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

May 4, 2023 updated by: David Victorson, Northwestern University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness Audio Program
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
Behavioral: Audio Program
Active Comparator: Music Audio Program
Music Audio Program is a daily audio session of peaceful and relaxing music
Behavioral: Audio Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implementation feasibility measured by enrollment rate
Time Frame: 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).
Baseline
Implementation feasibility measured by retention rate
Time Frame: 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).
Throughout study completion, a total of four months.
Implementation feasibility measured by intervention adherence
Time Frame: 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.
Throughout the study intervention period, a total of 4 weeks.
Program acceptability measured by a post-program survey at 4-weeks
Time Frame: 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.
Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Significant change in fatigue using the PROMIS Fatigue questionnaire
Time Frame: 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.
baseline; Week 4; Month 1; Month 3
Significant change in anxiety using the PROMIS Anxiety questionnaire
Time Frame: 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.
baseline; Week 4; Month 1; Month 3
Change in depression using the PROMIS Depression questionnaire
Time Frame: 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.
baseline; Week 4; Month 1; Month 3
Change in sleep using the PROMIS Sleep Disturbance questionnaire
Time Frame: 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.
baseline; Week 4; Month 1; Month 3
Change in uncertainty intolerance using the Intolerance for Uncertainty Scale
Time Frame: 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.
baseline; Week 4; Month 1; Month 3
Change in fear of recurrence using the MAX-PC Fear of Recurrence sub-scale
Time Frame: 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.
baseline; Week 4; Month 1; Month 3
Change in mindfulness using the Mindful Attention Awareness Scale
Time Frame: 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.
baseline; Week 4; Month 1; Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: David E Victorson, PhD, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2015

Primary Completion (Actual)

January 8, 2018

Study Completion (Actual)

January 8, 2018

Study Registration Dates

First Submitted

December 12, 2018

First Submitted That Met QC Criteria

February 21, 2019

First Posted (Actual)

February 22, 2019

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00200537

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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