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

NCT ID: NCT03852017

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-11
• Study Completion Date: 2018-01-08

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Audio Program

Intervention Type: BEHAVIORAL

Music Audio Program

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

Group Type: ACTIVE_COMPARATOR

Audio Program

Intervention Type: BEHAVIORAL

Interventions

Audio Program

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

David Victorson

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David E Victorson, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

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Other Identifiers

STU00200537

Identifier Type: -

Identifier Source: org_study_id