Investigating Mindfulness and Music to Ease Radiation Side Effects in Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Audio Program
Sponsored by
About this trial
This is an interventional supportive care trial for Prostate Cancer focused on measuring prostate cancer, mindfulness, music
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mindfulness Audio Program
Music Audio Program
Arm Description
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
Music Audio Program is a daily audio session of peaceful and relaxing music
Outcomes
Primary Outcome Measures
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).
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).
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03852017
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 11, 2015 (Actual)
Primary Completion Date
January 8, 2018 (Actual)
Study Completion Date
January 8, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, mindfulness, music
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness Audio Program
Arm Type
Experimental
Arm Description
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
Arm Title
Music Audio Program
Arm Type
Active Comparator
Arm Description
Music Audio Program is a daily audio session of peaceful and relaxing music
Intervention Type
Behavioral
Intervention Name(s)
Audio Program
Primary Outcome Measure Information:
Title
Implementation feasibility measured by enrollment rate
Description
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).
Time Frame
Baseline
Title
Implementation feasibility measured by retention rate
Description
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).
Time Frame
Throughout study completion, a total of four months.
Title
Implementation feasibility measured by intervention adherence
Description
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.
Time Frame
Throughout the study intervention period, a total of 4 weeks.
Title
Program acceptability measured by a post-program survey at 4-weeks
Description
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.
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Significant change in fatigue using the PROMIS Fatigue questionnaire
Description
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.
Time Frame
baseline; Week 4; Month 1; Month 3
Title
Significant change in anxiety using the PROMIS Anxiety questionnaire
Description
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.
Time Frame
baseline; Week 4; Month 1; Month 3
Title
Change in depression using the PROMIS Depression questionnaire
Description
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.
Time Frame
baseline; Week 4; Month 1; Month 3
Title
Change in sleep using the PROMIS Sleep Disturbance questionnaire
Description
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.
Time Frame
baseline; Week 4; Month 1; Month 3
Title
Change in uncertainty intolerance using the Intolerance for Uncertainty Scale
Description
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.
Time Frame
baseline; Week 4; Month 1; Month 3
Title
Change in fear of recurrence using the MAX-PC Fear of Recurrence sub-scale
Description
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.
Time Frame
baseline; Week 4; Month 1; Month 3
Title
Change in mindfulness using the Mindful Attention Awareness Scale
Description
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.
Time Frame
baseline; Week 4; Month 1; Month 3
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David E Victorson, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Investigating Mindfulness and Music to Ease Radiation Side Effects in Prostate Cancer
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