To disclose or not to disclose: an ethnographic exploration of factors contributing to the (non) disclosure of Ghanaian women's breast cancer diagnosis to social networks.

BACKGROUND: Although there may be theoretical support linking positive health outcomes with cancer disclosure to social networks, women from contexts such as Ghana where cancer is not openly talked about may have concerns around breast cancer disclosure. Women may not be able to share their experiences about their diagnosis, which may prevent them from receiving support. This study aimed to obtain the views of Ghanaian women diagnosed with breast cancer about factors contributing to (non) disclosure. METHODS: This study is based on secondary findings from an ethnographic study that employed participant observation and semi-structured face to face interviews. The study was conducted at a breast clinic in a Teaching Hospital in southern Ghana. 16 women diagnosed with breast cancer (up to stage 3); five relatives nominated by these women and ten healthcare professionals (HCPs) participated in the study. Factors contributing to breast cancer (non) disclosure were explored. Data were analysed using a thematic approach. RESULTS: The analysis indicated that most of the women and family members were very reticent about breast cancer disclosure and were secretive with distant relatives and wider social networks. Whilst remaining silent about their cancer diagnosis helped women protect their identities, prevented spiritual attack, and bad advice, the need for emotional and financial support for cancer treatment triggered disclosure to close family, friends, and pastors. Some women were discouraged from persevering with conventional treatment following disclosure to their close relatives. CONCLUSIONS: Breast cancer stigma and fears around disclosure hindered women from disclosing to individuals in their social networks. Women disclosed to their close relatives for support, but this was not always safe. Health care professionals are well placed to explore women's concerns and facilitate disclosure within safe spaces to enhance engagement with breast cancer care services.

Implementing a nurse-delivered cognitive behavioural therapy intervention to reduce the impact of hot flushes/night sweats in women with breast cancer: a qualitative process evaluation of the MENOS4 trial.

BACKGROUND: Hot flushes and night sweats are life-altering symptoms experienced by many women after breast cancer treatment. A randomised controlled trial (RCT) was conducted to explore the effectiveness of breast care nurse (BCN)-led group cognitive behavioural therapy (CBT). This paper reported findings from a qualitative process evaluation to optimise the CBT intervention and explore the determinants of implementation into routine practice. METHODS: Qualitative process evaluation occurred in parallel with the RCT to explore patient and healthcare staff experiences and perspectives using semi-structured interviews pre-and post-intervention. Normalisation Process Theory (NPT) informed data collection, analysis, and reporting of findings. The analysis involved inductive thematic analysis, NPT coding manual and subsequent mapping onto NPT constructs. RESULTS: BCNs (n = 10), managers (n = 2), surgeons (n = 3) and trial participants (n = 8) across six recruiting sites took part. All stakeholders believed group CBT met a need for non-medical hot flushes/night sweats treatment, however, had little exposure or understanding of CBT before MENOS4. BCNs believed the work fitted with their identity and felt confident in delivering the sessions. Despite little understanding, patients enrolled onto group CBT because the BCNs were trusted to have the knowledge and understanding to support their needs and despite initial scepticism, reported great benefit from group-based participation. Both managers and surgeons were keen for BCNs to take responsibility for all aspects of CBT delivery, but there were some tensions with existing clinical commitments and organisational priorities. CONCLUSIONS: Both healthcare staff and patient participants believe BCN-led group CBT is a beneficial service but barriers to long-term implementation into routine care suggest there needs to be multi-level organisational support. TRIAL REGISTRATION: NCT02623374 - Last updated 07/12/2015 on ClinicalTrials.gov PRS.

Prevalence and determinants of depression up to 5 years after colorectal cancer surgery: results from the ColoREctal Wellbeing (CREW) study.

AIM: Depression experienced by people with colorectal cancer (CRC) is an important clinical problem affecting quality of life. Recognition of depression at key points in the pathway enables timely referral to support. This study aimed to examine depression before and 5 years after surgery to examine its prevalence and identify determinants. METHOD: The ColoREctal Wellbeing (CREW) study is a prospective UK cohort study involving 872 adults with nonmetastatic CRC recruited before surgery with curative intent. Questionnaires completed before surgery and 3, 9, 15, 24, 36, 48 and 60 months after surgery captured socio-demographics and assessed depression (Centre for Epidemiologic Studies Depression Scale, CES-D) and other psychosocial factors. Clinical details were also gathered. We present the prevalence of clinically significant depression (CES-D ≥ 20) over time and its predictors assessed before and 2 years after surgery. RESULTS: Before surgery, 21.0% of the cohort reported CES-D ≥ 20 reducing to 14.7% 5 years after surgery. Presurgery risk factors predicting subsequent depression were clinically significant depression and anxiety, previous mental health service use, low self-efficacy, poor health, having neoadjuvant treatment and low social support. Postsurgery risk factors at 2 years predicting subsequent depression were clinically significant depression, negative affect, cognitive dysfunction, accommodation type and poor health. CONCLUSION: Depression is highly pervasive in people with CRC, exceeding prevalence in the general population across follow-up. Our findings emphasize the need to screen and treat depression across the pathway. Our novel data highlight key risk factors of later depression at important and opportune time points: before surgery and at the end of routine surveillance. Early recognition and timely referral to appropriate support is vital to improve long-term psychological outcomes.

The cultural and structural influences that 'hide' information from women diagnosed with breast cancer in Ghana: an ethnography.

BACKGROUND: Socio-cultural factors may influence the uptake of breast cancer treatments. This study aimed to explore these socio-cultural influences on treatment decision-making for women in Ghana. METHOD: An ethnographic approach was adopted. Observation was conducted of women newly diagnosed with breast cancer, nominated relatives, nurses and doctors at a breast clinic in Ghana. Semi-structured interviews followed participant observation. Thematic analysis was employed. FINDINGS: Over 16 weeks (July 2017-November 2017), 31 participants were observed and 29 took part in semi-structured interviews. Three overarching themes were identified: (1) unequal power relationships; (2) Language barriers and (3) structural constraints. Following a breast cancer diagnosis, essential information necessary for treatment decision making is 'hidden' from women due to an unequal patient-provider relationship. Patients acknowledged cultural behaviours of deference to experts. Doctors deliberately misrepresented treatment information to women to encourage them to undergo surgical treatment. Structural issues such as the lack of privacy during consultations hindered quality patient engagement with decision-making. High treatment costs and the lack of resources to assist women with fertility after treatment impeded open discussions around these issues. Language barriers included a lack of terms in the local Twi language to explain cancer and its treatment. There was also an absence of appropriate information materials. CONCLUSION: Findings highlight the need for health professionals to be aware of the socio-cultural factors that limit access to quality information which is needed for informed treatment decision making. Policies that aim to provide adequate logistics; increase staffing levels; improve staff cultural awareness training and remove financial barriers are recommended.

Cancer diagnosis, treatment and care: A qualitative study of the experiences and health service use of Roma, Gypsies and Travellers.

BACKGROUND: Early diagnosis and treatment are key to reducing deaths from cancer, but people from Black and Minority Ethnic (BME) groups are more likely to encounter delays in entering the cancer care system. Roma, Gypsies and Travellers are ethnic minorities who experience extreme health inequalities. OBJECTIVE: To explore the experiences of cancer diagnosis, treatment and care among people who self-identify as Roma or Gypsies and Travellers. METHODS: A participatory qualitative approach was taken. Peer researchers conducted semi-structured interviews (n = 37) and one focus group (n = 4) with community members in Wales and England, UK. RESULTS: Cancer fatalism is declining, but Roma, Gypsies and Travellers experience barriers to cancer healthcare at service user, service provider and organisational levels. Communication was problematic for all groups, and Roma participants reported lack of access to interpreters within primary care. Clear communication and trusting relationships with health professionals are highly valued and most frequently found in tertiary care. CONCLUSION: This study suggests that Roma, Gypsies and Travellers are motivated to access health care for cancer diagnosis and treatment, but barriers experienced in primary care can prevent or delay access to diagnostic and treatment services. Organisational changes, plus increased cultural competence among health professionals, have the potential to reduce inequalities in early detection of cancer.

Knowledge and experience of cancer prevention and screening among Gypsies, Roma and Travellers: a participatory qualitative study.

BACKGROUND: The incidence of cancer is increasing worldwide, which has led to greater public health focus on primary prevention. Ethnic minorities have lower awareness of cancer risk factors and services, and are at greater risk of cancer mortality. While Gypsies, Roma and Travellers have poor health outcomes even in comparison with other ethnic minorities, little is known about how they view and enact primary prevention. This study takes a participatory approach to explore knowledge and experience of cancer prevention and screening in these communities. METHODS: Peer researchers conducted interviews (n = 37) and a focus group (n = 4) with a purposive sample of community members in Wales and South-West England. Participants self-identified as Roma (from Slovakia and Romania) or as Gypsies, Travellers or Showpeople (here described as Gypsy/Travellers). A third of the sample were Roma, and a quarter male, with ages ranging from 18 to 77 years. Data were collected from October 2018 to March 2019. RESULTS: Women and men knew that lifestyle factors, such as healthy diet, stopping smoking, drinking less alcohol and using sun protection, contribute to cancer risk reduction. However, there was a widespread lack of confidence in the effectiveness of these measures, particularly in relation to smoking. Traditional cultural beliefs were shared by Roma and Gypsy/Travellers, but did not necessarily affect the behaviour of individuals. Most women participated in cervical and breast screening but few Gypsy/Traveller men would engage with bowel screening, which conflicted with community ideals of stoical masculinity. Roma participants described language barriers to screening, with confusion about differences in timing and eligibility between the UK and Slovakian programmes; this led some to access screening abroad. CONCLUSION: This study provides new knowledge about how Gypsies, Roma and Travellers keep healthy and prevent disease, giving insights into similarities and differences between ages, sexes and communities. These culturally distinct and high-need ethnic minorities have specific needs in relation to cancer prevention and screening, which merit targeted and acceptable health promotion to reduce health inequalities.

Effectiveness of nurse-led group CBT for hot flushes and night sweats in women with breast cancer: Results of the MENOS4 randomised controlled trial.

OBJECTIVE: Troublesome hot flushes and night sweats (HFNS) are experienced by many women after treatment for breast cancer, impacting significantly on sleep and quality of life. Cognitive behavioural therapy (CBT) is known to be effective for the alleviation of HFNS. However, it is not known if it can effectively be delivered by specialist nurses. We investigated whether group CBT, delivered by breast care nurses (BCNs), can reduce the impact of HFNS. METHODS: We recruited women with primary breast cancer following primary treatment with seven or more HFNS/week (including 4/10 or above on the HFNS problem rating scale), from six UK hospitals to an open, randomised, phase 3 effectiveness trial. Participants were randomised to Group CBT or usual care (UC). The primary endpoint was HFNS problem rating at 26 weeks after randomisation. Secondary outcomes included sleep, depression, anxiety and quality of life. RESULTS: Between 2017 and 2018, 130 participants were recruited (CBT:63, control:67). We found a 46% (6.9-3.7) reduction in the mean HFNS problem rating score from randomisation to 26 weeks in the CBT arm and a 15% (6.5-5.5) reduction in the UC arm (adjusted mean difference -1.96, CI -3.68 to -0.23, P = .039). Secondary outcomes, including frequency of HFNS, sleep, anxiety and depression all improved significantly. CONCLUSION: Our results suggest that specialist nurses can be trained to deliver CBT effectively to alleviate troublesome menopausal hot flushes in women following breast cancer in the NHS setting.

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.

Comorbidities are associated with poorer quality of life and functioning and worse symptoms in the 5 years following colorectal cancer surgery: Results from the ColoREctal Well-being (CREW) cohort study.

OBJECTIVE: More people are living with the consequences of cancer and comorbidity. We describe frequencies of comorbidities in a colorectal cancer cohort and associations with health and well-being outcomes up to 5 years following surgery. METHODS: Prospective cohort study of 872 colorectal cancer patients recruited 2010 to 2012 from 29 UK centres, awaiting curative intent surgery. Questionnaires administered at baseline (pre-surgery), 3, 9, 15, 24 months, and annually up to 5 years. Comorbidities (and whether they limit activities) were self-reported by participants from 3 months. The EORTC QLQ-C30 and QLQ-CR29 assessed global health/quality of life (QoL), symptoms, and functioning. Longitudinal analyses investigated associations between comorbidities and health and well-being outcomes. RESULTS: At baseline, the mean age of participants was 68 years, with 60% male and 65% colon cancer. Thirty-two per cent had 1 and 40% had ≥2 comorbidities. The most common comorbidities were high blood pressure (43%), arthritis/rheumatism (32%), and anxiety/depression (18%). Of those with comorbidities, 37% reported at least 1 that limited their daily activities. Reporting any limiting comorbidities was associated with poorer global health/QoL, worse symptoms, and poorer functioning on all domains over 5-year follow-up. Controlling for the most common individual comorbidities, depression/anxiety had the greatest deleterious effect on outcomes. CONCLUSIONS: Clinical assessment should prioritise patient-reported comorbidities and whether these comorbidities limit daily activities, as important determinants of recovery of QoL, symptoms, and functioning following colorectal cancer. Targeted interventions and support services, including multiprofessional management and tailored assessment and follow-up, may aid recovery of health and well-being in these individuals.

MENOS4 trial: a multicentre randomised controlled trial (RCT) of a breast care nurse delivered cognitive behavioural therapy (CBT) intervention to reduce the impact of hot flushes in women with breast cancer: Study Protocol.

BACKGROUND: Women who have been treated for breast cancer may identify vasomotor symptoms, such as hot flushes and night sweats (HFNS), as a serious problem. HFNS are unpleasant to experience and can have a significant impact on daily life, potentially leading to reduced adherence to life saving adjuvant hormonal therapy. It is known that Cognitive Behavioural Therapy (CBT) is effective for the alleviation of hot flushes in both well women and women who have had breast cancer. Most women with breast cancer will see a breast care nurse and there is evidence that nurses can be trained to deliver psychological treatments to a satisfactory level, whilst also maintaining treatment fidelity. The research team will assess whether breast care nurses can effectively deliver a CBT intervention to alleviate hot flushes in women with breast cancer. METHODS: This study is a multi-centre phase III individually randomised controlled trial of group CBT versus usual care to reduce the impact of hot flushes in women with breast cancer. 120-160 women with primary breast cancer experiencing seven or more problematic HFNS a week will be randomised to receive either treatment as usual (TAU) or participation in the group CBT intervention plus TAU (CBT Group). A process evaluation using May's Normalisation Process Theory will be conducted, as well as practical and organisational issues relating to the implementation of the intervention. Fidelity of implementation of the intervention will be conducted by expert assessment. The cost effectiveness of the intervention will also be assessed. DISCUSSION: There is a need for studies that enable effective interventions to be implemented in practice. There is good evidence that CBT is helpful for women with breast cancer who experience HFNS, yet it is not widely available. It is not yet known whether the intervention can be effectively delivered by breast care nurses or implemented in practice. This study will provide information on both whether the intervention can effectively help women with hot flushes and whether and how it can be translated into routine clinical practice. TRIAL REGISTRATION: ISRCTN 12824632 . Registered 25-01-2017.

Social support following diagnosis and treatment for colorectal cancer and associations with health-related quality of life: Results from the UK ColoREctal Wellbeing (CREW) cohort study.

OBJECTIVE: Social support is acknowledged as important in cancer survivorship, but little is known about change in support after cancer diagnosis and factors associated with this, particularly in colorectal cancer. The CREW cohort study investigated social support up to 2 years following curative intent surgery for colorectal cancer. METHODS: A total of 871 adults recruited pre-treatment from 29 UK centres 2010 to 2012 consented to follow-up. Questionnaires at baseline, 3, 9, 15, and 24 months post-surgery included assessments of social support (Medical Outcomes Study-Social Support Survey, MOS-SSS) and health-related quality of life (HRQoL). Socio-demographic, clinical and treatment details were collected. Longitudinal analyses assessed social support over follow-up, associations with participant characteristics, and HRQoL. RESULTS: Around 20% were living alone and 30% without a partner. Perceived social support declined in around 29% of participants, with 8% of these reporting very low levels overall from baseline to 2 years (mean MOS-SSS overall score < 40 on a scale from 0 to 100). Older age, female gender, greater neighbourhood deprivation, presence of co-morbidities, and rectal cancer site were significantly associated with reductions in perceived support. Poorer HRQoL outcomes (generic health/QoL, reduced wellbeing, anxiety, and depression) were significantly associated with lower levels of social support. CONCLUSIONS: Levels of social support decline following colorectal cancer diagnosis and treatment in nearly a third of patients and are an important risk factor for recovery of HRQoL. Assessment of support early on and throughout follow-up would enable targeted interventions to improve recovery, particularly in the more vulnerable patient groups at risk of poorer social support.

A web-based intervention (RESTORE) to support self-management of cancer-related fatigue following primary cancer treatment: a multi-centre proof of concept randomised controlled trial.

PURPOSE: Cancer-related fatigue (CRF) is a frequent and distressing symptom experienced after cancer treatment. RESTORE is the first web-based resource designed to enhance self-efficacy to manage CRF following curative-intent treatment. The aim of this study is to test the proof of concept and inform the design of an effectiveness trial. METHODS: A multi-centre parallel-group two-armed (1:1) exploratory randomised controlled trial (RCT) with qualitative process evaluation was employed in the study. Participants (≥18 years; ≤5 years post treatment with moderate to severe fatigue) were recruited and randomly assigned to RESTORE or a leaflet. Feasibility and acceptability were measured by recruitment, attrition, intervention adherence, completion of outcome measures and process evaluation. Change in self-efficacy to manage CRF was also explored. Outcome measures were completed at baseline (T0), 6 weeks (T1) and 12 weeks (T2). Data were analysed using mixed-effects linear regression and directed content analysis. RESULTS: One hundred and sixty-three people participated in the trial and 19 in the process evaluation. The intervention was feasible (39 % of eligible patients consented) and acceptable (attrition rate 36 %). There was evidence of higher fatigue self-efficacy at T1 in the intervention group vs comparator (mean difference 0.51 [-0.08 to 1.11]), though the difference in groups decreased by 12 weeks. Time since diagnosis influenced perceived usefulness of the intervention. Modifications were suggested. CONCLUSION: Proof of concept was achieved. The RESTORE intervention should be subject to a definitive trial with some adjustments. Provision of an effective supportive resource would empower cancer survivors to manage CRF after treatment completion. TRIAL REGISTRATION: ISRCTN67521059.

Rebuilding self-confidence after cancer: a feasibility study of life-coaching.

BACKGROUND: Cancer survivors often experience decreased self-confidence which impacts negatively on their ability to self-manage the practical, social and emotional problems frequently faced as they emerge from end of treatment. This was a feasibility study of a life-coaching intervention, designed to rebuild confidence of survivors and support transition to life after cancer treatment. METHODS: A one group pre-test, post-test design was used, recruiting participants from community organisations. Eligibility criteria are as follows: <1 year of completion of primary cancer treatment, aged >18, no metastases, and no mental health problems. Participants received one individualised face-to-face and five telephone coaching sessions over 3 months. Outcome measures are as follows: New General Self-Efficacy Scale, Hope Scale, Personal Well-being Index, Assessment of Survivorship Concerns, Quality of Life in Adult Cancer Survivors, Hospital Anxiety and Depression Scale, Social Difficulties Index, and a goal attainment score. Interviews explored feasibility, acceptability and impact of life-coaching and research design. RESULTS: Nine women and two men were recruited, representing varying cancer diagnoses. All outcome measures were sensitive to change and indicated positive trends post-intervention. Participant interviews indicated the intervention was well received and had a positive impact. Lessons were learnt about study design, recruitment and intervention delivery. CONCLUSIONS: Life-coaching has a potential to enable cancer survivors to manage the transition to life beyond cancer and effect change on a range of outcomes. The intervention was feasible to deliver and acceptable to survivors at a time when many struggle to make sense of life. It merits further evaluation through a randomised controlled trial.

Moving forward: a qualitative research inquiry to inform the development of a resource pack for women following primary breast cancer treatment.

While the UK charity Breast Cancer Care has extensive resources for women with breast cancer, this research partnership developed the first resource driven and informed by primary research with these women, exploring their needs and developing the resource according to need. Data were collected from focus groups with breast cancer survivors and telephone interviews with health professionals and experts, which explored the needs of women after primary cancer treatment, and were analyzed using thematic analysis. As well as information, these women needed resources to help them regain control over life, adapt to a changed body, and restore lost confidence.

The JACS prospective cohort study of newly diagnosed women with breast cancer investigating joint and muscle pain, aches, and stiffness: pain and quality of life after primary surgery and before adjuvant treatment.

BACKGROUND: Breast cancer affects one in eight UK women during their lifetime: many of these women now receive adjuvant chemotherapy and hormone therapy. Joint and muscle pains, aches, and stiffness are common but the natural history, aetiology and impact of these symptoms are unknown. A cohort study of newly diagnosed women with primary breast cancer was established to explore this. In this paper we present study methods and sample characteristics, describe participants' experience of musculoskeletal pain at baseline interview, and explore its impact on quality of life. METHODS: Women with non-metastatic breast cancer were recruited following primary surgery into a multi-centre cohort study. They received questionnaires by post five times (baseline, 3, 6 , 9 and 12 months) to investigate prevalence, severity, location and correlates of musculoskeletal pain, and impact on quality-of-life. Pain was measured by the Nordic musculoskeletal questionnaire, the Brief Pain Inventory, and MSK-specific questions, and quality of life by the SF-36 and FACIT scales. RESULTS: 543 women (mean age 57 years, range 28-87, 64% postmenopausal) were recruited following surgery for primary breast cancer from breast cancer clinics in eight hospitals. Fifteen per cent of the eligible cohort was missed; 28% declined to participate. Joint or muscle aches, pains or stiffness were reported by 69% women with 28% specifically reporting joint pain/aches/stiffness. Quality of life, as measured by the FACT-B and adjusted for age, depression, surgery and analgesic use, is significantly worse in all domains in those with musculoskeletal problems than those without. CONCLUSIONS: Our findings highlights the importance of a better understanding of these symptoms and their impact on the lives of women with primary breast cancer so that healthcare professionals are better equipped to support patients and to provide accurate information to inform treatment decisions. Further papers from this study will address these issues.

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.

Critical research gaps and translational priorities for the successful prevention and treatment of breast cancer.

INTRODUCTION: Breast cancer remains a significant scientific, clinical and societal challenge. This gap analysis has reviewed and critically assessed enduring issues and new challenges emerging from recent research, and proposes strategies for translating solutions into practice. METHODS: More than 100 internationally recognised specialist breast cancer scientists, clinicians and healthcare professionals collaborated to address nine thematic areas: genetics, epigenetics and epidemiology; molecular pathology and cell biology; hormonal influences and endocrine therapy; imaging, detection and screening; current/novel therapies and biomarkers; drug resistance; metastasis, angiogenesis, circulating tumour cells, cancer 'stem' cells; risk and prevention; living with and managing breast cancer and its treatment. The groups developed summary papers through an iterative process which, following further appraisal from experts and patients, were melded into this summary account. RESULTS: The 10 major gaps identified were: (1) understanding the functions and contextual interactions of genetic and epigenetic changes in normal breast development and during malignant transformation; (2) how to implement sustainable lifestyle changes (diet, exercise and weight) and chemopreventive strategies; (3) the need for tailored screening approaches including clinically actionable tests; (4) enhancing knowledge of molecular drivers behind breast cancer subtypes, progression and metastasis; (5) understanding the molecular mechanisms of tumour heterogeneity, dormancy, de novo or acquired resistance and how to target key nodes in these dynamic processes; (6) developing validated markers for chemosensitivity and radiosensitivity; (7) understanding the optimal duration, sequencing and rational combinations of treatment for improved personalised therapy; (8) validating multimodality imaging biomarkers for minimally invasive diagnosis and monitoring of responses in primary and metastatic disease; (9) developing interventions and support to improve the survivorship experience; (10) a continuing need for clinical material for translational research derived from normal breast, blood, primary, relapsed, metastatic and drug-resistant cancers with expert bioinformatics support to maximise its utility. The proposed infrastructural enablers include enhanced resources to support clinically relevant in vitro and in vivo tumour models; improved access to appropriate, fully annotated clinical samples; extended biomarker discovery, validation and standardisation; and facilitated cross-discipline working. CONCLUSIONS: With resources to conduct further high-quality targeted research focusing on the gaps identified, increased knowledge translating into improved clinical care should be achievable within five years.

Lessons learnt recruiting to a multi-site UK cohort study to explore recovery of health and well-being after colorectal cancer (CREW study).

BACKGROUND: The UK leads the world in recruitment of patients to cancer clinical trials, with a six-fold increase in recruitment during 2001-2010. However, there are large variations across cancer centres. This paper details recruitment to a large multi-centre prospective cohort study and discusses lessons learnt to enhance recruitment. METHODS: During CREW (ColoREctal Wellbeing) cohort study set up and recruitment, data were systematically collected on all centres that applied to participate, time from study approval to first participant recruited and the percentage of eligible patients recruited into the study. RESULTS: 30 participating NHS cancer centres were selected through an open competition via the cancer networks. Time from study approval to first participant recruited took a median 124 days (min 53, max 290). Of 1350 eligible people in the study time frame, 78% (n = 1056) were recruited into the study, varying from 30-100% eligible across centres. Recruitment of 1056 participants took 17 months. CONCLUSION: In partnership with the National Cancer Research Network, this successful study prioritised relationship building and education. Key points for effective recruitment: pre-screening and selection of centres; nurses as PIs; attendance at study days; frequent communication and a reduced level of consent to enhance uptake amongst underrepresented groups.

Outcomes of a nurse-delivered psychosocial intervention for weight- and eating-related distress in family carers of patients with advanced cancer.

BACKGROUND: International expert consensus is that psychosocial intervention is likely to help advanced cancer patients and their family carers affected by weight loss and poor appetite. PURPOSE: To investigate the potential for a psychosocial intervention, the Macmillan Approach to Weight and Eating (MAWE), to mitigate weight- and eating-related distress in carers of patients with advanced cancer. METHOD: A controlled before and after study was conducted with carers of advanced cancer patients living in the community in the South of England in 2006-7. It used mixed methods to compare carers exposed to MAWE (n=12) with a control group (n=14). RESULTS: Weight- and eating-related distress improved in carers exposed to MAWE. Qualitative analysis found that MAWE may help carers by providing information, reassurance, and support for self-management. CONCLUSION: This preliminary study of MAWE suggests that it provides benefits as a supportive intervention. Further testing is warranted using a more robust experimental design.

A multicentre randomised controlled trial of a guided self-help cognitive behavioural therapy to MANage the impact of hot flushes and night sweats in patients with prostate CANcer undergoing androgen deprivation therapy (MANCAN2).

BACKGROUND: Androgen deprivation therapy (ADT) is prescribed to almost half of all men diagnosed with prostate cancer. Although ADT is effective treatment, with virtually all men with advanced disease showing initial clinical response, it is associated with troublesome side effects including hot flushes and night sweats (HFNS). HFNS can be both frequent and severe and can have a significant impact on quality of life (QoL). They can occasionally be so debilitating that patients stop ADT altogether, despite the increased risk of disease relapse or death. Previous research has found that guided self-help cognitive behavioural therapy (CBT) can be effective in reducing HFNS due to ADT when delivered by a clinical psychologist. MANCAN2 aims test whether we can train the existing NHS Prostate Cancer Nurse Specialist (CNS) team to deliver guided self-help CBT and whether it is effective in reducing the impact of HFNS in men undergoing ADT. METHODS: MANCAN2 is a phase III multicentre randomised controlled trial and process evaluation. Between 144 and 196 men with prostate cancer who are currently receiving ADT and are experiencing problematic HFNS will be individually randomised in a 1:1 ratio in groups of 6-8 participants to either treatment as usual (TAU) or participation in the guided self-help CBT intervention plus TAU. A process evaluation using the normalisation process theory (NPT) framework will be conducted, to understand the CNS team's experiences of delivering the intervention and to establish the key influencers to its implementation as a routine practice service. Fidelity of implementation of the intervention will be conducted by expert assessment. The cost-effectiveness of the intervention and participant adherence to the trial intervention will also be assessed. DISCUSSION: MANCAN2 will advance the program of work already conducted in development of management strategies for HFNS. This research will determine whether the severity of ADT-induced HFNS in men with prostate cancer can be reduced by a guided self-help CBT intervention, delivered by the existing NHS prostate cancer CNS team, within a multicentre study. The emphasis on this existing team, if successful, should facilitate translation through to implementation in routine practice. TRIAL REGISTRATION: ISRCTN reference 58720120 . Registered 13 December 2022.