CBT-based Online Self-help Training to Reduce Fear and Distress After Cancer (CAREST Randomized Trial): 24 Months Follow-up Using Latent Growth Models and Latent Class Analysis.

BACKGROUND: Psychological distress (PD) and fear of cancer recurrence (FCR) are common consequences of surviving cancer. Online self-help training could help many cancer survivors deal with PD and FCR at low costs. PURPOSE: To evaluate the long-term effectiveness of the CAncer REcurrence Self-help Training (CAREST trial) to reduce PD and FCR. Moreover, to evaluate the relation between FCR and PD across time and identify subgroups representing different change trajectories in FCR over time and their predictors. METHODS: This multicenter randomized controlled trial included 262 female breast cancer survivors, assigned to online self-help training or care as usual. Participants completed questionnaires at baseline and four times during the 24-month follow-up. The primary outcomes were PD and FCR (Fear of Cancer Recurrence Inventory). Latent growth curve modeling (LGCM) and repeated measures latent class analysis (RMLCA) were performed, both according to the intention-to-treat principle. RESULTS: LGCM showed no differences between the average latent slope in both groups for both PD and FCR. The correlation between FCR and PD at baseline was moderate for the intervention group and strong for the CAU group and did not significantly decrease over time in both groups. RMLCA revealed five latent classes and several predictors of class membership. CONCLUSIONS: We did not find a long-term effect of the CBT-based online self-help training in reducing PD or FCR, nor in their relation. Therefore, we recommend adding professional support to online interventions for FCR. Information about FCR classes and predictors may contribute to improvement of FCR interventions.

Many people experience distress and fear of recurrence after surviving cancer. Online psychological interventions have benefits, such as easy accessibility, flexibility, and low costs. But do they really help? In this study, we evaluated whether an online self-help training could reduce distress and fear of recurrence in breast cancer survivors. We compared two groups of patients; one received online self-help training and the other did not. Our first finding is that cancer survivors stay distressed and fearful for a long time (24 months in our study). A second finding is that we found five groups of patients with distinct levels of fear of recurrence and predictors for this fear. For instance, one group consisted of younger women with severe fear and more mental problems. Another group consisted of older women with mild fear but more physical problems. The most important finding of this study is that we did not find an effect of our self-help training. The persistence of distress and fear, and the different groups of cancer survivors with their specific characteristics and needs, underline the importance of developing effective psychological interventions. Given the benefits of online interventions, we recommend future studies concerning online interventions that provide professional support.

Factor structure of the Fear of Cancer Recurrence Inventory (FCRI): Comparison of international FCRI factor structure data and factor analysis of the Dutch FCRI-NL using three predominantly breast cancer samples.

OBJECTIVE: Factor structure results of Fear of Cancer Recurrence Inventory (FCRI) translations are inconclusive. Through investigating the factor structure, this study aimed to improve the FCRI and its usability. Therefore, we did a comprehensive comparison of the factor structure results of all translations, by exploring and improving the structure of the Dutch FCRI-NL and by testing this new factor structure in two patient samples. METHODS: To compare factor structure results of FCRI translations, we did a literature search using PubMed and Google Scholar. We performed exploratory factor analysis (EFA) in a mixed cancer sample. The confirmatory factor analyses (CFAs) were secondary analyses performed in two randomized controlled trial samples: consecutive breast cancer patients and distressed, mainly breast cancer patients. RESULTS: All translations showed comparable and reasonable factor structure results; however, the FCRI factor structure can be improved. The EFA resulted in a four-factor solution: fear of cancer recurrence (FCR) severity, cognitive coping, impact of FCR on functioning and behavioural coping. However, the 4-factor CFAs did not fit the sample 2 and 3 data well. CONCLUSION: Further exploring the FCRI-NL factor structure did not result in a psychometrically stronger FCRI-NL. Therefore, we recommend retaining the 7-factor FCRI-NL.

No effect of CBT-based online self-help training to reduce fear of cancer recurrence: First results of the CAREST multicenter randomized controlled trial.

OBJECTIVE: Fear of cancer recurrence (FCR) is a common consequence of surviving cancer; therefore, easily accessible self-help training could help many cancer survivors deal with FCR at low costs. The CAncer REcurrence Self-help Training (CAREST) trial evaluates the effectiveness of an online-tailored self-help training on the basis of evidence-based cognitive behavioral therapy principles in breast cancer survivors. Also, possible predictors for benefitting from the online self-help training were examined. METHODS: This multicenter randomized controlled trial included 262 female breast cancer survivors, randomly assigned to either online self-help training (n = 130) or care as usual (CAU; n = 132). Participants completed questionnaires at baseline (T0), 3 months (T1; after intervention), and 9 months (T2). The primary outcome was FCR (Fear of Cancer Recurrence Inventory Severity subscale). Both effectiveness and predictors were analyzed with latent growth curve modeling (LGCM) according to the intention-to-treat principle. RESULTS: LGCM showed no differences between the average latent slope in both groups (χ21  = .23, P = .63), suggesting that the treatments did not differ in their change in FCR over time. Moreover, no differences were found in the effects of the predictors on the latent slope in both groups (χ21  = .12, P = .73), suggesting that no significant predictors were found for the effect of the intervention on FCR. CONCLUSION: There was no effect of the CBT-based online self-help training "Less fear after cancer" in the current study. Therefore, we recommend adding professional support to online interventions for FCR.

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.

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).

Translation and validation of the Dutch version of the Fear of Cancer Recurrence Inventory (FCRI-NL).

OBJECTIVE: The study objectives are to translate the FCRI in Dutch, and to explore the factor structure and the psychometric qualities of the Dutch translation of the Fear of Cancer Recurrence Inventory (FCRI-NL). METHOD: The original French-Canadian FCRI had been forward-backward translated into English by the developers, and this method was also used to translate the English version of the FCRI into Dutch. Patients were recruited via patient organizations between July 2011 and October 2013. To replicate the original 7-factor structure of the FCRI, confirmatory factor analysis (CFA) was performed. To examine the psychometric qualities, reliability (Cronbach's alpha), test-retest reliability (intra-class correlations; ICC), and convergent and divergent validity (Spearman's correlations) were calculated. RESULTS: From 290 cancer patients, 255 (88%) were eligible for analysis (aged 51.0±9.8years, 88.6% women). CFA showed a reasonable yet suboptimal fit of the hypothesized model to the data. The FCRI-NL has good reliability (Cronbach's α=0.93 for the total scale and α=0.75-0.92 for the subscales) and test-retest reliability (ICC=0.84 for the total scale and ICC=0.56-0.87 for the subscales). Convergent (r=0.53-0.66 for the FCRI-NL and r=0.48-0.57 for the FCRI-SF-NL) and divergent (r=-0.20--0.07 for the FCRI-NL and r=-0.28--0.17 for the FCRI-SF-NL) validity was demonstrated. CONCLUSION: The FCRI-NL seems to have sufficient psychometric properties. However, the FCRI-NL total score should be interpreted with caution. The Severity subscale (FCRI-SF-NL) may be a valuable screening tool for fear of cancer recurrence severity in clinical care.