IMMERSE PC: Investigating Mindfulness and Music to Ease Radiation Side Effects in Prostate Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Northwestern University
- Enrollment
- 59
- Primary Endpoint
- Program acceptability measured by a post-program survey at 4-weeks
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Mindfulness Audio Program
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
Intervention: Audio Program (Behavioral)
Music Audio Program
Music Audio Program is a daily audio session of peaceful and relaxing music
Intervention: Audio Program (Behavioral)
Outcomes
Primary Outcomes
Program acceptability measured by a post-program survey at 4-weeks
Time Frame: Week 4
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.
Implementation feasibility measured by retention rate
Time Frame: Throughout study completion, a total of four months.
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).
Implementation feasibility measured by enrollment rate
Time Frame: Baseline
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).
Implementation feasibility measured by intervention adherence
Time Frame: Throughout the study intervention period, a total of 4 weeks.
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.
Secondary Outcomes
- Change in depression using the PROMIS Depression questionnaire(baseline; Week 4; Month 1; Month 3)
- Significant change in anxiety using the PROMIS Anxiety questionnaire(baseline; Week 4; Month 1; Month 3)
- Change in fear of recurrence using the MAX-PC Fear of Recurrence sub-scale(baseline; Week 4; Month 1; Month 3)
- Change in mindfulness using the Mindful Attention Awareness Scale(baseline; Week 4; Month 1; Month 3)
- Significant change in fatigue using the PROMIS Fatigue questionnaire(baseline; Week 4; Month 1; Month 3)
- Change in sleep using the PROMIS Sleep Disturbance questionnaire(baseline; Week 4; Month 1; Month 3)
- Change in uncertainty intolerance using the Intolerance for Uncertainty Scale(baseline; Week 4; Month 1; Month 3)
Investigators
David Victorson
Associate Professor
Northwestern University