Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT03853902
Status:
COMPLETED
Last Update Posted:
2023-05-11
First Post:
2018-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mindfulness Online for Symptom Alleviation and Improvement in Cancer of the Prostate
Sponsor:
Northwestern University
Organization:
Study Overview
Official Title:
MOSAIC-P: Mindfulness Online for Symptom Alleviation and Improvement in Cancer of the Prostate
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: