Adapting and testing a brief intervention to reduce maternal anxiety during pregnancy (ACORN): report of a feasibility randomized controlled trial.

BACKGROUND: We investigated the acceptability and feasibility of a new brief intervention for maternal prenatal anxiety within maternity services in London and Exeter, UK. METHODS: One hundred fourteen pregnant individuals attending their 12-week scan at a prenatal clinic with elevated symptoms of anxiety (GAD-7 score of ≥7) were randomly assigned to either the ACORN intervention + Treatment as usual (TAU) (n = 57) or to usual care only (n = 57). The ACORN intervention consisted of 3 2-h group sessions, led by a midwife and psychological therapist, for pregnant individuals and their partners. The intervention included psychoeducation about anxiety, strategies for problem-sovling and tolerating uncertainty during pregnancy, including communicating about these with others, and mindfulness exercises. RESULTS: Engagement rates with ACORN met or exceeded those in primary care services in England. In the intervention arm, 77% (n = 44) of participants attended at least one session, 51% (n = 29) were adherent, defined as attending two or more sessions. Feedback was positive, and participants in the ACORN treatment group demonstrated evidence of a larger drop in their levels of anxiety than the participants in the TAU-only group (Cohen's d = 0.42). CONCLUSION: The ACORN intervention was acceptable to pregnant individuals and their partners and resulted in reductions in anxiety. With further evaluation in a larger-scale trial with child outcomes, there is significant potential for large scale public health benefit.

A Randomized Controlled Trial of a Nurse-Led Supportive Care Package (SurvivorCare) for Survivors of Colorectal Cancer.

INTRODUCTION: Colorectal cancer (CRC) and its treatments can cause distressing sequelae. We conducted a multicenter randomized controlled trial aiming to improve psychological distress, supportive care needs (SCNs), and quality of life (QOL) of patients with CRC. The intervention, called SurvivorCare (SC), comprised educational materials, needs assessment, survivorship care plan, end-of-treatment session, and three follow-up telephone calls. METHODS: At the end of treatment for stage I-III CRC, eligible patients were randomized 1:1 to usual care (UC) or to UC plus SC. Distress (Brief Symptom Inventory 18), SCNs (Cancer Survivors' Unmet Needs measure), and QOL (European Organization for Research and Treatment of Cancer [EORTC] QOL questionnaires C30 and EORTC CRC module CR29) were assessed at baseline and at 2 and 6 months (follow-up 1 [FU1] and FU2, respectively). The primary hypothesis was that SC would have a beneficial effect on distress at FU1. The secondary hypotheses were that SC would have a beneficial effect on (a) SCN and QOL at FU1 and on (b) distress, SCNs, and QOL at FU2. A total of 15 items assessed experience of care. RESULTS: Of 221 patients randomly assigned, 4 were ineligible for the study and 1 was lost to FU, leaving 110 in the UC group and 106 in the SC group. Patients' characteristics included the following: median age, 64 years; men, 52%; colon cancer, 56%; rectal cancer, 35%; overlapping sites of disease, 10%; stage I disease, 7%; stage II, 22%; stage III, 71%. Baseline distress and QOL scores were similar to population norms. Between-group differences in distress at FU1 (primary outcome) and at FU2, and SCNs and QOL at FU1 and FU2 were small and nonsignificant. Patients in the SC group were more satisfied with survivorship care than those in the UC group (significant differences on 10 of 15 items). CONCLUSION: The addition of SC to UC did not have a beneficial effect on distress, SCNs, or QOL outcomes, but patients in the SC group were more satisfied with care. IMPLICATIONS FOR PRACTICE: Some survivors of colorectal cancer report distressing effects after completing treatment. Strategies to identify and respond to survivors' issues are needed. In a randomized controlled trial, the addition of a nurse-led supportive care package (SurvivorCare) to usual post-treatment care did not impact survivors' distress, quality of life, or unmet needs. However, patients receiving the SurvivorCare intervention were more satisfied with survivorship care. Factors for consideration in the design of subsequent studies are discussed.

Practical recommendations for addressing the psychological needs of unaccompanied asylum-seeking children in England: A literature and service review.

BACKGROUND: Globally, there is an increasing trend of forcibly displaced people, of which over 40% are children. Unaccompanied asylum-seeking children (UASC) are at risk of experiencing psychological distress and developing mental health difficulties. However, in the UK, the approach from statutory mental health services is inconsistent across different geographical areas. AIM: This report outlines recommendations for statutory mental health services in the UK in relation to working with UASC. METHOD: A rapid evaluation method was adopted including interviewing fifteen key informants as well as reviewing existing clinical guidelines. Key informants included clinicians, service managers, social workers and commissioners from Local Authorities, National Health Services, and third sector partners. Recommendations were synthesised using narrative synthesis. RESULTS AND CONCLUSION: Existing service provision and barriers to the implementation of interventions were summarised and compared against existing guidelines. The report presents recommendations on assessments, screening tools, and psychological interventions for developing a pathway for UASC within statutory services.

Globally, there is an increasing trend of asylum seekers and refugees, and 40% of which are children. Unaccompanied asylum-seeking children (UASC) are at risk of experiencing psychological distress and developing mental health difficulties. Yet, service provision for this population is inconsistent across different regions in the UK and may not be sufficient to meet their psychosocial needs. We hope to provide recommendations for services in England on how to better support UASC through reviewing the existing literature, clinical guidelines, and interviewing different service providers in the country in order to identify gaps in services. We interviewed key informants, including clinicians, service managers, social workers and commissioners from Local Authorities, National Health Services, and third sector partners. We present findings on how to improve the current assessment, screening and psychological interventions for UASC.

SCORE: a randomised controlled trial evaluating shared care (general practitioner and oncologist) follow-up compared to usual oncologist follow-up for survivors of colorectal cancer.

Background: SCORE is the first randomised controlled trial (RCT) to examine shared oncologist and general practitioner (GP) follow-up for survivors of colorectal cancer (CRC). SCORE aimed to show that shared care (SC) was non-inferior to usual care (UC) on the EORTC QLQ-C30 Global Health Status/Quality of Life (GHQ-QoL) scale to 12 months. Methods: The study recruited patients from five public hospitals in Melbourne, Australia between February 2017 and May 2021. Patients post curative intent treatment for stage I-III CRC underwent 1:1 randomisation to SC and UC. SC replaced two oncologist visits with GP visits and included a survivorship care plan and primary care management guidelines. Assessments were at baseline, 6 and 12 months. Difference between groups on GHQ-QoL to 12 months was estimated from a mixed model for repeated measures (MMRM), with a non-inferiority margin (NIM) of -10 points. Secondary endpoints included quality of life (QoL); patient perceptions of care; costs and clinical care processes (CEA tests, recurrences). Registration ACTRN12617000004369p. Findings: 150 consenting patients were randomised to SC (N = 74) or UC (N = 76); 11 GPs declined. The mean (SD) GHQ-QoL scores at 12 months were 72 (20.2) for SC versus 73 (17.2) for UC. The MMRM mean estimate of GHQ-QoL across the 6 month and 12 month follow-up was 69 for SC and 73 for UC, mean difference -4.0 (95% CI: -9.0 to 0.9). The lower limit of the 95% CI did not cross the NIM. There was no clear evidence of differences on other QoL, unmet needs or satisfaction scales. At 12 months, the majority preferred SC (40/63; 63%) in the SC group, with equal preference for SC (22/62; 35%) and specialist care (22/62; 35%) in UC group. CEA completion was higher in SC. Recurrences similar between arms. Patients in SC on average incurred USD314 less in health costs versus UC patients. Interpretation: SC seems to be an appropriate and cost-effective model of follow-up for CRC survivors. Funding: Victorian Cancer Agency and Cancer Australia.

Therapist-supported online cognitive therapy for post-traumatic stress disorder (PTSD) in young people: protocol for an early-stage, parallel-group, randomised controlled study (OPTYC trial).

INTRODUCTION: Post-traumatic stress disorder (PTSD) is a disabling psychiatric condition that affects a significant minority of young people exposed to traumatic events. Effective face-to-face psychological treatments for PTSD exist. However, most young people with PTSD do not receive evidence-based treatment. Remotely delivered digital interventions have potential to significantly improve treatment accessibility. Digital interventions have been successfully employed for young people with depression and anxiety, and for adults with PTSD. However, digital interventions to treat PTSD in young people have not been evaluated. The Online PTSD Treatment for Young People & Carers (OPTYC) trial will evaluate the feasibility, acceptability and initial indications of clinical efficacy of a novel internet-delivered Cognitive Therapy for treatment of PTSD in young people (iCT-PTSD-YP). METHODS AND ANALYSIS: This protocol describes a two-arm, parallel-groups, single-blind (outcome assessor), early-stage randomised controlled trial, comparing iCT-PTSD-YP with a waiting list (WL) comparator. N=34 adolescents (12-17 years old), whose primary problem is PTSD after exposure to a single traumatic event, will be recruited from 14 NHS Child and Adolescent Mental Health Services in London and southeast England, from secondary schools and primary care in the same region, or via self-referral from anywhere in the UK using the study website. Individual patient-level randomisation will allocate participants in a 1:1 ratio, randomised using minimisation according to sex and baseline symptom severity. The primary study outcomes are data on feasibility and acceptability, including recruitment, adherence, retention and adverse events (AEs). The primary clinical outcome is PTSD diagnosis 16 weeks post-randomisation. Secondary clinical outcomes include continuous measures of PTSD, anxiety and depression symptoms. Regression analyses will provide preliminary estimates of the effect of iCT-PTSD-YP on PTSD diagnosis, symptoms of PTSD, anxiety and depression relative to WL. Process-outcome evaluation will consider which mechanisms mediate recovery. Qualitative interviews with young people, families and therapists will evaluate acceptability. ETHICS AND DISSEMINATION: The study was approved by a UK Health Research Authority Research Ethics Committee (19/LO/1354). For participants aged under 16, informed consent will be provided by carers and the young person will be asked for their assent; participants aged 16 years or older can provide informed consent without their parent or caregiver's involvement. Findings will be disseminated broadly to participants, healthcare professionals, the public and other relevant groups. Study findings will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN16876240.

Implementing Narrative Exposure Therapy for unaccompanied asylum-seeking minors with post-traumatic stress disorder: A pilot feasibility report.

There are high rates of post-traumatic stress disorder (PTSD) in unaccompanied asylum-seeking minors (UAM) and there is a requirement for feasible, acceptable and evidence-based treatments. Narrative Exposure Therapy (NET) is a short-term treatment for PTSD following multiple traumatic events. This article aims to examine the applicability of NET for UAM in routine clinical practice and to provide preliminary feasibility, acceptability and effectiveness data. The participants were four UAM receiving NET within a dedicated child and adolescent mental health service for refugee children. Semi-structured interviews were conducted to understand the acceptability of this approach and standardised measures of PTSD were used to provide preliminary data regarding the effectiveness of NET for these clients. The clients attended NET consistently with few missed appointments. At post-treatment, two clients' symptom scores were below the clinical cut-off for PTSD and all three clients who completed NET met reliable improvement criteria. The clients reported improvements in functional outcomes and mentioned that they would encourage other young people with similar difficulties to engage in NET. This study was limited by the small sample size and naturalistic time limitations in clinicians' contracts. This article highlights that it is possible to implement NET within routine clinical practice and observed improvements in PTSD symptoms and functional outcomes for UAM.

SCORE: Shared care of Colorectal cancer survivors: protocol for a randomised controlled trial.

BACKGROUND: Colorectal cancer (CRC) is the most common cancer affecting both men and women. Survivors of CRC often experience various physical and psychological effects arising from CRC and its treatment. These effects may last for many years and adversely affect QoL, and they may not be adequately addressed by standard specialist-based follow-up. Optimal management of these effects should harness the expertise of both primary care and specialist care. Shared models of care (involving both the patient's primary care physician [PCP] and specialist) have the potential to better support survivors and enhance health system efficiency. METHODS/DESIGN: SCORE (Shared care of Colorectal cancer survivors) is a multisite randomised controlled trial designed to optimise and operationalise a shared care model for survivors of CRC, to evaluate the acceptability of the intervention and study processes, and to collect preliminary data regarding the effects of shared care compared with usual care on a range of patient-reported outcomes. The primary outcome is QoL measured using the European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaire. Secondary outcomes are satisfaction with care, unmet needs, continuity of care and health resource use. The shared care model involves replacement of two routine specialist follow-up visits with PCP visits, as well as the provision of a tailored survivorship care plan and a survivorship booklet and DVD for CRC survivors. All consenting patients will be randomised 1:1 to either shared care or usual care and will complete questionnaires at three time points over a 12-month period (baseline and at 6 and 12 months). Health care resource use data will also be collected and used to evaluate costs. DISCUSSION: The evaluation and implementation of models of care that are responsive to the holistic needs of cancer survivors while reducing the burden on acute care settings is an international priority. Shared care between specialists and PCPs has the potential to enhance patient care and outcomes for CRC survivors while offering improvements in health care resource efficiency. If the findings of the present study show that the shared care intervention is acceptable and feasible for CRC survivors, the intervention may be readily expanded to other groups of cancer survivors. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12617000004369p . Registered on 3 January 2017; protocol version 4 approved 24 February 2017.

Adapting and testing a brief intervention to reduce maternal anxiety during pregnancy (ACORN): study protocol for a randomised controlled trial.

BACKGROUND: National guidelines in the UK, United States of America, Canada, and Australia have recently stressed the importance of identifying and treating antenatal anxiety and depression. However, there is little research into the most effective and acceptable ways of helping women manage their symptoms of anxiety and stress during pregnancy. Research indicates the necessity to consider the unique needs and concerns of perinatal populations to ensure treatment engagement, highlighting the need to develop specialised treatments which could be integrated within routine antenatal healthcare services. This trial aims to develop a brief intervention for antenatal anxiety, with a focus on embedding the delivery of the treatment within routine antenatal care. METHODS/DESIGN: This study is a two-phase feasibility trial. In phase 1 we will develop and pilot a brief intervention for antenatal anxiety, blended with group support, to be led by midwives. This intervention will draw on cognitive behavioural principles and wider learning from existing interventions that have been used to reduce anxiety in expectant mothers. The intervention will then be tested in a pilot randomised controlled trial in phase 2. The following outcomes will be assessed: (1) number of participants meeting eligibility criteria, (2) number of participants consenting to the study, (3) number of participants randomised, (4) number of sessions completed by those in the intervention arm, and (5) number of participants completing the post-intervention outcome measures. Secondary outcomes comprise: detailed feedback on acceptability, which will guide further development of the intervention; and outcome data on symptoms of maternal and paternal anxiety and depression, maternal quality of life, quality of couple relationship, mother-child bonding, infant temperament and infant sleep. DISCUSSION: The study will provide important data to inform the design of a future full-scale randomised controlled trial of a brief intervention for anxiety during pregnancy. This will include information on its acceptability and feasibility regarding implementation within current antenatal services, which will inform whether ultimately this provision could be rolled out widely in healthcare settings. TRIAL REGISTRATION: Current Controlled Trials ISRCTN95282830 . Registered on 29 October 2014.

Psychological distress, quality of life, symptoms and unmet needs of colorectal cancer survivors near the end of treatment.

PURPOSE: This study investigated psychological morbidity, quality of life (QoL), colorectal cancer (CRC)-specific symptoms and supportive care needs in a CRC population at the end of treatment (EOT). METHODS: CRC survivors (n = 152) completed a post-treatment baseline questionnaire as part of a multisite supportive care randomised controlled trial (SurvivorCare). CRC survivors had completed treatment with curative intent within 0 to 6 months. Measures are as follows: Brief Symptom Inventory 18 (BSI-18) (psychological morbidity), EORTC QLQ-C30 and QLQ-CR29 (QoL and CRC-specific symptoms and problems) and Cancer Survivors' Unmet Needs (CaSUN) measure with a simplified response format (unmet needs). Linear regression models were used to compare participants' QoL with a general population sample. Correlation analysis examined associations between psychological morbidity, QoL and CRC-specific symptoms and problems. RESULTS: Average participant age was 64 years, and 51% were male. The majority (68%) had stage 3 disease. In comparison to population norms, CRC survivors had lower depression and anxiety scores (47.4 and 45.6, respectively) but higher somatisation, and lower role, cognitive and social functioning (p < 0.001). CRC survivors had higher fatigue, nausea/vomiting, appetite loss, diarrhoea and financial problems (all p < 0.001), as well as pain (p = 0.002) and constipation (p = 0.019). CRC-specific psychological scores were positively correlated with all three BSI domain scores, and pain and fatigue symptom scores on the QLQ-C30 while negatively correlated with all five functional scales of the QLQ-C30. CONCLUSIONS: CRC survivors reported good mental health at EOT. Role and social functioning were impaired compared to population norms, possibly related to physical symptoms. IMPLICATIONS FOR CANCER SURVIVORS: Findings may help guide consultations with patients and inform the design of more tailored supportive care interventions. TRIAL REGISTRATION: ACTRN12610000207011.

Seroprevalence of hepatitis C virus in haemophiliacs in Jamaica.

Haemophilic patients (n = 90) and household contacts (n = 40) were tested for serological markers of hepatitis B virus (HBV), hepatitis C virus (HCV) and elevated serum aminotransferases using commercially prepared reagents. Of the haemophiliacs 41% (37/90) tested positive for antibodies to HCV (anti-HCV); 36% (32/90) antibodies to hepatitis B core antigen (anti-HBc); 54% (49/90) antibodies to hepatitis B surface antigen (anti-HBs) and 2% (2/90) hepatitis B surface antigen. On the other hand, 29% (26/90) of the patients and 90% (36/40) of the household contacts tested negative for all of the viral markers. Anti-HCV positivity in the haemophilic patients correlated positively with anti-HBc (p < 0.025). Increasing age (odds ratio 2.09; p < 0.01), severity of disease (odds ratio 6.2; p < 0.05) and the requirement for transfusion (odds ratio 3.2; p < 0.05) were risk factors for anti-HCV positivity. The presence of anti-HBc (odds ratio 3.8; p < 0.01) and coinfection with HCV and HBV also correlated positively with age (odds ratio 2.5; p < 0.01). The provision of anti-HCV screened donor blood and virally inactivated blood products for treatment of all haemophilic patients are goals that must be achieved.

Evaluating a nurse-led survivorship care package (SurvivorCare) for bowel cancer survivors: study protocol for a randomized controlled trial.

BACKGROUND: Colorectal cancer (CRC) is the most common cancer affecting both men and women in Australia. The illness and related treatments can cause distressing adverse effects, impact on emotional and psychological well-being, and adversely affect social, occupational and relationship functioning for many years after the end of treatment or, in fact, lifelong. Current models of follow-up fail to address the complex needs arising after treatment completion. Strategies to better prepare and support survivors are urgently required. We previously developed a nurse-led supportive care program (SurvivorCare) and tested it in a pilot study involving 10 CRC survivors. The intervention was found to be highly acceptable, appropriate, relevant and useful. METHODS/DESIGN: This study is a multisite, randomised controlled trial, designed to assess the impact of the addition of the SurvivorCare intervention to usual post-treatment care, for people with potentially cured CRC. SurvivorCare comprises the provision of survivorship educational materials, a tailored survivorship care plan, an individually tailored nurse-led, face-to-face end of treatment consultation and three subsequent telephone calls. Eligible patients have completed treatment for potentially cured CRC. Other eligibility criteria include stage I to III disease, age greater than 18 years and adequate understanding of English. All consenting patients complete questionnaires at three time points over a six-month period (baseline, two and six months). Measures assess psychological distress, unmet needs and quality of life. DISCUSSION: This supportive care package has the potential to significantly reduce individual suffering, whilst reducing the burden of follow-up on acute cancer services through enhanced engagement with and utilisation of general practitioners and community based services. If the intervention is successful in achieving the expected health benefits, it could be disseminated readily. All training and supporting materials have been developed and standardised. Furthermore, the intervention could easily be adapted to other cancer or chronic disease settings. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry ACTRN12610000207011.

Development and pilot testing of a nurse-led posttreatment support package for bowel cancer survivors.

BACKGROUND: Colorectal cancer (CRC) is the most common cancer affecting both men and women in Australia. The illness and related treatments can cause distressing adverse effects, impact on emotional and psychological well-being, and adversely affect social, occupational, and relationship functioning. Current models of follow-up fail to address the complex needs arising after treatment completion. Strategies to better prepare and support survivors are urgently required. OBJECTIVES: This study aimed to develop and pilot test an innovative supportive care program for people with potentially curative CRC. METHODS: The SurvivorCare intervention was developed by a multidisciplinary team using 3 key principles: (1) promote patient involvement and engagement; (2) address the specific needs of individual patients, and (3) use evidence-based strategies to promote well-being and reduce treatment sequelae. It also addressed 4 essential components of survivorship planning, defined by the US Institute of Medicine. Ten survivors completed questionnaires and satisfaction interviews before and after receiving the intervention. RESULTS: SurvivorCare comprises survivorship educational materials (booklet, DVD, and question prompt list), a tailored survivorship care plan, a tailored nurse-led end-of-treatment consultation, and 3 follow-up telephone calls. Pilot data demonstrated that survivors considered the intervention appropriate, relevant, and useful. CONCLUSIONS: SurvivorCare is a well-received, comprehensive intervention that will now be evaluated in a randomized controlled trial aiming to reduce distress and unmet needs and improve quality of life in CRC survivors. IMPLICATIONS FOR PRACTICE: If SurvivorCare is shown to be effective, it will be possible to quickly and broadly disseminate this model of care.

The views of bowel cancer survivors and health care professionals regarding survivorship care plans and post treatment follow up.

GOALS OF WORK: Increasing numbers of people survive cancer beyond diagnosis and treatment. Many survivors have ongoing needs and they may encounter fragmented, poorly coordinated follow up care. Survivorship care plans (SCP) have been promoted as a key aspect of survivorship care. This study aimed to survey key stakeholders in the care of people with colorectal cancer (survivors, primary care providers and hospital-based healthcare professionals) regarding follow-up and SCP. PATIENTS AND METHODS: In study 1, cancer survivors completed a questionnaire regarding their follow-up and experiences during survivorship. Participants' primary care physicians completed a phone interview regarding proposed SCP elements. A subgroup of survivors reviewed a sample SCP and participated in a phone interview regarding this. In study 2, healthcare professionals working with colorectal cancer patients completed a questionnaire regarding follow-up and proposed elements of a SCP. MAIN RESULTS: Twenty survivors completed the questionnaire, 14 primary care providers completed a phone interview and 12 survivors reviewed the sample SCP. Ninety-five healthcare professionals (30 medical professionals and 65 nurses) completed the questionnaire. There was strong support for core elements of the SCP. Additionally, nurses and survivors expressed support for supportive care and psychosocial elements. There was lack of consensus regarding who should prepare and discuss the SCP. CONCLUSIONS: There is strong support for the development and use of SCPs for bowel cancer survivors. There is some variation in opinion regarding ideal content of the SCP, who might prepare it, and how it might be discussed and utilised. IMPLICATIONS FOR CANCER SURVIVORS: Overcoming identified barriers to implementing SCPs for bowel cancer survivors is necessary for high quality cancer care.