Reducing Emotional Distress, Enhancing Function and Improving Network Engagement in Adolescent and Young Adult Oncology

Cancer Clinical Trial

— REDEFINEAYAO  

Official title:

REDEFINE AYAO: Reducing Emotional Distress, Enhancing Function and Improving Network Engagement in Adolescent and Young Adult Oncology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02495376
• Other study ID #: STU00093614
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: December 2017

Study information

• Verified date: July 2021
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We propose to examine the effects of mindfulness based stress reduction (MBSR) on outcomes of health related quality of life, disease symptoms, and biological correlates of stress in a sample of young adults with cancer. The proposed work will serve as an essential foundation for launching a program of clinical stress reduction research with this traditionally underserved population and has the potential to lead to the discovery of specific, modifiable psychosocial, behavioral, and biological mechanisms from which to address the problem of health disparities with this group.

Description:

Primary Objective Examine the feasibility and acceptability of MBSR with YACs. We hypothesize that MBSR will be feasible and acceptable with this population, which will be assessed through examination of response rate and study attrition variables.

Secondary Objectives

1. Evaluate the effects of MBSR on outcomes of health related quality of life and disease symptoms among YACs.

2. Explore the impact of different forms of eHealth maintenance support following the MBSR intervention (instructor-delivered, peer-delivered, no message) to help uphold intervention effects over time.

3. Compare intervention and control groups on changes in biologic measures of stress (blood pressure, pulse, salivary cortisol, CRP and IL-6 biomarkers) over a 32-week period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• Must have a diagnosis of any cancer between ages 18-39

• Must have signed and dated informed consent form, which includes agreeing to study procedures

• Must be currently between 18-39 years of age

• Must be able to read, write, speak and understand English

• Must be able to perform basic activities of daily living

• Must be cognitively intact and free of serious psychiatric illness

• Must have the ability to use a touchscreen keypad on a tablet device

• Must be willing to commit to either the MBSR course or waitlist control condition

• Must be willing to commit to eHealth intervention maintenance conditions

• Must be willing to complete all assessments

Exclusion Criteria:

• Bedridden, or physical debilitation such that study participation would not be feasible or would create undue hardship

• History of diagnosed severe mental illness or hospitalization for chronic psychiatric reasons, as identified by referring physicians

• Regular user of mindfulness-based stress reduction or a similar mind-body therapy (e.g., yoga, meditation), which is defined as = 3 times a week for the past 2 weeks

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• MBSR
Based primarily on the instruction of mindfulness meditation and yoga, MBSR 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.

Locations

Country	Name	City	State
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Northwestern University	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Northwestern University	American Cancer Society, Inc., Robert H. Lurie Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (90)

Adam EK, Doane LD, Zinbarg RE, Mineka S, Craske MG, Griffith JW. Prospective prediction of major depressive disorder from cortisol awakening responses in adolescence. Psychoneuroendocrinology. 2010 Jul;35(6):921-31. doi: 10.1016/j.psyneuen.2009.12.007. Epub 2010 Jan 15. — View Citation

Adam EK, Kumari M. Assessing salivary cortisol in large-scale, epidemiological research. Psychoneuroendocrinology. 2009 Nov;34(10):1423-36. doi: 10.1016/j.psyneuen.2009.06.011. Epub 2009 Jul 31. Review. — View Citation

Adam TC, Hasson RE, Ventura EE, Toledo-Corral C, Le KA, Mahurkar S, Lane CJ, Weigensberg MJ, Goran MI. Cortisol is negatively associated with insulin sensitivity in overweight Latino youth. J Clin Endocrinol Metab. 2010 Oct;95(10):4729-35. doi: 10.1210/jc.2010-0322. Epub 2010 Jul 21. — View 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. — View 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. — View 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. — View Citation

Barnes PM, Bloom B, Nahin RL. Complementary and alternative medicine use among adults and children: United States, 2007. Natl Health Stat Report. 2008 Dec 10;(12):1-23. — View Citation

Bishop SR, Lau M, Shapiro S, et al. Mindfulness: A Proposed Ooperational Definition. Clinical Psychology: Science and Practice. 2004 2004;11(3):230-241.

Bleyer A. Older adolescents with cancer in North America deficits in outcome and research. Pediatr Clin North Am. 2002 Oct;49(5):1027-42. Review. — View Citation

Bleyer A. The adolescent and young adult gap in cancer care and outcome. Curr Probl Pediatr Adolesc Health Care. 2005 May-Jun;35(5):182-217. Review. — View Citation

Bleyer A. Young adult oncology: the patients and their survival challenges. CA Cancer J Clin. 2007 Jul-Aug;57(4):242-55. Review. — View 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. Review. — View Citation

Brown J. A review of the evidence on technology-based interventions for the treatment of tobacco dependence in college health. Worldviews Evid Based Nurs. 2013 Aug;10(3):150-62. doi: 10.1111/wvn.12000. Epub 2013 Feb 19. Review. — View Citation

Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. — View Citation

Burke ME, Albritton K, Marina N. Challenges in the recruitment of adolescents and young adults to cancer clinical trials. Cancer. 2007 Dec 1;110(11):2385-93. Review. — View Citation

Callahan ST, Cooper WO. Uninsurance and health care access among young adults in the United States. Pediatrics. 2005 Jul;116(1):88-95. — View 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. Epub 2006 May 2. — View 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. — View 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. — View 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. — View 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. — View Citation

Cella D, Chang CH. A discussion of item response theory and its applications in health status assessment. Med Care. 2000 Sep;38(9 Suppl):II66-72. — View Citation

Chang C-H, Cella D. Equating health-related quality of life instruments in applied oncology settings. Physical Medicine and Rehabilitation: States of the Art Reviews. 1997 1997;11(2):397-406.

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. Review. — View Citation

Clements AD, Parker CR. The relationship between salivary cortisol concentrations in frozen versus mailed samples. Psychoneuroendocrinology. 1998 Aug;23(6):613-6. — View Citation

Coccia PF, Altman J, Bhatia S, Borinstein SC, Flynn J, George S, Goldsby R, Hayashi R, Huang MS, Johnson RH, Beaupin LK, Link MP, Oeffinger KC, Orr KM, Pappo AS, Reed D, Spraker HL, Thomas DA, von Mehren M, Wechsler DS, Whelan KF, Zebrack BJ, Sundar H, Shead DA. Adolescent and young adult oncology. Clinical practice guidelines in oncology. J Natl Compr Canc Netw. 2012 Sep;10(9):1112-50. — View 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. — View Citation

Crom DB, Lensing SY, Rai SN, Snider MA, Cash DK, Hudson MM. Marriage, employment, and health insurance in adult survivors of childhood cancer. J Cancer Surviv. 2007 Sep;1(3):237-45. doi: 10.1007/s11764-007-0026-x. — View Citation

Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. — View Citation

Esmer G, Blum J, Rulf J, Pier J. Mindfulness-based stress reduction for failed back surgery syndrome: a randomized controlled trial. J Am Osteopath Assoc. 2010 Nov;110(11):646-52. Erratum in: J Am Osteopath Assoc. 2011 Jan;111(1):3. J Am Osteopath Assoc. 2011 Jul;111(7):424. — View 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 1998;5:544-554.

Ferrari A, Montello M, Budd T, Bleyer A. The challenges of clinical trials for adolescents and young adults with cancer. Pediatr Blood Cancer. 2008 May;50(5 Suppl):1101-4. doi: 10.1002/pbc.21459. Review. — View 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. — View Citation

Gershon RC, Cella D, Fox NA, Havlik RJ, Hendrie HC, Wagster MV. Assessment of neurological and behavioural function: the NIH Toolbox. Lancet Neurol. 2010 Feb;9(2):138-9. doi: 10.1016/S1474-4422(09)70335-7. — View Citation

Gershon RC. Computer adaptive testing. J Appl Meas. 2005;6(1):109-27. Review. — View Citation

Gershon RC. The effect of individual differences variables on the assessment of ability for computerized adaptive testing, Northwestern University; 1996.

Gotay CC, Pagano IS. Assessment of Survivor Concerns (ASC): a newly proposed brief questionnaire. Health Qual Life Outcomes. 2007 Mar 13;5:15. — View 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. — View 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. — View Citation

Hall AE, Boyes AW, Bowman J, Walsh RA, James EL, Girgis A. Young adult cancer survivors' psychosocial well-being: a cross-sectional study assessing quality of life, unmet needs, and health behaviors. Support Care Cancer. 2012 Jun;20(6):1333-41. doi: 10.1007/s00520-011-1221-x. Epub 2011 Jul 1. — View Citation

Hambleton RK. Emergence of item response modeling in instrument development and data analysis. Med Care. 2000 Sep;38(9 Suppl):II60-5. — View Citation

Hambleton RK. Principles and selected applications of Item Response Theory. In: Linn R, ed. Educational Measurement: Third Edition. New York: American Council on Education; 1989:147-200.

Hankin V. Mindfulness Based Stress Reduction in Couples Battling Multiple Sclerosis. Midwestern Psychological Association. 2008 2008;18th Annual Meeting:12.

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. Review. — View 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. Review. — View Citation

Jacobsen PB, Davis K, Cella D. Assessing quality of life in research and clinical practice. Oncology (Williston Park). 2002 Sep;16(9 Suppl 10):133-9. Review. — View 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. — View Citation

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

Kirchhoff AC, Lyles CR, Fluchel M, Wright J, Leisenring W. Limitations in health care access and utilization among long-term survivors of adolescent and young adult cancer. Cancer. 2012 Dec 1;118(23):5964-72. doi: 10.1002/cncr.27537. Epub 2012 Sep 24. — View 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. — View 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. — View Citation

Kwak M, Zebrack BJ, Meeske KA, Embry L, Aguilar C, Block R, Hayes-Lattin B, Li Y, Butler M, Cole S. Prevalence and predictors of post-traumatic stress symptoms in adolescent and young adult cancer survivors: a 1-year follow-up study. Psychooncology. 2013 Aug;22(8):1798-806. doi: 10.1002/pon.3217. Epub 2012 Nov 8. — View Citation

Lai J-S, Cella D, Choi S, Teresi JA, Hays RD, Stone AA. Developing a fatigue item bank for the Patient-Reported Outcomes Measurement Information System (PROMIS FIB version 1). Presented at the Meeting of the Survey Methods in Multicultural, Multinational, and Multiregional Contexts (3MC), Berlin, Germany. 2008.

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. — View Citation

Lengacher CA, Johnson-Mallard V, Post-White J, Moscoso MS, Jacobsen PB, Klein TW, Widen RH, Fitzgerald SG, Shelton MM, Barta M, Goodman M, Cox CE, Kip KE. Randomized controlled trial of mindfulness-based stress reduction (MBSR) for survivors of breast cancer. Psychooncology. 2009 Dec;18(12):1261-72. doi: 10.1002/pon.1529. — View Citation

Levine A, Zagoory-Sharon O, Feldman R, Lewis JG, Weller A. Measuring cortisol in human psychobiological studies. Physiol Behav. 2007 Jan 30;90(1):43-53. Epub 2006 Oct 19. Review. — View Citation

Martin S, Ulrich C, Munsell M, Taylor S, Lange G, Bleyer A. Delays in cancer diagnosis in underinsured young adults and older adolescents. Oncologist. 2007 Jul;12(7):816-24. — View 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. Review. — View 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. — View Citation

Mattson MR, Demshar RK, Daly BJ. Quality of life of young adult survivors of hematologic malignancies. Cancer Nurs. 2013 Mar-Apr;36(2):E1-7. doi: 10.1097/NCC.0b013e31824242dd. — View Citation

McDade TW, Burhop J, Dohnal J. High-sensitivity enzyme immunoassay for C-reactive protein in dried blood spots. Clin Chem. 2004 Mar;50(3):652-4. — View 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. Review. — View Citation

McDade TW. Development and validation of assay protocols for use with dried blood spot samples. Am J Hum Biol. 2014 Jan-Feb;26(1):1-9. doi: 10.1002/ajhb.22463. Epub 2013 Oct 15. Review. — View Citation

McHorney CA, Cohen AS. Equating health status measures with item response theory: illustrations with functional status items. Med Care. 2000 Sep;38(9 Suppl):II43-59. — View Citation

Mor V, Allen S, Malin M. The psychosocial impact of cancer on older versus younger patients and their families. Cancer. 1994 Oct 1;74(7 Suppl):2118-27. Review. — View Citation

Mor V, Malin M, Allen S. Age differences in the psychosocial problems encountered by breast cancer patients. J Natl Cancer Inst Monogr. 1994;(16):191-7. — View Citation

NCCAM Definition of Mind Body Medicine. 2011.

Norman CD, Yip AL. eHealth promotion and social innovation with youth: using social and visual media to engage diverse communities. Stud Health Technol Inform. 2012;172:54-70. — View 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. — View Citation

Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. — View Citation

Phillips-Salimi CR, Andrykowski MA. Physical and mental health status of female adolescent/young adult survivors of breast and gynecological cancer: a national, population-based, case-control study. Support Care Cancer. 2013 Jun;21(6):1597-604. doi: 10.1007/s00520-012-1701-7. Epub 2013 Jan 10. — View 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®): depression, anxiety, and anger. Assessment. 2011 Sep;18(3):263-83. doi: 10.1177/1073191111411667. Epub 2011 Jun 21. — View Citation

Research OoBaSS. Progress and promise in research on social and cultural dimensions of health: A research agenda. Bethesda, MD: National Institutes of Health; 2001.

Revicki DA, Chen WH, Harnam N, Cook KF, Amtmann D, Callahan LF, Jensen MP, Keefe FJ. Development and psychometric analysis of the PROMIS pain behavior item bank. Pain. 2009 Nov;146(1-2):158-69. doi: 10.1016/j.pain.2009.07.029. Epub 2009 Aug 15. — View Citation

Rotheram-Borus MJ, Tomlinson M, Gwegwe M, Comulada WS, Kaufman N, Keim M. Diabetes buddies: peer support through a mobile phone buddy system. Diabetes Educ. 2012 May-Jun;38(3):357-65. doi: 10.1177/0145721712444617. Epub 2012 Apr 30. — View Citation

Schmidt S, Grossman P, Schwarzer B, Jena S, Naumann J, Walach H. Treating fibromyalgia with mindfulness-based stress reduction: results from a 3-armed randomized controlled trial. Pain. 2011 Feb;152(2):361-369. doi: 10.1016/j.pain.2010.10.043. Epub 2010 Dec 13. — View 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. — View 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. Review. — View Citation

Stanton AL, Bower JE, Low CA. Posttraumatic growth after cancer. In: Calhoun LG, Tedeschi RG, editors. Handbook of Posttraumatic Growth: Research and Practice. Mahwah: Lawrence Erlbaum Associates, Inc; 2006:138-175.

Subrahmanyam K, Greenfield P. Online communication and adolescent relationships. Future Child. 2008 Spring;18(1):119-46. Review. — View Citation

Van den Bulck J. Adolescent use of mobile phones for calling and for sending text messages after lights out: results from a prospective cohort study with a one-year follow-up. Sleep. 2007 Sep;30(9):1220-3. — View Citation

Victorson D, Cella D, Wagner LI, Kramer L, Smith ML. Measuring quality of life in cancer survivors. In: Feuerstein M, ed. Handbook of cancer survivorship. New York, NY: Springer; 2007:79-112.

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 2010;138(4):e180-e181.

Vøllestad 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. — View Citation

Ware JE Jr, Bjorner JB, Kosinski M. Practical implications of item response theory and computerized adaptive testing: a brief summary of ongoing studies of widely used headache impact scales. Med Care. 2000 Sep;38(9 Suppl):II73-82. — View Citation

White PH. Access to health care: health insurance considerations for young adults with special health care needs/disabilities. Pediatrics. 2002 Dec;110(6 Pt 2):1328-35. — View Citation

Williams SR, McDade TW. The use of dried blood spot sampling in the national social life, health, and aging project. J Gerontol B Psychol Sci Soc Sci. 2009 Nov;64 Suppl 1:i131-6. doi: 10.1093/geronb/gbn022. Epub 2009 Feb 25. — View 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. — View Citation

Woolford SJ, Barr KL, Derry HA, Jepson CM, Clark SJ, Strecher VJ, Resnicow K. OMG do not say LOL: obese adolescents' perspectives on the content of text messages to enhance weight loss efforts. Obesity (Silver Spring). 2011 Dec;19(12):2382-7. doi: 10.1038/oby.2011.266. Epub 2011 Aug 25. — View Citation

Wyatt G, Sikorskii A, Rahbar MH, Victorson D, Adams L. Intervention fidelity: aspects of complementary and alternative medicine research. Cancer Nurs. 2010 Sep-Oct;33(5):331-42. doi: 10.1097/NCC.0b013e3181d0b4b7. — View Citation

* Note: There are 90 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility assessed through examination of response rate and study attrition variables	feasibility assessed through examination of response rate and study attrition variables	week 33
Secondary	effects on health related quality of life accessed through online questionnaires	effects on health related quality of life accessed through online questionnaires	baseline and study weeks 8, 16, 24, and 32
Secondary	the impact of eHealth maintenance support accessed through text message response	the impact of eHealth maintenance support accessed through text message response	weekly, for the 8 consecutive weeks after the MBSR course
Secondary	compare between-group changes in biologic measures of stress accessed through biomarkers	compare between-group changes in biologic measures of stress accessed through	baseline and study weeks 16 and 32

External Links

•   American Cancer Society I. Cancer in Teens and Young Adults: Not Much Improvement? Accessed on February 24, 2013.