Investigating Mindfulness and Music to Ease Radiation Side Effects in Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

IMMERSE PC: Investigating Mindfulness and Music to Ease Radiation Side Effects in Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03852017
• Other study ID #: STU00200537
• Status: Completed
• Phase: N/A
• Start date: November 11, 2015
• Est. completion date: January 8, 2018

Study information

• Verified date: May 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: January 8, 2018
• Est. primary completion date: January 8, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Audio Program

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

References & Publications (33)

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline
Primary	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).	Throughout study completion, a total of four months.
Primary	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.	Throughout the study intervention period, a total of 4 weeks.
Primary	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.	Week 4
Secondary	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.	baseline; Week 4; Month 1; Month 3
Secondary	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.	baseline; Week 4; Month 1; Month 3
Secondary	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.	baseline; Week 4; Month 1; Month 3
Secondary	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.	baseline; Week 4; Month 1; Month 3
Secondary	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.	baseline; Week 4; Month 1; Month 3
Secondary	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.	baseline; Week 4; Month 1; Month 3
Secondary	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.	baseline; Week 4; Month 1; Month 3