The eCALM Trial-eTherapy for cancer appLying mindfulness: online mindfulness-based cancer recovery program for underserved individuals living with cancer in Alberta: protocol development for a randomized wait-list controlled clinical trial

Kristin A Zernicke, Tavis S Campbell, Michael Speca, Kelley McCabe-Ruff, Steven Flowers, Dale A Dirkse, Linda E Carlson, Kristin A Zernicke, Tavis S Campbell, Michael Speca, Kelley McCabe-Ruff, Steven Flowers, Dale A Dirkse, Linda E Carlson

Abstract

Background: Elevated stress can exacerbate cancer symptom severity, and after completion of primary cancer treatments, many individuals continue to have significant distress. Mindfulness-Based Cancer Recovery (MBCR) is an 8-week group psychosocial intervention consisting of training in mindfulness meditation and yoga designed to mitigate stress, pain, and chronic illness. Efficacy research shows face-to-face (F2F) MBCR programs have positive benefits for cancer patients; however barriers exist that impede participation in F2F groups. While online MBCR groups are available to the public, none have been evaluated.

Primary objective: determine whether underserved patients are willing to participate in and complete an online MBCR program.

Secondary objectives: determine whether online MBCR will mirror previous efficacy findings from F2F MBCR groups on patient-reported outcomes.

Method/design: The study includes cancer patients in Alberta, exhibiting moderate distress, who do not have access to F2F MBCR. Participants will be randomized to either online MBCR, or waiting for the next available group. An anticipated sample size of 64 participants will complete measures online pre and post treatment or waiting period. Feasibility will be tracked through monitoring numbers eligible and participating through each stage of the protocol.

Discussion: 47 have completed/completing the intervention. Data suggest it is possible to conduct a randomized waitlist controlled trial of online MBCR to reach underserved cancer survivors.

Trial registration: Clinical Trials.gov Identifier: NCT01476891.

Figures

Figure 1
Figure 1
Overall trial design and participant flow diagram.

References

    1. Walker MS, Zona DM, Fisher EB. Depressive symptoms after lung cancer surgery: their relation to coping style and social support. Psychooncology. 2006;15:684–693. doi: 10.1002/pon.997.
    1. Roscoe JA, Morrow GR, Hickok JT, Bushunow P, Matteson S, Rakita D, Andrews PL. Temporal interrelationships among fatigue, circadian rhythm and depression in breast cancer patients undergoing chemotherapy treatment. Support Care Cancer. 2002;IS:329–336.
    1. Carlson LE, Angen M, Cullum J, Goodey E, Koopmans J, Lamont L, McRae JH, Martin M, Pelletier G, Robinson J, Simpson JSA, Tillotson L, Bultz BD. High levels of untreated distress and fatigue in cancer patients. Br J Cancer. 2004;90:2297–2304.
    1. Carlson LE, Bultz BD. Cancer distress screening: Needs, methods and models. J Psychosom Res. 2003;55:403–409. doi: 10.1016/S0022-3999(03)00514-2.
    1. Sellick SM, Edwardson AD. Screening new cancer patients for psychological distress using the hospital anxiety and depression scale. Psychooncology. 2007;16:534–542. doi: 10.1002/pon.1085.
    1. Zabora J, Brintzenhofeszoc K, Curbow B, Hooker C, Piantadosi S. The prevalence of psychological distress by cancer site. Psychooncology. 2001;10:19–28. doi: 10.1002/1099-1611(200101/02)10:1<19::AID-PON501>;2-6.
    1. Bultz BD, Carlson LE. Emotional distress: The 6th vital sign in cancer care. Psychooncology. 2006;15:93–95. doi: 10.1002/pon.1022.
    1. Kangas M, Henry J, Bryant R. The relationship between acute stress disorder and posttraumatic stress disorder following cancer. J Consult Clin Psychol. 2005;73:360–364.
    1. Kissane DW, Grabsch B, Love A, Clarke DM, Bloch S, Smith GC. Psychiatric disorder in women with early stage and advanced breast cancer: A comparative analysis. Aust N Z J Psychiatry. 2004;38:320–326. doi: 10.1080/j.1440-1614.2004.01358.x.
    1. Carlson LE, Labelle LE, Garland SN, Hutchins ML, Birnie K. In: Clinical handbook of mindfulness. Didonna F, editor. New York, NY: Springer; 2009. Mindfulness-based interventions in oncology; pp. 383–404.
    1. Labelle LE, Campbell TS, Carlson LE. Mindfulness-based stress reduction in oncology: Evaluating mindfulness and rumination as mediators of change in depressive symptoms. Mindfulness. 2010;1:28–40. doi: 10.1007/s12671-010-0005-6.
    1. Kabat-Zinn J. Full catastrophe living: Using the wisdom of your body and mind to face stress, pain and illness. New York: Bantam Doubleday Dell Publishing Group, Inc; 1990.
    1. Carlson LE, Speca M. In: Handbook of Cancer Survivorship. Feurestein M, editor. New York, NY: Springer; 2007. Managing daily and long-term stress; pp. 339–360.
    1. Lamanque P, Daneault S. Does meditation improve the quality of life for patients living with cancer? Can Fam Physician/Medecin De Famille Canadien. 2006;52:474–475.
    1. Mackenzie MJ, Carlson LE, Speca M. Mindfulness-based stress reduction (MBSR) in oncology: Rationale and review. Evid Base Integr Med. 2005;2:139–145. doi: 10.2165/01197065-200502030-00005.
    1. Matchim Y, Armer J. Measuring the psychological impact of mindfulness meditation on health among patients with cancer: A literature review. Oncol Nurs Forum. 2007;34:1059–1066. doi: 10.1188/07.ONF.1059-1066.
    1. Ott MJ, Norris RL, Bauer-Wu SM. Mindfulness meditation for oncology patients: A discussion and critical review. Integr Cancer Ther. 2006;5:98–108. doi: 10.1177/1534735406288083.
    1. Smith JE, Richardson J, Hoffman C, Pilkington K. Mindfulness-based stress reduction as supportive therapy in cancer care: Systematic review. J Adv Nurs. 2005;52:315–327. doi: 10.1111/j.1365-2648.2005.03592.x.
    1. Shigaki CL, Glass B, Schopp LH. Mindfulness-based stress reduction in medical settings. J Clin Psychol Med Settings. 2006;13:209–216. doi: 10.1007/s10880-006-9033-8.
    1. Ledesma D, Kumano H. Mindfulness-based stress reduction and cancer: A meta-analysis. Psychooncology. 2008;18:571–579.
    1. Brown KW, Ryan RM. The benefits of being present: Mindfulness and its role in psychological well-being. J Personal Soc Psychol. 2003;84:822–848.
    1. 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;9:112–123. doi: 10.1007/s005200000206.
    1. 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;12:278–285. doi: 10.1207/s15327558ijbm1204_9.
    1. Garland SM, Carlson LE, Cook S, Lansdell L, Speca M. A non-randomized comparison of mindfulness-based stress reduction and healing arts programs for facilitating post-traumatic growth and spirituality in cancer outpatients. Support Care Cancer. 2007;15:949–961. doi: 10.1007/s00520-007-0280-5.
    1. Shapiro SL, Bootzin RR, Figueredo AJ, Lopez AM, Schwartz GE. The efficacy of mindfulness-based stress reduction in the treatment of sleep disturbance in women with breast cancer: An exploratory study. J Psychosom Res. 2003;54:85–91. doi: 10.1016/S0022-3999(02)00546-9.
    1. Speca M, Carlson LE, Goodey E, Angen M. A randomized, wait-list controlled clinical trial: The effect of a mindfulness meditation-based stress reduction program on mood and symptoms of stress in cancer outpatients. Psychosom Med. 2000;62:613–622.
    1. Tacon AM, Caldera YM, Ronaghan C. Mindfulness-based stress reduction in women with breast cancer. Fam Syst Health. 2004;22:193–203.
    1. Tacon AM. Mindfulness effects on symptoms of distress in women with cancer. Journal of Cancer Pain and Symptom Palliation. 2006;2:17–22. doi: 10.1300/J427v02n01_04.
    1. 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;18:1261–1272. doi: 10.1002/pon.1529.
    1. Carlson LE, Speca M, Faris P, Patel KD. One year prepost intervention follow-up of psychological, immune, endocrine and blood pressure outcomes of mindfulness-based stress reduction (MBSR) in breast and prostate cancer outpatients. Brain Behav Immun. 2007;21:1038–1049. doi: 10.1016/j.bbi.2007.04.002.
    1. 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. Psychoneuroendocrinolog. 2004;29:448–474. doi: 10.1016/S0306-4530(03)00054-4.
    1. Madden M. Chronic disease and the internet. 2010. Pew Internet & American LifeProject [online]. Retrieved May 12, from .
    1. Bargh JA, McKenna KYA. The internet and social life. Annu Rev Psychol. 2004;55:573–590. doi: 10.1146/annurev.psych.55.090902.141922.
    1. Barak A, Hen L, Boniel-Nissim M, Shapira N. A comprehensive review and a meta-analysis of the effectiveness of Internet-based psychotherapeutic interventions. J Technol Hum Serv. 2008;26:109–160. doi: 10.1080/15228830802094429.
    1. Gardner-Nix J, Backman S, Barbati J, Grummitt J. Evaluating distance education of mindfulness-based meditation programme for chronic pain management. J Telemed Telecare. 2008;14:88–92. doi: 10.1258/jtt.2007.070811.
    1. Owen JE, Klapow JC, Roth DL, Shuster JL Jr, Bellis J, Meredith R, Tucker DC. Randomized pilot of a self-guided internet coping group for women with early-stage breast cancer. Ann Behav Med. 2005;30:54–64. doi: 10.1207/s15324796abm3001_7.
    1. Carlson LE, Speca M. Mindfulness-based cancer recovery: A step-by-step MBSR approach to help you cope with treatment and reclaim your life. Oakland, CA: New Harbinger Publications, Inc; 2010.
    1. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: Distress management. Version 2. Fort Washington, PA; 2013.
    1. Jacobsen PB, Donovan KA, Trask PC, Fleishman SB, Zabora J, Baker F, Holland JC. Screening for psychologic distress in ambulatory cancer patients. Cancer. 2005;103:1494–1502. doi: 10.1002/cncr.20940.
    1. Dolbeault S, Mignot V, Gauvain-Piquard A, Mandereau L, Asselain B, Medioni J. Evaluation of psychological distress and quality of life in French cancer patients: validation of the French version of the memorial distress thermometer. Psychooncology. 2003;12:S225.
    1. McNair DA, Lorr M, Droppelman LF. Profile of mood states. San Diego: Educational and Industrial Testing Service; 1971.
    1. Carlson LE, Thomas BC. Development of the Calgary Symptoms of Stress Inventory (C-SOSI) Int J Behav Med. 2007;14:249–256. doi: 10.1007/BF03003000.
    1. Peterman AH, Fitchett G, Brady MJ, Hernandez L, Cella D. Measuring spiritual well-being in people with cancer: The functional assessment of chronic illness therapy–spiritual well-being scale (FACIT-sp) Ann Behav Med. 2002;24:49–58. doi: 10.1207/S15324796ABM2401_06.
    1. Tedeschi RG, Calhoun LG. The posttraumatic growth inventory: Measuring the positive legacy of trauma. J Trauma Stress. 1996;9:455–471. doi: 10.1002/jts.2490090305.
    1. Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006;13:27–45. doi: 10.1177/1073191105283504.
    1. 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;65:571–581. doi: 10.1097/01.PSY.0000074003.35911.41.
    1. Dattalo P. Determining sample size: Balancing power, precision and practicality – Pocket guide to social work research methods. New York: Oxford University Press; 2008.

Source: PubMed

3
Subscribe