Prostate Cancer
Conditions
Keywords
prostate cancer, mindfulness, music
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.
Interventions
BEHAVIORALAudio Program
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implementation feasibility measured by enrollment rate | 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 retention rate | 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 intervention adherence | 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. |
| Program acceptability measured by a post-program survey at 4-weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in uncertainty intolerance using the Intolerance for Uncertainty Scale | baseline; Week 4; Month 1; Month 3 | 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. |
| Significant change in fatigue using the PROMIS Fatigue questionnaire | baseline; Week 4; Month 1; Month 3 | 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. |
| Change in mindfulness using the Mindful Attention Awareness Scale | baseline; Week 4; Month 1; Month 3 | 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. |
| Change in fear of recurrence using the MAX-PC Fear of Recurrence sub-scale | baseline; Week 4; Month 1; Month 3 | 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. |
| Significant change in anxiety using the PROMIS Anxiety questionnaire | baseline; Week 4; Month 1; Month 3 | 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 | baseline; Week 4; Month 1; Month 3 | 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 | baseline; Week 4; Month 1; Month 3 | 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. |
Outcome results
None listed