Clinical trial NCT03852017: Investigating Mindfulness and Music to Ease Radiation Side Effects in Prostate Cancer
Official title: IMMERSE PC: Investigating Mindfulness and Music to Ease Radiation Side Effects in Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate cancer
mindfulness
music
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2019-02-22
Enrollment: 59
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Implementation feasibility measured by enrollment rate
timeFrame: Baseline
measure: Implementation feasibility measured by retention rate
timeFrame: Throughout study completion, a total of four months.
measure: Implementation feasibility measured by intervention adherence
timeFrame: Throughout the study intervention period, a total of 4 weeks.
measure: Program acceptability measured by a post-program survey at 4-weeks
timeFrame: Week 4
Secondary outcomes:
measure: Significant change in fatigue using the PROMIS Fatigue questionnaire
timeFrame: baseline; Week 4; Month 1; Month 3
measure: Significant change in anxiety using the PROMIS Anxiety questionnaire
timeFrame: baseline; Week 4; Month 1; Month 3
measure: Change in depression using the PROMIS Depression questionnaire
timeFrame: baseline; Week 4; Month 1; Month 3
measure: Change in sleep using the PROMIS Sleep Disturbance questionnaire
timeFrame: baseline; Week 4; Month 1; Month 3
measure: Change in uncertainty intolerance using the Intolerance for Uncertainty Scale
timeFrame: baseline; Week 4; Month 1; Month 3
measure: Change in fear of recurrence using the MAX-PC Fear of Recurrence sub-scale
timeFrame: baseline; Week 4; Month 1; Month 3
measure: Change in mindfulness using the Mindful Attention Awareness Scale
timeFrame: baseline; Week 4; Month 1; Month 3
Other outcomes:
Locations:
Study officials:
affiliation: Northwestern University
name: David E Victorson, PhD
role: PRINCIPAL_INVESTIGATOR
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