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Trial Title: Music Therapy at TMH Infusion Center

NCT ID: NCT06450626

Condition: Music Therapy

Conditions: Keywords:
Chemotherapy
Infusion Therapy

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Listening Music Intervention
Description: 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.
Arm group label: Listening Music Intervention

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Lifespan Cancer Institute at The Miriam Hospital

Address:
City: Providence
Zip: 02906
Country: United States

Status: Recruiting

Contact:
Last name: Fred J Schiffman, MD
Email: fschiffman@lifespan.org

Start date: June 19, 2024

Completion date: December 2024

Lead sponsor:
Agency: Brown University
Agency class: Other

Collaborator:
Agency: The Warren Alpert Medical School of Brown University
Agency class: Other

Source: Brown University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06450626

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