms (MusAS) study is a single-center, non-blind, randomized
controlled trial with three parallel arms (two experimental and one control,
with usual care) to verify the efficacy of distinct music listening approaches
for diminishing adverse events during chemotherapy. A sample of 25 participants
per group will be recruited, including women with breast cancer in stages 1 to
3 at a Brazilian oncologic referral hospital. The Music Therapy group will have
an individualized interview with a music therapist, who will tailor a
personalized playlist to each participant, whereas the Music Medicine group
will listen to a standard playlist. The primary outcome is cancer-related
fatigue (FACT-F), and the secondary outcomes are health-related quality of life
(FACT-G), adverse events, (PRO-CTCAE), anxiety and depression symptoms (HADS),
mood (VAMS), and the biological markers of inflammation (CRP, IL-6, IL-10, and
Interferon-gamma). Results: The results will inform the potential
integration of music-based interventions in clinical practice for managing
cancer-related fatigue and other associated symptoms. Conclusions: The
strengths of MusAS are the inclusion of a homogeneous population and the
incorporation of biomarkers as an objective measure. To our knowledge,
this is the first 3-arm trial with music in oncology from Latin America. It is
registered in the Brazilian Register of Clinical Trials
(ensaiosclinicos.gov.br), code RBR-68w9xsy.
Keywords: Breast cancer.
Emotional distress. Music therapy. Biomarkers. Adverse drug reactions.
RESUMO
Contexto: A fadiga relacionada
ao câncer é o sintoma mais relatado do tratamento, especialmente na
quimioterapia, associada a sintomas psicológicos. Intervenções não
farmacológicas são recomendadas para manejar sintomas, incluindo intervenções
baseadas em música. Método: O proposto estudo Música no Alívio de
Sintomas (MusAS) é um estudo controlado, randomizado, não cego, de centro
único, com três braços paralelos (dois experimentais e um controle, de
tratamento padrão) para verificar a eficácia de abordagens distintas de audição
musical para diminuir as reações adversas na quimioterapia. Será recrutada uma
amostra de 25 participantes por grupo, mulheres com câncer de mama nos estágios
1 a 3 em um hospital oncológico brasileiro de referência. O grupo Musicoterapia
terá entrevista individualizada com musicoterapeuta, que customizará uma playlist
personalizada para cada participante, enquanto o grupo Música e Medicina escutará
uma playlist padronizada. O desfecho primário é fadiga relacionada ao
câncer (FACT-F), e os secundários são qualidade de vida relacionada à saúde
(FACT-G), reações adversas (PRO-CTCAE), sintomas de ansiedade e depressão
(HADS), estados de humor (VAMS) e marcadores biológicos de inflamação (CRP,
IL-6, IL-10 e Interferon-gama). Resultados: Os resultados informarão a
possível integração de intervenções baseadas em música na prática clínica para manejar
a fadiga relacionada ao câncer e outros sintomas. Conclusão: Pontos
fortes são a inclusão de uma população homogênea e a incorporação de
biomarcadores como medida objetiva. Até onde sabemos, esse é o primeiro estudo
de três braços com música na oncologia da América Latina. Ele está registrado
no Registro Brasileiro de Ensaios Clínicos (ensaiosclinicos.gov.br), código RBR-68w9xsy.
Palavras-chave: Câncer de mama.
Estresse emocional. Musicoterapia. Biomarcadores. Reações adversas.
BACKGROUND
Breast cancer is the most diagnosed cancer
worldwide and the leading cause of cancer death among women (Sung et al.,
2021). In Brazil, the National Institute of Cancer estimates there will be
74,000 new breast cancer cases in women for the three-year period 2023-2025 (INCA,
2022). Despite the safety and efficacy of current treatment options, patients
often experience long-lasting physical, physiological, and psychological
symptoms post-treatment (So et al., 2021).
CRF, a multidimensional symptom encompassing
physical, cognitive, social, and emotional components, is the most reported
adverse effect of cancer treatment (Berger et al., 2015). Defined as a
persistent feeling of tiredness not proportional to recent activity and
impacting functionality, CRF is particularly linked to chemotherapy in breast
cancer patients and is associated with emotional symptoms like depression and
anxiety (Berger et al., 2015; Kuhnt et al., 2019). This underscores the need
for non-pharmacological interventions to mitigate fatigue and related
psychological symptoms during cancer care (Berger et al., 2015; Sleight et al.,
2022).
Music-based interventions have been
implemented in oncology for various outcomes across different types of cancer
treatment modalities and settings (Bradt et al., 2021; Nguyen et al., 2022; Qi et
al., 2021). These interventions fall into two main categories: Music Therapy
(MT) and Music Medicine (MM). MM involves healthcare personnel using
pre-selected recorded music to assist patients during medical procedures, while
MT involves a trained therapist providing a wider range of music-based
interventions tailored to the patient's preferences and needs informed by an
assessment, treatment and evaluation process within a therapeutic relationship
(Bradt et al., 2021; Wheeler et al., 2019).
The latest Cochrane review with
meta-analyses showed a small effect of music interventions on fatigue, with low
certainty evidence (SMD −0.28, 95% CI −0.46 to −0.10, P =
0.002) (Bradt et al., 2021). Sensitivity analysis revealed evidence of effect
for MT (SMD −0.36, 95% CI −0.61 to −0.12, P = 0.004, I2 =
0%), but not for MM (Bradt et al., 2021). However, trials were heterogeneous in
terms of cancer type, stage, and treatment modality.
Regarding the chemotherapy treatment, Nguyen
et al. (2022) pooled the results from nine trials on music interventions in
chemotherapy, finding a medium-size effect on anxiety (SMD: −0.29, 95%
CI−0.50 to−0.08, p=0.006, I 2=62%) and no significant effect for
depression. Although Qi et al. (2021) found a significant effect of music
interventions on CRF in a meta-analysis (SMD −0.88, 95% CI −1.49 to
−0.26, P = 0.005), their sensitivity analysis involving women with breast
cancer did not find evidence of effect.
Given the association of CRF and emotional
symptoms with chemotherapy (Berger et al., 2015; Sleight et al., 2022),
non-pharmacological interventions are essential to alleviate the adverse
effects of cancer treatment (Berger et al., 2015). Although music-based
interventions have shown promise, the heterogeneity of samples and the limited
number of trials, specifically during chemotherapy, highlight the need for
further research. To our knowledge, no trials have investigated CRF outcomes
using multiple music intervention groups.
Therefore, the Music for Alleviating
Symptoms (MusAS) trial aims to assess the efficacy of music listening during
chemotherapy for CRF in two experimental groups and one control group. The
first group will use a personalized playlist tailored by a music therapist (MT
group); the second group will use a standard playlist (MM group); and the third
group will be a wait-list control group receiving usual care.
This manuscript proposes the rationale and
methods of the MusAS study, based on the Reporting Guidelines for Music-based
Interventions (Robb et al., 2010) and on the Standard Protocol Items:
Recommendations for Intervention Trials (SPIRIT) by Chan et al. (2013).
CONCEPTUAL FRAMEWORK
This study is informed by the 3-P
conceptual model for CRF, which identifies predisposing, precipitating, and
perpetuating factors for this symptom (Sleight et al., 2022). Poor quality of
sleep, pain, depression, and neuroticism are considered predisposing factors
for CRF, chemotherapy and inflammation are amongst precipitating factors, and poor
nutrition and sedentarism are perpetuating factors (Sleight et al., 2022). For
minimizing CRF during oncologic treatment, therapies focusing on the patient’s
sense of self-efficacy are recommended (Sleight et al., 2022).
Enhancing self-efficacy reduces fatigue,
depression, and anxiety in oncologic patients (Merluzzi et al., 2019).
Additionally, preferred music listening is related to reduced stress (Burns et
al., 2018), improved pain control (Linnemann et al., 2015) and to analgesia due
to perceived choice (Howlin et al., 2022).
Furthermore, music stimulates the reward
system, reducing psychophysiological symptoms (Chen et al., 2020). Whether as a
distraction, a comfort, or a pleasant stimulus, preferred music listening can
offer safety and predictability to oncologic patients (Bradt et al., 2014). So,
music listening can enhance agency and sense of control for the MT group or
provide relaxation and distraction for the MM group, aiding symptom management
(Nguyen et al., 2022).
Design and Setting
MusAS is a single-site, three-arm,
randomized controlled trial at Erasto Gaertner Hospital, a referral oncologic
center in the city of Curitiba, Brazil. The hospital treats 75% of cases from
the Brazilian unified health system annually (LPCC, 2022). The chemotherapy
unit consists of five rooms with around 5 to six armchairs each, organized by
the infusion duration. Breast cancer patients usually have their chemotherapy
in the fast chemo room, with their procedures lasting from one and a half to
two hours.
Ethics
This study received approval
from the Institutional Ethics and Research Review Commission for human
participant research under the number 62711822.4.0000.0098. The trial is also
registered at the ReBEC portal, the Brazilian Register of Clinical Trials
(ensaiosclinicos.gov.br), under the code RBR-68w9xsy.
Patient Population
Eligible participants are women aged 18 or
over, diagnosed with initial or locally advanced breast cancer, and referred to
chemotherapy. They must have adequate hearing and cognitive function to
understand the study's aims and interact with auditory stimuli. Exclusion
criteria include undergoing palliative care treatment, having a treatment plan
of fewer than six total cycles of chemotherapy, or having significant
comorbidities that would limit participation in the study (such as psychotic
episodes or severe intellectual disability).
Sample Size Calculation
The sample size was determined using
G*Power 3.1.9.7, considering repeated measures ANOVA design with three groups
and three time points (baseline, post-intervention, and follow-up). The
calculation was guided by previous studies on music interventions in oncology,
particularly Lima et al. (2020), which evaluated the impact of music listening
on quality of life, anxiety, and depression in breast cancer patients
undergoing chemotherapy.
Although Lima et al. (2020) did not
explicitly report the effect size, we estimated Cohen’s d = 0.81 based on their
reported means and standard deviations. Given this evidence, we set f = 0.35
for the power calculation. Using α = 0.05 and 80% power, the G*Power
analysis recommended a minimum of 21 participants per group (total N = 63). To
account for potential dropout and variability in real-world clinical settings,
we increased the sample size to 25 participants per group (total N = 75),
ensuring robustness while maintaining feasibility within the study constraints.
Randomization and Stratification
Patients will be randomized in a 1:1:1 ratio
to a MT intervention group, a MM intervention group, and a usual care group,
using block randomization. Randomization will be conducted using the website
Randomizer (randomizer.org). For allocation concealment purposes, the
randomized sequence will be with a MusAS researcher not involved in data
collection – immediately contacted upon recruitment.
The sample will be is stratified into four
groups: starting neoadjuvant chemotherapy (before surgery and 0 to 3
chemotherapy sessions completed), middle or end of neoadjuvant chemotherapy
(before surgery and four or more chemotherapy sessions completed), starting
adjuvant chemotherapy (after surgery and 0 to 3 chemotherapy sessions
completed), and middle or end of adjuvant chemotherapy (after surgery and four
or more chemotherapy sessions completed).
Data Collection
Data will be collected at three times. Time
one (T1) will be recruitment, baseline assessments, randomization, and MT
interview (for the MT group).
Time two (T2) will occur within 2 to 7 days
after T1, in the participant’s scheduled chemotherapy. Participants of
experimental groups will receive their assigned playlist, a hardcopy list of
the tunes’ titles and composers, will use headphones, and will receive
instructions to skip, repeat, or change tunes, and to adjust the volume. Mood
scales will be used for pre and post-intervention assessments. The Control
group will be assessed with the same scales within a 45-minute interval during
chemotherapy.
Time three (T3) will occur within 7 to 21
days after T2, before or after the participant’s scheduled oncology
consultation or blood sample collection – usually 2 to 7 days before their next
chemotherapy session. Participants will be assessed with the same measures as baseline
assessments and will be given space for questions and orientations, such as on
external and free MT services for continued treatment. The Control group will
also receive the standard playlist to listen to during their next chemotherapy
session if they wish.
The Table 1 shows the data collection
summary of the MusAS trial.
Music Therapy Intervention Rationale
The MT arm will involve a personalized
playlist tailored by a music therapist after an assessment interview with each
participant. The rationale for this intervention is based on participant-led,
meaningful stimuli to elicit positive feelings (Burns et al., 2018; Chanda
& Levitin, 2013). Furthermore, the MT interview is intended to provide the
participant with a sense of control and personal agency (Burns et al., 2018;
Merluzzi et al., 2019) and allows the music therapist to understand the
emotional characteristics of the music according to the participant’s criteria
(Rossetti, 2014). Building trust during the interview may help participants
focus more on the musical materials (Witte et al., 2021), leading to more
positive responses.
Music Therapy Intervention Description
Participants in the MT group will complete
the Music Profile Assessment form, which includes questions about musical
background, preferences, and dislikes, as well as the functions and uses of
music in their daily lives. This form was specifically created for this trial,
based on existing music background questionnaires (Hanser & Mandel, 2010;
Meadows et al., 2015; Magee et al., 2023).
Following this, participants will be
interviewed by a music therapist. The interview will explore the participant’s
relationship with music, positive memories associated with favorite tunes, and
interpersonal relationships linked to musical materials. The therapist will
also discuss how the participant copes with the treatment, and their
expectations for the “chemotherapy with music” day. This interview aims to
build a positive therapeutic relationship and trust, which can contribute to
positive emotional changes (Witte et al., 2021).
The music therapist will ask about the
participant’s goals for the music playlist and listen to their preferences and
symbolic associations. The participant will be asked to suggest a title for the
playlist. This process provides opportunities for decision-making and control,
enhancing the participant’s sense of self-efficacy and agency, which are
protective factors against cancer-related fatigue (Sleight et al., 2022; Witte et
al., 2021).
The music therapist will also provide
orientations on how the participant can listen to the personalized playlist
during her chemotherapy. The professional may give instructions on breathing
with the music, reading or remembering the lyrics, imagining a safe and calm
place, etc., according to the participant’s goals. These orientations are based
on Burns et al. (2008) study, where the music therapist added an educational
component for music imagery and relaxation for participants undergoing
chemotherapy.
The music therapist will then select music
from the participant’s preferences and data from the MT interview for a
45-minute collection. The selection will use The Music Characterization System
(Rossetti, 2014), considering the arousal-valence model (Vuilleumier &
Trost, 2015) and the participant’s goals. The music therapist will select the
tunes according to their salience for the participant and determine the degree
of relaxation-activation for each tune according to their music elements, as
Rossetti (2014) recommended. The professional will arrange the tunes so the
ones with more activation components start, gradually moving to the ones with
more relaxation components and progressively moving to the ones with activation
components.
The music therapist will also prepare a
letter for each participant, listing the titles and artists of each tune and
providing personalized listening recommendations. This strategy targets the
participant’s goals and choices to enhance their self-efficacy during treatment
(Merluzzi et al., 2019).
Music Medicine Intervention Rationale
The rationale for the MM arm is based on
music as distractive and relaxing stimuli for managing pain and stress (Huang
& Huang, 2023). Soft music with low arousal is recommended for symptom
relief (Chanda & Levitin, 2013; Linnemann et al., 2015).
Previous reviews have shown that
pre-selected music provides more benefits for symptom management, such as
reduced anxiety, than participant-selected (Nguyen et al., 2022). So, a
standard playlist was chosen for relaxation and distraction, replicating
stimuli from other MM studies (Bulfone et al., 2009; Lima et al., 2020).
Music Medicine Intervention Description
The playlist consists of a 45-min music
selection of nine tunes from previous studies with similar population and
settings (Bulfone et al., 2009; Lima et al., 2020). The titles are: “Suite from
the Man Who Planted Trees” (Paul Winter Consort); “Nature’s Harmony Just Before
DayBreak” (Glorious Sunrise); “Small Steps to the Moon” (Cecilia Chailly); “Far
Away” (Yiruma); “River Flows in You” (Yiruma); “Heart” (Yiruma); “Hello /
Lacrimosa” (The Piano Guys); “In the Arms of the Angel” (Sarah McLachlan); and
“An Ocean of Memories” (Jamos Horner).
Interventionists and Treatment Fidelity
The MusAS trial has a team of eight
researchers for data collection, including four undergraduate medicine
students, one physiotherapist graduate student, one statistician, and two music
therapists with over 15 years of experience. One of the music therapists, who
holds a bachelor's degree in MT, a master's degree in Creative Arts Therapy -
Music, and is a doctorate scholar, will conduct the interviews and tailor the
playlists for the MT group. To ensure treatment fidelity, she will train the
entire team through meetings, videos, written materials, and ongoing onsite
supervision. Furthermore, interventions will be discontinued upon participant’s
request at any given time.
Efficacy Outcomes and Measures
Despite the challenges subjective measures
may have in their validation processes (Sijtsma, 2009), our team determined the
scales based on recommended guidelines (Bower et al., 2024; Fabi et al., 2020),
their application length, their previous implementation in music-based trials
in oncology (Bradt et al., 2021) and their routine use in the research site.
Additionally, MusAS trial includes objective measures (biomarkers). They are
presented as follows.
Primary Outcome
The primary efficacy outcome of the MusAS
trial is the change in cancer-related fatigue, measured by the Functional
Assessment of Cancer Therapy-Fatigue scale (FACT-F) at baseline versus 7 to 21
days after one chemotherapy session across the three groups. The FACT-F is a
tool with excellent psychometric properties (Seyidova-Khoshknabi et al., 2011),
recommended by Oncology societies (Bower et al., 2024; Fabi et al., 2020),
validated in Brazilian Portuguese (Ishikawa et al., 2010) and previously used
in a Brazilian cohort (Alcântara-Silva et al., 2018). Fatigue was determined as
the primary endpoint due to its high prevalence as a symptom from oncologic
treatment (Berger et al., 2015).
Secondary Outcomes
Secondary efficacy outcomes of the MusAS
trial include health related quality of life, symptoms of anxiety and
depression, adverse effects from chemotherapy, biomarkers of inflammation, and
mood states.
Health-Related Quality of Life is measured
by the Functional Assessment of Cancer Therapy – General (FACT-G), a validated
assessment with good responsiveness (Luckett et al., 2010), with a Brazilian
Portuguese validated version (Ishikawa et al., 2010). Symptoms of Anxiety and
Depression are assessed by the Hospital Anxiety and Depression Scale (HADS), a
validated screening tool widely used in oncologic settings (Vodermaier &
Millman, 2011) and recommended for screening emotional symptoms (Mitchell et al.,
2010). There is a validated Brazilian Portuguese version of HADS (Botega et al.,
1995).
Adverse Effects from Chemotherapy are
evaluated by the Patient-Reported Outcomes version of the Common Terminology
Criteria for Adverse Events (PRO-CTCAE), a validated and reliable tool for
assessing adverse symptoms (Basch et al., 2014; Dueck et al., 2015) and
previously used in a Brazilian cohort (Lima et al., 2020). Five items will be
measured: nausea, vomiting, headache, insomnia, and fatigue, as these are
frequently experienced during infusion and associated with cancer-related
fatigue (So et al., 2021).
Biomarkers of Inflammation include
interleukin (IL-6), interleukin (IL-10), C-reactive protein (CRP), and
Interferon-gamma. These biomarkers were selected for their potential to predict
fatigue levels and their association with fatigue-related depression due to
inflammatory processes in the central nervous system (Bower, 2019; Sleight et
al., 2022). They have been used in previous studies to verify their association
with fatigue and depression levels (Lengacher et al., 2019; Liu et al., 2012).
Lastly, mood states are assessed by Visual
Analogue Mood Scales (VAMS), validated by Stern et al. (1997) and widely used
in research settings (Machado et al., 2019; Rijsbergen, 2012), including
oncologic music-based trials worldwide (Dalli et al. 2023; Harper et al., 2023)
and in Brazil (Doro et al., 2016). Six mood categories are measured: happiness,
sadness, calmness, tension, energy, and tiredness. These scales will be used
pre- and post-music listening during chemotherapy for the experimental groups
and within a 45-minute interval for the control group. This timing is chosen
due to VAMS's ability to assess the present moment and ease of use (Machado et
al., 2019; Rijsbergen, 2012).
Other Measures
Given that
music can be a source of both pleasantness and discomfort (Murakami, 2021) the
MusAS trial will monitor adverse events during chemotherapy. Researchers are
trained to ask participants about their comfort with the music and to register
any adverse symptoms.
Additionally, self-report forms will
document how each group listened to the playlist (e.g., skipping or repeating
tunes), the frequency of music listening between T2 and T3, and participants'
perceptions of their experience in T2 (comfort, relaxation, and passage of
time). These questionnaires will help assess the safety of the music-based
interventions and compare participants' experiences across different groups.
Data Analysis
All collected data will be entered into a
Google Sheets document linked to the study's official email by one researcher.
To ensure accuracy, a second researcher will independently review the data
before proceeding with statistical analysis. To maintain blinding, groups will
be coded using letters instead of intervention/control labels.
Statistical analyses will be conducted using
JAMOVI (version 2.3.36, The Jamovi Project, 2022). Baseline characteristics of
the three groups will be compared using the χ² test or Fisher’s exact test
for categorical variables and one-way ANOVA or Kruskal-Wallis test for
continuous variables, depending on data normality, which will be assessed using
the Kolmogorov-Smirnov test. A significance level of α = 0.05 will be
adopted for all statistical tests.
The efficacy analysis will follow an
intention-to-treat (ITT) approach, including all participants who attended at
least one intervention session. To assess the impact of the intervention on
dependent variables – including cancer-related fatigue (FACT-F), health-related
quality of life (FACT-G), adverse effects (PRO-CTCAE), symptoms of anxiety and
depression (HADS), and mood states (VAMS) – a repeated measures ANOVA will be
employed. This model will evaluate within-group changes over time and
between-group differences at multiple time points (T1 and T3). For post hoc
comparisons, Tukey's test will be conducted to explore significant differences
identified by repeated measures ANOVA.
Results will be interpreted in terms of both
clinical and statistical significance. Findings will be presented using tables
and graphical visualizations to illustrate trends over time and differences
between groups. The discussion will contextualize results in relation to
existing literature and the study hypotheses.
DISCUSSION
This protocol outlines the rationale and
methods of the MusAS study, a three-arm randomized controlled trial comparing
music listening in two intervention groups (personalized and standard playlist)
and a control group. Methodological strengths include applying music-based
interventions specifically to women with non-metastatic breast cancer and
providing a rationale for using different music methods for the two
experimental groups. Additionally, to our knowledge, this may be the first
study using CRP, IL-6, IL-10, and interferon-gamma as biomarkers in music
interventions during chemotherapy. Additionally, this may be the first
three-arm RCT using music in oncology from Latin America. This is particularly
relevant as the targeted group may be underrepresented in research and
collectivistic societies may have different criteria for music preferences and
functions than individualistic societies (Schäfer et al., 2012).
Limitations
The MusAS trial protocol has some
limitations. Firstly, it is a single-site study, which may impact
generalizability of its results (Kahn et al., 2012). Secondly, it is a
non-blinded study, meaning that researchers collecting the data will know to
which group each participant belongs after randomization. Although masking is
not possible at T2 due to the intervention's characteristics (Bradt et al.,
2021), masking researchers responsible for the assessments at recruitment and
at the end of the data collection would ensure more quality to the study (Costa
et al., 2017). This decision for a non-blinded study was influenced by data
collection schedules and the researchers' scholarships periods.
Lastly, another limitation of the MusAS
study is that each participant in the experimental groups will listen to a
playlist during a single chemotherapy session. Although this provides only a
snapshot of the participants' experience during chemotherapy cycles, it was
necessary to establish this frequency for the feasibility of the study. The
literature supports changes in cancer-related fatigue and related outcomes
after a single session (Qi et al., 2021).
Innovation
Despite the limitations, the MusAS trial is
innovative in comparing interventions based on MT and MM principles during
chemotherapy. Similar studies have been conducted with cancer patients before
surgery (Palmer et al., 2015) and undergoing other oncologic treatments (Bradt et
al., 2014), comparing active and receptive methods (i.e. using live and
recorded music). In this trial, the focus is on comparing the same method –
music listening – with different delivery approaches: one standardized and
easily replicable and the other personalized and mediated by a trained music
therapist.
CONCLUSION
The results of the MusAS trial will
demonstrate the effectiveness of music listening in alleviating cancer-related
fatigue, improving health-related quality of life, reducing adverse effects,
alleviating symptoms of anxiety and depression, enhancing mood, and influencing
inflammatory biomarkers in women with breast cancer undergoing chemotherapy.
This trial is expected to contribute significantly to the fields of MM and MT,
highlighting the potential of music as non-pharmacological interventions in
infusion settings.
Funding
This trial protocol was financed by the
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - Brazil (CAPES) -
Finance Code 001. It has also been supported by the Conselho Nacional de
Desenvolvimento Científico e Tecnológico (CNPq). Hadiak laboratories will finance the
biomarker analyses for the MusAS trial.
Disclosure Statement
The fourth author is a business partner of
the lab in charge of the biological analyses. There are no other
conflicts of interest to declare.
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Received:
11/10/2024
Accepted: 02/28/2025