Effects of a Sound Intervention on Physical and Emotional Well-Being in Patients with Cancer: A Prospective Randomized Trial.

Introduction

Cancer remains a disease with a significant impact on morbidity and mortality but also on quality of life [ 1 , 2 , 3 ]. In addition to the ongoing effort to develop improved therapies with the goal of extending survival, complementary therapies that potentially improve physical and emotional well-being of cancer patients are also gaining importance [ 4 ]. Music therapy is traditionally being used, especially in palliative medicine [ 5 ]. In 2019, the German Institute for Quality and Efficiency in Health Care endorsed the general complementary use of music therapy for cancer patients [ 6 ]. Nevertheless, this therapy has so far been reserved for only a few patients and is not widely available. Positive aspects of music therapy have been described in terms of anxiety, depression, and pain, as well as fatigue in cancer patients [ 7 ].

Whether music therapy can influence physical well-being is also of particular interest. In anaesthesiology and intensive care medicine, music therapy has been shown to have positive effects on vital signs and pain [ 8 , 9 , 10 ]. However, few data are available for cancer patients, although many patients suffer from physical symptoms caused by the disease itself or by the side effects of anti-cancer therapy.

The present study investigated the effects of a self-administered 4-week sound intervention on physical and emotional well-being in outpatients with cancer. In addition to self-rated quality of life assessment using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30), sleep quality, pain, fatigue, and fear of disease progression were assessed in a standardized manner as well. Two self-applied sound interventions, which can be performed by the patients themselves without the need for a music therapist, were used for this purpose and compared in regard to the patient response.

Patients and Methods

This study was performed at the outpatient department (TagesTherapieZentrum, TTZ) of the Mannheim Cancer Center (MCC), University Medical Centre Mannheim, University of Heidelberg, Germany. It was designed as a prospective randomized exploratory trial. Blinding was not possible due to the nature of the intervention. Recruitment started in June 2019 and ended in September 2020.

The study was conducted according to the principles of the Declaration of Helsinki and was approved by the Local Ethical Committee, Medical Ethics Commission II, Faculty of Medicine Mannheim, University of Heidelberg, Germany (2019-671N). Data protection was in accordance with the EU Data Protection Directive.

Study Design

Patients suffering from cancer aged >18 years and treated at the TTZ of the MCC were included in this study and randomized to a self-applied sound intervention. Individual musical activity was used as a stratification criterion (Fig. 1 , flowchart).

Data were collected using standardized questionnaires both at baseline and after 4 weeks. Time and duration of the sound intervention were documented by a patient logbook. After 2 weeks, a visit took place to assess the compliance on basis of the logbook and to identify any emotional stress caused by the intervention or to answer questions from the study participants.

Baseline Characteristics

Information on gender, age, profession, height, and weight (to calculate the BMI) were obtained. In addition, the study participants were asked whether they are musically active.

Questionnaires

Patients were asked to complete self-assessment questionnaires on pain, fatigue, quality of life, fear of tumour progression, and sleep quality. The following standardized questionnaires served as survey instruments: the Pittsburgh Sleep Quality Index (PSQI), the EORTC QLQ-C30, Visual Analogue Scale (VAS) for pain and fatigue, and the Fear of Progression (FoP) questionnaire (German version).

Sound Intervention

Patients were randomized to a sound intervention, either to active “music playing” with a monochord (“Heaven and Earth” [ 11 ]) or to passive sound intervention (MP3 player and headphones to listen to a given music compilation comprising classical music). Both interventions were self-applied by all study participants over a period of 4 weeks in the evening before bedtime for about 15 min, which was documented by a patient logbook.

Patients in the active group received an introduction how to play the instrument. The study participants were advised to maintain a supine position during the intervention and to place the monochord on the chest to ensure optimal transmission of the vibrations. The body monochord is intuitively playable and does not require any musical background. However, there are several playing techniques that the study participants were introduced to: plucking individual strings (as on a guitar), strumming of multiple strings, and continuous sound generation by stroking the strings continuously. In addition, it was shown that the instrument can be played at different volumes and speeds. They were asked to document the tuning of the instrument daily. During a visit after 2 weeks, the tuning of the instrument was also controlled and corrected if necessary.

Outcomes

The primary endpoint of this exploratory trial was to describe the rate of patients with improvement in at least one of the five administered survey instruments/questionnaires without worsening of any other between the baseline and final assessment (in the following, referred to as “response”).

Sample Size Calculation

In order to obtain an accurate estimation of the proportion of responders, a sample size calculation was carried out using PASS 11 (NCSS, Utah, USA). Patients were randomized 1:1 with using the following stratification criterion: active music making (defined as regularly playing an instrument or singing). Assuming a response rate of 45–65%, a precise estimate with a 95% confidence interval (CI) range of about 25% can be guaranteed for a number of 60–70 patients.

Statistical Analysis and Definition of Response

Quantitative variables were evaluated using statistical parameters (N, arithmetic mean, standard deviation, median, minimum, and maximum), and qualitative variables were evaluated in the form of frequency tables. Categorical variables were evaluated with the help of contingency tables. The χ 2 test was used to compare the two sound interventions or the Fisher's exact test if the requirements of the χ 2 test were not met.

The survey instruments (PSQI, QLQ-C30, VAS for pain and fatigue, and FoP) were analysed descriptively both for measurement time and for intervention group. In addition, the differences to the baseline value were calculated and also analysed descriptively. The comparison between active and passive sound intervention is of explorative nature. The Wilcoxon signed-rank test was used for this purpose. Furthermore, each survey instrument/questionnaire was categorized using a response criterion as follows:

PSQI: the questionnaire is composed of 19 questions comprising 7 subscales, with a score ranging from 0 to 21. Scores of 0–5 are generally considered good sleep quality, while 6–10 indicate moderate sleeping problems, and >10 are often found in chronic sleep disorders. Accordingly, the patients were divided into 3 categories. A change to a higher category corresponds to worsening or to a lower category to response [ 12 ].

QLQ-C30: the questionnaire is composed of 30 questions, comprising 15 subscales on three domains (global health status, functional scales, and symptom scales), with a score ranging from 0 to 100 points for all subscales [ 13 ]. A higher score in global health status or functional scales represents a higher quality of life or better level of functioning. However, in the symptom subscale, a higher score represents a higher level of symptoms or problems. Accordingly, a change of +10 points corresponds to an improvement in QoL/level of functioning or an increase in symptoms, while a change of −10 corresponds to a worse QoL/level of functioning or decrease in symptoms.

VAS: the VAS ranges from 0 to 10 [ 14 ]. A difference up to > −1 corresponds to worsening or > +1 to response.

FoP: the questionnaire is composed of 43 questions comprising 5 subscales (affective reactions, partnership/family, occupation, loss of autonomy, and coping with anxiety) [ 15 ]. A difference up to > −14 corresponds to worsening or > +14 to response.

The overall response was determined from the individual scales and defined as improvement in at least one dimension, with the other scores remaining the same or having improved between the baseline and final assessment. All statistical analyses were performed with SAS 9.4. (SAS Institute Inc., North Carolina, USA). Statistical significance was assumed at p < 0.05.

Results

Baseline Characteristics

73 patients were included in the study, of which 29 were male (40%) and 44 patients (60%) were female. Patients were randomized to either active music playing ( n = 34, 47%) or passive sound intervention ( n = 39, 53%). The median age was 52.0 years (range 21–79). The study population was of normal weight with a mean BMI of 25.2 ± 5.5 kg/m 2 . The vast majority of patients (41, 56%) were employed, 18 (25%) were retired, six (8%) were unemployed or a househusband/wife, and five (7%) were self-employed. Only one person (2%) was a student, and the information on profession is missing for two study participants (3%). A total of 14 subjects (19%) stated that they were musically active (Table 1 ).

Compliance of Sound Intervention

The patient logbook was completed by 68 of 73 (94%) participants. Within the period of 4 weeks, the sound intervention was carried out on a median of 26 days (range 5–28). In total, 57 patients (78%) implemented the intervention in their daily routine on at least 24 days. In the active group, 28 study participants (82%) documented the intervention on at least 24 days, compared to 29 (74%) in the passive intervention group (Table 1 ).

Primary Endpoint

In terms of the primary endpoint, more patients in the passive group showed a response and exhibited an improvement in at least one dimension without worsening of any other: n = 15 (39%) versus n = 9 (27%). The response for the individual scales as well as the overall response did not differ significantly between the active and the passive group, except for VAS fatigue ( p = 0.049). Moreover, a trend for improved QLQ-C30 response was noticed in the passive group: n = 12 (31%) versus n = 3 (9%), p = 0.06 (Table 2 ). The response did not differ between musically active and nonmusical patients. The overall response on an individual basis and according to randomized group is depicted in Figure 2 .

Analysis of Questionnaires

Patients filled in different self-assessment questionnaires at the beginning and at the end of the study (complete results can be obtained from online suppl. Table ST1 ; see www.karger.com/doi/10.1159/000528187 for all online suppl. material).

FoP: the evaluation was performed for each of the 5 dimensions of the questionnaire. Both in the total population and in the passive group, the intervention resulted in a significant reduction in affective reactions (anxiety). In the active group, there was also a trend toward a median reduction of 2.5 scale points but without reaching statistical significance ( p = 0.09) (Fig. 3 ). No differences were found for the other dimensions (partnership/family, occupation, loss of autonomy, coping with anxiety).

VAS pain: for the parameter pain, no improvement (independent of the group) could be achieved by a sound intervention.

VAS fatigue: patients in the passive group more often reported improvement in VAS fatigue ( p = 0.049).

QLQ-C30: the evaluation was performed for each of the 15 dimensions of the questionnaire (global health status, five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea/vomiting), six single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties). No differences could be observed for global health status. With regard to the functional scales, an improvement was achieved only for social functioning in the passive group ( p = 0.02) (Fig. 4 ). No change could be achieved for the symptom scales in either group. There were no differences between the two groups with regard to symptoms, except for dyspnoea, which patients in the passive group reported less frequently after the intervention ( p = 0.04).

PSQI: no difference was found between the interventions for sleep quality, neither in the total population nor within the groups.

Discussion

The current prospective randomized explorative study evaluated patient response to a 4-week, self-administered sound intervention. Effects on a number of dimensions of physical and emotional well-being, such as quality of life, sleep quality, pain, fatigue, and affective reactions were assessed. Main findings of these trials can be summarized as follows:

A numerically higher percentage of patients in the passive group reached the primary endpoint. Response differences in favour of the passive group were seen with the VAS fatigue and with QLQ-30 questionnaires.

Sound intervention significantly improved social functioning and shortness of breath in the passive group, according to QLQ-C30.

Sound intervention resulted in a significant reduction in terms of affective reactions as a domain of the FoP questionnaire.

Music therapy refers to the specific use of music or musical elements with the professional supervision of a music therapist, whereby active interventions can be distinguished from receptive forms [ 16 ]. So far, music interventions are rarely offered as part of oncologically supportive measures in clinical practice with the exception of the palliative care setting. Since cancer patients often have many routine visits or due to side effects of tumour treatment and fatigue, many patients may refrain from further appointments. Therefore, simple measures, without the need for appointments with a music therapist, which can be performed at home, might be preferable. In the present study, we randomized oncological outpatients into two groups, whereby one group listened to a given classical music compilation with headphones and the other was instructed to actively play a monochord. This monochord is easy to handle and play regardless of potential musical background after a brief instruction. Approximately 20% of our study participants stated that they were musically active. Musical activity was used as a stratification criterion to ensure balanced study arms in this regard. Of note, study results were not different between musically active and inactive patients.

While the active practice of music in music therapy should improve well-being and strengthen self-confidence, receptive music therapy focuses on relaxation [ 17 ]. The patient response for the individual scales as well as the overall response did not differ significantly between the active and the passive group except for fatigue, where 28% of patients in the passive group reported significant improvement after the 4-week intervention. Fatigue is one of the most commonly experienced cancer symptoms, affecting 70–100% of patients with cancer [ 18 ]. Several meta-analyses and randomized trials have shown positive effects of music therapy on fatigue [ 19 , 20 , 21 ]. A recent study showed that home-based music therapy even may have lasting effects on fatigue [ 22 ]. This supports our findings that a self-administered music therapy is also able to exert positive effects. Burns et al. [ 23 ] surveyed the preferences for music therapy (either music making or music listening) in cancer patients, where 44% of patients would prefer a receptive intervention. In contrast, Standley et al. [ 24 ] showed greater benefits for active music making in premature infants. We observed a trend for improved quality of life and overall response in the passive group, suggesting that a passive sound intervention may be more effective than active music making in cancer patients. Especially, in the passive group, the music intervention resulted in a significant reduction in affective reactions, while the active group only demonstrated a trend toward less affective reactions. Affective reactions included disease-related anxiety (fear of progression, death), fear of treatment (recurring appointments, side effects of therapy), physical symptoms (palpitations, (stomach) pain, sleep disturbance), or an irritable state up to a loss of joy of life. This observation has also been made in other studies [ 25 , 26 , 27 ].

Social functioning is an important determinant that impacts health outcomes and mortality among patients, comparable to classical clinical risk factors, such as smoking or hypertension [ 28 ]. A cancer diagnosis often leads to social withdrawal. There are several reasons for this. Psychological disorders such as depression or anxiety disorders are often associated with cancer [ 29 ]. In addition, physical resilience is reduced by cancer itself or by side effects of tumour-reducing therapies, which makes participation in social life more difficult [ 30 ]. Some patients perceive the visible treatment side effects (weight, hair loss, nausea) as stigmatization [ 31 , 32 ]. Sound intervention was able to improve social functioning in the passive group. However, the extent to which this could also have prognostic implications cannot be answered on the basis of the currently available literature.

In addition to possible effects on emotional well-being, physical symptoms were also assessed. Patients in the passive group reported less frequently dyspnoea after the intervention, while 75% of the patients in the active group reported no change or even a worsening. Dyspnoea is a very common symptom in cancer patients with and without direct lung involvement [ 33 ]. Systemic opioids or promethazine are often used for symptom management, but complementary and alternative medicine is also used increasingly [ 34 , 35 ]. Another common symptom in cancer patients is pain. Although positive effects of music therapy on pain in cancer patients have already been described [ 27 , 36 , 37 ], we did not observe improvements in either group in this study. However, avoiding worsening of pain may of course be regarded as a treatment goal in cancer patients.

No adverse effects of music therapy have been described so far. We also did not notice any worsening of emotional or physical symptoms, but the expected response rate in this exploratory pilot study was somewhat lower than expected. One may speculate that active music making is perceived as burdensome by cancer patients and that music listening can be more easily integrated into daily life. In patients exposed to elevated stress levels, preferred music exerted better effects on stress reduction than default sedative music did [ 38 ]. The extent to which cancer patients' music preferences also play a role in response needs to be investigated in further trials, as well as whether listening to music in combination with relaxation techniques may achieve better effects.

It is conceivable that an optimistic attitude leads to improved treatment adherence in cancer patients [ 39 , 40 ]. In addition, optimism keeps patients involved and engaged in treatment goals, leading to an improved emotional well-being [ 41 ]. Patients in our cohort performed the sound interventions on a median of 26 days, with approximately 80% of the patients implementing the intervention in their daily routine on at least 24 days. This is consistent with adherence rates for conventional therapies in cancer, which range from 70 to 80% [ 42 ]. However, a clinical trial, due to its nature, could lead to a positive selection, as patients with a higher motivation and thus better adherence, might be more likely to participate in a study.

Conclusion

In this exploratory randomized trial, a 4-week sound intervention was feasible and safe in oncological outpatients. Passive sound intervention was able to improve patient-reported outcomes in terms of social functioning, fatigue, and affective reactions, while active music playing did not impact on these parameters. The predefined overall response rate was numerically higher with passive sound intervention.

Statement of Ethics

This study was conducted according to the principles of the Declaration of Helsinki and was approved by the Local Ethical Committee, Medical Ethics Commission II, Faculty of Medicine Mannheim, University of Heidelberg, Germany (2019-671N). Written informed consent was obtained from all patients. This clinical trial is registered within the ISRCTN Registry (registration number 70947363).

Conflict of Interest Statement

Prof. Ralf-Dieter Hofheinz is a member of the Editorial Board of Oncology Research and Treatment. Apart from that, no other conflicts of interest are to be disclosed.

Funding Sources

This study received no specific funding.

Author Contributions

Rosa Meissner and Prof. Ralf-Dieter Hofheinz conceived the study. Rosa Meissner and Lara Heinemann performed the examinations and the data collection. Data were further processed by Christina Reyser to be statistically analysed by Prof. Iris Burkholder. Dr. Kirsten Merx, Dr. Simone Weingaertner, Dr. Athansios Mavratzas, and Dr. Nadine Schulte helped identify eligible patients and supported recruitment and study enrolment. Kathrin Christians supervised the musical aspects of the project. Dr. Anna Hohneck prepared the initial manuscript draft with essential scientific input of Prof. Wolf-Karsten Hofmann and Prof. Ralf-Dieter Hofheinz. All authors approved the final version.

Data Availability Statement

All data generated or analysed during this study are included in this article and its online supplementary materials. Further enquiries can be directed to the corresponding author.

Supplementary Material

Supplementary data

Click here for additional data file.

Funding Statement

This study received no specific funding.

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Associated Data

Supplementary Materials

Supplementary data

Click here for additional data file.

Data Availability Statement

All data generated or analysed during this study are included in this article and its online supplementary materials. Further enquiries can be directed to the corresponding author.