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.

The development of a template for psychological assessment of women considering risk-reducing or contralateral prophylactic mastectomy: A national Delphi consensus study.

OBJECTIVE: Risk-reducing mastectomies (RRM) and contralateral prophylactic mastectomies (CPM) are increasingly prevalent strategies to reduce breast cancer risk. Given the associated physical and emotional challenges, presurgical psychological assessment is frequently recommended for this population, yet limited research exists to guide this. This study aimed to reach a consensus on the most relevant content and format of a psychological consultation prior to RRM/CPM. METHODS: A modified two-round online Delphi study was conducted Australia-wide. Expert participants (n = 25), including psychologists, surgeons, nurses, oncologists, genetic specialists, and researchers completed a round-one survey, informed by a literature review, previous qualitative study and expert clinicians' input. This required participants to rate their agreement with 36 statements regarding potential content of a psychological consultation and provide feedback on format/structure. A round-two survey comprised items that had not reached consensus and six new items suggested by participants. Parameters for statement consensus were set a priori at >75% agreement. RESULTS: Expert participants indicated agreement with the majority of statements (39/42, 92.8%), endorsing that the assessment should include (1) patient understanding of the RRM/CPM procedure/cancer risk, (2) potential physical/emotional impact of surgery, (3) informed decision-making, and (4) past/current psychological issues (anxiety and body image). A provisional assessment template and user manual is provided. CONCLUSIONS: This research culminated in a consensus-based template to guide psychological assessment of women considering RRM/CPM. This enables health professionals to assess suitability for surgery and preempt challenges within a standardised framework. Future evaluation of the acceptability and effectiveness of the template in clinical settings is warranted.

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.

Fear of Cancer Recurrence: A Practical Guide for Clinicians.

With increasing cancer survival, fear of cancer recurrence (FCR) is becoming a prominent clinical issue. FCR is prevalent, distressing, and long-lasting, and can negatively impact patients' quality of life, use of health services, and adherence to follow-up recommendations. Novel targeted therapies may increase risk of FCR because of longer treatment duration and follow-up, increased prognostic precision, and omission of treatment based on genomic status. Oncologists can assess and screen for FCR using validated measures; provide adequate information about prognosis, signs and symptoms of recurrence, and behavioral strategies for risk reduction and follow-up; and warn patients and families that FCR may be an issue in survivorship. It is important to normalize FCR and encourage patients to discuss it if it is a concern. Patients with severe FCR should be referred to psycho-oncology staff, who can apply some of the novel psychotherapeutic interventions that have emerged to address this condition.

Randomized Trial of ConquerFear: A Novel, Theoretically Based Psychosocial Intervention for Fear of Cancer Recurrence.

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.

A systematic review of women's satisfaction and regret following risk-reducing mastectomy.

OBJECTIVE: A systematic review of quantitative and qualitative studies, to describe patient satisfaction and regret associated with risk-reducing mastectomies (RRM), and the patient-reported factors associated with these among women at high risk of developing breast cancer. METHODS: Studies were identified using Medline, CINAHL, Embase and PsycInfo databases (1995-2016). Data were extracted and crosschecked for accuracy. Article quality was assessed using standardised criteria. RESULTS: Of the 1657 unique articles identified, 30 studies met the inclusion criteria (n=23 quantitative studies, n=3 qualitative studies, n=4 mixed-method studies). Studies included were cross-sectional (n=23) or retrospective (n=7). General satisfaction with RRM, decision satisfaction and aesthetic satisfaction were generally high, although some women expressed regret around their decision and dissatisfaction with their appearance. Factors associated with both patient satisfaction and regret included: post-operative complications, body image changes, psychological distress and perceived inadequacy of information. CONCLUSION: While satisfaction with RRM was generally high, some women had regrets and expressed dissatisfaction. Future research is needed to further explore RRM, and to investigate current satisfaction trends given the ongoing improvements to surgical and clinical practice. PRACTICE IMPLICATIONS: Offering pre-operative preparation, decisional support and continuous psychological input may help to facilitate satisfaction with this complex procedure.

An exploration of Australian psychologists' role in assessing women considering risk-reducing or contralateral prophylactic mastectomy.

OBJECTIVES: Given increasing rates of risk-reducing mastectomies (RRM) and contralateral prophylactic mastectomies (CPM), and the potentially significant psychological sequelae of this irreversible procedure, health professionals (HPs) regularly refer patients to psychologists for pre-operative assessment and support. This is the first study to provide qualitative insights from HPs into the role of psychologists who are working with women considering RRM or CPM. MATERIALS AND METHODS: 24 HPs (psychologists, surgeons, breast care nurses and genetic counsellors) experienced in treating patients before or after RRM/CPM completed semi-structured interviews (n = 15) or participated in a focus group (n = 10). Interviews were qualitatively analysed using Framework methods. RESULTS: Qualitative analysis revealed four interconnected themes: (1) perceived patient motivation to undergo RRM/CPM; (2) HP reasons for psychologist referral; (3) role of the psychologist; and (4) value of psychologist involvement. The reported psychologist role included: mental health assessment, checking understanding of information, ensuring informed decision-making, preparation for the procedure, and management of post-surgical challenges. CONCLUSION: Psychologists are perceived by HPs to have a key role in the multi-disciplinary care of patients considering RRM or CPM.

Fear of cancer recurrence: a theoretical review and novel cognitive processing formulation.

PURPOSE: Fear of cancer recurrence (FCR) is prevalent among survivors. However, a comprehensive and universally accepted theoretical framework of FCR to guide intervention is lacking. This paper reviews theoretical frameworks previously used to explain FCR and describes the formulation of a novel theoretical framework for FCR. METHODS: A systematic review of the literature was undertaken to identify conceptual frameworks or theories applied to FCR. MEDLINE, PubMED, CINAHL, AMED, PsycINFO and Web of Science were searched. Identified conceptual frameworks were reviewed for strength of evidence supporting their validity. RESULTS: Of 558 papers initially identified, 16 made reference to six different conceptual frameworks relating to FCR. The most comprehensive and evidence-based theoretical approach is the Common Sense Model (CSM). Other approaches have limited evidence supporting their application to FCR. Two theoretical approaches developed in the context of emotional disorders that appear to be highly relevant to FCR: the Self-Regulatory Executive Function (S-REF) model and Relational Frame Theory were combined with the CSM to produce a novel cognitive processing account of FCR. CONCLUSIONS: Few conceptual frameworks have been used consistently to guide FCR research, and not all frameworks are empirically well supported, suggesting that further discussion regarding the conceptualisation of FCR is needed. The novel theoretical framework for FCR presented highlights the multidimensional nature of FCR and the importance of cognitive processing and metacognitions in the development and maintenance of FCR. IMPLICATIONS FOR CANCER SURVIVORS: The novel theoretical formulation of FCR outlined here provides a much-needed comprehensive framework to further investigate and address FCR in cancer survivors.

Conquer fear: protocol of a randomised controlled trial of a psychological intervention to reduce fear of cancer recurrence.

BACKGROUND: Up 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/DESIGN: This 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. DISCUSSION: If 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 REGISTRATION: ACTRN12612000404820.