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Completed

NCT Number: NCT03852017

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Audio Program

Behavioral

Primary outcomes

  1. 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).

  2. 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).

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 22, 2019
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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