Study protocol of the CAREST-trial: a randomised controlled trial on the (cost-) effectiveness of a CBT-based online self-help training for fear of cancer recurrence in women with curatively treated breast cancer

Sanne Jasperine van Helmondt, Marije Liesbeth van der Lee, Jolanda de Vries, Sanne Jasperine van Helmondt, Marije Liesbeth van der Lee, Jolanda de Vries

Abstract

Background: One of the most prevalent long-term consequences of surviving breast cancer is fear of cancer recurrence (FCR), which is associated with higher (mental) healthcare costs and lower surveillance rates. The majority of breast cancer survivors report a need for professional help in dealing with FCR. An easy-accessible and cost-effective evidence-based psychological intervention for reducing FCR is lacking. In the current study an online self-help training to reduce FCR will be evaluated. In addition, the secondary aim of this study is to identify factors that predict whether women can benefit from the online self-help training or not.

Methods/design: A multi-centre, parallel-groups, randomised controlled trial will be conducted to evaluate the (cost-) effectiveness of the CAREST-trial. A sample of 454 women with curatively treated breast cancer will be recruited from 8 hospitals in the Netherlands. Participants will be randomised to the intervention or usual care group (1:1). Self-report measures will be completed at baseline, 3 (post-intervention), 9, and 24 months. Primary outcome is FCR severity; secondary outcomes are healthcare costs, health status, and psychological distress. The online tailored self-help training "Less fear after cancer" is based on cognitive behavioural therapy and consists of 2 basic modules (psycho-education; basic principles of cognitive behavioural therapy) and 4 optional modules (rumination; action; relaxation; reassurance) to choose from. Each module consists of an informative part (texts, videos, audio files) and a practical part (exercises). For every patient, the intervention will be available for three months. Personal online support by an e-mail coach is available.

Discussion: Online self-help training may be an easy-accessible and cost-effective treatment to reduce the impact of FCR at an early stage in a large group of breast cancer survivors. A strength is the 24 months follow-up period in the health economic evaluation. The results of the study will provide information on the possible strengths and benefits of online self-help training for FCR in breast cancer survivors.

Trial registration: This study is registered at the Netherlands Trial Register ( NTR4119 , date registered: August 15, 2013).

Keywords: Breast cancer; CBT; Cost-effectiveness; Fear of cancer recurrence; Online; RCT; Self-help.

Figures

Fig. 1
Fig. 1
Screenshot of the “Less fear after cancer” online self-help training

References

    1. Dutch Cancer Society . Cancer in the Netherlands until 2020. Amsterdam: Dutch Cancer Society; 2011.
    1. Siegel R, Ma J, Zou Z, Jemal A. Cancer statistics, 2014. CA Cancer J Clin. 2014;64:9–29. doi: 10.3322/caac.21208.
    1. Simard S, Savard J. Fear of Cancer Recurrence Inventory: development and initial validation of a multidimensional measure of fear of cancer recurrence. Support Care Cancer. 2009;17:241–51. doi: 10.1007/s00520-008-0444-y.
    1. Koch L, Bertram H, Eberle A, Holleczek B, Schmid-Höpfner S, Waldmann A, Zeissig SR, Brenner H, Arndt V. Fear of recurrence in long-term breast cancer survivors - still an issue. Results on prevalence, determinants, and the association with quality of life and depression from the Cancer Survivorship - A multi-regional population-based study. Psycho Oncol. 2014;23:547–54. doi: 10.1002/pon.3452.
    1. Thewes B, Butow P, Bell ML, Beith J, Stuart-Harris R, Grossi M, Capp A, Dalley D. Fear of cancer recurrence in young women with a history of early-stage breast cancer: a cross-sectional study of prevalence and association with health behaviours. Support Care Cancer. 2012;20:2651–9. doi: 10.1007/s00520-011-1371-x.
    1. Lebel S, Beattie S, Arès I, Bielajew C. Young and worried: age and fear of recurrence in breast cancer survivors. Health Psychol. 2013;32:695–705. doi: 10.1037/a0030186.
    1. Liu Y, Pérez M, Schootman M, Aft RL, Gillanders WE, Jeffe DB. Correlates of fear of cancer recurrence in women with ductal carcinoma in situ and early invasive breast cancer. Breast Cancer Res Treat. 2011;130:165–73. doi: 10.1007/s10549-011-1551-x.
    1. Crist JV, Grunfeld EA. Factors reported to influence fear of recurrence in cancer patients: a systematic review. Psycho Oncol. 2013;22:978–86. doi: 10.1002/pon.3114.
    1. Thewes B, Bell ML, Butow P. Fear of cancer recurrence in young early-stage breast cancer survivors: the role of metacognitive style and disease-related factors. Psycho Oncol. 2013;22:2059–63. doi: 10.1002/pon.3252.
    1. Mehnert A, Koch U, Sundermann C, Dinkel A. Predictors of fear of recurrence in patients one year after cancer rehabilitation: a prospective study. Acta Oncol. 2013;52:1102–9. doi: 10.3109/0284186X.2013.765063.
    1. Mitchell AJ, Ferguson DW, Gill J, Paul J, Symonds P. Depression and anxiety in long-term cancer survivors compared with spouses and healthy controls: a systematic review and meta-analysis. Lancet Oncol. 2013;14:721–32. doi: 10.1016/S1470-2045(13)70244-4.
    1. Koch L, Jansen L, Brenner H, Arndt V. Fear of recurrence and disease progression in long-term (≥5 years) cancer survivors - a systematic review of quantitative studies. Psycho Oncol. 2013;22:1–11. doi: 10.1002/pon.3022.
    1. Vickberg SMJ. The Concerns About Recurrence Scale (CARS): a systematic measure of women’s fears about the possibility of breast cancer recurrence. Ann Behav Med. 2003;25:16–24. doi: 10.1207/S15324796ABM2501_03.
    1. Mehnert A, Berg P, Henrich G, Herschbach P. Fear of cancer progression and cancer-related intrusive cognitions in breast cancer survivors. Psycho Oncol. 2009;18:1273–80. doi: 10.1002/pon.1481.
    1. Mellon S, Kershaw TS, Northouse LL, Freeman-Gibb L. A family-based model to predict fear of recurrence for cancer survivors and their caregivers. Psycho Oncol. 2007;16:214–23. doi: 10.1002/pon.1074.
    1. Gil KM, Mishel MH, Belyea M, Germino B, Porter LS, Carlton LaNey I, Stewart J. Triggers of uncertainty about recurrence and long-term treatment side effects in older African American and Caucasian breast cancer survivors. Oncol Nurs Forum. 2004;31:633–9. doi: 10.1188/04.ONF.633-639.
    1. Lebel S, Tomei C, Feldstain A, Beattie S, McCallum M. Does fear of cancer recurrence predict cancer survivors’ health care use? Support Care Cancer. 2013;21:901–6. doi: 10.1007/s00520-012-1685-3.
    1. Kuehn T, Klauss W, Darsow M, Regele S, Flock F, Maiterth C, Dahlbender R, Wendt I, Kreienberg R. Long-term morbidity following axillary dissection in breast cancer patients - clinical assessment, significance for life quality and the impact of demographic, oncologic and therapeutic factors. Breast Cancer Res Tr. 2000;64:275–86. doi: 10.1023/A:1026564723698.
    1. Simard S, Thewes B, Humphris G, Dixon M, Hayden C, Mireskandari S, Ozakinci G. Fear of cancer recurrence in adult cancer survivors: a systematic review of quantitative studies. J Cancer Surviv. 2013;7:300–22. doi: 10.1007/s11764-013-0272-z.
    1. Bower JE, Ganz PA, Desmond KA, Bernaards C, Rowland JH, Meyerowitz BE, Belin TR. Fatigue in long-term breast carcinoma survivors: A longitudinal investigation. Cancer. 2006;106:751–8. doi: 10.1002/cncr.21671.
    1. Jansen F, Van Uden-Kraan CF, Van Zwieten V, Witte BI, Leemans CR, Verdonck-de Leeuw IM. Cancer survivors’ perceived need for supportive care and their attitude towards self-management and e health. Support Care Cancer. 2015;23:1679–88. doi: 10.1007/s00520-014-2514-7.
    1. Armes J, Crowe M, Colbourne L, Morgan H, Murrells T, Oakley C, Palmer N, Ream E, Young A, Richardson A. Patients’ supportive care needs beyond the end of cancer treatment: A prospective, longitudinal survey. J Clin Oncol. 2009;27:6172–9. doi: 10.1200/JCO.2009.22.5151.
    1. Leykin Y, Thekdi SM, Shumay DM, Muñoz RF, Riba M, Dunn LB. Internet interventions for improving psychological well-being in psycho-oncology: review and recommendations. Psycho Oncol. 2012;21:1016–25. doi: 10.1002/pon.1993.
    1. Völker C, Van der Lee ML, Pet A. The fear of cancer recurrence [article in Dutch] GZ-psychologie. 2011;3:30–8. doi: 10.1007/s41480-011-0029-0.
    1. Ziner KW, Sledge GW, Bell CJ, Johns S, Miller KD, Champion VL. Predicting fear of breast cancer recurrence and self-efficacy in survivors by age at diagnosis. Oncol Nurs Forum. 2012;39:287–95. doi: 10.1188/12.ONF.287-295.
    1. Gil KM, Mishel MH, Belyea M, Germino B, Porter LS, Clayton M. Benefits of the uncertainty management intervention for African American and White older breast cancer survivors: 20-month outcomes. Int J Behav Med. 2006;13:286–94. doi: 10.1207/s15327558ijbm1304_3.
    1. Herschbach P, Book K, Dinkel A, Berg P, Waadt S, Duran G, Engst-Hastreiter U, Henrich G. Evaluation of two group therapies to reduce fear of progression in cancer patients. Support Care Cancer. 2010;18:471–9. doi: 10.1007/s00520-009-0696-1.
    1. Schroevers M, van der Lee ML, Pet A. Cognitive behavioural therapy [in Dutch: Cognitieve gedragstherapie] In: de Haes J, van Weezel L, Sanderman R, editors. Psychological care in oncology [in Dutch: Psychologische patiëntenzorg in de oncologie] Assen: Van Gorcum; 2009. pp. 227–38.
    1. Andrews G, Cuijpers P, Craske MG, McEvoy P, Titov N. Computer therapy for the anxiety and depressive disorders is effective, acceptable and practical health care: a meta-analysis. PLoS One. 2010;5:e13196. doi: 10.1371/journal.pone.0013196.
    1. Christensen H, Batterham P, Calear A. Online interventions for anxiety disorders. Curr Opin Psychiatry. 2014;27:7–13. doi: 10.1097/YCO.0000000000000019.
    1. Van’t Hof E, Cuijpers P, Stein DJ. Self-help and Internet-guided interventions in depression and anxiety disorders: a systematic review of meta-analyses. CNS Spectr. 2009;14:34–40.
    1. Stiegelis HE, Hagedoorn M, Sanderman R, Bennenbroek FT, Buunk BP, van den Bergh AC, Botke G, Ranchor AV. The impact of an informational intervention on the association between control and illness uncertainty before and psychological distress after radiotherapy. Psycho Oncol. 2004;13:248–59. doi: 10.1002/pon.738.
    1. Eysenbach G. The law of attrition. J Med Internet Res. 2005;7:e11. doi: 10.2196/jmir.7.1.e11.
    1. Spek V, Cuijpers P, Nyklícek I, Riper H, Keyzer J, Pop V. Internet-based cognitive behaviour therapy for symptoms of depression and anxiety: a meta-analysis. Psychol Med. 2007;37:319–28. doi: 10.1017/S0033291706008944.
    1. Haug T, Nordgreen T, Öst LG, Havik OE. Self-help treatment of anxiety disorders: a meta-analysis and meta-regression of effects and potential moderators. Clin Psychol Rev. 2012;32:425–45. doi: 10.1016/j.cpr.2012.04.002.
    1. Berger T, Caspar F, Richardson R, Kneubühler B, Sutter D, Andersson G. Internet-based treatment of social phobia: a randomized controlled trial comparing unguided with two types of guided self-help. Behav Res Ther. 2011;49:158–69. doi: 10.1016/j.brat.2010.12.007.
    1. Carlbring P, Nilsson-Ihrfelt E, Waara J, Kollenstam C, Buhrman M, Kaldo V, Söderberg M, Ekselius L, Andersson G. Treatment of panic disorder: live therapy vs. self-help via the Internet. Behav Res Ther. 2005;43:1321–33. doi: 10.1016/j.brat.2004.10.002.
    1. Matcham F, Rayner L, Hutton J, Monk A, Steel C, Hotopf M. Self-help interventions for symptoms of depression, anxiety and psychological distress in patients with physical illnesses: a systematic review and meta-analysis. Clin Psychol Rev. 2014;34:141–57. doi: 10.1016/j.cpr.2014.01.005.
    1. 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:S77–86. doi: 10.1016/j.pec.2010.07.040.
    1. Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010;8:18. doi: 10.1186/1741-7015-8-18.
    1. Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, Doré CJ, Parulekar WR, Summerskill WSM, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;2013(158):200–7. doi: 10.7326/0003-4819-158-3-201302050-00583.
    1. Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586. doi: 10.1136/bmj.e7586.
    1. 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;19:289–98. doi: 10.1002/pon.1570.
    1. Custers JAE, van den Berg SW, van Laarhoven HWM, Bleiker EMA, Gielissen MFM, Prins JB. The Cancer Worry Scale: detecting fear of recurrence in breast cancer survivors. Cancer Nurs. 2013;37:E44–50. doi: 10.1097/NCC.0b013e3182813a17.
    1. Bouwmans C, Hakkaart-van Roijen L, Koopmanschap M, Krol M, Severens H, Brouwer W. Medical Consumption Questionnaire. Rotterdam: Institute for Medical Technology Assessment; 2013.
    1. Hakkaart-van Roijen L, Tan SS, Bouwmans CAM. Dutch Manual on Cost Investigations: Methods and Standard Cost-Prizes for Economic Evaluations in Healthcare. [Handleiding Voor Kostenonderzoek. Methoden En Standaard Kostprijzen Voor Economische Evaluaties in de Gezondheidszorg] Diemen: College voor zorgverzekeringen; 2011.
    1. Lamers LM, Stalmeier PFM, Mcdonnell J, Krabbe PFM, Van Busschbach JJ. Measuring the quality of life in economic evaluations: the Dutch EQ-5D tariff. Ned Tijdschr Geneesk. 2005;149:1574–8.
    1. Rabin R, De Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001;33:337–43. doi: 10.3109/07853890109002087.
    1. Van Reenen M, Oppe M. EQ-5D-3L User Guide, Version 5.1. Rotterdam: EuroQol Research Foundation; 2015.
    1. Drummond MF, Sculpher MJ, Torrance GW, O’Brien BJ, Stoddart GL. Methods for the Economic Evaluation of Health Care Programmes. 3. New York: Oxford University Press; 2005.
    1. Brazier J, Jones N, Kind P. Testing the validity of the Euroqol and comparing it with the SF-36 health survey questionnaire. Qual Life Res. 1993;2:169–80. doi: 10.1007/BF00435221.
    1. Van Agt HM, Essink-Bot ML, Krabbe PF, Bonsel GJ. Test-retest reliability of health state valuations collected with the EuroQol questionnaire. Soc Sci Med. 1994;39:1537–44. doi: 10.1016/0277-9536(94)90005-1.
    1. Hurst NP, Kind P, Ruta D, Hunter M, Stubbings A. Measuring health-related quality of life in rheumatoid arthritis: validity, responsiveness and reliability of EuroQol (EQ-5D) Br J Rheumatol. 1997;36:551–9. doi: 10.1093/rheumatology/36.5.551.
    1. Bogaarts MPJ, Den Oudsten BL, Roukema JA, Van Riel JMGH, Beerepoot LV, De Vries J. Development of the Psychosocial Distress Questionnaire-Breast Cancer (PDQ-BC): a breast cancer-specific screening instrument for psychosocial problems. Support Care Cancer. 2011;19:1485–93. doi: 10.1007/s00520-010-0968-9.
    1. Bogaarts MPJ, Den Oudsten BL, Roukema JA, Van Riel JMGH, Beerepoot LV, De Vries J. The Psychosocial Distress Questionnaire-Breast Cancer (PDQ-BC) is a useful instrument to screen psychosocial problems. Support Care Cancer. 2012;20:1659–65. doi: 10.1007/s00520-011-1256-z.
    1. Bogaarts MPJ, Den Oudsten BL, Roukema JNA, Van Riel JMGH, Beerepoot LSV, De Vries J. Reliability and validity of the Psychosocial Distress Questionnaire-Breast Cancer. J Nurs Meas. 2014;22:14–28. doi: 10.1891/1061-3749.22.2.E14.
    1. Bandura A. Guide for constructing self-efficacy scales. In: Urdan T, Pajares F, editors. Self-efficacy beliefs of adolescents. Greenwich, CT: Information Age Publishing; 2006:307–337.
    1. Norman CD, Skinner HA. eHEALS: the eHealth literacy scale. J Med Internet Res. 2006;8:e27. doi: 10.2196/jmir.8.4.e27.
    1. Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a short form of the Patient Activation Measure. Health Serv Res. 2005;40:1918–30. doi: 10.1111/j.1475-6773.2005.00438.x.
    1. Healthcare consumer and self-management scale [in Dutch: Vragenlijst zorgconsument en zelfmanagement]. []. Accessed 6 Mar 2014.
    1. Teeuw B, Schwarzer R, Jerusalem M. Dutch Adaptation of the General Self-Efficacy Scale. 1994. []. Accessed 6 Mar 2014.
    1. Chronic Disease Self-Efficacy Scales. []. Accessed 6 Mar 2014.
    1. Simard S, Savard J, Ivers H. Fear of cancer recurrence: specific profiles and nature of intrusive thoughts. J Cancer Surviv. 2010;4:361–71. doi: 10.1007/s11764-010-0136-8.
    1. Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009;41:1149–60. doi: 10.3758/BRM.41.4.1149.
    1. Owen JE, Klapow JC, Roth DL, Shuster JL, 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. David N, Schlenker P, Prudlo U, Larbig W. Online counseling via e-mail for breast cancer patients on the German internet: preliminary results of a psychoeducational intervention. Psychosoc Med. 2011;8:1–13.
    1. Hedeker D, Gibbons RD. Longitudinal data analysis. Hoboken: Wiley; 2006.

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