social support, social functioning, physical functioning, role functioning and optimism. There was no effect on FCRI subscales ‘coping strategies’ and ‘reassurance seeking‘. Higher scores on these subscales may reflect both versatility and dysfunctional coping. Therefore, the aggregated FCRI total score should be interpreted with caution [50].
In the intention-to-treat analyses strong effects were found, even though one third in bCBT were non-completers and one-third of the CAU participants had received ad- ditional supportive care. Per-protocol analyses were considered redundant. Our findings are in line with a feasibility study, a pilot study and two trials that reported beneficial effects of individual and group face-to-face therapies on FCR [12-15]. The effect size (0.76) lies in the range of ESs for individual and group psychotherapy for anxiety (0.56), depression (0.53), distress (1.01) and QoL (0.89) in cancer survivors[43]. A meta-review found that ehealth interventions combined with professional guidance produced equivalent effects as classic face-to-face therapies [18]. Blended care therefore appears to be a promising approach. The intervention was delivered by highly motivated and experienced therapists, which may partially account for the large effects.
Therapist treatment adherence was satisfactory. Log data analysis showed that bCBT participants regularly logged into the website and completed nearly all homework assignments, indicating good therapy compliance. Intervention non-completion rate was 34%. This percentage is somewhat higher than the non-completion rate for group FCR interventions (20-24%)[14,12] but lower than that of an individual nurse-delivered intervention (42%)[13]. In current study, six patients discontinued therapy due to thera- pist reasons. During sick leave of one therapist, four patients were offered to continue therapy with another therapist but all declined. While the protocol stated that the thera- pist should aim to defer referral to other psychological services during the intervention trial two patients were referred which was a deviation from protocol.
This study has several limitations. Despite adequate power and a rigorous recruitment method, it is not certain to what extent the results of the present study generalize to other cancer survivors with high FCR. Firstly, the response rate to the initial study invita- tion letter was low (21%). However, it is noteworthy that the invitation was provided to a group of patients who were not screened for FCR and that due to the opt-in recruit- ment method reasons for non-response are not known. Based on Dutch FCR prevalence estimates of high FCR, it is likely that around one-third of patients who received the invitation had high FCR. Furthermore, research conducted in the Netherlands and the UK suggests that around 20% of cancer survivors require help dealing with FCR [51,52], so the response rate to the initial invitation in this study is consistent with the preva- lence and unmet need for help with FCR reported in the literature. Secondly, healthcare professionals were sometimes reluctant to recruit participants for this trial due to the no treatment control group. Therefore, some survivors were referred to psychosocial
services outside the study context. Future studies on the implementation and effective- ness of FCR interventions should explore uptake by cancer survivors in clinical settings and barriers and facilitators of participation in blended therapy for FCR.
Some design limitations warrant further comment. The study did not include an active control group and we cannot rule out that therapist attention resulted in the observed changes. Therefore, the reported findings may be an overestimation of the treatment effects. Secondly, while using an online component in therapy is innovative, 16% required to use a workbook rather than the website. This suggests that web-based therapy may not suit everyone. Finally, the small sample sizes do not allow comparisons among patient subgroups to identify moderators of the treatment effect. Nevertheless, the present study offers novel insights on the efficacy of bCBT for cancer survivors.
Screening for high FCR and making referrals to psychological services is an impor- tant role for healthcare professionals. Given that some FCR is normal, many health professionals find it difficult to identify patients with high FCR. Developing educational programs for health professionals concerning the prevalence of FCR, characteristics, consequences and treatments for FCR is therefore a priority.
ACknoWleDGMenTs
We are grateful to the patients for their participation in this trial and to the oncologists, radiotherapists, urologists and nurse specialists of the Radboud University Medical Centre, Nijmegen; Canisius-Wilhelmina Hospital, Nijmegen; Maasziekenhuis Pantein, Boxmeer; Hospital Bernhoven, Uden/Veghel and Hospital Gelderse Vallei Ede for their efforts in referring patients to the trial. We would like to thank Dr. R. Donders from the Department of Biostatistics of the Radboud University Medical Centre for his critical reflection and contribution to the data analysis plan; S. Logger, L. Schulting and C. van Batenburg for their contribution to the treatment integrity check; and Dr. P. Servaes and D. Marcelissen for carrying out the intervention.
fInAnCIAl DIsClosURe
This research is funded by the Dutch Cancer Society (Grant number KUN 2012–5545), awarded to dr. Marieke F.M. Gielissen, Prof. dr. Judith B. Prins en Prof. dr. Anne E. M. Speckens.
SWORD: effect study 147
7
ConflICTs of InTeResT None AUTHoR ConTRIbUTIonsConception and design: Judith Prins, Anne Speckens, Marieke Gielissen Acquisition of data: Marieke van de Wal
Analysis and interpretation of data: All authors. Drafting of manuscript: All authors.
Critical revision: All authors.
RefeRenCes
1. Lebel S, Ozakinci G, Humphris GM, et al: From normal response to clinical problem: definition and clinical features of fear of cancer recurrence. Support Care Cancer 24:3265-3268, 2016
2. Lee-Jones C, Humphris G, Dixon R, et al: Fear of cancer recurrence—a literature review and proposed cognitive formulation to explain exacerbation of recurrence fears. Psychooncology 6:95–105, 1997
3. Simard S, Thewes B, Humphris G, et al: Fear of cancer recurrence in adult cancer survivors: a systematic review of quantitative studies. J Cancer Surviv 7:300-322, 2013
4. Crist JV, Grunfeld AE: Factors reported to influence fear of recurrence in cancer patients: a system- atic review. Psychooncology 22:978-986, 2013
5. Koch L, Jansen L, Brenner H, et al: Fear of recurrence and disease progression in long-term (>/= 5 years) cancer survivors-a systematic review of quantitative studies. Psychooncology 22:1-11, 2013
6. Kim Y, Carver CS, Spillers RL, et al: Dyadic effects of fear of recurrence on the quality of life of cancer survivors and their caregivers. Qual Life Res 21:517-25, 2012
7. Custers JAE, Gielissen MFM, De Wilt JHW, et al: Towards an evidence-based model of Fear of Cancer Recurrence. J Cancer Surviv (in press)
8. Custers JAE, Gielissen MFM, Janssen SHV, et al: Fear of cancer recurrence in colorectal cancer survivors. Support Care Cancer 24:555–562, 2016.
9. Custers JAE, Berg van den SW, Laarhoven van HW, et al: The Cancer Worry Scale. Detecting Fear of Recurrence in Breast Cancer Survivors. Cancer Nurs 37:E44-50, 2014
10. Van de wal MA, van Oort I, Schouten J, et al: Fear of cancer recurrence in prostate cancer survivors. Acta Oncol 55:821-827, 2016
11. Thewes B, Brebach R, Dzidowska M, et al: Current approaches to managing fear of cancer recur- rence; a descriptive survey of psychosocial and clinical health professionals. Psychooncology 23: 390-396, 2014
12. Herschbach P, Book K, Dinkel A, et al: Evaluation of two group therapies to reduce fear of progres- sion in cancer patients. Support Care Cancer 18: 471-479, 2010
13. Humphris G, Rogers SN: AFTER and beyond: cancer recurrence fears and a test of an intervention in oral and oropharyngeal patients. Social Science and Dentistry 2:29-38, 2012
14. Lebel S, Maheu C, Lefebvre M, et al: Addressing fear of cancer recurrence among women with cancer: a feasibility and preliminary outcome study. J Cancer Surviv 8:485-496, 2014
15. Smith A, Thewes B, Turner J, et al: Pilot of a theoretically grounded psychologist-delivered inter- vention for fear of cancer recurrence (Conquer Fear). Psychooncology 24:967-970, 2015 16. Clover KA, Mitchell AJ, Britton B, et al: Why do oncology outpatients who report emotional dis-
tress decline help? Psychooncology 24:812–818, 2015
17. Wentzel J, Van der Vaart R, Bohlmeijer E, et al: Mixing Online and Face-to-Face Therapy: How to Benefit From Blended Care in Mental Health Care. JMIR Ment Health 3,e9, 2016
18. Andersson G, Cuijpers P, Carlbring P, et al: Guided Internet-based vs. face-to-face cognitive behav- ior therapy for psychiatric and somatic disorders: a systematic review and meta-analysis. World Psychiatry 13:288–295, 2014
19. van Beugen S, Ferwerda M, Hoeve D, et al: Internet-Based Cognitive Behavioral Therapy for Pa- tients With Chronic Somatic Conditions: A Meta-Analytic Review. J Med Internet Res 16:e88, 2014 20. Hedman E, Ljótsson B, Lindefors N: Cognitive behavior therapy via the internet: a systematic review of applications, clinical efficacy and cost–effectiveness. Expert Rev Pharmacoecon Out- comes Res 12:745–764, 2012
21. McAlpine H, Joubert L, Martin-Sanchez F, et al: A systematic review of types and efficacy of online interventions for cancer patients. Patient Educ Couns 98:283–295, 2015
22. van de Wal MA, Gielissen MFM, Servaes P, et al: Study protocol of the SWORD-study: a randomised controlled trial comparing combined online and face-to-face cognitive behaviour therapy versus treatment as usual in managing fear of cancer recurrence. BMC Psychology 3:12-25, 2015 23. Leventhal H, Meyer D, Nerenz DR. The common sense representation of illness danger. In: Rach-
man S, editor. Contributions to Medical Psychology. Vol. 2. New York: Pergamon Press; 1980. p. 17-30
24. van de Wal MA, Servaes P, Berry R, et al: Cognitive behaviour therapy for fear of cancer recurrence - a case study. J Clin Psychol Med S, submitted.
25. Perepletchikova F, Treat TA, Kazdin AE: Treatment integrity in psychotherapy research: Analysis of the studies and examination of associated factors. J Consult Clin Psych 75:829–841, 2007 26. Waltz J, Addis ME, Koerner K, et al: Testing the integrity of a psychotherapy protocol: Assessment
of adherence and competence. J Consult Clin Psych 61:620–630, 1993
27. Hepner KA, Howard S, Paddock SM, et al: A Fidelity Coding Guide for a Group Cognitive Behavioral Therapy for Depression. http://www.rand.org/pubs/technical_reports/TR980.html.
28. Altman DG: Practical statistics for medical research. London: Chapman and Hall, 1991
29. Douma KF, Aaronson NK, Vasen HF, et al: Psychological distress and use of psychosocial support in familial adenomatous polyposis. Psychooncology 19:289–298, 2010
30. 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 17:241-251, 2009 31. Horowitz M, Wilner N, Alvarez W: Impact of Event Scale: a measure of subjective stress. Psychosom
Med 41:209-218, 1979
32. Van der Ploeg E, Mooren TT, Kleber RJ, et al: Construct validation of the dutch version of the impact of event scale. Psychol Assessment 16:16-26, 2004
33. Zigmond AS, Snaith RP: The hospital anxiety and depression scale. Acta Psychiatr Scand 67:361– 370, 1983
SWORD: effect study
149