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.

Exploring Fear of Cancer Recurrence in a Sample of Heterogeneous Distressed Cancer Patients with and Without a Psychiatric Disorder.

Fear of Cancer Recurrence (FCR) is a concern among cancer patients. Recent insights suggest that FCR should be viewed as a distinct syndrome. However, few studies have explored its overlap with psychiatric morbidity. We examined this overlap in a sample of distressed cancer patients. Self-referred patients (n = 245) were assessed with the Structured Clinical Interview for DSM-IV-TR Axis-I disorders and the Fear of Cancer Recurrence Inventory-Short Form. Proportions of patients with and without a psychiatric disorder meeting validated cut-offs for screening and clinically relevant FCR were compared. The prevalence of psychiatric disorders was 36%. Clinically relevant FCR was found in 198 patients (81%). Patients with a current psychiatric disorder reported clinically relevant FCR more frequently (89%) compared to those with no disorder (77%). Of patients reporting clinically relevant FCR, the majority (61%) did not additionally meet the criteria for a psychiatric disorder. These findings suggest that there should be particular attention for patients with elevated levels of FCR, warranting FCR-specific treatment.Trial registry number Clinicaltrials.gov NCT02138513.

Cost-utility of individual internet-based and face-to-face Mindfulness-Based Cognitive Therapy compared with treatment as usual in reducing psychological distress in cancer patients.

OBJECTIVE: It was previously determined that group-based face-to-face Mindfulness-Based Cognitive Therapy (MBCT) and individual internet-based MBCT (eMBCT) are equally efficacious compared with treatment as usual (TAU) in reducing psychological distress. In this study, the incremental cost-utility of both interventions compared with TAU was assessed. METHODS: This cost-utility study included 245 self-referred heterogeneous cancer patients with psychological distress who were randomized to MBCT, eMBCT or TAU. Healthcare costs and (informal) work-related productivity losses were assessed by interview. Outcomes were expressed in EuroQol-5D-3L utility scores and quality-adjusted life years (QALY). An economic evaluation with a time-horizon of 3 months was conducted from the societal perspective in the intention-to-treat sample. In addition, secondary explorative analyses of costs and quality of life during the 9-month follow-up were conducted based on linear extrapolation of TAU. RESULTS: Paid work-related productivity losses and societal costs were lower in both intervention conditions compared with TAU during the 3-month intervention period. Moreover, quality of life (utility scores) improved in eMBCT versus TAU (Cohen's d: .54) and MBCT versus TAU (.53). At a willingness to pay of €20000 per QALY, the mean incremental net monetary benefit was €1916 (SD=€783) in eMBCT and €2365 (SD=€796) in MBCT versus TAU. Exploration of costs demonstrated an equal pattern of eMBCT and MBCT being superior to TAU. Quality of life at 9-month follow-up remained improved in both interventions. CONCLUSIONS: Results indicate that eMBCT and MBCT are cost-saving treatments whilst simultaneously improving quality of life for distressed cancer patients.

Predictors and Effects of Usage of an Online Mindfulness Intervention for Distressed Cancer Patients: Usability Study.

BACKGROUND: One in three cancer patients experience high psychological distress. Mindfulness-based interventions are effective in reducing psychological distress in this patient group. However, these interventions lack availability and flexibility, which may compromise participation in the intervention for cancer patients experiencing late symptoms like fatigue or pain. Therefore, mindfulness-based interventions are increasingly offered via the internet. However, little is known about the usage of these online mindfulness-based interventions. OBJECTIVE: The aim of this study was to (1) predict uptake of and adherence to online mindfulness-based cognitive therapy (eMBCT) using baseline patient characteristics (demographic, cancer-related, personality, and psychological variables) and (2) examine the relations between adherence and treatment outcomes in eMBCT for cancer patients. METHODS: A total of 125 cancer patients were assigned to eMBCT in a parent randomized controlled trial comparing MBCT and eMBCT with treatment as usual in distressed cancer patients. Various usage measures of eMBCT were automatically tracked within the online program. Based on activity of use, participants were classified as nonusers, minimal users, low users, and intended users. Questionnaires were used to assess baseline characteristics (preintervention) and outcomes (pre- and postintervention). To answer the research questions, data were analyzed with t tests, χ2 tests, and linear regression models. RESULTS: Based on weekly activity, participants were classified as nonusers (n=17, 13.6%), who completed no exercises in MBCT; minimal users (n=31, 24.8%), who completed at least one exercise of one to three sessions; low users (n=12, 9.6%), who completed at least one exercise of four to seven sessions; and intended users (n=65, 52.0%), who completed at least one exercise of eight to nine sessions. Nonusers had more fear of cancer recurrence at baseline than users (uptake), and intended users were more conscientious than minimal and low users (adherence). Intended users reported a larger reduction in psychological distress and more improvement of positive mental health (ie, emotional, psychological, and social well-being) after the intervention than other participants. CONCLUSIONS: This study showed that adherence was related to improved patient outcomes. Patients with strong fear of recurrence or low levels of conscientiousness should receive extra attention, as they are less likely to respectively start or complete eMBCT. Future research may focus on the development of flexible and adaptive eMBCT programs to fit individual needs.

Development of the Therapeutic Alliance and its Association With Internet-Based Mindfulness-Based Cognitive Therapy for Distressed Cancer Patients: Secondary Analysis of a Multicenter Randomized Controlled Trial.

BACKGROUND: Mindfulness-based cognitive therapy (MBCT) is an evidence-based group-based psychological treatment in oncology, resulting in reduction of depressive and anxiety symptoms. Internet-based MBCT (eMBCT) has been found to be an effective alternative for MBCT. The therapeutic alliance (the bond between therapist and patient,) is known to have a significant impact on psychological treatment outcomes, including MBCT. A primary concern in the practice of eMBCT is whether a good therapeutic alliance can develop. Although evidence for the beneficial effect of therapist assistance on treatment outcome in internet-based interventions (IBIs) is accumulating, it is still unclear whether the therapeutic alliance is related to outcome in IBIs. OBJECTIVE: This study aimed to (1) explore whether early therapeutic alliance predicts treatment dropout in MBCT or eMBCT, (2) compare the development of the therapeutic alliance during eMBCT and MBCT, and (3) examine whether early therapeutic alliance is a predictor of the reduction of psychological distress and the increase of mental well-being at posttreatment in both conditions. METHODS: This study was part of a multicenter randomized controlled trial (n=245) on the effectiveness of MBCT or eMBCT for distressed cancer patients. The therapeutic alliance was measured at the start of week 2 (ie, early therapeutic alliance), week 5, and week 9. Outcome measures were psychological distress, measured with the Hospital Anxiety and Depression Scale, and mental well-being, measured with the Mental Health Continuum-Short Form. RESULTS: The strength of early therapeutic alliance did not predict treatment dropout in MBCT or eMBCT (B=-.39; P=.21). Therapeutic alliance increased over time in both conditions (F2,90=16.46; Wilks λ=0.732; P<.001). This increase did not differ between eMBCT and MBCT (F1,91=0.114; P=.74). Therapeutic alliance at week 2 predicted a decrease in psychological distress (B=-.12; t114=-2.656; P=.01) and an increase in mental well-being (B=.23; t113=2.651; P=.01) at posttreatment. The relationship with reduction of psychological distress differed between treatments: a weaker early therapeutic alliance predicted higher psychological distress at posttreatment in MBCT but not in eMBCT (B=.22; t113=2.261; P=.03). CONCLUSIONS: A therapeutic alliance can develop in both eMBCT and MBCT. Findings revealed that the strength of early alliance did not predict treatment dropout. Furthermore, the level of therapeutic alliance predicted reduced psychological distress and increased mental well-being at posttreatment in both conditions. Interestingly, the strength of therapeutic alliance appeared to be more related to treatment outcome in group-based MBCT than in eMBCT. TRIAL REGISTRATION: ClinicalTrials.gov NCT02138513; https://clinicaltrials.gov/ct2/show/NCT02138513.

Therapeutic alliance-not therapist competence or group cohesion-contributes to reduction of psychological distress in group-based mindfulness-based cognitive therapy for cancer patients.

Mindfulness-based cognitive therapy (MBCT) is an innovative evidence-based intervention in mental and somatic health care. Gaining knowledge of therapeutic factors associated with treatment outcome can improve MBCT. This study focused on predictors of treatment outcome of MBCT for cancer patients and examined whether group cohesion, therapeutic alliance, and therapist competence predicted reduction of psychological distress after MBCT for cancer patients. Moreover, it was examined whether therapist competence facilitated therapeutic alliance or group cohesion. Multilevel analyses were conducted on a subsample of patients collected in a larger randomized controlled trial on individual internet-based versus group-based MBCT versus treatment as usual in distressed cancer patients. The current analyses included the 84 patients who completed group-based MBCT out of 120 patients who were randomized to group-based MBCT. Group cohesion and therapist competence did not predict reduction in psychological distress, whereas therapeutic alliance did. In addition, therapist competence did not predict therapeutic alliance but was associated with reduced group cohesion. Our findings revealed that therapeutic alliance significantly contributed to reduction of psychological distress in MBCT for cancer patients. Elaborating the clinical implications of the predictive significance of therapeutic alliance might be of added value to enhance the potential effect of MBCT.

Mindfulness-based stress reduction for breast cancer patients: a mixed method study on what patients experience as a suitable stage to participate.

PURPOSE: Breast cancer is associated with high levels of psychological distress. Mindfulness-based stress reduction (MBSR) has proven to be effective in reducing distress in cancer patients. In several studies, patients who are currently undergoing somatic anticancer treatment are excluded from participating in MBSR. Little is known about what would be the most suitable stage of disease to offer MBSR. We examined whether stage of disease facilitated and/or hindered participation in MBSR for breast cancer patients. METHOD: A mixed method design was used. Self-report questionnaires on psychological distress (HADS) and quality of life (EORTC QLQ-C30) were administered before and after MBSR. Five focus groups and three semi-structured individual interviews were conducted. Qualitative data were analyzed with the constant comparative method in order to develop a grounded theory. RESULTS: Sixty-four females participated in MBSR. In 52 patients who completed the questionnaires, psychological distress improved significantly. Qualitative data showed that participating in MBSR both during and after anticancer treatment has specific advantages and disadvantages. Interestingly, being emotionally ready to take part in MBSR seems equally important as physical ability. Informing patients at an early stage seemed to strengthen autonomy and self-management skills. CONCLUSIONS: In contrast to the common practice to tailoring the timing of MBSR to physical impairments or demands of the anticancer treatment, our findings revealed that emotional readiness is equally important to take into account. These findings might support professionals in their choices whether and when to inform and refer patients to MBSR.

Mindfulness-Based Cognitive Therapy for Cancer Patients Delivered via Internet: Qualitative Study of Patient and Therapist Barriers and Facilitators.

BACKGROUND: The number of patients living with cancer is growing, and a substantial number of patients suffer from psychological distress. Mindfulness-based interventions (MBIs) seem effective in alleviating psychological distress. Unfortunately, several cancer patients find it difficult, if not impossible, to attend a group-based course. Internet-based MBIs (eMBIs) such as Internet-based mindfulness-based cognitive therapy (eMBCT) may offer solutions. However, it is yet to be studied what facilitators and barriers cancer patients experience during eMBCT. OBJECTIVE: This study aimed to explore facilitators and barriers of individual asynchronous therapist-assisted eMBCT as experienced by both patients and therapists. METHODS: Patients with heterogeneous cancer diagnoses suffering from psychological distress were offered eMBCT. This 9-week intervention mirrored the group-based MBCT protocol and included weekly asynchronous written therapist feedback. Patients were granted access to a website that contained the eMBCT protocol and a secured inbox, and they were asked to practice and fill out diaries on which the therapist provided feedback. In total, 31 patients participated in an individual posttreatment interview on experienced facilitators and barriers during eMBCT. Moreover, eight therapists were interviewed. The data were analyzed with qualitative content analysis to identify barriers and facilitators in eMBCT. RESULTS: Both patients and therapists mentioned four overarching themes as facilitators and barriers: treatment setting (the individual and Internet-based nature of the treatment), treatment format (how the treatment and its guidance were organized and delivered), role of the therapist, and individual patient characteristics. CONCLUSIONS: The eMBCT provided flexibility in when, where, and how patients and therapists engage in MBCT. Future studies should assess how different eMBCT designs could further improve barriers that were found.

Face-to-Face and Internet-Based Mindfulness-Based Cognitive Therapy Compared With Treatment as Usual in Reducing Psychological Distress in Patients With Cancer: A Multicenter Randomized Controlled Trial.

Purpose Mindfulness-based cognitive therapy (MBCT) has been shown to alleviate psychological distress in patients with cancer. However, patients experience barriers to participating in face-to-face MBCT. Individual Internet-based MBCT (eMBCT) could be an alternative. The study aim was to compare MBCT and eMBCT with treatment as usual (TAU) for psychological distress in patients with cancer. Patients and Methods We obtained ethical and safety approval to include 245 patients with cancer with psychological distress (≥ 11 on the Hospital Anxiety and Depression Scale) in the study. They were randomly allocated to MBCT (n = 77), eMBCT (n = 90), or TAU (n = 78). Patients completed baseline (T0) and postintervention (T1) assessments. The primary outcome was psychological distress on the Hospital Anxiety and Depression Scale. Secondary outcomes were psychiatric diagnosis, fear of cancer recurrence, rumination, health-related quality of life, mindfulness skills, and positive mental health. Continuous outcomes were analyzed using linear mixed modeling on the intention-to-treat sample. Because both interventions were compared with TAU, the type I error rate was set at P < .025. Results Compared with TAU, patients reported significantly less psychological distress after both MBCT (Cohen's d, .45; P < .001) and eMBCT (Cohen's d, .71; P < .001) . In addition, post-treatment prevalence of psychiatric diagnosis was lower with both MBCT (33% improvement; P = .030) and eMBCT (29% improvement; P = .076) in comparison with TAU (16%), but these changes were not statistically significant. Both interventions reduced fear of cancer recurrence and rumination, and increased mental health-related quality of life, mindfulness skills, and positive mental health compared with TAU (all Ps < .025). Physical health-related quality of life did not improve ( P = .343). Conclusion Compared with TAU, MBCT and eMBCT were similarly effective in reducing psychological distress in a sample of distressed heterogeneous patients with cancer.