Mindfulness Online for Symptom Alleviation and Improvement in Cancer of the Prostate

Study Overview
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Brief Summary
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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
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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.

Official Title
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MOSAIC-P: Mindfulness Online for Symptom Alleviation and Improvement in Cancer of the Prostate

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: Mindfulness Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized into a mindfulness course online or a mindfulness course in-person
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Program Online<br>Online 4-week mindfulness program that is intended to reduce stress and improve the quality of life of patients with metastatic prostate cancer | Behavioral: Mindfulness Program<br>* Mindfulness Program<br>|
| Active Comparator: Mindfulness Program Face-to-Face<br>In-person 4-week mindfulness program that is intended to reduce stress and improve the quality of life of patients with metastatic prostate cancer | Behavioral: Mindfulness Program<br>* Mindfulness Program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain interference using the PROMIS Pain Interference questionnaire | Participants were administered the PROMIS Pain Interference questionnaire. The PROMIS Pain Interference measures the self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. PROMIS Pain interference also incorporates items probing sleep and enjoyment in life, though it only contains one sleep item. The PROMIS Pain Interference is generic rather than disease-specific. It assesses pain interference over the past seven days. Each question has five response options ranging in value from one to five (1=not at all; 2=a little bit; 3=somewhat; 4=quite a bit; 5=very much). To find the total raw score, sum the values of the response to each question. The lowest possible raw score is 8; the highest possible raw score is 40. A higher score represents more of the concept being measured. | baseline, week 4 | 
| Change in sleep using the PROMIS Sleep Disturbance questionnaire | Participants were administered the PROMIS Sleep Disturbance questionnaire. The PROMIS Sleep Disturbance assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. It does not focus on symptoms of specific sleep disorders, nor does it provide subjective estimates of sleep quantities. The PROMIS Sleep Disturbance is universal rather than disease-specific. It assesses sleep disturbance over the past seven days. Each question has five response options ranging in value from one to five (1=not at all; 2=a little bit; 3=somewhat; 4=quite a bit; 5=very much). To find the total raw score, sum the values of the response to each question. The lowest possible raw score is 8; the highest possible raw score is 40. A higher score represents more of the concept being measured. | baseline, week 4 | 
| Change in depression using the PROMIS Depression questionnaire | Participants were administered the PROMIS Depression questionnaire. The PROMIS Depression assesses self-reported negative mood (sadness, guilt), views of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). Somatic symptoms are not included, which eliminates consideration of these items' confounding effects when assessing patients with co-morbid physical conditions. The PROMIS Depression is universal rather than disease-specific. It assesses depression over the past seven days. Each question has five response options ranging in value from one to five (1=never; 2=rarely; 3=sometimes; 4=often; 5=always). To find the total raw score, sum the values of the response to each question. The lowest possible raw score is 8; the highest possible raw score is 40. A higher score represents more of the concept being measured. | baseline, week 4 | 
| Change in anxiety using the PROMIS Anxiety questionnaire | Participants were administered the PROMIS Anxiety questionnaire. The PROMIS Anxiety measures self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). Anxiety is best differentiated by symptoms that reflect autonomic arousal and experience of threat. Only one behavioral avoidance item is included; therefore, behavioral fear avoidance is not fully evaluated. The PROMIS Anxiety is universal rather than disease-specific. It assesses anxiety over the past seven days. Each question has five response options ranging in value from one to five (1=never; 2=rarely; 3=sometimes; 4=often; 5=always). To find the total raw score, sum the values of the response to each question. The lowest possible raw score is 8; the highest possible raw score is 40. A higher score represents more of the concept being measured. | baseline, week 4 | 
| Change in fatigue using the PROMIS Fatigue questionnaire | Participants were administered the PROMIS Fatigue questionnaire. The PROMIS Fatigue evaluates a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities.The PROMIS Fatigue is universal rather than disease-specific. It assesses fatigue over the past seven days. Each question has five response options ranging in value from one to five (1=never; 2=rarely; 3=sometimes; 4=often; 5=always). To find the total raw score, sum the values of the response to each question. The lowest possible raw score is 8; the highest possible raw score is 40. A higher score represents more of the concept being measured. | baseline, week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, mindfulness, MBSR, online course