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Reducing the Effects of Active Surveillance Stress, Uncertainty and Rumination Thru Engagement in Mindfulness Education (REASSUREME)

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Health promotion

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring prostate cancer, active surveillance, MBSR, couples, health promotion, quality of life, mindfulness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Must be diagnosed with prostate cancer and on active surveillance within the past 36 months (or the spouse or significant other of someone with prostate cancer on active surveillance)
Must be at least 18 years of age
Must be able to read, write, speak and understand English
Must be able to perform basic activities of daily living (as determined by referring physician)
Must be cognitively intact and free of serious psychiatric illness (as determined by referring physician)
Must have access to the internet and ability to locate the assessment URL and/or ability to use a touchscreen keypad on a tablet device
Must be willing to commit to the 8-week MBSR or Health Promotion course, which includes attending weekly, 2.5 hours classes over an 8 week period, a half-day retreat between week 6 and 7 , and daily homework assignments
Must be willing to complete study assessments

Exclusion Criteria:

Unable to provide consent
Bedridden, or physical debilitation such that study participation would not be feasible or would create undue hardship

Sites / Locations

Northwestern University
NorthShore University HealthSystem
University of Michigan
Fox Chase Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MBSR (Mindfulness condition)

HealthPro (Control Matched Condition)

Arm Description

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 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.

Outcomes

Primary Outcome Measures

longitudinal change in psychological responses as assessed through online survey

Secondary Outcome Measures

relation between psychological responses to AS as assessed by online survey

dyadic factors on psychological responses as assessed by online survey

Full Information

NCT ID

NCT02871752

First Posted

August 5, 2016

Last Updated

March 9, 2023

Sponsor

Northwestern University

Collaborators

Fox Chase Cancer Center, University of Michigan, NorthShore University HealthSystem, National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT02871752

Brief Title

Reducing the Effects of Active Surveillance Stress, Uncertainty and Rumination Thru Engagement in Mindfulness Education

Acronym

REASSUREME

Official Title

Reducing the Effects of Active Surveillance Stress, Uncertainty and Rumination Thru Engagement in Mindfulness Education

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

August 10, 2016 (Actual)

Primary Completion Date

January 30, 2023 (Actual)

Study Completion Date

January 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

Collaborators

Fox Chase Cancer Center, University of Michigan, NorthShore University HealthSystem, National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

prostate cancer, active surveillance, MBSR, couples, health promotion, quality of life, mindfulness

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

225 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MBSR (Mindfulness condition)

Arm Type

Experimental

Arm Description

Arm Title

HealthPro (Control Matched Condition)

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Health promotion

Intervention Description

mindfulness-based stress reduction

Primary Outcome Measure Information:

Title

longitudinal change in psychological responses as assessed through online survey

Description

longitudinal change in psychological responses as assessed through online survey

Time Frame

Baseline, Week 8, Month 6, Month 12

Secondary Outcome Measure Information:

Title

relation between psychological responses to AS as assessed by online survey

Description

relation between psychological responses to AS as assessed by online survey

Time Frame

Baseline, Week 8, Month 6, Month 12

Title

dyadic factors on psychological responses as assessed by online survey

Description

dyadic factors on psychological responses as assessed by online survey

Time Frame

Baseline, Week 8, Month 6, Month 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Must be diagnosed with prostate cancer and on active surveillance within the past 36 months (or the spouse or significant other of someone with prostate cancer on active surveillance) Must be at least 18 years of age Must be able to read, write, speak and understand English Must be able to perform basic activities of daily living (as determined by referring physician) Must be cognitively intact and free of serious psychiatric illness (as determined by referring physician) Must have access to the internet and ability to locate the assessment URL and/or ability to use a touchscreen keypad on a tablet device Must be willing to commit to the 8-week MBSR or Health Promotion course, which includes attending weekly, 2.5 hours classes over an 8 week period, a half-day retreat between week 6 and 7 , and daily homework assignments Must be willing to complete study assessments Exclusion Criteria: Unable to provide consent Bedridden, or physical debilitation such that study participation would not be feasible or would create undue hardship

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David E Victorson, Ph.D.

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

NorthShore University HealthSystem

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Fox Chase Cancer Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19111

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

11745222

Citation

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.

Results Reference

background

PubMed Identifier

15858824

Citation

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.

Results Reference

background

PubMed Identifier

12203744

Citation

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.

Results Reference

background

Citation

American Cancer Society, Cancer Facts and Figures 2013. American Cancer Society, 2013.

Results Reference

background

PubMed Identifier

15717315

Citation

Salminen EK, Portin RI, Koskinen AI, Helenius HY, Nurmi MJ. Estradiol and cognition during androgen deprivation in men with prostate carcinoma. Cancer. 2005 Apr 1;103(7):1381-7. doi: 10.1002/cncr.20962.

Results Reference

background

PubMed Identifier

15274067

Citation

Krupski TL, Smith MR, Lee WC, Pashos CL, Brandman J, Wang Q, Botteman M, Litwin MS. Natural history of bone complications in men with prostate carcinoma initiating androgen deprivation therapy. Cancer. 2004 Aug 1;101(3):541-9. doi: 10.1002/cncr.20388. Erratum In: Cancer. 2004 Nov 15;101(10):2370.

Results Reference

background

PubMed Identifier

11413511

Citation

Smith MR, McGovern FJ, Fallon MA, Schoenfeld D, Kantoff PW, Finkelstein JS. Low bone mineral density in hormone-naive men with prostate carcinoma. Cancer. 2001 Jun 15;91(12):2238-45.

Results Reference

background

PubMed Identifier

12231056

Citation

Smith MR. Osteoporosis during androgen deprivation therapy for prostate cancer. Urology. 2002 Sep;60(3 Suppl 1):79-85; discussion 86.

Results Reference

background

PubMed Identifier

12476433

Citation

Pirl WF, Siegel GI, Goode MJ, Smith MR. Depression in men receiving androgen deprivation therapy for prostate cancer: a pilot study. Psychooncology. 2002 Nov-Dec;11(6):518-23. doi: 10.1002/pon.592.

Results Reference

background

PubMed Identifier

15959911

Citation

Dale W, Bilir P, Han M, Meltzer D. The role of anxiety in prostate carcinoma: a structured review of the literature. Cancer. 2005 Aug 1;104(3):467-78. doi: 10.1002/cncr.21198.

Results Reference

background

PubMed Identifier

15017184

Citation

Cooperberg MR, Broering JM, Litwin MS, Lubeck DP, Mehta SS, Henning JM, Carroll PR; CaPSURE Investigators. The contemporary management of prostate cancer in the United States: lessons from the cancer of the prostate strategic urologic research endeavor (CapSURE), a national disease registry. J Urol. 2004 Apr;171(4):1393-401. doi: 10.1097/01.ju.0000107247.81471.06.

Results Reference

background

PubMed Identifier

16713065

Citation

Roemeling S, Roobol MJ, Postma R, Gosselaar C, van der Kwast TH, Bangma CH, Schroder FH. Management and survival of screen-detected prostate cancer patients who might have been suitable for active surveillance. Eur Urol. 2006 Sep;50(3):475-82. doi: 10.1016/j.eururo.2006.04.019. Epub 2006 May 3.

Results Reference

background

PubMed Identifier

23392076

Citation

Ganz PA, Barry JM, Burke W, Col NF, Corso PS, Dodson E, Hammond ME, Kogan BA, Lynch CF, Newcomer L, Seifter EJ, Tooze JA, Viswanath KV, Wessells H. NIH State-of-the-Science Conference Statement: Role of active surveillance in the management of men with localized prostate cancer. NIH Consens State Sci Statements. 2011 Dec 5-7;28(1):1-27.

Results Reference

background

PubMed Identifier

14761814

Citation

Parker C. Active surveillance: towards a new paradigm in the management of early prostate cancer. Lancet Oncol. 2004 Feb;5(2):101-6. doi: 10.1016/S1470-2045(04)01384-1.

Results Reference

background

PubMed Identifier

15224088

Citation

Parker C. Active surveillance of early prostate cancer: rationale, initial results and future developments. Prostate Cancer Prostatic Dis. 2004;7(3):184-7. doi: 10.1038/sj.pcan.4500720.

Results Reference

background

PubMed Identifier

23271780

Citation

Bergman J, Litwin MS. Quality of life in men undergoing active surveillance for localized prostate cancer. J Natl Cancer Inst Monogr. 2012 Dec;2012(45):242-9. doi: 10.1093/jncimonographs/lgs026.

Results Reference

background

PubMed Identifier

23422588

Citation

Kazer MW, Psutka SP, Latini DM, Bailey DE Jr. Psychosocial aspects of active surveillance. Curr Opin Urol. 2013 May;23(3):273-7. doi: 10.1097/MOU.0b013e32835eff24.

Results Reference

background

PubMed Identifier

11305069

Citation

Carlson LE, Ursuliak Z, Goodey E, Angen M, Speca M. The effects of a mindfulness meditation-based stress reduction program on mood and symptoms of stress in cancer outpatients: 6-month follow-up. Support Care Cancer. 2001 Mar;9(2):112-23. doi: 10.1007/s005200000206.

Results Reference

background

PubMed Identifier

9097338

Citation

Astin JA. Stress reduction through mindfulness meditation. Effects on psychological symptomatology, sense of control, and spiritual experiences. Psychother Psychosom. 1997;66(2):97-106. doi: 10.1159/000289116.

Results Reference

background

PubMed Identifier

19801710

Citation

Wong SY. Effect of mindfulness-based stress reduction programme on pain and quality of life in chronic pain patients: a randomised controlled clinical trial. Hong Kong Med J. 2009 Oct;15 Suppl 6:13-4. No abstract available.

Results Reference

background

PubMed Identifier

19432513

Citation

Chiesa A, Serretti A. Mindfulness-based stress reduction for stress management in healthy people: a review and meta-analysis. J Altern Complement Med. 2009 May;15(5):593-600. doi: 10.1089/acm.2008.0495.

Results Reference

background

PubMed Identifier

19023879

Citation

Ledesma D, Kumano H. Mindfulness-based stress reduction and cancer: a meta-analysis. Psychooncology. 2009 Jun;18(6):571-9. doi: 10.1002/pon.1400.

Results Reference

background

PubMed Identifier

20488270

Citation

Bohlmeijer E, Prenger R, Taal E, Cuijpers P. The effects of mindfulness-based stress reduction therapy on mental health of adults with a chronic medical disease: a meta-analysis. J Psychosom Res. 2010 Jun;68(6):539-44. doi: 10.1016/j.jpsychores.2009.10.005. Epub 2009 Dec 9.

Results Reference

background

Citation

Kabat-Zinn, J., Full Catastrophe Living: Using the Wisdom of your Mind to Face Stress, Pain and Illness. 1990, New York: Dell Publishing.

Results Reference

background

PubMed Identifier

1609875

Citation

Kabat-Zinn J, Massion AO, Kristeller J, Peterson LG, Fletcher KE, Pbert L, Lenderking WR, Santorelli SF. Effectiveness of a meditation-based stress reduction program in the treatment of anxiety disorders. Am J Psychiatry. 1992 Jul;149(7):936-43. doi: 10.1176/ajp.149.7.936.

Results Reference

background

PubMed Identifier

21320700

Citation

Vollestad J, Sivertsen B, Nielsen GH. Mindfulness-based stress reduction for patients with anxiety disorders: evaluation in a randomized controlled trial. Behav Res Ther. 2011 Apr;49(4):281-8. doi: 10.1016/j.brat.2011.01.007. Epub 2011 Jan 27.

Results Reference

background

PubMed Identifier

20882729

Citation

Gross CR, Kreitzer MJ, Thomas W, Reilly-Spong M, Cramer-Bornemann M, Nyman JA, Frazier P, Ibrahim HN. Mindfulness-based stress reduction for solid organ transplant recipients: a randomized controlled trial. Altern Ther Health Med. 2010 Sep-Oct;16(5):30-8.

Results Reference

background

PubMed Identifier

21397868

Citation

Gross CR, Kreitzer MJ, Reilly-Spong M, Wall M, Winbush NY, Patterson R, Mahowald M, Cramer-Bornemann M. Mindfulness-based stress reduction versus pharmacotherapy for chronic primary insomnia: a randomized controlled clinical trial. Explore (NY). 2011 Mar-Apr;7(2):76-87. doi: 10.1016/j.explore.2010.12.003.

Results Reference

background

PubMed Identifier

12883107

Citation

Carlson LE, Speca M, Patel KD, Goodey E. Mindfulness-based stress reduction in relation to quality of life, mood, symptoms of stress, and immune parameters in breast and prostate cancer outpatients. Psychosom Med. 2003 Jul-Aug;65(4):571-81. doi: 10.1097/01.psy.0000074003.35911.41.

Results Reference

background

PubMed Identifier

16262547

Citation

Carlson LE, Garland SN. Impact of mindfulness-based stress reduction (MBSR) on sleep, mood, stress and fatigue symptoms in cancer outpatients. Int J Behav Med. 2005;12(4):278-85. doi: 10.1207/s15327558ijbm1204_9.

Results Reference

background

PubMed Identifier

20129404

Citation

Matousek RH, Dobkin PL, Pruessner J. Cortisol as a marker for improvement in mindfulness-based stress reduction. Complement Ther Clin Pract. 2010 Feb;16(1):13-9. doi: 10.1016/j.ctcp.2009.06.004. Epub 2009 Jul 4.

Results Reference

background

PubMed Identifier

21457893

Citation

Matousek RH, Pruessner JC, Dobkin PL. Changes in the cortisol awakening response (CAR) following participation in mindfulness-based stress reduction in women who completed treatment for breast cancer. Complement Ther Clin Pract. 2011 May;17(2):65-70. doi: 10.1016/j.ctcp.2010.10.005. Epub 2010 Nov 26.

Results Reference

background

PubMed Identifier

14749092

Citation

Carlson LE, Speca M, Patel KD, Goodey E. Mindfulness-based stress reduction in relation to quality of life, mood, symptoms of stress and levels of cortisol, dehydroepiandrosterone sulfate (DHEAS) and melatonin in breast and prostate cancer outpatients. Psychoneuroendocrinology. 2004 May;29(4):448-74. doi: 10.1016/s0306-4530(03)00054-4.

Results Reference

background

PubMed Identifier

17327889

Citation

Lamanque P, Daneault S. [Does meditation improve the quality of life for patients living with cancer?]. Can Fam Physician. 2006 Apr;52(4):474-5. French.

Results Reference

background

PubMed Identifier

17878133

Citation

Matchim Y, Armer JM. Measuring the psychological impact of mindfulness meditation on health among patients with cancer: a literature review. Oncol Nurs Forum. 2007 Sep;34(5):1059-66. doi: 10.1188/07.ONF.1059-1066.

Results Reference

background

PubMed Identifier

21356643

Citation

Matchim Y, Armer JM, Stewart BR. Mindfulness-based stress reduction among breast cancer survivors: a literature review and discussion. Oncol Nurs Forum. 2011 Mar;38(2):E61-71. doi: 10.1188/11.ONF.E61-E71.

Results Reference

background

PubMed Identifier

16685074

Citation

Ott MJ, Norris RL, Bauer-Wu SM. Mindfulness meditation for oncology patients: a discussion and critical review. Integr Cancer Ther. 2006 Jun;5(2):98-108. doi: 10.1177/1534735406288083.

Results Reference

background

PubMed Identifier

16194185

Citation

Smith JE, Richardson J, Hoffman C, Pilkington K. Mindfulness-Based Stress Reduction as supportive therapy in cancer care: systematic review. J Adv Nurs. 2005 Nov;52(3):315-27. doi: 10.1111/j.1365-2648.2005.03592.x. Erratum In: J Adv Nurs. 2006 Mar;53(5):618.

Results Reference

background

PubMed Identifier

11696736

Citation

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.

Results Reference

background

PubMed Identifier

17532857

Citation

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.

Results Reference

background

PubMed Identifier

36563902

Citation

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.

Results Reference

result

PubMed Identifier

31285713

Citation

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.

Results Reference

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Reducing the Effects of Active Surveillance Stress, Uncertainty and Rumination Thru Engagement in Mindfulness Education

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