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| Name | Class |
|---|---|
| Endeavor Health | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness text/email message | Experimental | 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. |
|
| Health promotion text/email message | Placebo Comparator | Weekly general/informational texts or emails about healthy living and lifestyle were sent. TYPES OF MESSAGES INCLUDED: Diet; Exercise; Sleep; Illness; Stress. |
|
| No text/email message | No Intervention | No texts or emails were sent. There are no examples or descriptions for these messages, because no messages were sent to this group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text or email message | Behavioral | Text or email messages sent to research participants |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David E Victorson, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States | ||
| NorthShore University HealthSystem |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17632144 | Background | Latini DM, Hart SL, Knight SJ, Cowan JE, Ross PL, Duchane J, Carroll PR; CaPSURE Investigators. The relationship between anxiety and time to treatment for patients with prostate cancer on surveillance. J Urol. 2007 Sep;178(3 Pt 1):826-31; discussion 831-2. doi: 10.1016/j.juro.2007.05.039. Epub 2007 Jul 16. | |
| 17992025 | Background |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D007680 | Kidney Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
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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.
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Participants were not told to which weekly text messaging group they were being assigned, or about the other groups.
| 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 |
| Evanston |
| Illinois |
| 60201 |
| United States |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D014571 | Urologic Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D001745 | Urinary Bladder Diseases |