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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
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
interventionNames
Behavioral: Audio Program
type
ACTIVE_COMPARATOR
label
Music Audio Program
description
Music Audio Program is a daily audio session of peaceful and relaxing music
interventionNames
Behavioral: Audio Program
Primary outcomes (4)
measure
Implementation feasibility measured by enrollment rate
timeFrame
Eligibility
Eligibility (as posted)
Sex
Male
Minimum age
18 Years
Show eligibility criteria text
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
References
Publications (33)
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Baseline
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).
measure
Implementation feasibility measured by retention rate
timeFrame
Throughout study completion, a total of four months.
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).
measure
Implementation feasibility measured by intervention adherence
timeFrame
Throughout the study intervention period, a total of 4 weeks.
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.
measure
Program acceptability measured by a post-program survey at 4-weeks
timeFrame
Week 4
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.
Secondary outcomes (7)
measure
Significant change in fatigue using the PROMIS Fatigue questionnaire
timeFrame
baseline; Week 4; Month 1; Month 3
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.
measure
Significant change in anxiety using the PROMIS Anxiety questionnaire
timeFrame
baseline; Week 4; Month 1; Month 3
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.
measure
Change in depression using the PROMIS Depression questionnaire
timeFrame
baseline; Week 4; Month 1; Month 3
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.
measure
Change in sleep using the PROMIS Sleep Disturbance questionnaire
timeFrame
baseline; Week 4; Month 1; Month 3
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.
measure
Change in uncertainty intolerance using the Intolerance for Uncertainty Scale
timeFrame
baseline; Week 4; Month 1; Month 3
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.
measure
Change in fear of recurrence using the MAX-PC Fear of Recurrence sub-scale
timeFrame
baseline; Week 4; Month 1; Month 3
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.
measure
Change in mindfulness using the Mindful Attention Awareness Scale
timeFrame
baseline; Week 4; Month 1; Month 3
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.
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