Music of Choice to Decrease Anxiety During Radiation Treatment

Study Overview
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Brief Summary
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The primary hypothesis of the study is that listening to music will reduce anxiety in female cancer patients during the first radiotherapy treatment session.

Detailed Description
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Receiving radiotherapy induces anxiety in at least 1/3 of patients who did not have a previously existing anxiety condition1. Female gender is a positive predictive factor for psychosocial decline during radiotherapy. One-fourth of patients disrupt their planned radiotherapy treatment course due to anxiety. Music therapy has demonstrated effectiveness in reducing anxiety when implemented in other medical settings including mechanical ventilation, burn debridement and venipuncture in pediatric patients. There have been some trials which have found a reduction in anxiety when pre-recorded music along with other relaxation techniques have been implemented during radiotherapy. This trial seeks to investigate the benefit of pre-recorded music alone in reducing anxiety experienced during the first radiotherapy treatment session in female cancer patients.

Official Title
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A Randomized Trial of Music to Decrease Anxiety in Women Starting Radiation Therapy for Cancer

Conditions
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Anxiety, Cancer

Intervention / Treatment
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* Other: Music


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled to receive radiotherapy for malignant tumor ECOG Performance Status 0-4 Fluent in English Language Inclusion in this study will not be based on race or ethnicity Patients must be deemed able to comply with the treatment plan. Patients must provide study specific informed consent prior to study entry. Exclusion Criteria: Prior history of radiation therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Consented, eligible female subjects to be randomized to Music or No Music to evaluate pre and post treatment anxiety level via STAI and SDT anxiety questionnaire at their first radiotherapy treatment for cancer.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music<br>Patients randomized to the music intervention arm will select a preferred genre of music from an internet based resource. | Other: Music<br>* The patient's preferred music will be played during the first radiotherapy treatment session from speakers located inside the treatment room. The duration of the music will be 10 to 20 minutes. The music will be turned off at the patient's request if it bothers them. Length of music playing and if the patient requested that it be turned off, will be recorded.<br>|
| No Intervention: No Music<br>These patient's will have no music playing during the first radiotherapy session. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change of STAI Score from within 2 hours prior to first RT session to 2 hours post first RT session. | Percent change in mean anxiety score as measured with the State-Trait Anxiety Inventory (STAI) questionnaire. Assessed by the mean value (pre minus post radiotherapy STAI score) divided by mean pre-treatment score multiplied by 100. A score of 39-40 on each subset suggests clinically significant anxiety. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change of SDT Score from within 2 hours prior to first RT session to 2 hours post first RT session. | Percentage change in mean anxiety score as measured with the Symptom Distress Thermometer (SDT). Scale of 0 - 10; with 10 being clinically significant distress. | baseline | 
| Magnitude change of STAI Score | The magnitude of change in anxiety score of STAI in high anxiety patients (pre-treatment STAI ≥ 40) as a result of listening to music during the first radiotherapy session. | baseline | 
| Magnitude change of SDT Score from within 2 hours prior to first RT session to 2 hours post first RT session. | The magnitude of change in anxiety score of SDT in high anxiety patients (pre-treatment SDT ≥ 4) as a result of listening to music during the first radiotherapy session. Scale of 0 - 10; with 10 being clinically significant distress. | baseline | 
| STAI High to Low Score Change from within 2 hours prior to first RT session to 2 hours post first RT session. | The number and percentage of patients who drop from a high to low anxiety level in both intervention groups using STAI scores. A score of 39-40 on each subset suggests clinically significant anxiety. | baseline | 
| SDT High to Low Score Change from within 2 hours prior to first RT session to 2 hours post first RT session. | The number and percentage of patients who drop from a high to low anxiety level in both intervention groups using SDT scores. Scale of 0 - 10; with 10 being clinically significant distress. | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety Reduction, Music Therapy, First Radiotherapy, Psychosocial Functioning, State - Trait Anxiety Inventory (STAI), Symptom Distress Thermometer (SDT)