Mind-Body Health in Uro-Oncology: Research Study

Study Overview
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Brief Summary
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In this study, the researchers will examine the effects of post-mindfulness intervention email and text messages to promote maintenance of intervention effects over time in a uro-oncology sample (clinically localized prostate, kidney, and bladder cancer) of patients and spouses.

Detailed Description
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Participant accrual will occur at NorthShore University HealthSystem's John and Carol Walter Center for Urological Health. During or prior to an office visit, a potential subject and possibly his/her spouse will speak with the physician or research staff to assess interest in discussing the study. All eligible participants will be enrolled into an 8-week mindfulness-based stress reduction (MBSR) course. Because the course content focuses on training in mindfulness meditation (and not cancer-specific issues), the researchers will allow for mixed cancer classes. Prior to the first class, all participants will complete baseline standardized patient reported outcomes (PROs) of health related quality of life, and undergo blood collection via finger prick. Following participation in the 8-week course, participants will complete their 8-week PRO and bio-marker assessments in a similar manner, and will be randomized to either 4 months of: 1) weekly mindfulness-specific text or email messages related to course teachings, 2) weekly general/informational texts or emails about healthy living and lifestyle, or 3) no texts or emails. PRO and bio-marker assessments will also be administered at 6 months, and PRO measures will be collected at 12 months.

Official Title
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Mind-Body Health in Uro-Oncology: A Randomized Controlled Trial

Conditions
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Prostate Cancer, Kidney Cancer, Bladder Cancer

Intervention / Treatment
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* Behavioral: Text or email message


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with clinically localized or locally advanced prostate, kidney or bladder cancer OR the spouse/significant other (married or living together ≥ 1 year) of a person with prostate, kidney or bladder cancer Spouses/significant others will only be included if their partners with cancer diagnoses will be participating 18 years old or older Proficient in comprehending spoken English. Proficient in reading and writing English. Exclusion Criteria: Is not able to receive email or text messages History of diagnosed severe mental illness or hospitalization for chronic psychiatric reasons, as identified by referring physicians, such that participation in MBSR group activities would be contraindicated. Vision- or hearing-impaired such that ability to listen to or observe MBSR course instructions is compromised. Diminished cognitive skills as to render consent meaningless Physical debilitation such that study participation would not be feasible or would create undue hardship. Participation in the intervention arm of the preceding study, Reducing Stress During Active Surveillance EH09-202.

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: Following participation in the 8-week course, participants will be randomized to either 4 months of: 1) weekly MBSR specific text or email messages related to course teachings, 2) weekly general/informational texts or emails about healthy living and lifestyle, or 3) no texts or emails.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness text/email message<br>Weekly MBSR specific text or email messages related to course teachings were sent. TYPES OF MESSAGES INCLUDED: Non-reaction; Non-Judgment; Awareness; Loving Kindness; Acceptance. | Behavioral: Text or email message<br>* Text or email messages sent to research participants<br>|
| Placebo Comparator: Health promotion text/email message<br>Weekly general/informational texts or emails about healthy living and lifestyle were sent. TYPES OF MESSAGES INCLUDED: Diet; Exercise; Sleep; Illness; Stress. | Behavioral: Text or email message<br>* Text or email messages sent to research participants<br>|
| No Intervention: No text/email message<br>No texts or emails were sent. There are no examples or descriptions for these messages, because no messages were sent to this group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in fatigue using the PROMIS Fatigue questionnaire | Examine change in fatigue between the intervention arms by comparing the responses on the PROMIS Fatigue questionnaire | baseline, 8 weeks, 6 months, 12 months | 
| change in depression using the PROMIS Depression questionnaire | Examine change in depression between the intervention arms by comparing the responses on the PROMIS Depression questionnaire | baseline, 8 weeks, 6 months, 12 months | 
| change in anxiety using the PROMIS Anxiety questionnaire | Examine change in anxiety between the intervention arms by comparing the responses on the PROMIS Anxiety questionnaire | baseline, 8 weeks, 6 months, 12 months | 
| change in sleep using the PROMIS Sleep Disturbance questionnaire | Examine change in sleep between the intervention arms by comparing the responses on the PROMIS Sleep Disturbance questionnaire | baseline, 8 weeks, 6 months, 12 months | 
| change in physical function using the PROMIS Physical Function questionnaire | Examine change in physical function between the intervention arms by comparing the responses on the PROMIS Physical Function questionnaire | baseline, 8 weeks, 6 months, 12 months | 
| change in stress using the State-Based Stress Visual Analogue Scale | Examine change in stress between the intervention arms by comparing the responses on the State-Based Stress Visual Analogue Scale | baseline, 8 weeks, 6 months, 12 months | 
| change in mindfulness using the 5-Facet Mindfulness Sub-scales | Examine change in mindfulness between the intervention arms by comparing the responses on the 5-Facet Mindfulness Subscales | baseline, 8 weeks, 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, mindfulness, eHealth, kidney cancer, bladder cancer, caregiver