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

NCT03852017 | Completed

• 1 other identifier: STU00200537
• Study Type: interventional
• Target: 59
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostate Cancer

Keywords

prostate cancer; mindfulness; music

Outcome Measures

Primary Outcomes (4)

• 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

• 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.

• 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.

• 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 Outcomes (7)

• Significant change in fatigue using the PROMIS Fatigue questionnaire

  baseline; Week 4; Month 1; Month 3

• Significant change in anxiety using the PROMIS Anxiety questionnaire

  baseline; Week 4; Month 1; Month 3

• Change in depression using the PROMIS Depression questionnaire

  baseline; Week 4; Month 1; Month 3

• Change in sleep using the PROMIS Sleep Disturbance questionnaire

  baseline; Week 4; Month 1; Month 3

• Change in uncertainty intolerance using the Intolerance for Uncertainty Scale

  baseline; Week 4; Month 1; Month 3

Study Arms (2)

Mindfulness Audio Program

EXPERIMENTAL

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

Music Audio Program

ACTIVE COMPARATOR

Music Audio Program is a daily audio session of peaceful and relaxing music

Behavioral: Audio Program

Interventions

Audio Program BEHAVIORAL

Mindfulness Audio Program; Music Audio Program

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• \- Regular user of mindfulness meditation, which is defined as ≥ 3 times a week for the past 4 weeks

Sponsors & Collaborators

• Northwestern University: lead

Related Publications (33)

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MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• David E Victorson, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: February 22, 2019
• Study Start: November 11, 2015
• Primary Completion: January 8, 2018
• Study Completion: January 8, 2018
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share