The Ottawa clinical fear of recurrence instruments: A screener, self-report, and clinical interview.

OBJECTIVE: Clinical fear of cancer recurrence (FCR) was recently defined by a group of experts during a Delphi study. Five criteria were agreed upon, namely: (a) high levels of preoccupation, (b) high levels of worry, (c) that are persistent, (d) hypervigilance and hypersensitivity to physical sensations that e) may result in functional impairment. No existing instruments comprehensively capture all these criteria for clinical FCR. METHODS: To remedy this gap, a set of three patient-reported outcome instruments including a one-item screener, self-report questionnaire, and semi-structured clinical interview, named the Ottawa Clinical Fear of Recurrence instruments, were developed. To do so, the research team first conducted a literature review of potential items. Additional FCR experts discussed the content of the screener and interview. The self-report's items were assessed for content validity by the same expert panel using Likert ratings and the Content Validity Index to narrow down the number of items. The three instruments were piloted with a group of cancer survivors to assess face validity following the European Organization for Research and Treatment of Cancer recommendations. RESULTS: The literature review and content validity assessment led to a final draft pre-pilot of 23 potential items for the self-report questionnaire. The instruments were piloted. Pilot study participants suggested changing wording and response options (particularly for the self-report) for greater clarity. CONCLUSIONS: Based on the feedback received, minor modifications were made, mostly for the self-report. In general, content and face validity for the three instruments were good for both experts and cancer survivors.

Mini-AFTERc: a controlled pilot trial of a nurse-led psychological intervention for fear of breast cancer recurrence.

OBJECTIVES: To determine the feasibility and acceptability of implementing the Mini-AFTERc intervention. DESIGN: Non-randomised cluster-controlled pilot trial. SETTING: Four NHS out-patient breast cancer centres in Scotland. PARTICIPANTS: Ninety-two women who had successfully completed primary treatment for breast cancer were screened for moderate levels of fear of cancer recurrence (FCR). Forty-five were eligible (17 intervention and 28 control) and 34 completed 3-month follow-up (15 intervention and 21 control). INTERVENTION: Mini-AFTERc, a single brief (30 min) structured telephone discussion with a specialist breast cancer nurse (SBCN) trained to target the antecedents of FCR. OUTCOMES: Feasibility and acceptability of Mini-AFTERc and the study design were assessed via recruitment, consent, retention rates, patient outcomes (measured at baseline, 2, 4, and 12 weeks), and post-study interviews with participants and SBCNs, which were guided by Normalisation Process Theory. RESULTS: Mini-AFTERc was acceptable to patients and SBCNs. SBCNs believe the implementation of Mini-AFTERc to be feasible and an extension of discussions that already happen routinely. SBCNs believe delivery, however, at the scale required would be challenging given current competing demands for their time. Recruitment was impacted by variability in the follow-up practices of cancer centres and COVID-19 lockdown. Consent and follow-up procedures worked well, and retention rates were high. CONCLUSIONS: The study provided invaluable information about the potential challenges and solutions for testing the Mini-AFTERc intervention more widely where limiting high FCR levels is an important goal following recovery from primary breast cancer treatment. TRIAL REGISTRATION: ClinicalTrials.gov, NCT0376382 . Registered on 4 December 2018.

Fear of cancer recurrence among Brazilian patients with cancer: Translation and cultural adaptation of FCR4/7 and FCRI-SF measures.

OBJECTIVE: Fear of cancer recurrence or progression (FCR) is considered one of the most common unmet needs among patients with cancer. This study sought to translate and evaluate the psychometric properties of the Fear of Cancer Recurrence scale (FCR4/7) and Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF). METHODS: This study involved three phases: (1) translation and cultural adaptation of the FCR4/7 and FCRI-SF measures, (2) validity and reliability testing of the Portuguese version of these measures, and (3) examining patient's perceptions of these measures. Eligible patients were diagnosed with localized breast cancer, and patients with metastatic cancer. Descriptive analyses were collated, and psychometric analysis were conducted (confirmatory factor analysis). RESULTS: A total of 200 patients were recruited (100 patients with localized and 100 patients with metastatic cancer). A significant proportion of patients reported moderate to severe FCR (FCR7: 32.0% and FCRI-SF: 43.0%). Female gender, younger age and metastatic cancer were associated with higher levels of FCR. Psychometric analyses suggested that the Portuguese versions of the FCR4/7 and FCRI-SF were valid, unidimensional in nature, with acceptable reliability coefficients across all scales. In a sub-sample qualitative analysis (n = 75), most patients were satisfied with the relevance of both measures. CONCLUSION: Our findings suggest the Portuguese versions of the FCR4/7 and FCRI-SF are valid tools to assess FCR among patients with localized and metastatic cancer. Future research can now extend our understanding of FCR and assess this construct among Portuguese speaking patients, to guide the development of effective and targeted interventions for patients globally.

How physicians respond to negative emotions in high-risk preoperative conversations.

OBJECTIVE: To investigate physicians' responses to negative emotions in high-risk preoperative conversations; and to explore the influencing factors of these responses. METHODS: One hundred and sixty-two audio recordings were coded using the Chinese Verona Coding Definition of Emotional Sequences (VR-CoDES). Big Five Personality Inventory Brief Version and Emotional Intelligence Scale were administered to explore the influencing factors of physicians' responses. SPSS 24.0 and R 3.6.3 LME4 Package were used for data analysis. RESULTS: Reduce Space (83%), referring to physicians' responses reducing the opportunities of patients to disclose emotions, was physicians' most frequent response to patients or families' emotions. The main responses were Information-advice (ERIa) and Ignoring (NRIa). Younger age, female, Agreeableness and Openness were factors positively associated with Explicit Provide Space (EP); Neuroticism was negatively correlated with EP. Extroversion was negatively correlated with Explicit Reduce Space (ER); Conscientiousness was negatively correlated with both EP and ER responses. Emotional intelligence had no significant influence on physicians' responses. CONCLUSION: The majority of physicians were inclined to reduce space by providing information advice or ignoring. Physicians' responses were correlated with their gender, age and personality traits. PRACTICE IMPLICATIONS: The trainees' gender, age and personality should be considered when conducting doctor-patient communication skills training.

Family-clinician shared decision making in intensive care units: Cluster randomized trial in China.

OBJECTIVE: To investigate if a Family-Clinician Shared Decision-Making (FCSDM) intervention benefits patients, families and intensive care units (ICUs) clinicians. METHODS: Six ICUs in China were allocated to intervention or usual care. 548 patients with critical illness, 548 family members and 387 ICU clinicians were included into the study. Structured FCSDM family meetings were held in the intervention group. Scales of SSDM, HADS, QoL2 and CSACD were used to assess families' satisfaction and distress, patients' quality of life, and clinicians' collaboration respectively. RESULTS: Comparing the intervention group with the control group at post-intervention, there were significant differences in the families' satisfaction (P = 0.0001), depression level (P = 0.005), and patients' quality of life (P = 0.0007). The clinicians' mean CSCAD score was more positive in the intervention group than controls (P < 0.05). There was no significant between-group differences on ICU daily medical cost, but the intervention group demonstrated shorter number of days' stay in ICU (P = 0.0004). CONCLUSION: The FCSDM intervention improved families' satisfaction and depression, shortened patients' duration of ICU stay, and enhanced ICU clinicians' collaboration. PRACTICE IMPLICATIONS: Further improvement and promotion of the FCSDM model are needed to provide more evidence to this field in China.

Which Head and Neck Cancer Patients Are Most at Risk of High Levels of Fear of Cancer Recurrence.

Background: Fear of cancer recurrence (FCR) is recognized as a common concern for patients with head and neck cancer (HNC). The aim of this study is to describe in greater detail the demographic and clinical characteristics of HCN patients who indicate a high level of FCR in their review consultation. Methods: A pragmatic cluster-controlled trial was conducted between January 2017 and December 2018 at two UK HNC centers (Leeds and Liverpool) to test the efficacy of a prompt tool called the Patient Concerns Inventory (PCI). Patients completed the PCI and the UW-QOLv4 which included a single 5 category rating of FCR. Secondary statistical analyses focused on variables associated with high FCR. Results: Two hundred and eighty-eight trial patients were recruited in this trial. At a median of 194 days after diagnosis and 103 days after the end of treatment 8% stated (n = 24) "I get a lot of fears of recurrence and these can really preoccupy my thoughts" and 3% (n = 8) "I am fearful all the time that my cancer might return, and I struggle with this." Thus, 11% (n = 32) responded in the worst two categories, 95% Confidence interval 7.7-15.3% for high FCR. Stepwise logistic regression resulted in female gender (p < 0.001), age (p = 0.007), and receiving financial benefits (p = 0.01) as independent predictors. Conclusions: Around one in ten HNC patients attending routine outpatient follow-up consultations report high FCR, however for female patients under the age of 55 the rate was one in three. This group requires specialist attention and could be the focus of a multicenter intervention trial.

Does Cancer Type Influence the Impact of Recurrence? A Review of the Experience of Patients With Breast or Prostate Cancer Recurrence.

Objective: Patients will experience a plethora of issues when faced with a recurrence of their cancer. It is unclear if cancer type is a significant factor in how recurrence is experienced by an individual. The aim of the current review is to explore the evidence base and summarise the experiences of patients specifically with a recurrence of breast or prostate cancer (the most common for women and men, respectively) and then provide a comparison of these experiences. These experiences include the physical, psychological and psychosocial issues that arise at this time. Methods: A systematic search was conducted of studies published between January 1994 and April 2019. Due to the mix of research designs used previously in the literature, this review was conducted in an integrative manner; allowing for inclusion of diverse research designs. Results were synthesised narratively, with data categorised according to physical, psychological, and psychosocial indices of quality of life. The review protocol was registered in the international database of prospective systematic reviews in health and social care- (CRD42019137381). Results: Fifteen breast cancer and six prostate cancer articles were identified, each reporting one relevant study. Patients reported several negative issues at the time of a breast or prostate cancer recurrence. Similarities were found between cancer types, with physical problems such as fatigue, psychological issues including anxiety and depressive symptoms, and psychosocial concerns such as issues with healthcare professionals common in both cancers. Certain findings were inconsistent across studies, with some experiences differing between studies rather than due to cancer type. Conclusions: Differences in the experience of recurrent cancer appear to be more heavily influenced by individual factors, rather than cancer type. Findings are confounded by gender; and should be considered preliminary. Effects of recurrence should be studied in samples where cancer type and gender are not confounded. Concerns are raised about available study quality and differing outcome measures in this interpretation. Care and support of the individual at the time of a cancer recurrence is a key focus. Future research suggestions with implications for clinical practise are included. Systematic Review Registration: PROSPERO 2019 CRD42019137381.

Improving quality of life through the routine use of the patient concerns inventory for head and neck cancer patients: main results of a cluster preference randomised controlled trial.

PURPOSE: The patient concerns inventory (PCI) is a prompt list allowing head and neck cancer (HNC) patients to discuss issues that otherwise might be overlooked. This trial evaluated the effectiveness of using the PCI at routine outpatient clinics for one year after treatment on health-related QOL (HRQOL). METHODS: A pragmatic cluster preference randomised control trial with 15 consultants, 8 'using' and 7 'not using' the PCI intervention. Patients treated with curative intent (all sites, disease stages, treatments) were eligible. RESULTS: Consultants saw a median (inter-quartile range) 16 (13-26) patients, with 140 PCI and 148 control patients. Of the pre-specified outcomes, the 12-month results for the mean University of Washington Quality of Life (UW-QOLv4) social-emotional subscale score suggested a small clinical effect of intervention of 4.6 units (95% CI 0.2, 9.0), p = 0.04 after full adjustment for pre-stated case-mix. Results for UW-QOLv4 overall quality of life being less than good at 12 months (primary outcome) also favoured the PCI with a risk ratio of 0.83 (95% CI 0.66, 1.06) and absolute risk 4.8% (- 2.9%, 12.9%) but without achieving statistical significance. Other non-a-priori analyses, including all 12 UWQOL domains and at consultant level also suggested better HRQOL with PCI. Consultation times were unaffected and the number of items selected decreased over time. CONCLUSION: This novel trial supports the integration of the PCI approach into routine consultations as a simple low-cost means of benefiting HNC patients. It adds to a growing body of evidence supporting the use of patient prompt lists more generally.

Development and Testing of a Novel Measure to Assess Fidelity of Implementation: Example of the Mini-AFTERc Intervention.

BACKGROUND: Fidelity of implementation (FOI) reflects whether an intervention was implemented in clinical practice according to the originally developed manual and is a key aspect in understanding intervention effectiveness. To illustrate this process of developing a fidelity measure, this study uses the Mini-AFTERc, a brief psychological intervention aimed at managing breast cancer patients' fear of cancer recurrence, as an example. OBJECTIVES: To illustrate the development of an FOI measure through (1) applying this process to the Mini-AFTERc intervention, by including the design of a scoring system and rating criteria; (2) content validating the FOI measure using thematic framework analysis as a qualitative approach; (3) testing consistency of the FOI measure using interrater reliability. METHODS: The FOI measure was developed, its scoring system modified and the rating criteria defined. Thematic framework analysis was conducted to content validate the FOI measure using nine intervention discussions between four specialist cancer nurses and four breast cancer patients, and one simulated breast cancer patient. Intraclass-correlation was conducted to assess interrater reliability. RESULTS: The qualitative findings suggested that the Mini-AFTERc FOI measure has content validity as it was able to measure all five components of the Mini-AFTERc intervention. The interrater reliability suggested a moderate to excellent degree of reliability among three raters, r ICC = 0.84, 95% CI [0.51, 0.96]. CONCLUSION: The study has illustrated the steps that an FOI measure can be developed through a systematic approach applied to the Mini-AFTERc intervention. The FOI measure was found to have content validity and was consistently applied, independently, by three researchers familiar with the Mini-AFTERc intervention. Future studies should determine whether similar levels of interrater reliability can be obtained by distributing written and/or video instructions to researchers who are unfamiliar with the FOI measure, using a larger sample. Employing developed and validated FOI measures such as the one presented for the Mini-AFTERc would facilitate implementation of interventions in the FCR field in clinical practice as intended. CLINICAL TRIAL REGISTRATION: www.ClinicalTrials.gov, identifier: NCT03763825.

Risk-based, 6-monthly and 24-monthly dental check-ups for adults: the INTERVAL three-arm RCT.

BACKGROUND: Traditionally, patients are encouraged to attend dental recall appointments at regular 6-month intervals, irrespective of their risk of developing dental disease. Stakeholders lack evidence of the relative effectiveness and cost-effectiveness of different recall strategies and the optimal recall interval for maintenance of oral health. OBJECTIVES: To test effectiveness and assess the cost-benefit of different dental recall intervals over a 4-year period. DESIGN: Multicentre, parallel-group, randomised controlled trial with blinded clinical outcome assessment at 4 years and a within-trial cost-benefit analysis. NHS and participant perspective costs were combined with benefits estimated from a general population discrete choice experiment. A two-stratum trial design was used, with participants randomised to the 24-month interval if the recruiting dentist considered them clinically suitable. Participants ineligible for 24-month recall were randomised to a risk-based or 6-month recall interval. SETTING: UK primary care dental practices. PARTICIPANTS: Adult, dentate, NHS patients who had visited their dentist in the previous 2 years. INTERVENTIONS: Participants were randomised to attend for a dental check-up at one of three dental recall intervals: 6-month, risk-based or 24-month recall. MAIN OUTCOMES: Clinical - gingival bleeding on probing; patient - oral health-related quality of life; economic - three analysis frameworks: (1) incremental cost per quality-adjusted life-year gained, (2) incremental net (societal) benefit and (3) incremental net (dental health) benefit. RESULTS: A total of 2372 participants were recruited from 51 dental practices; 648 participants were eligible for the 24-month recall stratum and 1724 participants were ineligible. There was no evidence of a significant difference in the mean percentage of sites with gingival bleeding between intervention arms in any comparison. For the eligible for 24-month recall stratum: the 24-month (n = 138) versus 6-month group (n = 135) had an adjusted mean difference of -0.91 (95% confidence interval -5.02 to 3.20); the risk-based (n = 143) versus 6-month group had an adjusted mean difference of -0.98 (95% confidence interval -5.05 to 3.09); the 24-month versus risk-based group had an adjusted mean difference of 0.07 (95% confidence interval -3.99 to 4.12). For the overall sample, the risk-based (n = 749) versus 6-month (n = 737) adjusted mean difference was 0.78 (95% confidence interval -1.17 to 2.72). There was no evidence of a difference in oral health-related quality of life between intervention arms in any comparison. For the economic evaluation, under framework 1 (cost per quality-adjusted life-year) the results were highly uncertain, and it was not possible to identify the optimal recall strategy. Under framework 2 (net societal benefit), 6-month recalls were the most efficient strategy with a probability of positive net benefit ranging from 78% to 100% across the eligible and combined strata, with findings driven by the high value placed on more frequent recall services in the discrete choice experiment. Under framework 3 (net dental health benefit), 24-month recalls were the most likely strategy to deliver positive net (dental health) benefit among those eligible for 24-month recall, with a probability of positive net benefit ranging from 65% to 99%. For the combined group, the optimal strategy was less clear. Risk-based recalls were more likely to be the most efficient recall strategy in scenarios where the costing perspective was widened to include participant-incurred costs, and in the Scottish subgroup. LIMITATIONS: Information regarding factors considered by dentists to inform the risk-based interval and the interaction with patients to determine risk and agree the interval were not collected. CONCLUSIONS: Over a 4-year period, we found no evidence of a difference in oral health for participants allocated to a 6-month or a risk-based recall interval, nor between a 24-month, 6-month or risk-based recall interval for participants eligible for a 24-month recall. However, people greatly value and are willing to pay for frequent dental check-ups; therefore, the most efficient recall strategy depends on the scope of the cost and benefit valuation that decision-makers wish to consider. FUTURE WORK: Assessment of the impact of risk assessment tools in informing risk-based interval decision-making and techniques for communicating a variable recall interval to patients. TRIAL REGISTRATION: Current Controlled Trials ISRCTN95933794. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme [project numbers 06/35/05 (Phase I) and 06/35/99 (Phase II)] and will be published in full in Health Technology Assessment; Vol. 24, No. 60. See the NIHR Journals Library website for further project information.

Traditionally, dentists have encouraged both patients at low risk and patients at high risk of developing dental disease to attend their dental practices for regular 6-month 'check-ups'. There is, however, little evidence available for either patients or dentists to use when deciding on the best dental recall interval (i.e. time between dental check-ups) for maintaining oral health. In this study, we wanted to find out, for adult patients who regularly attend the dentist, what interval of time between dental check-ups maintains optimum oral health and represents value for money. A total of 2372 adults who regularly attended 51 different dental practices across Scotland, Northern Ireland, England and Wales were involved. Patients aged 18 years or over who received all or part of their care as NHS patients were randomly allocated to groups to receive a check-up either every 6 months, at an individualised recall interval based on their own risk of oral disease (risk-based recall), or every 24 months (if considered at low risk by their dentist). The recruited adults completed questionnaires at their first trial appointment and then every year of the 4-year study. Their attendance at recall appointments was recorded and they received a clinical assessment taken by study staff at the end of their involvement at year 4. After 4 years, there was no evidence of a difference in the oral health of patients allocated to a 6-month or variable risk-based recall interval. For patients considered by their dentists to be suitable for a 24-month recall interval, there was no difference between those in the 24-month, 6-month or risk-based recall intervals. However, people greatly value and are willing to pay for frequent dental check-ups. The recall strategy that offers the best value for money to patients and the NHS, therefore, depends on what people and decision-makers wish to value within a health-care system.

The relationship between fears of cancer recurrence and patient age: A systematic review and meta-analysis.

BACKGROUND: Fears of cancer recurrence (FCR) is one of the most prevalent concerns and a common unmet need reported by cancer patients. Patient age is a demographic variable that has been linked to FCR, among others. Although it is recognised by researchers that age and FCR may be negatively correlated, the strength of this correlation has yet to be established. AIM: The aims of this study were to (a) conduct a meta-analysis to investigate the overall association of patient age in years with FCR across studies from 2009 to February 2019 and (b) scrutinise for patterns of these effect sizes across studies. METHODS AND RESULTS: Peer-reviewed papers were gathered from the literature via online databases (PubMed, EMBASE, MEDLINE, and PsycINFO). Systematic review guidelines including a quality assessment were applied to the 31 selected studies (pooled participant N size = 19 777). The meta-analysis demonstrated a significant negative association between age and FCR (ES = -0.12; 95% CI, -0.17, -0.07). Meta-regression revealed the association of patient age and FCR significantly reduced over the last decade. A significant effect (ß = -0.17, P = 0.005) of breast cancer versus other cancers on this age by FCR association was also identified. CONCLUSION: The reliable and readily accessible personal information of age of patient can be utilised as a weak indicator of FCR level especially in the breast cancer field, where the majority of studies were drawn. The suggestion that age and FCR association may be attenuated in recent years requires confirmation.

Improving quality of life through the routine use of the patient concerns inventory for head and neck cancer patients: baseline results in a cluster preference randomised controlled trial.

PURPOSE: The main aim of this paper is to present baseline demographic and clinical characteristics and HRQOL in the two groups of the Patient Concerns Inventory (PCI) trial. The baseline PCI data will also be described. METHODS: This is a pragmatic cluster preference randomised control trial with 15 consultant clusters from two sites either 'using' (n = 8) or 'not using' (n = 7) the PCI at a clinic for all of their trial patients. The PCI is a 56-item prompt list that helps patients raise concerns that otherwise might be missed. Eligibility was head and neck cancer patients treated with curative intent (all sites, stage of disease, treatments). RESULTS: From 511 patients first identified as eligible when screening for the multi-disciplinary tumour board meetings, 288 attended a first routine outpatient baseline study clinic after completion of their treatment, median (IQR) of 103 (71-162) days. At baseline, the two trial groups were similar in demographic and clinical characteristics as well as in HRQOL measures apart from differences in tumour location, tumour staging and mode of treatment. These exceptions were cluster (consultant) related to Maxillofacial and ENT consultants seeing different types of cases. Consultation times were similar, with PCI group times taking about 1 min longer on average (95% CL for the difference between means was from - 0.7 to + 2.2 min). CONCLUSION: Using the PCI in routine post-treatment head and neck cancer clinics do not elongate consultations. Recruitment has finished but 12-month follow-up is still ongoing.

High Fear of Cancer Recurrence in Chinese Newly Diagnosed Cancer Patients.

BACKGROUND: Fear of cancer recurrence (FCR) is common among cancer patients and of high clinical relevance. This study explores the prevalence and correlates of FCR in Chinese newly diagnosed cancer population. METHODS: This is a multicentre, cross-sectional study that includes 996 patients with mixed cancer diagnosis. All recently diagnosed patients completed a questionnaire consisting of the following: Fear of Progression Questionnaire-Short Form (FoP-Q-SF), General Anxiety Disorder Questionnaire (GAD-7), and Patient Health Questionnaire (PHQ-9). Univariate analyses, multivariate logistic regression analyses, and structural equation modeling (SEM) was performed to examine the association between tested variables and FCR. RESULTS: Of the 996 patients, 643 (64.6%) reported high FCR (scored ≥ 34 in the FoP-Q-SF). Chemotherapy (OR = 1.941), Childhood severe illness experience (OR = 2.802), depressive (OR = 1.153), and anxiety (OR = 1.249) symptoms were positively associated with high FCR, while higher monthly income (OR = 0.592) was negatively associated with high FCR. SEM indicated that emotional disturbances (anxiety and depression) directly influenced FCR, while emotional disturbances partly mediated the association between personal monthly income and FCR. CONCLUSION: High FCR is a frequently reported problem among newly diagnosed cancer patients. Various factors increased the likelihood of the development of FCR. Flexible psychological interventions are needed for patients with high FCR.

A controlled pilot trial of a nurse-led intervention (Mini-AFTERc) to manage fear of cancer recurrence in patients affected by breast cancer.

BACKGROUND: Fear of cancer recurrence (FCR) is common in people affected by breast cancer. FCR is associated with increased health service and medication use, anxiety, depression and reduced quality of life. Existing interventions for FCR are time and resource intensive, making implementation in a National Health Service (NHS) setting challenging. To effectively manage FCR in current clinical practice, less intensive FCR interventions are required. Mini-AFTERc is a structured 30-min counselling intervention delivered over the telephone and is designed to normalise moderate FCR levels by targeting unhelpful behaviours and misconceptions about cancer recurrence.This multi-centre non-randomised controlled pilot trial will investigate the feasibility of delivering the Mini-AFTERc intervention, its acceptability and usefulness, in relation to specialist breast cancer nurses (SBCNs) and patients. This protocol describes the rationale, methods and analysis plan for this pilot trial of the Mini-AFTERc intervention in everyday practice. METHODS: This study will run in four breast cancer centres in NHS Scotland, two intervention and two control centres. SBCNs at intervention centres will be trained to deliver the Mini-AFTERc intervention. Female patients who have completed primary breast cancer treatment in the previous 6 months will be screened for moderate FCR (FCR4 score: 10­14). Participants at intervention centres will receive the Mini-AFTERc intervention within 2 weeks of recruitment. SBCNs will audio record the intervention telephone discussions with participants. Fidelity of intervention implementation will be assessed from audio recordings. All participants will complete three separate follow-up questionnaires assessing changes in FCR, anxiety, depression and quality of life over 3 months. Normalisation process theory (NPT) will form the framework for semi-structured interviews with 20% of patients and all SBCNs. Interviews will explore participants' experience of the study, acceptability and usefulness of the intervention and factors influencing implementation within clinical practice. The ADePT process will be adopted to systematically problem solve and refine the trial design. DISCUSSION: Findings will provide evidence for the potential effectiveness, fidelity, acceptability and practicality of the Mini-AFTERc intervention, and will inform the design and development of a large randomised controlled trial (RCT). TRIAL REGISTRATION: ClinicalTrials.gov: NCT0376382. Registered 4th December 2018, https://clinicaltrials.gov/ct2/show/NCT03763825.

Specialist breast cancer nurses' views on implementing a fear of cancer recurrence intervention in practice: a mixed methods study.

INTRODUCTION: Fear of cancer recurrence (FCR) in people with breast cancer affects treatment recovery, quality of life, service utilisation and relationships. Our aim was to investigate how specialist breast cancer nurses (SBCN) respond to their patients' fears of cancer recurrence and analyse SBCN's views about embedding a new psychological intervention, the Mini-AFTERc, into their consultations. METHOD: A mixed methods sequential design was used, informed by normalisation process theory. Phase 1: UK SBCNs were emailed a web-based survey to investigate how breast cancer survivors' FCR is currently identified and managed, and their willingness to utilise the Mini-AFTERc. Phase 2: a purposive sample of respondents (n = 20) were interviewed to augment phase 1 responses, and explore views on the importance of addressing FCR, interest in the Mini-AFTERc intervention, its content, skills required and challenges to delivering the intervention. RESULTS: Ninety nurses responded to the survey. When SBCN's were asked to identify the proportion of patients experiencing FCR in their caseload, there was no consensus on the size of the problem or unmet need. They estimated that 20-100% people experience moderate FCR and 10-70% severe FCR. The interviews identified that clinical conversations are focused primarily on giving information about signs and symptoms of recurrence rather than addressing the psychological aspects of fear. CONCLUSION: Findings indicate wide variability in how FCR was identified, assessed and supported by a sample of UK SBCNs. The introduction of a structured intervention into practice was viewed favourably and has implications for nursing and health professional ways of working in all cancer services.

Association of depression and anxiety with different aspects of dental anxiety in pregnant mothers and their partners.

OBJECTIVES: The aim was to confirm the factor structure of Modified Dental Anxiety Scale (MDAS) and to investigate whether the association of these factors with general anxiety and depression varied across gender. METHODS: The FinnBrain Birth Cohort Study (www.finnbrain.fi) data from the first collection point at gestational week 14 were used. Of the invited participants (n = 5790), 3808 (66%) expectant mothers and 2623 fathers or other partners of the mother agreed to participate, and 3095 (81.3%) mothers and 2011 (76.7%) fathers returned the self-report questionnaire. Dental anxiety was measured with the MDAS, general anxiety symptoms with Symptom Checklist-90 (anxiety subscale) and depressive symptoms with the Edinburgh Postnatal Depression Scale. Multiple group confirmatory factor analysis (MGCFA) was conducted to test the equivalence of the factor structure and multiple group SEM (MGSEM) to test the configural invariance (unconstrained model) and metric invariance (structural weights model), across genders. RESULTS: Of those consenting, 3022 (98%) women and 1935 (96%) men answered the MDAS. The MGCFA indicated good convergent validity for the two-factor model for MDAS, but somewhat low discriminant validity (factors demonstrated 72% shared variance). The MDAS items loaded clearly higher for the assigned factor than to the other factor (differences in loadings >0.2), indicating that the 2-factor model has merit. According to the final MGSEM model, anxiety symptoms were directly related to anticipatory dental anxiety, but not to treatment-related dental anxiety. CONCLUSIONS: When assessing dental anxiety with MDAS, considering also its two factors may help clinicians in understanding the nature of patient's dental anxiety.

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.

Communication skills training for the radiotherapy team to manage cancer patients' emotional concerns: a systematic review.

OBJECTIVES: Many cancer patients experience high levels of anxiety and concern during radiotherapy, often with long-lasting effects on their well-being. This systematic review aims to describe and determine the effectiveness of communication skills training (CST) for the radiotherapy team (RT) to improve conversations in this setting and to support patients with emotional concerns. DESIGN: Systematic review. INTERVENTIONS: CST for RT members. DATA SOURCES: On 17 April 2018, databases Medline, Embase, Scopus and PsycNET were searched. ELIGIBILITY CRITERIA, POPULATION, INTERVENTION, COMPARISON, OUTCOMEPICO: Quantitative and/or qualitative articles were included that evaluate the effect of a CST for RT members (vs no CST) on communication behaviours and patients' emotional concerns. DATA EXTRACTION AND SYNTHESIS: Articles were appraised using the mixed-methods appraisal tool, and a narrative synthesis was performed. RESULTS: Of the nine included articles, five were randomised controlled trials, three were mixed-methods and one used repeated measurements. Four of the five different CST programmes managed to increase emotional communicative behaviour from the RT, and all studies measuring patient communicative behaviour found an improvement in at least one of the hypothesised outcomes. Two studies examining patient anxiety and concerns found a positive effect of the CST, although one found a negative effect; two other studies without a positive effect on mood made use of both empathic CST and tools. CONCLUSIONS: There are promising indications that CST can be successfully introduced to improve emotional conversations between RT members and patients. With the right support, the RT can play an important role to help patients cope with their emotional concerns. Future work is necessary to confirm initial promising results and to ensure the learnt communication skills are sustained.

Automated screening for distress: A perspective for the future.

Distress is a complex condition, which affects a significant percentage of cancer patients and may lead to depression, anxiety, sadness, suicide and other forms of psychological morbidity. Compelling evidence supports screening for distress as a means of facilitating early intervention and subsequent improvements in psychological well-being and overall quality of life. Nevertheless, despite the existence of evidence-based and easily administered screening tools, for example, the Distress Thermometer, routine screening for distress is yet to achieve widespread implementation. Efforts are intensifying to utilise innovative, cost-effective methods now available through emerging technologies in the informatics and computational arenas.

Modelling reassurances of clinicians with hidden Markov models.

BACKGROUND: A key element in the interaction between clinicians and patients with cancer is reassurance giving. Learning about the stochastic nature of reassurances as well as making inferential statements about the influence of covariates such as patient response and time spent on previous reassurances are of particular importance. METHODS: We fit Hidden Markov Models (HMMs) to reassurance type from multiple time series of clinicians' reassurances, decoded from audio files of review consultations between patients with breast cancer and their therapeutic radiographer. Assuming a latent state process driving the observations process, HMMs naturally accommodate serial dependence in the data. Extensions to the baseline model such as including covariates as well as allowing for fixed effects for the different clinicians are straightforward to implement. RESULTS: We found that clinicians undergo different states, in which they are more or less inclined to provide a particular type of reassurance. The states are very persistent, however switches occasionally occur. The lengthier the previous reassurance, the more likely the clinician is to stay in the current state. CONCLUSIONS: HMMs prove to be a valuable tool and provide important insights for practitioners. TRIAL REGISTRATION: Trial Registration number: ClinicalTrials.gov: NCT02599506. Prospectively registered on 11th March 2015.