The novel theoretical formulation of FCR outlined here provides a much-needed comprehensive framework to further investigate and address FCR in cancer survivors.

Purpose Fear of cancer recurrence (FCR) is prevalent, distressing, and long lasting. This study evaluated the impact of a theoretically/empirically based intervention (ConquerFear) on FCR. Methods Eligible survivors had curable breast or colorectal cancer or melanoma, had completed treatment (not including endocrine therapy) 2 months to 5 years previously, were age > 18 years, and had scores above the clinical cutoff on the FCR Inventory (FCRI) severity subscale at screening. Participants were randomly assigned at a one-to-one ratio to either five face-to-face sessions of ConquerFear (attention training, metacognitions, acceptance/mindfulness, screening behavior, and values-based goal setting) or an attention control (Taking-it-Easy relaxation therapy). Participants completed questionnaires at baseline (T0), immediately post-therapy (T1), and 3 (T2) and 6 months (T3) later. The primary outcome was FCRI total score. Results Of 704 potentially eligible survivors from 17 sites and two online databases, 533 were contactable, of whom 222 (42%) consented; 121 were randomly assigned to intervention and 101 to control. Study arms were equivalent at baseline on all measured characteristics. ConquerFear participants had clinically and statistically greater improvements than control participants from T0 to T1 on FCRI total ( P < .001) and severity subscale scores ( P = .001), which were maintained at T2 ( P = .017 and P = .023, respectively) and, for FCRI total only, at T3 ( P = .018), and from T0 to T1 on three FCRI subscales (coping, psychological distress, and triggers) as well as in general anxiety, cancer-specific distress (total), and mental quality of life and metacognitions (total). Differences in FCRI psychological distress and cancer-specific distress (total) remained significantly different at T3. Conclusion This randomized trial demonstrated efficacy of ConquerFear compared with attention control (Taking-it-Easy) in reduction of FCRI total scores immediately post-therapy and 3 and 6 months later and in many secondary outcomes immediately post-therapy. Cancer-specific distress (total) remained more improved at 3- and 6-month follow-up.

BackgroundUp to 70% of cancer survivors report clinically significant levels of fear of cancer recurrence (FCR). Despite the known negative impact of FCR on psychological wellbeing and quality of life, little research has investigated interventions for high FCR. Our team has developed and piloted a novel intervention (Conquer Fear) based on the Self-Regulatory Executive Function Model and Relational Frame Theory and is evaluating Conquer Fear in a randomised controlled trial (RCT). We aim to compare the efficacy and cost-efficacy of the Conquer Fear Intervention and relaxation training in reducing the impact of FCR.Methods/designThis study is a multi-centre RCT with 260 participants randomised either to the Conquer Fear Intervention or relaxation training. Both interventions will be delivered in five sessions over 10 weeks by trained psychologists, psychiatrists and social workers with five or more years experience in oncology. Conquer Fear sessions use attentional training, detached mindfulness, meta-cognitive therapy, values clarification and psycho-education to help patients change the way they regulate and respond to thoughts about cancer recurrence. Relaxation training includes training in progressive and passive muscle relaxation, meditative relaxation, visualisation and “quick relaxation” techniques. Relaxation was chosen to control for therapist time and attention and has good face-validity as an intervention. The primary outcome is fear of cancer recurrence. Secondary outcomes include distress, quality of life, unmet needs, and health care utilisation. Participants complete questionnaires prior to starting the intervention, immediately after completing the intervention, 3 and 6 months later. Eligible participants are early-stage breast or colorectal cancer survivors who have completed hospital-based treatment between 2 months and 5 years prior to study entry and report a score in the clinical range on the Fear of Cancer Recurrence Inventory. The biostatistician is blinded to group allocation and participants are blinded to which intervention is being evaluated. Randomisation is computer generated, stratified by therapist, and uses sequentially numbered sealed envelopes.DiscussionIf successful, the study will provide an evidence-based intervention to reduce psychological morbidity in cancer survivors, and reduce overall health care costs due to more appropriate use of follow-up care and other health services in this very large population.Trial registrationTrial registration: ACTRN12612000404820

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.

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.