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

BMC Complementary and Alternative Medicine

Linda E Carlson⁴  Dale A Dirkse²  Steven Flowers¹  Kelley McCabe-Ruff³  Michael Speca⁴  Tavis S Campbell²  Kristin A Zernicke² 

[1] Enloe Medical Center, Chico, California, USA;Department of Psychosocial Resources, Tom Baker Cancer Center, 2202 – 2nd Street SW, Calgary, Alberta, T2S 3C1, Canada;eMindful Inc., Vero Beach, Florida, USA;Department of Oncology, University of Calgary, Calgary, Alberta, Canada

关键词: Yoga;    Meditation;    Stress reduction;    Online;    Randomized waitlist controlled trial;    Oncology;    Cancer;    Mindfulness;   

Others  :  1231116
DOI  :  10.1186/1472-6882-13-34

 received in 2012-11-11, accepted in 2013-02-08,  发布年份 2013

【 摘 要 】

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

【 授权许可】

   
2013 Zernicke et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [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.
• [2]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.
• [3]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.
• [4]Carlson LE, Bultz BD: Cancer distress screening: Needs, methods and models. J Psychosom Res 2003, 55:403-409.
• [5]Sellick SM, Edwardson AD: Screening new cancer patients for psychological distress using the hospital anxiety and depression scale. Psychooncology 2007, 16:534-542.
• [6]Zabora J, Brintzenhofeszoc K, Curbow B, Hooker C, Piantadosi S: The prevalence of psychological distress by cancer site. Psychooncology 2001, 10:19-28.
• [7]Bultz BD, Carlson LE: Emotional distress: The 6th vital sign in cancer care. Psychooncology 2006, 15:93-95.
• [8]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.
• [9]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.
• [10]Carlson LE, Labelle LE, Garland SN, Hutchins ML, Birnie K: Mindfulness-based interventions in oncology. In Clinical handbook of mindfulness. Edited by Didonna F. New York, NY: Springer; 2009:383-404.
• [11]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.
• [12]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.
• [13]Carlson LE, Speca M: Managing daily and long-term stress. In Handbook of Cancer Survivorship. Edited by Feurestein M. New York, NY: Springer; 2007:339-360.
• [14]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.
• [15]Mackenzie MJ, Carlson LE, Speca M: Mindfulness-based stress reduction (MBSR) in oncology: Rationale and review. Evid Base Integr Med 2005, 2:139-145.
• [16]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.
• [17]Ott MJ, Norris RL, Bauer-Wu SM: Mindfulness meditation for oncology patients: A discussion and critical review. Integr Cancer Ther 2006, 5:98-108.
• [18]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.
• [19]Shigaki CL, Glass B, Schopp LH: Mindfulness-based stress reduction in medical settings. J Clin Psychol Med Settings 2006, 13:209-216.
• [20]Ledesma D, Kumano H: Mindfulness-based stress reduction and cancer: A meta-analysis. Psychooncology 2008, 18:571-579.
• [21]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.
• [22]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.
• [23]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.
• [24]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.
• [25]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.
• [26]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.
• [27]Tacon AM, Caldera YM, Ronaghan C: Mindfulness-based stress reduction in women with breast cancer. Fam Syst Health 2004, 22:193-203.
• [28]Tacon AM: Mindfulness effects on symptoms of distress in women with cancer. Journal of Cancer Pain and Symptom Palliation 2006, 2:17-22.
• [29]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.
• [30]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.
• [31]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.
• [32]Madden M: Chronic disease and the internet. 2010. Pew Internet & American LifeProject [online]. Retrieved May 12, from http://pewinternet.org/Reports/2010/Chronic-Disease.aspx webcite
• [33]Bargh JA, McKenna KYA: The internet and social life. Annu Rev Psychol 2004, 55:573-590.
• [34]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.
• [35]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.
• [36]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.
• [37]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.
• [38]National Comprehensive Cancer Network: NCCN clinical practice guidelines in oncology: Distress management. Version 2. Fort Washington, PA; 2013.
• [39]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.
• [40]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.
• [41]McNair DA, Lorr M, Droppelman LF: Profile of mood states. San Diego: Educational and Industrial Testing Service; 1971.
• [42]Carlson LE, Thomas BC: Development of the Calgary Symptoms of Stress Inventory (C-SOSI). Int J Behav Med 2007, 14:249-256.
• [43]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.
• [44]Tedeschi RG, Calhoun LG: The posttraumatic growth inventory: Measuring the positive legacy of trauma. J Trauma Stress 1996, 9:455-471.
• [45]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.
• [46]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.
• [47]Dattalo P: Determining sample size: Balancing power, precision and practicality – Pocket guide to social work research methods. New York: Oxford University Press; 2008.