Clinical trial NCT03853902: Mindfulness Online for Symptom Alleviation and Improvement in Cancer of the Prostate
Official title: MOSAIC-P: Mindfulness Online for Symptom Alleviation and Improvement in Cancer of the Prostate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate cancer
mindfulness
MBSR
online course
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Endeavor Health
First posted: 2019-02-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized into a mindfulness course online or a mindfulness course in-person
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study, the researchers will examine the effects of a 4-week online mindfulness intervention, compared to a face-to-face mindfulness intervention, to reduce self-reported symptoms of fatigue, anxiety, depression, sleep disturbance, and pain interference in a sample of patients with metastatic prostate cancer.

Detailed description: Participants will be recruited from multiple locations, including NorthShore University Health System's Kellogg Cancer Center (KCC) and local community organizations (e.g., UsToo meetings, Cancer Wellness Center). Participating physician researchers will identify their eligible patients from the electronic medical record and will mail them a letter of invitation to learn more about the study and consider enrolling. Each participant will be e-mailed a link to the baseline questionnaire. After baseline completion, participants will be randomized, using an online random number generator, to the online course or face-to-face course. Course orientation for both groups will be held on the same night, but at different times. The separate orientations will be scheduled with a thirty minute break in between, in order to prevent intermixing of the groups and potential dissatisfaction among participants about their assigned group. In the orientation for the online class, participants will become familiar with the online video conferencing program Zoom, be introduced to other group participants, and receive a clear overview of what to expect for the 4-week mindfulness course. In the orientation for the face-to-face class, participants will be introduced to other group participants and receive a clear overview of what to expect for the 4-week mindfulness course. Participants will meet for approximately 2.5 hours each week for 4 weeks online or face-to-face. In addition, a face to face half day retreat will occur after the third class, in which participants from both face to face and online courses may attend. In the event that a participant unexpectedly misses a class, the instructor will follow-up with them and review the material covered in class. The class instructor may contact participants up to 3 times to review class expectations and teachings prior to or during the 4-week program. Participants will once again be asked to complete the online assessment.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of clinically advanced prostate cancer (e.g., castrate-sensitive, metastatic \[clinical metastasis\], castrate-resistant, non-metastatic \[rising PSA on LHRH\], castrate-resistant, metastatic)
* Receiving some form of cancer treatment (e.g., androgen deprivation therapy, chemotherapy
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-217
* At least 18 years of age
* Able to speak, read and understand English
* Able to perform basic activities of daily living (as determined by referring physician)
* Cognitively intact and free of serious psychiatric illness (as determined by referring physician)
* Access to internet connection within a room where patient will not be interrupted. This room needs to have an open space of about 6ft by 5 ft to allow for gentle movement and stretching.
* Access to a laptop or desktop computer with a camera. In the event that a patient does not have access to a computer, but is committed to the course, a laptop will be lent to him from the Department of Medical Social Sciences at Northwestern University.
* Willing to commit to the online MBSR course
* Willing to complete pre- and post-test assessments
* Physically able to participate in gentle Hatha yoga postures that are geared towards cancer patient populations, as determined by referring physician or medical team member

Exclusion Criteria:

* Regular user of MBSR or a similar mind-body therapy, which is defined as ≥ 4 times a week for the past 2 weeks
* Men with a short life expectancy as determined by the referring oncologist

Primary outcomes:
measure: Change in pain interference using the PROMIS Pain Interference questionnaire
timeFrame: baseline, week 4
measure: Change in sleep using the PROMIS Sleep Disturbance questionnaire
timeFrame: baseline, week 4
measure: Change in depression using the PROMIS Depression questionnaire
timeFrame: baseline, week 4
measure: Change in anxiety using the PROMIS Anxiety questionnaire
timeFrame: baseline, week 4
measure: Change in fatigue using the PROMIS Fatigue questionnaire
timeFrame: baseline, week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
Study officials:
affiliation: Northwestern University
name: David E Victorson, PhD
role: PRINCIPAL_INVESTIGATOR
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