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

Northwestern University

Status: Completed

Conditions: Prostate Cancer

Treatments: Behavioral: Audio Program

Study type: Interventional

Funder types: Other

Identifiers

NCT03852017

STU00200537

Details and patient eligibility

About

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.

Full 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.

Enrollment: 59 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 2 patient groups

Mindfulness Audio Program

Experimental group

Description:

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

Treatment:

Behavioral: Audio Program

Music Audio Program

Active Comparator group

Description:

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

Treatment:

Behavioral: Audio Program