Investigating Mindfulness and Music to Ease Radiation Side Effects in Prostate Cancer

Study Overview
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Brief Summary
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In this study, the researchers will examine the implementation feasibility, acceptability, and initial effects of a brief eHealth mindfulness intervention, compared to brief relaxing music, to reduce self-reported symptoms of fatigue, anxiety, depression and sleep disturbance in a sample of localized prostate cancer patients during the receipt of radiation therapy.

Detailed Description
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Eligible patients will be recruited from Northwestern Medicine's Department of Radiation Oncology and Northwestern Memorial Hospital. Participants will complete an online questionnaire prior to beginning the intervention. Following implementation pre-testing, the intervention will begin on Week 2 of radiation therapy and last 4 weeks. Upon arrival for their treatment visit, they will receive the audio program from the clinic staff. They will start the program prior to their treatment. Participants will be asked to listen to the audio-program during their radiation treatment visits, using a Bluetooth-enabled MP3 player with speaker instead of headphones or earbuds because they are not permitted during radiation therapy. The patient's ears need to be free to hear a possible communication from the radiation therapists if need be. Audio program recordings will run 3-12 minutes. Participants will turn off the program after their audio session has ended and return the audio program to the clinic staff after their treatment visit. Participants will complete an online question immediately after completing the intervention, and again 1 and 3 months later.

Official Title
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IMMERSE PC: Investigating Mindfulness and Music to Ease Radiation Side Effects in Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: Audio Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with clinically localized prostate cancer Will receive at least 7 weeks of daily radiation therapy At least 18 years of age Able to speak and understand English Cognitively intact and free of serious psychiatric illness (as determined by referring physician) Exclusion Criteria: - Regular user of mindfulness meditation, which is defined as ≥ 3 times a week for the past 4 weeks

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

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: Following implementation pre-testing, we will use a pilot randomized-controlled design to compare 2 groups: Group A: Mindfulness (n=25), a daily audio-session, which teaches emotional self-regulation skills through the adoption of mindful awareness practices into one's life; and Group B: Relaxing Music (n=25) - a daily audio session of peaceful and relaxing music. Participants will be assessed at baseline just prior to randomization to the two study arms (T1), followed by assessments at the end of the intervention period (T2), and 1 month (T3) and 3 months (T4) after the 4-week intervention period.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Audio Program<br>Mindfulness Audio Program is a daily audio-session, which teaches emotional self-regulation skills through the adoption of mindful awareness practices into one's life | Behavioral: Audio Program<br> <br> |
| Active Comparator: Music Audio Program<br>Music Audio Program is a daily audio session of peaceful and relaxing music | Behavioral: Audio Program<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implementation feasibility measured by enrollment rate | This indicator of implementation feasibility for the program being delivered is defined by the overall enrollment rate being >/= 70% (e.g., total number of individuals enrolled/total number approached). | Baseline | 
| Implementation feasibility measured by retention rate | This indicator of implementation feasibility for the program delivered is defined by the retention rate being >/=70% (e.g., total number of individuals who remained in the trial until the end of requested participation/total number of individuals enrolled). | Throughout study completion, a total of four months. | 
| Implementation feasibility measured by intervention adherence | This indicator of implementation feasibility for the program delivered is defined by an adherence rate of >/=70% of all possible listening opportunities during the study intervention period. | Throughout the study intervention period, a total of 4 weeks. | 
| Program acceptability measured by a post-program survey at 4-weeks | Program acceptability will be assessed using a brief, Likert-type survey assessing participant enjoyment, satisfaction, perceived benefit, and ease of use. Acceptability is defined as ≥70% of survey responses in affirmation of this. | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significant change in fatigue using the PROMIS Fatigue questionnaire | Participants were administered the PROMIS Fatigue questionnaire. Significant change was indicated by a p<.05 on fatigue scores between baseline and follow up time points between study arms. | baseline; Week 4; Month 1; Month 3 | 
| Significant change in anxiety using the PROMIS Anxiety questionnaire | Participants were administered the PROMIS Anxiety questionnaire. Significant change was indicated by a p<.05 on anxiety scores between baseline and follow up time points between study arms. | baseline; Week 4; Month 1; Month 3 | 
| Change in depression using the PROMIS Depression questionnaire | Participants were administered the PROMIS Depression questionnaire. Significant change was indicated by a p<.05 on depression scores between baseline and follow up time points between study arms. | baseline; Week 4; Month 1; Month 3 | 
| Change in sleep using the PROMIS Sleep Disturbance questionnaire | Participants were administered the PROMIS Sleep Disturbance questionnaire. Significant change was indicated by a p<.05 on sleep disturbance scores between baseline and follow up time points between study arms. | baseline; Week 4; Month 1; Month 3 | 
| Change in uncertainty intolerance using the Intolerance for Uncertainty Scale | Participants were administered the Intolerance for Uncertainty questionnaire. Significant change was indicated by a p<.05 on uncertainty intolerance scores between baseline and follow up time points between study arms. | baseline; Week 4; Month 1; Month 3 | 
| Change in fear of recurrence using the MAX-PC Fear of Recurrence sub-scale | Participants were administered the MAX-PC Fear of Recurrence questionnaire. Significant change was indicated by a p<.05 on fear of recurrence scores between baseline and follow up time points between study arms. | baseline; Week 4; Month 1; Month 3 | 
| Change in mindfulness using the Mindful Attention Awareness Scale | Participants were administered the Mindful Attention Awareness Scale. Significant change was indicated by a p<.05 on mindfulness scores between baseline and follow up time points between study arms. | baseline; Week 4; Month 1; Month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, mindfulness, music