Finding My Way: protocol of a randomised controlled trial evaluating an internet self-help program for cancer-related distress

BMC Cancer

Lisa Beatty²  Emma Kemp²  Tracey Wade¹  Bogda Koczwara³ 

[1] School of Psychology, Flinders University, Adelaide 5001, SA, Australia

[2] Flinders Centre for Innovation in Cancer, Flinders Medical Centre, Flinders Drive, Bedford Park 5042, SA, Australia

[3] School of Medicine, Flinders University, Adelaide 5001, SA, Australia

关键词: RCT;    CBT;    Coping;    Distress;    Intervention;    Internet;    Psycho-oncology;    Cancer;   

Others  :  1177475
DOI  :  10.1186/s12885-015-1322-x

 received in 2014-12-18, accepted in 2015-04-20,  发布年份 2015

【 摘 要 】

Background

A cancer diagnosis elicits greater distress than any other medical diagnosis, and yet very few studies have evaluated the efficacy of structured online self-help therapeutic programs to alleviate this distress. This study aims to assess the efficacy over time of an internet Cognitive Behaviour Therapy (iCBT) intervention (‘Finding My Way’) in improving distress, coping and quality of life for individuals with a recent diagnosis of early stage cancer of any type.

Methods/Design

The study is a multi-site Randomised Controlled Trial (RCT) seeking to enrol 188 participants who will be randomised to either the Finding My Way Intervention or an attention-control condition. Both conditions are delivered online; with 6 modules released once per week, and an additional booster module released one month after program-completion. Participants complete online questionnaires on 4 occasions: at baseline (immediately prior to accessing the modules); post-treatment (immediately after program-completion); then three and six months later. Primary outcomes are general distress and cancer-specific distress, with secondary outcomes including Health-Related Quality of Life (HRQoL), coping, health service utilisation, intervention adherence, and user satisfaction. A range of baseline measures will be assessed as potential moderators of outcomes. Eligible participants are individuals recently diagnosed with any type of cancer, being treated with curative intent, aged over 18 years with sufficient English language literacy, internet access and an active email account and phone number. Participants are blinded to treatment group allocation. Randomisation is computer generated and stratified by gender.

Discussion

Compared to the few prior published studies, Finding My Way will be the first adequately powered trial to offer an iCBT intervention to curatively treated patients of heterogeneous cancer types in the immediate post-diagnosis/treatment period. If found efficacious, Finding My Way will assist with overcoming common barriers to face-to-face therapy in a cost-effective and accessible way, thus helping to reduce distress after cancer diagnosis and consequently decrease the cancer burden for individuals and the health system.

Trial registration

Australian New Zealand Clinical Trials Registry ACTRN12613000001796 16.10.13

【 授权许可】

   
2015 Beatty et al.; licensee BioMed Central.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Turner J, Zapart S, Pedersen K, Rankin N, Luxford K, Fletcher J: Clinical practice guidelines for the psychosocial care of adults with cancer. Psycho-Oncology 2005, 14:159-73.
• [2]Carlson LE, Angen M, Cullum J, Goodey E, Koopmans J, Lamont L, et al.: High levels of untreated distress and fatigue in cancer patients. Br J Cancer 2004, 90:2297-304.
• [3]Zabora J, Brintzenhofeszoc K, Curbow B, Hooker C, Piantadosi S: The prevalence of psychological distress by cancer site. Psycho-Oncology 2001, 10:19-28.
• [4]Boyes AW, Girgis A, Zucca AC, Lecathelinais C: Anxiety and depression among long-term survivors of cancer in Australia: results of a population-based survey. Med J Aust 2009, 190:s94-8.
• [5]Bultz BD, Carlson LE: Emotional distress: the sixth vital sign in cancer care. J Clin Oncol 2005, 23:6440-1.
• [6]Cancer Australia, Cancer Council Australia: Review of national cancer control activity in Australia. Cancer Australia, Canberra; 2010.
• [7]Fann JR, Thomas-Rich AM, Katon WJ, Cowley D, Pepping M, McGregor BA, et al.: Major depression after breast cancer: a review of epidemiology and treatment. Gen Hosp Psychiatry 2008, 30:112-26.
• [8]Hack TF, Degner LF: Coping responses following breast cancer diagnosis predict psychological adjustment three years later. Psycho-Oncology 2004, 13:235-47.
• [9]Beatty L, Koczwara B: An effectiveness study of a CBT group program for women with breast cancer. Clin Psychol 2010, 14:45-53.
• [10]Classen C, Kraemer HC, Blasey C, Giese-Davis J, Koopman C, Palesh OG, et al.: Supportive-expressive group therapy for primary breast cancer patients: a randomized prospective multicenter trial. Psycho-Oncology 2008, 17:438-47.
• [11]Zimmermann T, Heinrichs N, Baucom DH: “Does One Size Fit All?” Moderators in psychosocial interventions for breast cancer patients: A meta-analysis. Ann Behav Med 2007, 34:225-39.
• [12]Foley E, Baillie A, Huxter M, Price M, Sinclair E: Mindfulness-based cognitive therapy for individuals whose lives have been affected by cancer: a randomised controlled trial. J Consult Clin Psychol 2010, 78:72-9.
• [13]Helgeson VS, Cohen S, Schulz R, Yasko J: Education and peer discussion group interventions and adjustment to breast cancer. Arch Gen Psychiatry 1999, 56:340-7.
• [14]Osborn RL, Demoncada AC, Feuerstein M: Psychosocial interventions for depression, anxiety, and quality of life in cancer survivors: Meta-analyses. Int J Psychiatry Med 2006, 36:13-34.
• [15]Wade TD, Nehmy T, Koczwara B: Predicting worries about health after breast cancer surgery. Psycho-Oncology 2005, 14:503-9.
• [16]Christensen H: Increasing access and effectiveness: using the internet to deliver low intensity CBT. In Oxford guide to low intensity CBT interventions. Edited by Bennett-Levy J, Richards DA, Farrand P, Christensen H, Griffiths KM, Kavanagh DJ, Klein B, Lau MA, Proudfood J, Ritterband LM. Oxford University Press, New York; 2010:53-68.
• [17]Beatty L, Lambert S: A systematic review of internet-based self-help therapeutic interventions to improve distress and disease-control among adults with chronic health conditions. Clin Psychol Rev 2013, 33:609-22.
• [18]Cuijpers P, van Straten A, Andersson G: Internet-administered cognitive behavior therapy for health problems: a systematic review. J Behav Med 2008, 31:169-77.
• [19]Griffiths KM, Farrer L, Christensen H: The efficacy of internet interventions for depression and anxiety disorders: a review of randomised controlled trials. Med J Aust 2010, 192:S4-11.
• [20]Newman MG, Szkodny LE, Llera SJ, Przeworski A: A review of technology-assisted self-help and minimal contact therapies for anxiety and depression: Is human contact necessary for therapeutic efficacy? Clin Psychol Rev 2011, 31:89-103.
• [21]Barak A, Klein B, Proudfoot J: Defining internet-supported therapeutic interventions. Ann Behav Med 2009, 38:4-17.
• [22]Nathan PE, Gorman JM: A guide to treatments that work. 3rd edition. Oxford University Press, New York; 2007.
• [23]Bader J, Strickman-Stein N: Evaluation of new multimedia formats for cancer communication. J Med Internet Res 2003, 5:e16.
• [24]Australian Bureau of Statistics: Household use of information technology, (Cat No. 8146.0). ABS, Canberra; 2006.
• [25]Beatty L, Koczwara B, Wade T: ‘Cancer Coping Online’: a pilot trial of a self-guided CBT internet intervention for cancer-related distress. Electronic J Applied Psychol 2011, 7:17-25.
• [26]Carpenter KM, Stoner SA, Schmitz K, McGregor BA, Doorenbos AZ: An online stress management workbook for breast cancer. J Behav Med 2014, 37:458-68.
• [27]Duffecy J, Sanford S, Wagner L, Begale M, Nawacki E, Mohr DC: Project onward: an innovative e-health intervention for cancer survivors. Psycho Oncolo 2013, 22:947-51.
• [28]Owen JE, Klapow JC, Roth DL, Shuster JL Jr, Bellis J, Meredith R, et al.: Randomized pilot of a self-guided internet coping group for women with early-stage breast cancer. Ann Behav Med 2005, 30:54-64.
• [29]Beatty L, Koczwara B, Rice J, Wade T: A randomised controlled trial to evaluate the effects of a self-help workbook intervention on distress, coping and QOL after breast cancer diagnosis. Med J Aust 2010, 193:S68-73.
• [30]Kraemer HC, Wilson GT, Fairburn CG, Agras WS: Mediators and moderators of treatment effects in randomized clinical trials. Arch Gen Psychiatry 2002, 59:877-83.
• [31]Stanton AL, Danoff-Burg S, Cameron CL, Bishop M, Collins CA, Kirk SB, et al.: Emotionally expressive coping predicts psychological and physical adjustment to breast cancer. J Consult Clin Psychol 2000, 68:875-82.
• [32]Schulz K, Altman D, Moher D: for the CONSORT Group: CONSORT: Statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010, 2010(340):698-702.
• [33]Lovibond SH, Lovibond PH: Manual for the Depression Anxiety Stress Scales (DASS). University of New South Wales, Sydney; 1995.
• [34]Foa EB, Riggs DS, Dancu CV, Rothbaum BO: Reliability and validity of a brief instrument for assessing posttraumatic stress disorder. J Trauma Stress 1993, 6:459-73.
• [35]Klee M, Groenvold M, Machin D: Quality of life of Danish women: population-based norms for the EORTC QLQ-C30. Qual Life Res 1997, 6:27-34.
• [36]Watson M, Law M, dos Santos M, Greer S, Baruch J, Bliss J: The Mini-MAC: further development of the mental adjustment to cancer scale. J Psychosoc Oncol 1994, 12:33-46.
• [37]Australian Bureau of Statistics: 1989–1990 National health survey users’ guide, (Cat No. 4363.0). ABS, Canberra; 1991.
• [38]Sherbourne CD, Stewart AL: The MOS social support survey. Soc Sci Med 1991, 32:705-14.
• [39]Miller SM: Monitoring and blunting: validation of a questionnaire to assess styles of information seeking under threat. J Pers Soc Psychol 1987, 52:345-53.
• [40]Gratz K, Roemer L: Multidimensional assessment of emotion regulation and dysregulation: development, factor structure, and inital validation of the difficulties in emotion regulation scale. J Psychopathol Behav Assess 2004, 26:41-54.
• [41]Thiels C, Schmidt U, Troop N, Treasure J, Garthe R: Compliance with a self-care manual in guided self-change for bulimia nervosa. Eur Eat Disord Rev 2001, 9:115-22.
• [42]Hedeker D, Gibbons RD, Waternaux C: Sample size estimation for longitudinal studies with attrition:comparing time related contrasts between two groups. J Educ Behav Stat 1999, 24:70-93.
• [43]Kaldo V, Levin S, Widarsson J, Buhrman M, Larsen H-C, Andersson G: Internet versus group cognitive-behavioral treatment of distress associated with tinnitus: a randomized controlled trial. Behav Ther 2008, 39:348-59.