My Road Ahead study protocol: a randomised controlled trial of an online psychological intervention for men following treatment for localised prostate cancer

BMC Cancer

Addie C Wootten⁶  Jo-Anne M Abbott¹  Katherine E Chisholm³  David W Austin³  Britt Klein⁵  Marita P McCabe³  Denny Meyer⁵  Anthony J Costello⁴  Declan G Murphy² 

[1] National eTherapy Centre, Swinburne University of Technology, Hawthorn, VIC, Australia

[2] Peter MacCallum Cancer Centre, East Melbourne, VIC, Australia

[3] Department of Psychology, Deakin University, Burwood, VIC, Australia

[4] Australian Prostate Cancer Research, East Melbourne, VIC, Australia

[5] Swinburne University of Technology, Hawthorn, VIC, Australia

[6] Department of Urology, Royal Melbourne Hospital, Parkville, VIC, Australia

关键词: CBT;    Web-based;    Men;    Distress;    Therapy;    Online;    E-intervention;    Prostate cancer;   

Others  :  859074
DOI  :  10.1186/1471-2407-14-83

 received in 2013-10-29, accepted in 2014-02-04,  发布年份 2014

【 摘 要 】

Background

There is a need for psychosocial interventions for men with prostate cancer to promote adaptive coping with the challenges and distress associated with diagnosis, treatment and recovery. In addition, interventions are needed that help to overcome barriers to psychosocial treatment such as limited face-to-face psychosocial support services, a shortage of adequately trained professionals, geographical distance, perceived and personal stigma and a preference for consumer-centric and self-directed learning. My Road Ahead is an online cognitive behaviour therapy (CBT) intervention for prostate cancer. This protocol describes a randomised controlled trial (RCT) that will evaluate the efficacy of this online intervention alone, the intervention in combination with a moderated online forum, and the moderated online forum alone.

Methods/design

This study utilises a RCT design with three groups receiving: 1) the 6-module My Road Ahead intervention alone; 2) the My Road Ahead intervention plus a moderated online forum; and 3) the moderated online forum alone. It is expected that 150 men with localised prostate cancer will be recruited into the RCT. Online measures will assess men’s psychological distress as well as sexual and relationship adjustment at baseline, post-intervention, 3 month follow-up and 6 month follow-up. The study is being conducted in Australia and participants will be recruited from April 2012 to Feb 2014. The primary aim of this study is to evaluate the efficacy of My Road Ahead in reducing psychological distress.

Discussion

To our knowledge, My Road Ahead is the first self-directed online psychological intervention developed for men who have been treated for localised prostate cancer. The RCT will assess the efficacy of this intervention in improving psychological well-being, sexual satisfaction, relationship satisfaction and overall quality of life. If successful, this intervention could provide much needed support to men receiving treatment for localised prostate cancer in a highly accessible manner.

Trial registration

Australian New Zealand Clinical Trials Registry Identifier: ACTRN12611000278932

【 授权许可】

   
2014 Wootten et al.; licensee BioMed Central Ltd.

【 图 表 】

【 参考文献 】

• [1]AIHW: Cancer in Australia 2010: an overview. In vol. Cancer series no. 60. Canberra: AIHW; 2010.
• [2]Evans SM, Millar JL, Davis ID, Murphy DG, Bolton DM, Giles GG, Frydenberg M, Andrianopoulos N, Wood JM, Frauman AG, et al.: Patterns of care for men diagnosed with prostate cancer in Victoria from 2008 to 2011. Med J Aust 2013, 198(10):540-545.
• [3]AIHW & AACR: Cancer in Australia 2012: an overview. In vol. Cancer Series no. 74. Canberra: AIHW; 2012.
• [4]Resnick MJ, Koyama T, Fan KH, Albertsen PC, Goodman M, Hamilton AS, Hoffman RM, Potosky AL, Stanford JL, Stroup AM, et al.: Long-term functional outcomes after treatment for localized prostate cancer. N Engl J Med 2013, 368(5):436-445.
• [5]Gray RE, Fitch MI, Phillips C, Labrecque M, Klotz L: Presurgery experiences of prostate cancer patients and their spouses. Cancer Pract 1999, 7:130-135.
• [6]Bokhour BG, Clark JA, Inui TS, Silliman RA, Talcott JA: Sexuality after treatment for early prostate cancer: Exploring the meanings of erectile dysfunction. J Gen Intern Med 2001, 16:649-655.
• [7]Blank TO, Bellizzi KM: After prostate cancer: predictors of well-being among long-term prostate cancer survivors. Cancer 2006, 106(10):2128-2135.
• [8]Couper JW, Bloch S, Love A, Duchesne G, Macvean M, Kissane DW: The psychosocial impact of prostate cancer on patients and their partners. Med J Aust 2006, 185(8):428-432.
• [9]Eller LS, Lev EL, Gejerman G, Colella J, Esposito M, Lanteri V, Scheuch J, Munver R, Lane P, Junchaya C, et al.: Prospective study of quality of life of patients receiving treatment for prostate cancer. Nurs Res 2006, 55(2 Suppl):S28-S36.
• [10]Hervouet S, Savard J, Simard S, Ivers H, Laverdiere J, Vigneault E, Fradet Y, Lacombe L: Psychological functioning associated with prostate cancer: cross-sectional comparison of patients treated with radiotherapy, brachytherapy, or surgery. J Pain Symptom Manage 2005, 30(5):474-484.
• [11]Korfage IJ, Essink-Bot ML, Janssens AC, Schroder FH, de Koning HJ: Anxiety and depression after prostate cancer diagnosis and treatment: 5-year follow-up. Br J Cancer 2006, 94(8):1093-1098.
• [12]Wootten AC, Burney S, Foroudi F, Frydenberg M, Coleman G, Ng KT: Psychological adjustment of survivors of localised prostate cancer: investigating the role of dyadic adjustment, cognitive appraisal and coping style. Psychooncology 2007, 16(11):994-1002.
• [13]Frick E, Tyroller M, Panzer M: Anxiety, depression and quality of life of cancer patients undergoing radiation therapy: A cross sectional study in a community hospital outpatient centre. Eur J Cancer Care 2007, 16:130-136.
• [14]Pirl WF, Siegel GI, Goode MJ, Smith MR: Depression in men receiving androgen deprivation therapy for prostate cancer: a pilot study. Psychooncology 2002, 11(6):518-523.
• [15]Smith DP, Supramaniam R, King MT, Ward J, Berry M, Armstrong BK: Age, health, and education determine supportive care needs of men younger than 70 years with prostate cancer. J Clin Oncol 2007, 25(18):2560-2566.
• [16]Wade TD, Lee C: The impact of breast cancer on the lives of middle-aged women: results from the Australian longitudinal study of women's health. Health Psychol 2005, 24(3):246-251.
• [17]Winefield HR, Coventry BJ, Lewis M, Harvey EJ: Attitudes of patients with breast cancer toward support groups. J Psychosoc Oncol 2003, 21(2):39-54.
• [18]Commonwealth Department of Health and Aged Care: Insights into the utilisation of health services in Australia based on linked administrative data. In Occasional Papers. Canberra: Commonwealth Department of Health and Aged Care; 2000.
• [19]Earle CC, Neville BA, Fletcher R: Mental health service utilization among long-term cancer survivors. J Cancer Surviv 2007, 1(2):156-160.
• [20]Chambers SK, Pinnock C, Lepore SJ, Hughes S, O'Connell DL: A systematic review of psychosocial interventions for men with prostate cancer and their partners. Patient Educ Couns 2011, 85(2):e75-e88.
• [21]Chisholm KE, McCabe MP, Wootten AC, Abbott JM: Review: psychosocial interventions addressing sexual or relationship functioning in men with prostate cancer. J Sex Med 2012, 9(5):1246-1260.
• [22]Zaider T, Manne S, Nelson C, Mulhall J, Kissane D: Loss of masculine identity, marital affection, and sexual bother in men with localized prostate cancer. J Sex Med 2012, 9(10):2724-2732.
• [23]Klein B: e-Interventions and psychology: Time to log on! InPsych 2010, 32:20-22.
• [24]Spek V, Cuijpers P, Nyklicek I, Riper H, Keyzer J, Pop V: Internet-based cognitive behaviour therapy for symptoms of depression and anxiety: a meta-analysis. Psychol Med 2007, 37(3):319-328.
• [25]Ritterband LM, Thorndike FP, Gonder-Frederick LA, Magee JC, Bailey ET, Saylor DK, Morin CM: Efficacy of an Internet-based behavioral intervention for adults with insomnia. Arch Gen Psychiatry 2009, 66(7):692-698.
• [26]Ritterband LM, Ardalan K, Thorndike FP, Magee JC, Saylor DK, Cox DJ, Sutphen JL, Borowitz SM: Real world use of an Internet intervention for pediatric encopresis. J Med Internet Res 2008, 10(2):e16.
• [27]Salzer MS, Palmer SC, Kaplan K, Brusilovskiy E, Ten Have T, Hampshire M, Metz J, Coyne JC: A randomized, controlled study of Internet peer-to-peer interactions among women newly diagnosed with breast cancer. Psychooncology 2010, 19(4):441-446.
• [28]Wiljer D, Urowitz S, Barbera L, Chivers ML, Quartey NK, Ferguson SE, To M, Classen CC: A qualitative study of an internet-based support group for women with sexual distress due to gynecologic cancer. J Cancer Educ 2011, 26(3):451-458.
• [29]Winzelberg AJ, Classen C, Alpers GW, Roberts H, Koopman C, Adams RE, Ernst H, Dev P, Taylor CB: Evaluation of an internet support group for women with primary breast cancer. Cancer 2003, 97(5):1164-1173.
• [30]van den Brink JL, Moorman PW, de Boer MF, van Bemmel JH, Pruyn JF, Verwoerd CD: An information system to support the care for head and neck cancer patients. Support Care Cancer 2003, 11(7):452-459.
• [31]Schover LR, Canada AL, Yuan Y, Sui D, Neese L, Jenkins R, Rhodes MM: A randomized trial of internet-based versus traditional sexual counseling for couples after localized prostate cancer treatment. Cancer 2012, 118(2):500-509.
• [32]Leykin Y, Thekdi SM, Shumay DM, Munoz RF, Riba M, Dunn LB: Internet interventions for improving psychological well-being in psycho-oncology: review and recommendations. Psychooncology 2012, 21(9):1016-1025.
• [33]Corboy D, McLaren S, McDonald J: Predictors of support service use by rural and regional men with cancer. Aust J Rural Health 2011, 19(4):185-190.
• [34]Schulze B: Mental-health stigma: expanding the focus, joining forces. Lancet 2009, 373(9661):362-363.
• [35]Cuijpers P, van Straten A, Warmerdam L, Andersson G: Psychological treatment of depression: a meta-analytic database of randomized studies. BMC Psychiatry 2008, 8:36. BioMed Central Full Text
• [36]Danaher BG, Seeley JR: Methodological issues in research on web-based behavioral interventions. Ann Behav Med 2009, 38(1):28-39.
• [37]Andersson E, Walen C, Hallberg J, Paxling B, Dahlin M, Almlov J, Kallstrom R, Wijma K, Carlbring P, Andersson G: A randomized controlled trial of guided Internet-delivered cognitive behavioral therapy for erectile dysfunction. J Sex Med 2011, 8(10):2800-2809.
• [38]Hesser H, Gustafsson T, Lunden C, Henrikson O, Fattahi K, Johnsson E, Zetterqvist Westin V, Carlbring P, Maki-Torkko E, Kaldo V, et al.: A randomized controlled trial of Internet-delivered cognitive behavior therapy and acceptance and commitment therapy in the treatment of tinnitus. J Consult Clin Psychol 2012, 80(4):649-661.
• [39]Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gotzsche PC, Lang T: The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 2001, 134(8):663-694.
• [40]Lovibond PF, Lovibond SH: The structure of negative emotional states: comparison of the depression anxiety stress scales (DASS) with the beck depression and anxiety inventories. Behav Res Ther 1995, 33(3):335-343.
• [41]Clark JA, Bokhour BG, Inui TS, Silliman RA, Talcott JA: Measuring patients' perceptions of the outcomes of treatment for early prostate cancer. Med Care 2003, 41(8):923-936.
• [42]Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A: The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology 1997, 49(6):822-830.
• [43]Schumm WR, Anderson SA, Benigas JE, McCutchen MB, Griffin CL, Morris JE, Race GS: Criterion-related validity of the Kansas Marital Satisfaction Scale. Psychol Rep 1985, 56(3):718.
• [44]Graham JM, Diebels KJ, Barnow ZB: The reliability of relationship satisfaction: a reliability generalization meta-analysis. J Fam Psychol 2011, 25(1):39-48.
• [45]Christensen A, Heavey CL: Gender and social structure in the demand/withdraw pattern of marital conflict. J Pers Soc Psychol 1990, 59(1):73-81.
• [46]Futris TG, Campbell K, Nielsen RB, Burwell ST: The Communication patterns questionnaire-short form: a review and assessment. Fam J 2010, 18:275-287.
• [47]Catania JA: Dyadic Sexual Communication Scale. In Handbook of sexuality-related measures. Edited by Davis CM, Yarber WL, Bauserman R, Schreer G, Davis SL. London: Sage; 1998:129-131.
• [48]Choi KH, Catania JA, Dolcini MM: Extramarital sex and HIV risk behavior among US adults: results from the National AIDS behavioral survey. Am J Public Health 1994, 84(12):2003-2007.
• [49]Rubin DB: Estimating causal effects from large data sets using propensity scores. Ann Intern Med 1997, 127(8 Pt 2):757-763.
• [50]Heckman JJ: Sample selection bias as a specification error. Econometrica 1979, 47(1):153-161.
• [51]Heck RH, Thomas SL, Tabata LN: An Introduction to Multilevel Modeling Techniques (Quantitative Methodology Series). Mahwah, NJ: Lawrence Erlbaum; 2008.
• [52]Raudenbush SW, Bryk AS: Hierarchical Linear Models: Applications and Data Analysis Methods. Thousand Oaks, CA: Sage; 2008.