Clinical trial NCT03852030: Mind-Body Health in Uro-Oncology: Research Study
Official title: Mind-Body Health in Uro-Oncology: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Kidney Cancer
Bladder Cancer
Keywords: prostate cancer
mindfulness
eHealth
kidney cancer
bladder cancer
caregiver
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Endeavor Health
First posted: 2019-02-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: change in fatigue using the PROMIS Fatigue questionnaire
timeFrame: baseline, 8 weeks, 6 months, 12 months
measure: change in depression using the PROMIS Depression questionnaire
timeFrame: baseline, 8 weeks, 6 months, 12 months
measure: change in anxiety using the PROMIS Anxiety questionnaire
timeFrame: baseline, 8 weeks, 6 months, 12 months
measure: change in sleep using the PROMIS Sleep Disturbance questionnaire
timeFrame: baseline, 8 weeks, 6 months, 12 months
measure: change in physical function using the PROMIS Physical Function questionnaire
timeFrame: baseline, 8 weeks, 6 months, 12 months
measure: change in stress using the State-Based Stress Visual Analogue Scale
timeFrame: baseline, 8 weeks, 6 months, 12 months
measure: change in mindfulness using the 5-Facet Mindfulness Sub-scales
timeFrame: baseline, 8 weeks, 6 months, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
Study officials:
affiliation: Northwestern University
name: David E Victorson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Mehnert A, Lehmann C, Schulte T, Koch U. Presence of symptom distress and prostate cancer-related anxiety in patients at the beginning of cancer rehabilitation. Onkologie. 2007 Nov;30(11):551-6. doi: 10.1159/000108578. Epub 2007 Oct 16.
citation: Miller DC, Sanda MG, Dunn RL, Montie JE, Pimentel H, Sandler HM, McLaughlin WP, Wei JT. Long-term outcomes among localized prostate cancer survivors: health-related quality-of-life changes after radical prostatectomy, external radiation, and brachytherapy. J Clin Oncol. 2005 Apr 20;23(12):2772-80. doi: 10.1200/JCO.2005.07.116.
citation: Liu J, Mittendorf T, von der Schulenburg JM. A structured review and guide through studies on health-related quality of life in kidney cancer, hepatocellular carcinoma, and leukemia. Cancer Invest. 2010 Mar;28(3):312-22. doi: 10.3109/07357900903287022.
citation: Somani BK, Gimlin D, Fayers P, N'dow J. Quality of life and body image for bladder cancer patients undergoing radical cystectomy and urinary diversion--a prospective cohort study with a systematic review of literature. Urology. 2009 Nov;74(5):1138-43. doi: 10.1016/j.urology.2009.05.087. Epub 2009 Sep 20.
citation: Carpentier MY, Fortenberry JD. Romantic and sexual relationships, body image, and fertility in adolescent and young adult testicular cancer survivors: a review of the literature. J Adolesc Health. 2010 Aug;47(2):115-25. doi: 10.1016/j.jadohealth.2010.04.005. Epub 2010 Jun 11.
citation: Kuczyk M, Machtens S, Bokemeyer C, Schultheiss D, Jonas U. Sexual function and fertility after treatment of testicular cancer. Curr Opin Urol. 2000 Sep;10(5):473-7. doi: 10.1097/00042307-200009000-00018.
citation: Huddart RA, Norman A, Moynihan C, Horwich A, Parker C, Nicholls E, Dearnaley DP. Fertility, gonadal and sexual function in survivors of testicular cancer. Br J Cancer. 2005 Jul 25;93(2):200-7. doi: 10.1038/sj.bjc.6602677.
citation: Matos E, Skrbinc B, Zakotnik B. Fertility in patients treated for testicular cancer. J Cancer Surviv. 2010 Sep;4(3):274-8. doi: 10.1007/s11764-010-0135-9. Epub 2010 Jul 3.
citation: Cella D. Quality of life in patients with metastatic renal cell carcinoma: the importance of patient-reported outcomes. Cancer Treat Rev. 2009 Dec;35(8):733-7. doi: 10.1016/j.ctrv.2009.07.003. Epub 2009 Aug 21.
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.
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.
citation: Kabat-Zinn J. Full Catastrophe Living: Using the Wisdom of your Mind to Face Stress, Pain and Illness. New York: Dell Publishing; 1990
citation: Bishop SR, Lau M, Shapiro S et al. Mindfulness: A Proposed Ooperational Definition. Clinical Psychology: Science and Practice 2004;11(3):230-241
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.
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.
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.
citation: McDade TW, Williams S, Snodgrass JJ. What a drop can do: dried blood spots as a minimally invasive method for integrating biomarkers into population-based research. Demography. 2007 Nov;44(4):899-925. doi: 10.1353/dem.2007.0038.
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.
citation: Fuligni AJ, Telzer EH, Bower J, Cole SW, Kiang L, Irwin MR. A preliminary study of daily interpersonal stress and C-reactive protein levels among adolescents from Latin American and European backgrounds. Psychosom Med. 2009 Apr;71(3):329-33. doi: 10.1097/PSY.0b013e3181921b1f. Epub 2009 Feb 5.
citation: Bankier B, Barajas J, Martinez-Rumayor A, Januzzi JL. Association between C-reactive protein and generalized anxiety disorder in stable coronary heart disease patients. Eur Heart J. 2008 Sep;29(18):2212-7. doi: 10.1093/eurheartj/ehn326. Epub 2008 Jul 4.
citation: Bankier B, Barajas J, Martinez-Rumayor A, Januzzi JL. Association between anxiety and C-reactive protein levels in stable coronary heart disease patients. Psychosomatics. 2009 Jul-Aug;50(4):347-53. doi: 10.1176/appi.psy.50.4.347.
citation: Bankier B, Barajas J, Martinez-Rumayor A, Januzzi JL. Association between major depressive disorder and C-reactive protein levels in stable coronary heart disease patients. J Psychosom Res. 2009 Mar;66(3):189-94. doi: 10.1016/j.jpsychores.2008.09.010. Epub 2008 Oct 9.
citation: Howren MB, Lamkin DM, Suls J. Associations of depression with C-reactive protein, IL-1, and IL-6: a meta-analysis. Psychosom Med. 2009 Feb;71(2):171-86. doi: 10.1097/PSY.0b013e3181907c1b. Epub 2009 Feb 2.
citation: O'Donovan A, Hughes BM, Slavich GM, Lynch L, Cronin MT, O'Farrelly C, Malone KM. Clinical anxiety, cortisol and interleukin-6: evidence for specificity in emotion-biology relationships. Brain Behav Immun. 2010 Oct;24(7):1074-7. doi: 10.1016/j.bbi.2010.03.003. Epub 2010 Mar 18.
citation: Corwin EJ, Johnston N, Pugh L. Symptoms of postpartum depression associated with elevated levels of interleukin-1 beta during the first month postpartum. Biol Res Nurs. 2008 Oct;10(2):128-33. doi: 10.1177/1099800408323220.
citation: Slavich GM, O'Donovan A, Epel ES, Kemeny ME. Black sheep get the blues: a psychobiological model of social rejection and depression. Neurosci Biobehav Rev. 2010 Sep;35(1):39-45. doi: 10.1016/j.neubiorev.2010.01.003. Epub 2010 Jan 18.
citation: Cella D, Yount S, Rothrock N, Gershon R, Cook K, Reeve B, Ader D, Fries JF, Bruce B, Rose M; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years. Med Care. 2007 May;45(5 Suppl 1):S3-S11. doi: 10.1097/01.mlr.0000258615.42478.55.
citation: GUTHRIE R, SUSI A. A SIMPLE PHENYLALANINE METHOD FOR DETECTING PHENYLKETONURIA IN LARGE POPULATIONS OF NEWBORN INFANTS. Pediatrics. 1963 Sep;32:338-43. No abstract available.
citation: McDade TW, Stallings JF, Worthman CM. Culture change and stress in Western Samoan youth: Methodological issues in the cross-cultural study of stress and immune function. Am J Hum Biol. 2000 Nov 1;12(6):792-802. doi: 10.1002/1520-6300(200011/12)12:63.0.CO;2-F.
citation: McDade TW, Leonard WR, Burhop J, Reyes-Garcia V, Vadez V, Huanca T, Godoy RA. Predictors of C-reactive protein in Tsimane' 2 to 15 year-olds in lowland Bolivia. Am J Phys Anthropol. 2005 Dec;128(4):906-13. doi: 10.1002/ajpa.20222.
citation: Snodgrass JJ, Leonard WR, Tarskaia LA, McDade TW, Sorensen MV, Alekseev VP, Krivoshapkin VG. Anthropometric correlates of C-reactive protein among indigenous Siberians. J Physiol Anthropol. 2007 Mar;26(2):241-6. doi: 10.2114/jpa2.26.241.
citation: McDade TW, Rutherford JN, Adair L, Kuzawa C. Adiposity and pathogen exposure predict C-reactive protein in Filipino women. J Nutr. 2008 Dec;138(12):2442-7. doi: 10.3945/jn.108.092700.
citation: Mei JV, Alexander JR, Adam BW, Hannon WH. Use of filter paper for the collection and analysis of human whole blood specimens. J Nutr. 2001 May;131(5):1631S-6S. doi: 10.1093/jn/131.5.1631S.
citation: McDade TW, Shell-Duncan B. Whole blood collected on filter paper provides a minimally invasive method for assessing human transferrin receptor level. J Nutr. 2002 Dec;132(12):3760-3. doi: 10.1093/jn/132.12.3760.
citation: Victorson D, Hankin V, Polster R, McCurdy M, McGuire M, Brendler C. Reducing Symptoms of Anxiety for Men with Prostate Cancer on Active Surveillance and their Spouses: Initial Findings from a Randomized Clinical Trial. The Journal of Urology 2010;138(4):e180-e181
citation: Eyberg S, Edwards D, Boggs S, Foote R. Maintaining the Treatment Effects of Parent Training: The Role of Booster Sessions and Other Maintenance Strategies. Clinical Psychology: Science and Practice 1998;5:544-554
citation: Simkin-Silverman LR, Wing RR, Boraz MA, Meilahn EN, Kuller LH. Maintenance of cardiovascular risk factor changes among middle-aged women in a lifestyle intervention trial. Womens Health. 1998 Fall;4(3):255-71.
citation: Heron KE, Smyth JM. Ecological momentary interventions: incorporating mobile technology into psychosocial and health behaviour treatments. Br J Health Psychol. 2010 Feb;15(Pt 1):1-39. doi: 10.1348/135910709X466063. Epub 2009 Jul 28.
citation: Kirsch NL, Shenton M, Rowan J. A generic, 'in-house', alphanumeric paging system for prospective activity impairments after traumatic brain injury. Brain Inj. 2004 Jul;18(7):725-34. doi: 10.1080/02699050310001646161.
citation: Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.
citation: Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.
citation: Carleton RN, Norton MA, Asmundson GJ. Fearing the unknown: a short version of the Intolerance of Uncertainty Scale. J Anxiety Disord. 2007;21(1):105-17. doi: 10.1016/j.janxdis.2006.03.014. Epub 2006 May 2.
citation: Trapnell PD, Campbell JD. Private self-consciousness and the five-factor model of personality: distinguishing rumination from reflection. J Pers Soc Psychol. 1999 Feb;76(2):284-304. doi: 10.1037//0022-3514.76.2.284.
citation: Roth AJ, Rosenfeld B, Kornblith AB, Gibson C, Scher HI, Curley-Smart T, Holland JC, Breitbart W. The memorial anxiety scale for prostate cancer: validation of a new scale to measure anxiety in men with with prostate cancer. Cancer. 2003 Jun 1;97(11):2910-8. doi: 10.1002/cncr.11386.
citation: Pilkonis PA, Choi SW, Reise SP, Stover AM, Riley WT, Cella D; PROMIS Cooperative Group. Item banks for measuring emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS(R)): depression, anxiety, and anger. Assessment. 2011 Sep;18(3):263-83. doi: 10.1177/1073191111411667. Epub 2011 Jun 21.
citation: Funk JL, Rogge RD. Testing the ruler with item response theory: increasing precision of measurement for relationship satisfaction with the Couples Satisfaction Index. J Fam Psychol. 2007 Dec;21(4):572-83. doi: 10.1037/0893-3200.21.4.572.
citation: Rose M, Bjorner JB, Becker J, Fries JF, Ware JE. Evaluation of a preliminary physical function item bank supported the expected advantages of the Patient-Reported Outcomes Measurement Information System (PROMIS). J Clin Epidemiol. 2008 Jan;61(1):17-33. doi: 10.1016/j.jclinepi.2006.06.025.
citation: Gershon R. Comparing short forms and CAT across PROMIS. 2009
citation: Amtmann D, Cook KF, Jensen MP, Chen WH, Choi S, Revicki D, Cella D, Rothrock N, Keefe F, Callahan L, Lai JS. Development of a PROMIS item bank to measure pain interference. Pain. 2010 Jul;150(1):173-182. doi: 10.1016/j.pain.2010.04.025.
citation: Buysse DJ, Yu L, Moul DE, Germain A, Stover A, Dodds NE, Johnston KL, Shablesky-Cade MA, Pilkonis PA. Development and validation of patient-reported outcome measures for sleep disturbance and sleep-related impairments. Sleep. 2010 Jun;33(6):781-92. doi: 10.1093/sleep/33.6.781.
citation: Clements AD, Parker CR. The relationship between salivary cortisol concentrations in frozen versus mailed samples. Psychoneuroendocrinology. 1998 Aug;23(6):613-6. doi: 10.1016/s0306-4530(98)00031-6.
citation: Kirschbaum C, Wolf OT, May M, Wippich W, Hellhammer DH. Stress- and treatment-induced elevations of cortisol levels associated with impaired declarative memory in healthy adults. Life Sci. 1996;58(17):1475-83. doi: 10.1016/0024-3205(96)00118-x.