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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA193331-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Fox Chase Cancer Center | OTHER |
| University of Michigan | OTHER |
| Endeavor Health | OTHER |
| National Cancer Institute (NCI) |
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We propose to examine the efficacy of couples-based mindfulness-based stress reduction (MBSR) on positive and negative psychological responses to active surveillance (AS) and AS adherence, with a sample of men on AS and their spouses.
The current study proposes to examine the efficacy of couples-based mindfulness-based stress reduction (MBSR) on positive and negative psychological responses to active surveillance (AS) and AS adherence, with a larger, more geographically representative sample of men on AS and their spouses. We will compare the MBSR intervention condition (Group A) with a health promotion and wellness condition (Group B) in a sample of prostate cancer patients and their spouses. We will evaluate its efficacy on self-reported measures of positive and negative psychological responses to AS.
PRIMARY AIM Examine longitudinal change in positive and negative psychological responses to AS between groups over time.
SECONDARY AIM Observe the relation between positive and negative psychological responses to AS and AS adherence between groups over time.
THIRD AIM Explore dyadic factors on positive and negative psychological responses to AS and AS adherence between groups over time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBSR (Mindfulness condition) | Experimental | MBSR (mindfulness-based stress reduction) is a group-based, 8-week program that was developed at the University of Massachusetts Stress Reduction Clinic under the direction of Jon Kabat-Zinn. MBSR is comprised of a structured, developmentally sequenced curriculum that uses a group format to experientially instruct participants in the practice of mindfulness meditation and mindful Hatha yoga. Each session includes different forms of meditation practice, such as cultivating awareness of thoughts, feelings and bodily sensations, and learning to incorporate this awareness during stressful emotional and/or physical life situations. Lesson activities include the following: (1) mindful meditation (e.g., awareness of breathing, body scan, sitting, walking); (2) yoga; and (3) group discussion. |
|
| HealthPro (Control Matched Condition) | Active Comparator | HealthPro is a health promotion program designed by Dr. David Victorson of Northwestern University Medical Social Sciences Department and his research team to function as a matched control for the MBSR intervention in this research study. The program teaches and promotes healthy behaviors, skills, and lifestyles. Major learning themes include: (1) health behavioral change readiness and self-assessment; (2) physical activity, movement, and non-sedentary lifestyles; (3) dietary and nutritional considerations for optimal health; (4) emotional wellness and coping with difficulties; (5) social engagement, relationships intimacy, and health; (6) managing bodily pain; (7) weight management and weight loss strategies; (8) health behavior maintenance over the long-term. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health promotion | Behavioral | mindfulness-based stress reduction |
|
| Measure | Description | Time Frame |
|---|---|---|
| longitudinal change in psychological responses as assessed through online survey | longitudinal change in psychological responses as assessed through online survey | Baseline, Week 8, Month 6, Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| relation between psychological responses to AS as assessed by online survey | relation between psychological responses to AS as assessed by online survey | Baseline, Week 8, Month 6, Month 12 |
| dyadic factors on psychological responses as assessed by online survey |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David E Victorson, Ph.D. | 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 |
|---|---|---|---|
| 11745222 | Background | Eton DT, Lepore SJ, Helgeson VS. Early quality of life in patients with localized prostate carcinoma: an examination of treatment-related, demographic, and psychosocial factors. Cancer. 2001 Sep 15;92(6):1451-9. doi: 10.1002/1097-0142(20010915)92:63.0.co;2-r. | |
| 15858824 | Background | Eton DT, Lepore SJ, Helgeson VS. Psychological distress in spouses of men treated for early-stage prostate carcinoma. Cancer. 2005 Jun 1;103(11):2412-8. doi: 10.1002/cncr.21092. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D006293 | Health Promotion |
| ID | Term |
|---|---|
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| NIH |
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dyadic factors on psychological responses as assessed by online survey |
| Baseline, Week 8, Month 6, Month 12 |
| Evanston |
| Illinois |
| 60201 |
| United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| 12203744 | Background | Eton DT, Lepore SJ. Prostate cancer and health-related quality of life: a review of the literature. Psychooncology. 2002 Jul-Aug;11(4):307-26. doi: 10.1002/pon.572. |
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| 11696736 | Background | Saxe GA, Hebert JR, Carmody JF, Kabat-Zinn J, Rosenzweig PH, Jarzobski D, Reed GW, Blute RD. Can diet in conjunction with stress reduction affect the rate of increase in prostate specific antigen after biochemical recurrence of prostate cancer? J Urol. 2001 Dec;166(6):2202-7. |
| 17532857 | Background | Pickles T, Ruether JD, Weir L, Carlson L, Jakulj F; SCRN Communication Team. Psychosocial barriers to active surveillance for the management of early prostate cancer and a strategy for increased acceptance. BJU Int. 2007 Sep;100(3):544-51. doi: 10.1111/j.1464-410X.2007.06981.x. Epub 2007 May 26. |
| 36563902 | Result | Victorson D, Morgan T, Kutikov A, Novakovic K, Kundu S, Horowitz B, Jackson K, Addington E, Murphy K, Sauer C, Brendler C. Mindfulness-based stress reduction for men on active surveillance for prostate cancer and their spouses: Design and methodology of a randomized controlled trial. Contemp Clin Trials. 2023 Feb;125:107059. doi: 10.1016/j.cct.2022.107059. Epub 2022 Dec 21. |
| 31285713 | Result | Schuette SAP, Cordero E, Slosburg K, Addington EL, Victorson D. A Scoping Review of Positive Lifestyle and Wellness Interventions to Inform the Development of a Comprehensive Health Promotion Program: "HealthPro". Am J Lifestyle Med. 2017 May 5;13(4):336-346. doi: 10.1177/1559827617704825. eCollection 2019 Jul-Aug. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |