Clinical trial NCT06450626: Music Therapy at TMH Infusion Center
Official title: Introduction of a Music-based Intervention for Patients Receiving Infusions at the Lifespan Cancer Institute Infusion Center in the Miriam Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Music Therapy
Keywords: Chemotherapy
Infusion Therapy
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: The Warren Alpert Medical School of Brown University
First posted: 2024-06-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to test the effects of a listening music intervention on the symptom burden carried by patients who are receiving infusions at the Lifespan Cancer Institute of Miriam Hospital in Providence, Rhode Island. The main questions it aims to answer are:

* Will a music therapy intervention help reduce physical and mental symptom burden?
* Will a music therapy intervention be beneficial on physiological parameters during the infusion sessions, such as heart rate, respiratory rate, and blood rate?

Participants will undergo the following main tasks:

* Prior to the infusion, participants will be given a pre-assessment survey reflecting on their previous experiences with infusions.
* During the infusion, participants will listen to a self-selected playlist either on their own device or on an iPad provided by the clinic, and vitals will be monitored.
* After the session, participants will be given a post-assessment survey to evaluate outcomes of the intervention.
* Participants will also be asked a set of qualitative questions about their overall experience with the music therapy session.

Detailed description: An estimated 17 million Americans are living with cancer, and the majority receive chemotherapy annually, which, in addition to common side effects like pain, fatigue, nausea, vomiting, and hair loss, also imposes a significant psychological and emotional toll on patients. Studies consistently show a high prevalence of depression and anxiety among cancer patients due to both the disease and the therapeutic burden, with prolonged chemotherapy being a particularly significant risk factor. This underscores the need for nonpharmacological and non-invasive treatments to reduce the negative emotional states, psychological burden, and stress that often accompany chemotherapy. Music therapy has increasingly been utilized in clinical settings as a complementary intervention, benefiting various populations, including those with dementia-related disorders, by treating cognitive and behavioral symptoms through social interaction and other acute benefits. Passive music therapy, such as listening to recorded or live music, has been shown to ease psychosocial symptoms, even in the absence of a trained music therapist. Overall, music therapy promotes wellness, manages stress, alleviates pain, enhances memory, improves communication, and supports physical rehabilitation. For instance, in hypertensive young adults, four weeks of passive music therapy significantly lowered systolic blood pressure and heart rate, suggesting a soothing and rehabilitative effect. Additionally, singing along to music boosts cytokine levels, indicating strengthened immunity through improved mood and reduced stress. Music therapy research supports its benefits for cancer patients, as studies have shown improved mood, reduced distress, increased resilience, and decreased anxiety and heart rate during chemotherapy. Despite these demonstrated benefits, music therapy services are under-resourced, particularly in Rhode Island, where only one licensed music therapist was reported in 2020, serving around 2000 clients across eight facilities. This project aims to implement a music therapy program at Miriam Hospital to enhance the well-being of chemotherapy patients and potentially expand to other Lifespan Infusion Centers in Rhode Island, such as Rhode Island Hospital and Newport Hospital. Given the lack of structured music therapy programs for oncology patients in Rhode Island, this initiative seeks to establish a formal music therapy offering at Miriam Hospital, setting the stage for broader adoption and integration of music therapy in cancer care across the state.

Eligibility criteria: Inclusion Criteria:

* Sufficient hearing capacity to hear music
* Scheduled for a chemotherapy infusion lasting at least 30 minutes
* Ability to complete pre- and post-assessments in English

Exclusion Criteria:

* Participants who have had a prior infusion session with a music therapy intervention

Primary outcomes:
measure: Effect of Music Listening Intervention on Common Symptoms Among Patients with Advanced Cancer via the Edmonton Symptom Assessment Scale
timeFrame: Baseline and 30 minutes (after the music listening intervention)
measure: Change from Baseline in Heart Rate After Music Listening Intervention
timeFrame: Baseline and 30 minutes (after the music listening intervention)
measure: Change from Baseline in Respiratory Rate After Music Listening Intervention
timeFrame: Baseline and 30 minutes (after the music listening intervention)
measure: Change from Baseline in Blood Pressure After Music Listening Intervention
timeFrame: Baseline and 30 minutes (after the music listening intervention)
measure: Qualitative Satisfaction Level After Music Listening Intervention
timeFrame: Baseline and 30 minutes (after the music listening intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Lifespan Cancer Institute at The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: Brown University
name: Fred J Schiffman, MD
role: STUDY_DIRECTOR
affiliation: Brown University
name: Diana A Wang, BA
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown University
name: Claire Lin, BA
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown University
name: Ishaani Khatri, BA
role: PRINCIPAL_INVESTIGATOR
References: