Randomized controlled trial of an individual blended cognitive behavioral therapy to reduce psychological distress among distressed colorectal cancer survivors: The COloRectal canceR distrEss reduCTion trial.

OBJECTIVE: Colorectal cancer survivors (CRCS) often experience high levels of distress. The objective of this randomized controlled trial was to evaluate the effect of blended cognitive behavior therapy (bCBT) on distress severity among distressed CRCS. METHODS: CRCS (targeted N = 160) with high distress (Distress Thermometer ≥5) between 6 months and 5 years post cancer treatment were randomly allocated (1:1 ratio) to receive bCBT, (14 weeks including five face-to-face, and three telephone sessions and access to interactive website), or care as usual (CAU). Participants completed questionnaires at baseline (T0), four (T1) and 7 months later (T2). Intervention participants completed bCBT between T0 and T1. The primary outcome analyzed in the intention-to-treat population was distress severity (Brief Symptom Inventory; BSI-18) immediately post-intervention (T1). RESULTS: 84 participants were randomized to bCBT (n = 41) or CAU (n = 43). In intention-to-treat analysis, the intervention significantly reduced distress immediately post-intervention (-3.86 points, 95% CI -7.00 to -0.73) and at 7 months post-randomization (-3.88 points, 95% CI -6.95 to -0.80) for intervention compared to CAU. Among secondary outcomes, at both time points, depression symptoms, anxiety symptoms, cancer worry, and cancer-specific distress were significantly lower in the intervention arm. Self-efficacy scores were significantly higher. Overall treatment satisfaction was high (7.4/10, N = 36) and 94% of participants would recommend the intervention to other colorectal cancer patients. CONCLUSIONS: The blended COloRectal canceR distrEss reduCTion intervention seems an efficacious psychological intervention to reduce distress severity in distressed CRCS. Yet uncertainty remains about effectiveness because fewer participants than targeted were included in this trial. TRIAL REGISTRATION: Netherlands Trial Register NTR6025.

ConquerFear-Group: A randomized controlled trial of an online-delivered group-based psychological intervention for fear of cancer recurrence in breast cancer survivors.

OBJECTIVE: Fear of cancer recurrence (FCR) is a distressing concern among cancer survivors. Interventions to address FCR need to be effective but also accessible and low cost. This randomized controlled trial evaluated the efficacy of an online group-based psychological intervention for FCR (ConquerFear-Group). METHODS: Eligible breast cancer (BC) survivors had completed primary treatment 3 months-5 years previously, were ≥18 years, and scored ≥22 on the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF). Participants were randomized to online ConquerFear-Group (focusing on metacognitive strategies, values-clarification, and education about follow-up behavior) or online group-based relaxation training (active control). Questionnaires were completed at baseline (T1), 1 week post-intervention (T2), three (T3) and six (T4) months later. The primary outcome was FCR (FCRI total). A number of secondary and process outcomes were also collected. Treatment effects were evaluated with mixed linear models. RESULTS: Of 866 eligible BC survivors, 475 (55%) completed the FCR screening, and 85 (18%) were randomized to ConquerFear-Group or relaxation training (2 × 6 groups). Compared with control participants, ConquerFear-Group participants experienced larger reductions in FCR (Cohen's d = 0.47, p = 0.001) and FCR severity (d = 0.57, p < 0.001), as well as mindfulness and decentering from baseline through follow-up, and improvements in emotion regulation (T2), worry (T2, T3) and rumination (T2) at some time points. CONCLUSIONS: The results demonstrated statistically significant and stable effects of ConquerFear-Group on FCR that were maintained over a 6-month period. It is suggested to investigate the program in a real-life setting, where a pragmatic trial can further demonstrate feasibility and effectiveness.

Reasons for non-participation in a psychological intervention trial for distress in colorectal cancer survivors.

OBJECTIVE: High psychological distress is reported by one third of colorectal cancer survivors (CRCS). However, intervention studies for CRCS have reported low participation rates. In this study, reasons for non-participation and low uptake in a psychological intervention trial were investigated. METHODS: CRCS were recruited for a randomized clinical trial on the efficacy of blended cognitive behavior therapy for psychological distress via databases, follow-up consultations, advertisements and an ongoing population-based study. The recruitment flow and reasons for non-participation were analyzed for patients recruited between 2016 and 2020. Subgroups were compared based on demographic, clinical and screening data. High distress as study entry criterion was measured with the Distress Thermometer (DT ≥ 5) and the problem list (PL). RESULTS: From all recruitment methods together, 1326 CRCS responded to the invitation letter of whom 510 (38%) were interested in receiving a screening questionnaire. Interested CRCS were significantly younger than non-interested CRCS (p < 0.001). Most non-interested CRCS reported having no complaints. Of interested CRCS, 448 (88%) completed screening with the DT of which 213 (48%) CRCS scored above the DT cutoff for high distress. The majority expressed no need for help resulting in 84 (4% of eligible) CRCS included in the trial. Younger age, shorter time since diagnosis and more problems on the PL were positively related to participation. CONCLUSIONS: In this study a low participation rate was found. However, patients with high distress and most in need for help were included in the trial. For future research it is recommended to perform pilot- and feasibility studies to optimize recruitment.

Psychosocial Aspects of Living Long Term with Advanced Cancer and Ongoing Systemic Treatment: A Scoping Review.

(1) Background: Studies examining the psychosocial impact of living long term on systemic treatment in advanced cancer patients are scarce. This scoping review aimed to answer the research question "What has been reported about psychosocial factors among patients living with advanced cancer receiving life-long systemic treatment?", by synthesizing psychosocial data, and evaluating the terminology used to address these patients; (2) Methods: This scoping review was conducted following the five stages of the framework of Arksey and O'Malley (2005); (3) Results: 141 articles published between 2000 and 2021 (69% after 2015) were included. A large variety of terms referring to the patient group was observed. Synthesizing qualitative studies identified ongoing uncertainty, anxiety and fear of disease progression or death, hope in treatment results and new treatment options, loss in several aspects of life, and worries about the impact of disease on loved ones and changes in social life to be prominent psychosocial themes. Of 82 quantitative studies included in the review, 76% examined quality of life, 46% fear of disease progression or death, 26% distress or depression, and 4% hope, while few studies reported on adaptation or cognitive aspects. No quantitative studies focused on uncertainty, loss, or social impact; (4) Conclusion and clinical implications: Prominent psychosocial themes reported in qualitative studies were not included in quantitative research using specific validated questionnaires. More robust studies using quantitative research designs should be conducted to further understand these psychological constructs. Furthermore, the diversity of terminology found in the literature calls for a uniform definition to better address this specific patient group in research and in practice.

Feasibility and preliminary efficacy of iConquerFear: a self-guided digital intervention for fear of cancer recurrence.

PURPOSE: Approximately 50% of cancer survivors experience moderate-severe fear of cancer recurrence (FCR). Self-guided digital interventions have potential to address the high level of FCR-related unmet needs at scale, but existing digital interventions have demonstrated variable engagement and efficacy. This study aimed to evaluate the feasibility and preliminary efficacy of iConquerFear, a five-module self-guided digital FCR intervention. METHODS: Eligible curatively treated breast cancer survivors were recruited. Participants reporting clinically significant FCR (≥ 13 on the Fear of Cancer Recurrence Inventory-Short Form; FCRI-SF) were given access to iConquerFear. Feasibility was indicated by > 50% of eligible participants enrolling in iConquerFear and recording moderate (≥ 120 min) or greater usage. Preliminary efficacy was evaluated via changes in self-reported FCR severity, anxiety, depression, intrusions and metacognitions from baseline to immediately and 3 months post-intervention. RESULTS: Fifty-four (83%) of 65 eligible participants enrolled in iConquerFear; six subsequently withdrew. Thirty-nine (83%) participants recorded moderate (n = 24; 120-599 min) or high (n = 15; ≥ 600 min) usage. Engagement levels increased with participant age (p = 0.043), but were lower in participants with higher baseline FCR (p = 0.028). Qualitative feedback indicated engagement was sometimes limited by difficulties with navigation and relating to featured survivors. Participants reported significantly improved FCR (mean reduction (95%CI): baseline to post-intervention - 3.44 (- 5.18, - 1.71), baseline to 3-month follow-up - 4.52 (- 6.25, - 2.78), p = < 0.001). CONCLUSION: iConquerFear is a feasible and potentially efficacious intervention for reducing FCR in breast cancer survivors. Easier navigation and more relatable examples may enhance engagement. IMPLICATIONS FOR CANCER SURVIVORS: iConquerFear may help address moderate but burdensome FCR levels in cancer survivors.

ConquerFear-group: Feasibility study with pilot results of a psychological intervention for fear of cancer recurrence delivered in groups.

OBJECTIVE: ConquerFear has been found to effectively reduce fear of cancer recurrence (FCR). Group interventions may be particularly effective for the treatment of FCR and could lower overall costs. Our objectives were therefore to adapt ConquerFear into a group format (ConquerFear-Group, CF-G), and to evaluate its feasibility, acceptability, and preliminary efficacy. METHODS: Eligible patients had completed treatment for breast cancer 3 months to 5 years previously, were ≥18 years, and scored ≥22 on the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF). The manual was first evaluated with seven patients (Pilot 1), adjusted in accordance with feedback from the patients, therapists, and the original ConquerFear developers. After further evaluation with eight patients (Pilot 2), and subsequent adjustments, the preliminary efficacy of the final manual was evaluated with 27 patients, randomized in blocks to CF-G (N = 13) or active control (AC) (relaxation training) (N = 14) (Pilot 3). The primary outcome was the FCRI total score. Secondary outcomes included general distress, quality-of-life, and process outcomes pertaining to metacognitions, decentering, and worry. All measures were completed at baseline, post-treatment, and at 3 and 6 months follow-up. RESULTS: Adjustments of the original ConquerFear manual (Pilot 1 and 2) included changes in the order of treatment components, simplified exercises, and shortened homework. Compared with ACs, CF-G participants reported greater reductions in FCRI total scores from baseline to post-treatment (Hedges's g = 0.59, p = 0.004), 3 months (g = 0.50, p = 0.026), and 6 months later (g = 0.93, p = 0.043). Differences corresponding to medium-to-large effect sizes (Pilot 3). Although non-significant, group differences concerning reductions in general distress and maladaptive metacognitions corresponded to small-to-medium effect sizes (g = 0.40-0.61; ps = 0.40-0.61). CONCLUSIONS: CF-G appears feasible and potentially efficacious in treating FCR in a breast cancer population. These preliminary results are promising but need to be confirmed in a larger randomized trial.

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.

Psychological aspects in patients with advanced cancer receiving lifelong systemic treatment: protocol for a scoping review.

INTRODUCTION: A better understanding of the molecular, genetic and immunological characteristics of cancer and the introduction of new systemic treatment regimens in the last decades, has led to better treatment outcomes and increased survival rates for patients with previously short lived cancers. However, there is no uniform description to refer to this growing group of patients with advanced cancer who now respond to new systemic treatments for longer periods. Furthermore, little is known about the unique psychological challenges these patients face, living with ongoing uncertainty about the course of their disease and life expectancy. The objective of this scoping review is to identify the psychological aspects experienced by, and the definitions used to refer to patients with advanced cancer receiving lifelong systemic treatment. METHODS AND ANALYSIS: This review will be among the first to summarise literature on the psychological issues in the growing group of advanced cancer patients undergoing long-term systemic treatment. Articles will be retrieved from six databases (MEDLINE, Embase, Web of Science, PsycINFO, CINAHL and the Cochrane Database of Systematic Reviews) and reviewed for eligibility by two investigators independently. Definitions and psychological challenges will be extracted and narratively summarised following a descriptive approach. Furthermore, results will contribute in providing a uniform definition for this patient group, and help to identify knowledge gaps to give direction to further research in this field. ETHICS AND DISSEMINATION: No ethical approval is required. The results of the scoping review will be submitted for publication to a scientific journal and presented at relevant conferences.

Not as Stable as We Think: A Descriptive Study of 12 Monthly Assessments of Fear of Cancer Recurrence Among Curatively-Treated Breast Cancer Survivors 0-5 Years After Surgery.

Purpose: Previous studies suggest one-third of breast cancer survivors (BCS) experience elevated fear of cancer recurrence (FCR) and that it remains stable. Most studies include long assessment intervals and aggregated group data. This study aimed to describe the individual trajectories of FCR when assessed monthly using both a statistical and descriptive approach. Methods: Participants were curatively-treated BCS 0-5 years post-surgery. Questionnaire data were collected monthly for 12 months. Primary outcome was FCR [Cancer Worry Scale (CWS)]. For the descriptive approach, 218 participants were classified as low (CWS ≤ 13 at each assessment), high (CWS ≥ 14 at each assessment), or fluctuating FCR (CWS scores above and below cut-off). Latent class growth analysis (LCGA; n = 377) was conducted to identify trajectories over time. Results: Around 58% of the women reported fluctuating CWS scores, 22% reported a consistently high and 21% consistently low course. Results of the LCGA confirmed the three-class approach including a stable high FCR group (13%), a low FCR group (40%), and a moderate FCR group (47%). Both the moderate and low scoring groups reported declining scores over time. Younger patients, higher educated patients, and those less satisfied with the medical treatment were more likely to belong to the moderate or high trajectory. Conclusion: Assessed monthly, the majority of BCS report fluctuating levels of FCR. Stepped-care models should assess FCR on multiple occasions before offering tailored interventions.

Development and usability evaluation of an online self-management intervention for fear of cancer recurrence (iConquerFear).

OBJECTIVE: To develop and evaluate the usability of iConquerFear, an online self-management adaptation of an efficacious face-to-face therapist-delivered treatment for fear of cancer recurrence (FCR). METHODS: iConquerFear development was theory based and person based. Development was guided by Ritterband et al's behaviour change model for internet interventions. iConquerFear end users (cancer survivors) provided iterative feedback in accordance with Yardley et al's person-based approach to maximise engagement and usability. Online focus groups and cognitive interviews were conducted to evaluate the usability of iConquerFear. Discussions were recorded, transcribed verbatim, and thematically analysed. RESULTS: Five online FCR modules were developed. Twenty-three cancer survivors (47% of those eligible) participated; 11/23 (58%) were breast cancer survivors, and average age was 53 years (SD = 10.8). Thematic saturation was reached after six focus groups (n = 16) and seven individual think-aloud interviews. Thematic analysis produced five overarching themes: easy navigation essential; satisfaction and engagement with content; flexible access is key; normalising and empowering; and a useful first step. CONCLUSIONS: Online self-management interventions like iConquerFear have the potential to address the unmet supportive care needs reported by burgeoning numbers of cancer survivors. However, that potential may not be realised unless interventions are rigorously developed and user tested, as benefits are constrained by limited engagement. Themes from the usability testing of iConquerFear highlight the importance of developing flexible, tailored, interactive, and contextual online self-management interventions for people with cancer.

Identifying the key characteristics of clinical fear of cancer recurrence: An international Delphi study.

OBJECTIVE: Without an agreed-upon set of characteristics that differentiate clinical from nonclinical levels of fear of cancer recurrence (FCR), it is difficult to ensure that FCR severity is appropriately measured, and that those in need of intervention are identified. The objective of this study was to establish expert consensus on the defining features of clinical FCR. METHOD: A three-round Delphi was used to reach consensus on the defining features of clinical FCR. Sixty-five experts in FCR (researchers, psychologists, physicians, nurses, and allied health professionals) were recruited to suggest and rate potential features of clinical FCR. Participants who indicated they could communicate diagnoses within their clinical role were also asked to consider the application of established DSM-5 and proposed ICD-11 diagnostic criteria (Health Anxiety, Illness Anxiety Disorder, Somatic Symptom Disorder) to clinical FCR. RESULTS: Participants' ratings suggested that the following four features are key characteristics of clinical FCR: (a) high levels of preoccupation; (b) high levels of worry; (c) that are persistent; and (d) hypervigilance to bodily symptoms. Of participants whose professional role allowed them to diagnose mental disorders, 84% indicated it would be helpful to diagnose clinical FCR, but the use of established diagnostic criteria related to health anxiety or somatic-related disorders to clinical FCR was not supported. This suggests that participants consider clinical FCR as a presentation that is specific to cancer survivors. CONCLUSION: Clinical FCR was conceptualized as a multidimensional construct. Further research is needed to empirically validate the proposed defining features.

Effect of Psychological Intervention on Fear of Cancer Recurrence: A Systematic Review and Meta-Analysis.

PURPOSE: Fear of cancer recurrence (FCR) is a significantly distressing problem that affects a substantial number of patients with and survivors of cancer; however, the overall efficacy of available psychological interventions on FCR remains unknown. We therefore evaluated this in the present systematic review and meta-analysis. METHODS: We searched key electronic databases to identify trials that evaluated the effect of psychological interventions on FCR among patients with and survivors of cancer. Controlled trials were subjected to meta-analysis, and the moderating influence of study characteristics on the effect were examined. Overall quality of evidence was evaluated using the GRADE system. Open trials were narratively reviewed to explore ongoing developments in the field (PROSPERO registration no.: CRD42017076514). RESULTS: A total of 23 controlled trials (21 randomized controlled trials) and nine open trials were included. Small effects (Hedges's g) were found both at postintervention (g = 0.33; 95% CI, 0.20 to 0.46; P < .001) and at follow-up (g = 0.28; 95% CI, 0.17 to 0.40; P < .001). Effects at postintervention of contemporary cognitive behavioral therapies (CBTs; g = 0.42) were larger than those of traditional CBTs (g = 0.24; ß = .22; 95% CI, .04 to .41; P = .018). At follow-up, larger effects were associated with shorter time to follow-up (ß = -.01; 95% CI, -.01 to -.00; P = .027) and group-based formats (ß = .18; 95% CI, .01 to .36; P = .041). A GRADE evaluation indicated evidence of moderate strength for effects of psychological intervention for FCR. CONCLUSION: Psychological interventions for FCR revealed a small but robust effect at postintervention, which was largely maintained at follow-up. Larger postintervention effects were found for contemporary CBTs that were focused on processes of cognition-for example, worry, rumination, and attentional bias-rather than the content, and aimed to change the way in which the individual relates to his or her inner experiences. Future trials could investigate how to further optimize and tailor interventions to individual patients' FCR presentation.

Smoking versus quitting and fear of cancer recurrence 9 years after diagnosis in the American Cancer Society's Longitudinal Study of Cancer Survivors-I (SCS-I).

BACKGROUND: Fear of cancer recurrence (FCR) adversely affects quality of life. Cigarette smoking increases the risk of recurrence and may exacerbate FCR among survivors who smoke. FCR also may motivate quitting, but research on whether quitting reduces long-term survivors' FCR is lacking. Among long-term survivors of various cancers, the authors investigated relationships between quitting (vs smoking) and FCR, controlling for sociodemographic, cancer-related, and health-related variables. METHODS: Data from the American Cancer Society's Longitudinal Study of Cancer Survivors-I were used in generalized estimating equations to compare FCR at 3 waves (T1-T3) after diagnosis between 2 groups; survivors who reported current smoking (n = 196) approximately 9 years after diagnosis (at T3) or who, based on T3 recall of quitting age, had quit smoking after diagnosis (n = 97). T3 cross-sectional analyses among current smokers examined associations of FCR with smoking level and intentions of quitting. RESULTS: A significant smoking status × time interaction (P = .003) indicated that only quitters experienced decreases in FCR from T1 to T3 (P = .007). At T3, FCR was significantly lower among quitters than among current smokers (P = .05), and current smokers reported that FCR caused more functioning impairments (eg, disruption of relationships, everyday activities, mood) than quitters (P = .001). Cross-sectional analyses (T3) among smokers found that heavier smoking predicted less attempts to cope with FCR (P = .04) and that reassurance behaviors (eg, self-examination for cancer) predicted stronger quitting intentions (P = .02). CONCLUSIONS: Quitting smoking lowers FCR, and FCR may disrupt functioning among continuing smokers. Interventions for FCR should be multimodal and should treat both psychological distress and health-related behaviors such as smoking.

Prevalence and clinical and psychological correlates of high fear of cancer recurrence in patients newly diagnosed with head and neck cancer.

BACKGROUND: Patients with head and neck cancer (HNC) are vulnerable to fear of cancer recurrence (FCR) and psychiatric morbidity. We investigated the prevalence of high FCR and demographic, clinical, psychological, and psychiatric factors associated with high FCR prior to the start of the treatment. METHODS: In a cross-sectional substudy of the large ongoing prospective NET-QUBIC study questionnaires and psychiatric interviews of 216 patients newly diagnosed with HNC were analyzed. RESULTS: High FCR was observed in 52.8% of patients and among those 21.1% also had a lifetime history of selected anxiety or major depressive disorder. FCR was not related to any clinical characteristics; however, younger age, higher anxiety symptoms, introversion, greater needs for support regarding sexuality, and being an exsmoker were significantly associated with higher FCR. CONCLUSION: Factors associated with high FCR provide us with a better conceptual understanding of FCR in patients newly diagnosed with HNC.

Long-term efficacy and cost-effectiveness of blended cognitive behavior therapy for high fear of recurrence in breast, prostate and colorectal Cancer survivors: follow-up of the SWORD randomized controlled trial.

BACKGROUND: Blended cognitive behaviour therapy (bCBT) is an effective treatment for fear of cancer recurrence (FCR) in curatively-treated breast, colorectal and prostate cancer survivors with high FCR. However, long-term outcomes are unknown. This study investigated the long-term efficacy and cost-effectiveness of bCBT compared with care as usual (CAU). METHODS: Eighty-eight cancer survivors with high FCR (Cancer Worry Scale ≥14) were randomly assigned to bCBT (n = 45) or CAU (n = 43). Data were collected at baseline and at three, nine and fifteen months from baseline and analysed by modified intention-to-treat. Efficacy was investigated with linear mixed-effects models. Cost-effectiveness was investigated from a societal perspective by comparing costs with quality-adjusted life-years (QALYs). RESULTS: Participants who received bCBT reported significantly lower FCR compared with CAU (mean difference of - 1.787 [95% CI -3.251 to - 0.323, p = 0.017] at 15 months follow-up), and proportionally greater self-rated and clinically significant improvement at each follow-up measurement. Total QALYs were non-significantly different between conditions when adjusted for utility score baseline differences (0.984 compared to 0.957, p = 0.385), while total costs were €631 lower (95% CI -1737 to 2794, p = 0.587). Intervention costs of bCBT were €466. The incremental cost-effectiveness ratio amounted to an additional €2049 per QALY gained, with a 62% probability that bCBT is cost-effective at a willingness to pay (WTP) threshold of €20,000 per QALY. Results were confirmed in sensitivity analyses. CONCLUSIONS: bCBT for cancer survivors with FCR is clinically and statistically more effective than CAU on the long-term. In addition, bCBT is a relatively inexpensive intervention with similar costs and QALYs as CAU. TRIAL REGISTRATION: The RCT was registered in the Dutch National Trial Register ( NTR4423 ) on 12-Feb-2014. This abstract was previously presented at the International Psycho-Oncology Society conference of 2018 and published online. (Psycho-oncology, 27(S3):8-55; 2018).

Cost-effectiveness of an intervention to reduce fear of cancer recurrence: The ConquerFear randomized controlled trial.

OBJECTIVE: Alongside a randomized controlled trial (RCT) evaluating the efficacy of the ConquerFear intervention for reducing fear of cancer recurrence in cancer survivors, the cost-effectiveness of this novel intervention was assessed, primarily from the health sector perspective, with broader societal productivity impacts assessed. METHODS: Health care resource use was collected by a tailored cost diary. Incremental costs were calculated as the difference in total costs between the intervention and control groups. Incremental cost-effectiveness ratios (ICERs) were estimated by cost-effectiveness and cost-utility analyses, comparing incremental costs with incremental outcomes measured. Nonparametric bootstrap analysis was performed to evaluate uncertainty in costs and outcomes. RESULTS: Cancer survivors were randomized into ConquerFear (n = 121), or an active control group receiving relaxation training (n = 101). Participants received on average 3.69 sessions, incurring an average cost of $297 per person, with no group difference. The ITT analysis results indicated a mean ICER $34 300 per quality-adjusted life year (QALY) with average incremental cost $488 and health gain of 0.0142 QALYs, from the health care sector perspective. Bootstrap analysis showed 30% of iterations were dominant and overall 53% ICERs were cost-effective as judged by the commonly used $50 000/QALY threshold. CONCLUSIONS: The ConquerFear intervention is associated with a modest cost and may provide good value for money, but further evidence is needed. Long-term cost-effectiveness needs further investigation to capture full benefits from the intervention beyond the trial follow-up.

A psychological intervention (ConquerFear) for treating fear of cancer recurrence: Views of study therapists regarding sustainability.

OBJECTIVE: ConquerFear is a metacognitive intervention for fear of cancer recurrence (FCR) with proven efficacy immmediately and 6 months post-treatment. This qualitative study documented barriers and facilitators to the sustainability of ConquerFear from the perspective of study therapists. METHODS: Fourteen therapists who had delivered ConquerFear in a randomised controlled trial completed a semi-structured phone interview, reaching theoretical saturation. Themes from thematic analysis were mapped to the Promoting Action on Research Implementation in Health Services (PARiHS) implementation framework. RESULTS: Participants were 13 males and one female with, on average, 14 years psycho-oncology experience. Nine over-arching themes were identified, falling into three domains, which when present, were facilitators, and if absent, were barriers: evidence (intervention credibility, experienced efficacy, perceived need for intervention); context (positive attitude to and capacity for survivorship/FCR care, favourable therapist orientation and flexibility, strong referral pathways); and facilitation of implementation (intervention/service fit, intervention/patient fit, and training, support, and provided resources). CONCLUSIONS: ConquerFear is a sustainable intervention in routine clinical practise. Facilitators included a sound evidence base; a receptive context; good fit between the intervention, therapist orientation, and patient need; and flexibility of delivery. Where absent, these factors served as barriers. These results have implications for enhancing uptake of psycho-oncology interventions in routine care.

Medical, demographic and psychological correlates of fear of cancer recurrence (FCR) morbidity in breast, colorectal and melanoma cancer survivors with probable clinically significant FCR seeking psychological treatment through the ConquerFear study.

PURPOSE: Despite the prevalence of fear of cancer recurrence (FCR), understanding of factors underlying clinically significant FCR is limited. This study examined factors associated with greater FCR morbidity, according to a cognitive processing model, in cancer survivors who screened positively for clinically significant FCR seeking psychological treatment through the ConquerFear trial. METHODS: Participants had completed treatment for breast, colorectal or melanoma cancer 2 months to 5 years previously and scored ≥ 13/36 on the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF). Hierarchical regression analyses examined associations between demographic, medical and psychological variables, namely metacognitions (MCQ-30), post-traumatic stress symptoms (IES-R) and FCR (FCRI total score). RESULTS: Two hundred and ten (95%) of the 222 cancer survivors who consented to the ConquerFear trial completed the baseline questionnaire. Participants were predominantly (89%) breast cancer survivors. The final regression model accounted for 68% of the variance in FCR (demographic and medical variables 13%, metacognitions 26%, post-traumatic stress symptoms 28%). Negative metacognitive beliefs about worry and intrusive post-traumatic stress symptoms were significant individual correlates of FCR, but negative beliefs about worry did not significantly moderate the impact of intrusions on FCR morbidity. CONCLUSIONS: Results provide partial support for the cognitive processing model of FCR. Psychological factors were found to play an important role in FCR morbidity after controlling for demographic/medical factors. More intrusive thoughts and negative beliefs about worry were strong independent predictors of FCR morbidity. Cancer survivors with clinically significant FCR may benefit from assessment for intrusive thoughts and metacognitions and delivery of trauma- and/or metacognitive-based interventions accordingly.

Re-validation and screening capacity of the 6-item version of the Cancer Worry Scale.

OBJECTIVE: Fear of cancer recurrence (FCR) is one of the major existential unmet needs of cancer survivors. Due to growing availability of evidenced-based interventions for high FCR, valid and reliable brief measures of FCR are needed. This study aimed to validate the 6-item Cancer Worry Scale (CWS) and to establish a cut-off score for high FCR. METHODS: Participants in this study were 1033 cancer survivors and patients recruited as part of 5 existing studies on FCR involving patients and survivors with gastro-intestinal stromal tumors, colorectal, breast, and prostate cancer. De-identified data of the CWS, Fear of Cancer Recurrence Inventory (FCRI), Impact of Event Scale, Hospital Anxiety and Depression Scale, and EORTC-QLQ-C30 were amalgamated for the analyses. Confirmatory factor analysis of the CWS was performed. Sensitivity and specificity were tested with the FCRI as gold standard. RESULTS: Results confirmed that the 6-item version of the CWS maintained good construct validity, convergent and divergent validity, and high internal consistency (α 0.90). The optimal cut-off for the 6-item CWS was 9 versus 10 using the 12 vs 13 FCRI-SF score (sensitivity 82%, specificity 83%) and the 15 vs 16 FCRI-SF score (sensitivity 88%, specificity 73%). Using the highest FCRI-SF cut-off (21 vs 22), the optimal CWS cut-off was 11 vs 12 (sensitivity 88%, specificity 81%). CONCLUSIONS: The present results provide researchers and clinicians with a brief valid and reliable measure of FCR which is suitable for measuring FCR in cancer patients and survivors.