Identifying the 'Active Ingredients' of an Effective Psychological Intervention to Reduce Fear of Cancer Recurrence: A Process Evaluation

Purpose: Psychological interventions targeting fear of cancer recurrence (FCR) are effective in reducing fear and distress. Process evaluations are an important, yet scarce adjunct to published intervention trials, despite their utility in guiding the interpretation of study outcomes and optimizing intervention design for broader implementation. Accordingly, this paper reports the findings of a process evaluation conducted alongside a randomized controlled trial of a psychological intervention for melanoma patients. Methods: Men and women with a history of Stage 0–II melanoma at high-risk of developing new primary disease were recruited via High Risk Melanoma Clinics across Sydney, Australia and randomly allocated to receive the psychological intervention (n = 80) or usual care (n = 84). Intervention participants received a tailored psycho-educational resource and three individual psychotherapeutic sessions delivered via telehealth. Qualitative and quantitative data on intervention context, processes, and delivery (reach, dose, and fidelity), and mechanisms of impact (participant responses, moderators of outcome) were collected from a range of sources, including participant surveys, psychotherapeutic session audio-recordings, and clinical records. Results: Almost all participants reported using the psycho-educational resource (97%), received all intended psychotherapy sessions (96%), and reported high satisfaction with both intervention components. Over 80% of participants would recommend the intervention to others, and a small proportion (4%) found discussion of melanoma-related experiences confronting. Perceived benefits included enhanced doctor-patient communication, talking more openly with family members about melanoma, and improved coping. Of potential moderators, only higher FCR severity at baseline (pre-intervention) was associated with greater reductions in FCR severity (primary outcome) at 6-month follow-up (primary endpoint). Conclusions: Findings support the acceptability and feasibility of a psychological intervention to reduce FCR amongst individuals at high risk of developing another melanoma. Implementation into routine melanoma care is an imperative next step, with FCR screening recommended to identify those most likely to derive the greatest psychological benefit.This work was supported by a Cancer Institute NSW Translational Program Grant (GM, SWM, 05/TPG/1-01 and 10/TPG/1-02) and a Beyond Blue Project Grant (NK, 630575). NK was the recipient of a National Heart Foundation of Australia Future Leader Fellowship (101229). MD received a PhD scholarship through a Cancer Institute NSW Fellowship to AC and a Sydney Catalyst Top-Up Research Scholar Award. PB was supported by a National Health and Medical Research Council (NHMRC) of Australia Senior Principal Research Fellowship (1022582). ST received an NHMRC Postgraduate Scholarship. RM was supported by an NHMRC Investigator Grant (1194703) and University of Sydney Robinson Fellowship. AC was supported by an NHMRC Career Development Fellowship (1147843). The study protocol was reviewed and endorsed by two National Clinical Trials Groups; the Psycho-oncology Co-operative Research Group (PoCoG), and the Australian and New Zealand Melanoma Trials Group (ANZMTG/MASC)

Genotype–phenotype correlation in PRKN- associated Parkinson’s disease

Bi-allelic pathogenic variants in PRKN are the most common cause of autosomal recessive Parkinson’s disease (PD). 647 patients with PRKN-PD were included in this international study. The pathogenic variants present were characterised and investigated for their effect on phenotype. Clinical features and progression of PRKN-PD was also assessed. Among 133 variants in index cases (n = 582), there were 58 (43.6%) structural variants, 34 (25.6%) missense, 20 (15%) frameshift, 10 splice site (7.5%%), 9 (6.8%) nonsense and 2 (1.5%) indels. The most frequent variant overall was an exon 3 deletion (n = 145, 12.3%), followed by the p.R275W substitution (n = 117, 10%). Exon3, RING0 protein domain and the ubiquitin-like protein domain were mutational hotspots with 31%, 35.4% and 31.7% of index cases presenting mutations in these regions respectively. The presence of a frameshift or structural variant was associated with a 3.4 ± 1.6 years or a 4.7 ± 1.6 years earlier age at onset of PRKN-PD respectively (p < 0.05). Furthermore, variants located in the N-terminus of the protein, a region enriched with frameshift variants, were associated with an earlier age at onset. The phenotype of PRKN-PD was characterised by slow motor progression, preserved cognition, an excellent motor response to levodopa therapy and later development of motor complications compared to early-onset PD. Non-motor symptoms were however common in PRKN-PD. Our findings on the relationship between the type of variant in PRKN and the phenotype of the disease may have implications for both genetic counselling and the design of precision clinical trials

Parent-child relationships following diagnosis of congenital heart disease

Children with congenital heart disease (CHD) and their parents may face numerous relational challenges, including marked distress, parent-child separations, child hospitalisations and neurodevelopmental delays. Despite this, limited research has examined how CHD diagnosis and treatment affects the parent-child relationship, or psychological interventions to ameliorate relational difficulties or distress. Multiple research methods were used to comprehensively investigate these areas. Study 1 systematically reviewed the literature on parent-child bonding, interaction, and child attachment in the CHD context. Overall, greater bonding and interactional difficulties were found amongst parents of children with CHD, compared to healthy controls. Study 2 tested a distance-delivered, technology-assisted adaptation of an observational parent-infant assessment. Preliminary evidence of feasibility and acceptability was found. Study 3 investigated the prevalence and predictors of relational risk amongst mothers and their 6-month old infants with complex CHD. Maternal sensitivity, infant cooperativeness and interactional synchrony were lower amongst this cohort, compared with healthy age-matched controls. Psychological and demographic variables predicted stronger risk for interactional dysynchrony than child medical or temperamental factors. Finally, Study 4 systematically reviewed the literature on psychological interventions for individuals affected by childhood-onset heart disease and their families. Parent-focused interventions showed preliminary efficacy in improving maternal distress, coping and family functioning. Significant gaps in the literature were found, however, including few theoretically based interventions and methodologically rigorous trials. Clinical and methodological implications of this thesis include a need for routine assessment of the parent-child relationship, and development and provision of effective psychotherapies in the pediatric cardiac setting

Maintaining Momentum in Infant Mental Health Research During COVID-19: Adapting Observational Assessments

Understanding the potential effects of the COVID-19 pandemic on the developing parent-infant relationship is a priority, especially for medically-fragile infants and their caregivers who face distinct challenges and stressors. Observational assessments can provide important insights into parent-child behaviors and relational risk; however, stay-at-home directives and physical distancing measures associated with COVID-19 have significantly limited opportunities for in-person observational parent-infant assessment. To maintain momentum in our research program during the pandemic, we rapidly pivoted to remote, technology-assisted parent-infant observational assessments. In this commentary, we offer a series of strategies and recommendations to assist researchers in adapting observational parent-infant paradigms. We also discuss the benefits, challenges, and limitations of distance-delivered assessments, and offer considerations for clinical service provision and future research during and post the COVID-19 pandemic

Supportive care of women with breast cancer: key concerns and practical solutions

Free to read on journal website (may need to create free account first

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

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.Participants had completed treatment for breast, colorectal or melanoma cancer 2\ua0months to 5\ua0years 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).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.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

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