BMC Cancer | |
Rationale of the BREAst cancer e-healTH [BREATH] multicentre randomised controlled trial: An Internet-based self-management intervention to foster adjustment after curative breast cancer by decreasing distress and increasing empowerment | |
Sanne W van den Berg2  Marieke F M Gielissen2  Petronella B Ottevanger1  Judith B Prins2  | |
[1] Department of Medical Oncology, Radboud University Medical Centre, Nijmegen, the Netherlands | |
[2] Department of Medical Psychology, Radboud University Medical Centre, Nijmegen, the Netherlands | |
关键词: RCT; eHealth; Empowerment; Adjustment; Intervention; Self-management; Internet; Breast cancer; | |
Others : 1080214 DOI : 10.1186/1471-2407-12-394 |
|
received in 2012-08-21, accepted in 2012-08-23, 发布年份 2012 | |
【 摘 要 】
Background
After completion of curative breast cancer treatment, patients go through a transition from patient to survivor. During this re-entry phase, patients are faced with a broad range of re-entry topics, concerning physical and emotional recovery, returning to work and fear of recurrence. Standard and easy-accessible care to facilitate this transition is lacking. In order to facilitate adjustment for all breast cancer patients after primary treatment, the BREATH intervention is aimed at 1) decreasing psychological distress, and 2) increasing empowerment, defined as patients’ intra- and interpersonal strengths.
Methods/design
The non-guided Internet-based self-management intervention is based on cognitive behavioural therapy techniques and covers four phases of recovery after breast cancer (Looking back; Emotional processing; Strengthening; Looking ahead). Each phase of the fully automated intervention has a fixed structure that targets consecutively psychoeducation, problems in everyday life, social environment, and empowerment. Working ingredients include Information (25 scripts), Assignment (48 tasks), Assessment (10 tests) and Video (39 clips extracted from recorded interviews). A non-blinded, multicentre randomised controlled, parallel-group, superiority trial will be conducted to evaluate the effectiveness of the BREATH intervention. In six hospitals in the Netherlands, a consecutive sample of 170 will be recruited of women who completed primary curative treatment for breast cancer within 4 months. Participants will be randomly allocated to receive either usual care or usual care plus access to the online BREATH intervention (1:1). Changes in self-report questionnaires from baseline to 4 (post-intervention), 6 and 10 months will be measured.
Discussion
The BREATH intervention provides a psychological self-management approach to the disease management of breast cancer survivors. Innovative is the use of patients’ own strengths as an explicit intervention target, which is hypothesized to serve as a buffer to prevent psychological distress in long-term survivorship. In case of proven (cost) effectiveness, the BREATH intervention can serve as a low-cost and easy-accessible intervention to facilitate emotional, physical and social recovery of all breast cancer survivors.
Trial registration
This study is registered at the Netherlands Trial Register (NTR2935)
【 授权许可】
2012 van den Berg et al.; licensee BioMed Central Ltd.
【 预 览 】
Files | Size | Format | View |
---|---|---|---|
20141202232248487.pdf | 1013KB | download | |
Figure 2. | 112KB | Image | download |
Figure 1. | 130KB | Image | download |
【 图 表 】
Figure 1.
Figure 2.
【 参考文献 】
- [1]Dutch Cancer Society: Cancer in the Netherlands until 2020. Amsterdam: Dutch Cancer Society; 2011.
- [2]Jemal A: Global cancer statistics (vol 61, pg 69, 2011). CA Cancer J Clin 2011, 61(2):134-135.
- [3]Autier P, Boniol M, La Vecchia C, Vatten L, Gavin A, Hery C, Heanue M: Disparities in breast cancer mortality trends between 30 European countries: retrospective trend analysis of WHO mortality database. Br Med J 2010, 341:c3620.
- [4]van Schoor G, Moss SM, Otten JDM, Donders R, Paap E, den Heeten GJ, Holland R, Broeders MJM, Verbeek ALM: Increasingly strong reduction in breast cancer mortality due to screening. Br J Cancer 2011, 104(6):910-914.
- [5]McCorkle R, Ercolano E, Lazenby M, Schulman-Green D, Schilling LS, Lorig K, Wagner EH: Self-management: enabling and empowering patients living with cancer as a chronic illness. CA Cancer J Clin 2011, 61(1):50-62.
- [6]Arnold EM: The cessation of cancer treatment as a crisis. Soc Work Health Care 1999, 29(2):21-38.
- [7]Allen JD, Savadatti S, Levy AG: The transition from breast cancer 'patient' to 'survivor'. Psycho-Oncol 2009, 18(1):71-78.
- [8]Mullan F: Re-entry - the educational-needs of the cancer survivor. Health Educ Q 1984, 10:88-94.
- [9]Stanton AL, Ganz PA, Rowland JH, Meyerowitz BE, Krupnick JL, Sears SR: Promoting adjustment after treatment for cancer. Cancer 2005, 104(11 Suppl):2608-2613.
- [10]Stanton AL: What happens Now? psychosocial care for cancer survivors after medical treatment completion. J Clin Oncol 2012, 30(11):1215-1220.
- [11]Mehnert A, Berg P, Henrich G, Herschbach P: Fear of cancer progression and cancer-related intrusive cognitions in breast cancer survivors. Psycho-Oncol 2009, 18(12):1273-1280.
- [12]Mehnert A: Employment and work-related issues in cancer survivors. Crit Rev Oncol Hematol 2011, 77(2):109-130.
- [13]Henselmans I, Helgeson VS, Seltman H, De Vries J, Sanderman R, Ranchor AV: Identification and prediction of distress trajectories in the first year after a breast cancer diagnosis. Health Psychol 2010, 29(2):160-168.
- [14]Helgeson VS, Snyder P, Seltman H: Psychological and physical adjustment to breast cancer over 4 years: Identifying distinct trajectories of change. Health Psychol 2004, 23(1):3-15.
- [15]Cappiello M, Cunningham RS, Knobf MT, Erdos D: Breast cancer survivors: information and support after treatment. Clin Nurs Res 2007, 16(4):278-293. discussion 294–301
- [16]Fors EA, Bertheussen GF, Thune I, Juvet LK, Elvsaas IKO, Oldervoll L, Anker G, Falkmer U, Lundgren S, Leivseth G: Psychosocial interventions as part of breast cancer rehabilitation programs? Results from a systematic review. Psycho-Oncol 2011, 20(9):909-918.
- [17]Graves KD: Social cognitive theory and cancer patients' quality of life: a meta-analysis of psychosocial intervention components. Health Psychol 2003, 22(2):210-219.
- [18]Tatrow K, Montgomery GH: Cognitive behavioral therapy techniques for distress and pain in breast cancer patients: A meta-analysis. J Behav Med 2006, 29(1):17-27.
- [19]Barlow J, Wright C, Sheasby J, Turner A, Hainsworth J: Self-management approaches for people with chronic conditions: a review. Patient Educ Couns 2002, 48(2):177-187.
- [20]Cimprich B, Janz NK, Northouse L, Wren PA, Given B, Given CW: Taking charge: a self-management program for women following breast cancer treatment. Psycho-Oncol 2005, 14(9):704-717.
- [21]Stanton AL, Ganz PA, Kwan L, Meyerowitz BE, Bower JE, Krupnick JL, Rowland JH, Leedham B, Belin TR: Outcomes from the moving beyond cancer psychoeducational, randomized, controlled trial with breast cancer patients. J Clin Oncol 2005, 23(25):6009-6018.
- [22]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. Psycho-Oncol 2012, 21(9):1016-1025.
- [23]Proudfoot J, Klein B, Barak A, Carlbring P, Cuijpers P, Lange A, Ritterband L, Andersson G: Establishing guidelines for executing and reporting internet intervention research. Cogn Behav Ther 2011, 40(2):82-97.
- [24]Duffecy J, Sanford S, Wagner L, Begale M, Nawacki E, Mohr DC: Project onward: an innovative e-health intervention for cancer survivors. Psycho-Oncol 2012.
- [25]Fogel J, Albert SM, Schnabel F, Ditkoff BA, Neugut AI: Use of the internet by women with breast cancer. J Med Internet Res 2002., 4(2)
- [26]Eysenbach G: The impact of the internet on cancer outcomes. CA Cancer J Clin 2003, 53(6):356-371.
- [27]Afshari M, Ghani MFA, Radzi NM: Use of the internet by breast cancer patients. Sci Res Essays 2011, 6(17):3571-3576.
- [28]Barlow JH, Bancroft GV, Turner AP: Self-management training for people with chronic disease: a shared learning experience. J Health Psychol 2005, 10(6):863-872.
- [29]Hoybye MT, Dalton SO, Christensen J, Ross L, Kuhn KG, Johansen C: Social and psychological determinants of participation in internet-based cancer support groups. Support Care Canc 2010, 18(5):553-560.
- [30]Andrykowski MA, Lykins E, Floyd A: Psychological health in cancer survivors. Semin Oncol Nurs 2008, 24(3):193-201.
- [31]Zimmerman MA: Psychological empowerment: issues and illustrations. Am J Community Psychol 1995, 23(5):581-599.
- [32]Schulz KF, Altman DG, Moher D: CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010, 340:c332.
- [33]Baker TB, Gustafson DH, Shaw B, Hawkins R, Pingree S, Roberts L, Strecher V: Relevance of CONSORT reporting criteria for research on eHealth interventions. Patient Educ Couns 2010, 81:S77-S86.
- [34]Arindell WA, Ettema JHM: Handleiding bij een multidimensionele psychopathologie-indicator. Symptom Checklist SCL-90. (Herziene uitgave). Lisse: Swets & Zeitlinger; 2003.
- [35]Prins JB, Bleijenberg G, Bazelmans E, Elving LD, de Boo TM, Severens JL, van der Wilt GJ, Spinhoven P, van der Meer JWM: Cognitive behaviour therapy for chronic fatigue syndrome: a multicentre randomised controlled trial. Lancet 2001, 357(9259):841-847.
- [36]Gielissen MFM, Verhagen S, Witjes F, Bleijenberg G: Effects of cognitive behavior therapy in severely fatigued disease-free cancer patients compared with patients waiting for cognitive behavior therapy: a randomized controlled trial. J Clin Oncol 2006, 24(30):4882-4887.
- [37]van den Berg SW, Gielissen MFM, Prins JB: Validation of an empowerment questionnaire in breast cancer survivors. Psycho-Oncol 2010, 19:S88-S89.
- [38]Zigmond AS, Snaith RP: The hospital anxiety and depression scale. Acta Psychiatr Scand 1983, 67(6):361-370.
- [39]Annunziata MA, Muzzatti B, Altoe G: Defining hospital anxiety and depression scale (HADS) structure by confirmatory factor analysis: a contribution to validation for oncological settings. Ann Oncol 2011, 22:2300-2333.
- [40]Vodermaier A, Millman RD: Accuracy of the hospital anxiety and depression scale as a screening tool in cancer patients: a systematic review and meta-analysis. Support Care Canc 2011, 19(12):1899-1908.
- [41]Spinhoven P, Ormel J, Sloekers PPA, Kempen GIJM, Speckens AEM, VanHemert AM: A validation study of the hospital anxiety and depression scale (HADS) in different groups of Dutch subjects. Psychol Med 1997, 27(2):363-370.
- [42]Alexander S, Palmer C, Stone PC: Evaluation of screening instruments for depression and anxiety in breast cancer survivors. Breast Canc Res Treat 2010, 122(2):573-578.
- [43]Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, Dehaes JCJM, et al.: The European-organization-for-research-and-treatment-of-cancer Qlq-C30 - a quality-of-life instrument for Use in international clinical-trials in oncology. J Natl Canc Inst 1993, 85(5):365-376.
- [44]Sprangers MAG, Groenvold M, Arraras JI, Franklin J, teVelde A, Muller M, Franzini L, Wiliams A, Dehaes HCJM, Hopwood P, et al.: The European organization for research and treatment of cancer breast cancer-specific quality-of-life questionnaire module: first results from a three-country field study. J Clin Oncol 1996, 14(10):2756-2768.
- [45]Albert US, Koller M, Lorenz W, Kopp I, Heitmann C, Stinner B, Rothmund M, Schulz KD: Quality of life profile: from measurement to clinical application. Breast 2002, 11(4):324-334.
- [46]Ahn SH, Park BW, Noh DY, Nam SJ, Lee ES, Lee MK, Kim SH, Lee KM, Park SM, Yun YH: Health-related quality of life in disease-free survivors of breast cancer with the general population. Ann Oncol 2007, 18(1):173-182.
- [47]Tuinman MA, Gazendam-Donofrio SM, Hoekstra-Weebers JE: Screening and referral for psychosocial distress in oncologic practice - Use of the distress thermometer. Cancer 2008, 113(4):870-878.
- [48]Hegel MT, Collins ED, Kearing S, Gillock KL, Moore CP, Ahles TA: Sensitivity and specificity of the distress thermometer for depression in newly diagnosed breast cancer patients. Psycho-Oncol 2008, 17(6):556-560.
- [49]Dabrowski M, Boucher K, Ward JH, Lovell MM, Sandre A, Bloch J, Carlquist L, Porter M, Norman L, Buys SS: Clinical experience with the NCCN distress thermometer in breast cancer patients. J Natl Compr Canc Netw 2007, 5(1):104-111.
- [50]Evers AWM, Kraaimaat FW, van Lankveld W, Jongen PJH, Jacobs JWG, Bijlsma JWJ: Beyond unfavorable thinking: the illness cognition questionnaire for chronic diseases. J Consult Clin Psychol 2001, 69(6):1026-1036.
- [51]Crombez G, Lauwerier E, Van Damme S, Goubert L, Vogelaers D, Evers AWM: The construct validity of the illness cognition questionnaire: the robustness of the three-factor structure across patients with chronic pain and chronic fatigue. Int J Behav Med 2010, 17(2):90-96.
- [52]Vissers W, Keijsers GPJ, van der Veld WM, de Jong CAJ, Hutschemaekers GJM: Development of the remoralization scale an extension of contemporary psychotherapy outcome measurement. Eur J Psychol Assess 2010, 26(4):293-301.
- [53]Pearlin LI, Schooler C: The structure of coping. J Health Soc Behav 1978, 19(1):2-21.
- [54]Henselmans I, Sanderman R, Helgeson VS, De Vries J, Smink A, Ranchor AV: Personal control over the cure of breast cancer: adaptiveness, underlying beliefs and correlates. Psycho-Oncol 2010, 19(5):525-534.
- [55]Boot JS, Holcombe C, Salmon P: Positive adjustment to breast cancer: development of a disease-specific measure and comparison of women diagnosed from 2 weeks to 5 years. Psycho-Oncol 2010, 19(11):1187-1194.
- [56]Joseph S: Psychometric evaluation of Horowitz's impact of event scale: a review. J Trauma Stress 2000, 13(1):101-113.
- [57]Creamer M, Bell R, Failla S: Psychometric properties of the impact of event scale - revised. Behav Res Ther 2003, 41(12):1489-1496.
- [58]van der Ploeg E, Mooren TT, Kleber RJ, van der Velden PG, Brom D: Construct validation of the Dutch version of the impact of event scale. Psychol Assess 2004, 16(1):16-26.
- [59]Carver CS: You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med 1997, 4(1):92-100.
- [60]Urcuyo KR, Boyers AE, Carver CS, Antoni MH: Finding benefit in breast cancer: relations with personality, coping, and concurrent well-being. Psychol Health 2005, 20(2):175-192.
- [61]Servaes P, Verhagen S, Bleijenberg G: Determinants of chronic fatigue in disease-free breast cancer patients: a cross-sectional study. Ann Oncol 2002, 13(4):589-598.
- [62]Gielissen MFM, Verhagen CAHH, Bleijenberg G: Cognitive behaviour therapy for fatigued cancer survivors: long-term follow-up. Br J Cancer 2007, 97(5):612-618.
- [63]Douma KFL, Aaronson NK, Vasen HFA, Gerritsma MA, Gundy CM, Janssen EPA, Vriends AHJT, Cats A, Verhoef S, Bleiker EMA: Psychological distress and use of psychosocial support in familial adenomatous polyposis. Psycho-Oncol 2010, 19(3):289-298.
- [64]Custers J, van den Berg SW, Laarhoven HWM, Bleiker EMA, Gielissen MFM, Prins JB: Cancer worry scale: a screening instrument for fear of cancer recurrence. Psycho-Oncol 2011, 20:S141-S142.
- [65]Watson M, Duvivier V, Wade Walsh M, Ashley S, Davidson J, Papaikonomou M, Murday V, Sacks N, Eeles R: Family history of breast cancer: what do women understand and recall about their genetic risk? J Med Genet 1998, 35(9):731-738.
- [66]Hopwood P, Shenton A, Lalloo F, Evans DG, Howell A: Risk perception and cancer worry: an exploratory study of the impact of genetic risk counselling in women with a family history of breast cancer. J Med Genet 2001, 38(2):139-142.
- [67]Servaes P, Verhagen S, Schreuder HW, Veth RP, Bleijenberg G: Fatigue after treatment for malignant and benign bone and soft tissue tumors. J Pain Symptom Manage 2003, 26(6):1113-1122.
- [68]Mesters I, van den Borne H, McCormick L, Pruyn J, de Boer M, Imbos T: Openness to discuss cancer in the nuclear family: scale, development, and validation. Psychosom Med 1997, 59(3):269-279.
- [69]van Oostrom I, Meijers-Heijboer H, Duivenvoorden HJ, Brocker-Vriends AH, van Asperen CJ, Sijmons RH, Seynaeve C, van Gool AR, Klijn JG, Tibben A: Family system characteristics and psychological adjustment to cancer susceptibility genetic testing: a prospective study. Clin Genet 2007, 71(1):35-42.
- [70]Denissen JJ, Geenen R, van Aken MA, Gosling SD, Potter J: Development and validation of a Dutch translation of the Big Five Inventory (BFI). J Pers Assess 2008, 90(2):152-157.
- [71]John OP, Srivastava S: The Big five trait taxonomy: history, measurement and theoretical perspectives. In Handbook of personality: theory and research. Edited by Pervin LA, John OP. New York: Guilford; 1999:102-138.
- [72]Hakkaart-Van Roijen L: Manual - Trimbos/iMTA questionnaire for costs associated with psychiatric illness (TiC-P). Rotterdam: Institute for Medical Technology Assessment; 2002.
- [73]Donkin L, Christensen H, Naismith SL, Neal B, Hickie IB, Glozier N: A systematic review of the impact of adherence on the effectiveness of e-therapies. J Med Internet Res 2011., 13(3)
- [74]Cuijpers P, van Straten A, Andersson G: Internet-administered cognitive behavior therapy for health problems: a systematic review. J Behav Med 2008, 31(2):169-177.
- [75]Christensen H, Griffiths KM, Farrer L: Adherence in internet interventions for anxiety and depression: systematic review. J Med Internet Res 2009., 11(2)