Music Therapy at TMH Infusion Center

NCT ID: NCT06450626

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-19
• Study Completion Date: 2024-12-31

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.

Conditions

Music Therapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Listening Music Intervention

Participants listen to 30 minutes of a music playlist of their choice.

Group Type: EXPERIMENTAL

Listening Music Intervention

Intervention Type: OTHER

Participants will listen to a music playlist while vitals are monitored, along with completing a pre- and post-assessment survey (both of which are the Edmonton Symptom Assessment Scale). Participants will also be asked a set of qualitative questions about their overall experience with the music therapy session.

Interventions

Listening Music Intervention

Participants will listen to a music playlist while vitals are monitored, along with completing a pre- and post-assessment survey (both of which are the Edmonton Symptom Assessment Scale). Participants will also be asked a set of qualitative questions about their overall experience with the music therapy session.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Warren Alpert Medical School of Brown University

UNKNOWN

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fred J Schiffman, MD

Role: STUDY_DIRECTOR

Brown University

Diana A Wang, BA

Role: PRINCIPAL_INVESTIGATOR

Brown University

Claire Lin, BA

Role: PRINCIPAL_INVESTIGATOR

Brown University

Ishaani Khatri, BA

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

Lifespan Cancer Institute at The Miriam Hospital

Providence, Rhode Island, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

STUDY00000448

Identifier Type: -

Identifier Source: org_study_id