Do palliative care patients and relatives think it would be acceptable to use Bispectral index (BIS) technology to monitor palliative care patients' levels of consciousness? A qualitative exploration with interviews and focus groups for the I-CAN-CARE research programme.

BACKGROUND: Bispectral index (BIS) monitoring uses electroencephalographic data as an indicator of patients' consciousness level. This technology might be a useful adjunct to clinical observation when titrating sedative medications for palliative care patients. However, the use of BIS in palliative care generally, and in the UK in particular, is under-researched. A key area is this technology's acceptability for palliative care service users. Ahead of trialling BIS in practice, and in order to ascertain whether such a trial would be reasonable, we conducted a study to explore UK palliative care patients' and relatives' perceptions of the technology, including whether they thought its use in palliative care practice would be acceptable. METHODS: A qualitative exploration was undertaken. Participants were recruited through a UK hospice. Focus groups and semi-structured interviews were conducted with separate groups of palliative care patients, relatives of current patients, and bereaved relatives. We explored their views on acceptability of using BIS with palliative care patients, and analysed their responses following the five key stages of the Framework method. RESULTS: We recruited 25 participants. There were ten current hospice patients in three focus groups, four relatives of current patients in one focus group and one individual interview, and eleven bereaved relatives in three focus groups and two individual interviews. Our study participants considered BIS acceptable for monitoring palliative care patients' consciousness levels, and that it might be of use in end-of-life care, provided that it was additional to (rather than a replacement of) usual care, and patients and/or family members were involved in decisions about its use. Participants also noted that BIS, while possibly obtrusive, is not invasive, with some seeing it as equivalent to wearable technological devices such as activity watches. CONCLUSIONS: Participants considered BIS technology might be of benefit to palliative care as a non-intrusive means of assisting clinical assessment and decision-making at the end of life, and concluded that it would therefore be acceptable to trial the technology with patients.

Clinician estimates of prognosis: accuracy and impact-a retrospective inpatient hospice study.

OBJECTIVE: To evaluate the accuracy and impact of clinicians' estimates of prognosis (CEP) in patients referred for hospice inpatient care. METHODS: Retrospective review of 12 months' referrals to a London hospice unit. Data extracted included date of referral, admission and death and CEP. RESULTS: N=383. Mean age 72 years (range 24-101). CEP accuracy: Median survival where CEP was 'days' (n=141) was 7 days (0-164); CEP 'weeks' (n=167) was 14 days (1-538); CEP 'months' (n=75) was 32 days (2-507). Kaplan-Meier survival curves showed significant difference between CEP of 'months' and 'weeks' (p<0.0001); 'months' and 'days' (p<0.0001); but not 'days' and 'weeks' (p=0.1). CEP impact: admission waiting time increased with increasing CEP: CEP 'days' (n=105) median 1 day (0-14); CEP 'weeks' (n=154) median 2 days (0-46); CEP 'months' (n=69) median 3 days (0-46). No significant difference was demonstrated in the number of discharge planning conversations between groups (0.9/patient). CONCLUSIONS: CEP was accurate in over half of the cases but did not adequately discriminate between those with prognoses of days or weeks. CEP may affect the prioritisation given to patients by hospices. Inaccurate CEP on referral forms may influence other aspects of care; however, further research is needed.

Drug therapy for delirium in terminally ill adults.

BACKGROUND: Delirium is a syndrome characterised by an acute disturbance of attention and awareness which develops over a short time period and fluctuates in severity over the course of the day. It is commonly experienced during inpatient admission in the terminal phase of illness. It can cause symptoms such as agitation and hallucinations and is distressing for terminally ill people, their families and staff. Delirium may arise from any number of causes and treatment should aim to address these causes. When this is not possible, or treatment is unsuccessful, drug therapy to manage the symptoms may become necessary. This is the second update of the review first published in 2004. OBJECTIVES: To evaluate the effectiveness and safety of drug therapies to manage delirium symptoms in terminally ill adults. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, CINAHL and PsycINFO from inception to July 2019, reference lists of retrieved papers, and online trial registries. SELECTION CRITERIA: We included randomised controlled trials of drug therapies in any dose by any route, compared to another drug therapy, a non-pharmacological approach, placebo, standard care or wait-list control, for the management of delirium symptoms in terminally ill adults (18 years or older). DATA COLLECTION AND ANALYSIS: We independently screened citations, extracted data and assessed risk of bias. Primary outcomes were delirium symptoms; agitation score; adverse events. Secondary outcomes were: use of rescue medication; cognitive status; survival. We applied the GRADE approach to assess the overall quality of the evidence for each outcome and we include eight 'Summary of findings' tables. MAIN RESULTS: We included four studies (three new to this update), with 399 participants. Most participants had advanced cancer or advanced AIDS, and mild- to moderate-severity delirium. Meta-analysis was not possible because no two studies examined the same comparison. Each study was at high risk of bias for at least one criterion. Most evidence was low to very low quality, downgraded due to very serious study limitations, imprecision or because there were so few data. Most studies reported delirium symptoms; two reported agitation scores; three reported adverse events with data on extrapyramidal effects; and none reported serious adverse events. 1. Haloperidol versus placebo There may be little to no difference between placebo and haloperidol in delirium symptoms within 24 hours (mean difference (MD) 0.34, 95% confidence interval (CI) -0.07 to 0.75; 133 participants). Haloperidol may slightly worsen delirium symptoms compared with placebo at 48 hours (MD 0.49, 95% CI 0.10 to 0.88; 123 participants with mild- to moderate-severity delirium). Haloperidol may reduce agitation slightly compared with placebo between 24 and 48 hours (MD -0.14, 95% -0.28 to -0.00; 123 participants with mild- to moderate-severity delirium). Haloperidol probably increases extrapyramidal adverse effects compared with placebo (MD 0.79, 95% CI 0.17 to 1.41; 123 participants with mild- to moderate-severity delirium). 2. Haloperidol versus risperidone There may be little to no difference in delirium symptoms with haloperidol compared with risperidone within 24 hours (MD -0.42, 95% CI -0.90 to 0.06; 126 participants) or 48 hours (MD -0.36, 95% CI -0.92 to 0.20; 106 participants with mild- to moderate-severity delirium). Agitation scores and adverse events were not reported for this comparison. 3. Haloperidol versus olanzapine We are uncertain whether haloperidol reduces delirium symptoms compared with olanzapine within 24 hours (MD 2.36, 95% CI -0.75 to 5.47; 28 participants) or 48 hours (MD 1.90, 95% CI -1.50 to 5.30, 24 participants). Agitation scores and adverse events were not reported for this comparison. 4. Risperidone versus placebo Risperidone may slightly worsen delirium symptoms compared with placebo within 24 hours (MD 0.76, 95% CI 0.30 to 1.22; 129 participants); and at 48 hours (MD 0.85, 95% CI 0.32 to 1.38; 111 participants with mild- to moderate-severity delirium). There may be little to no difference in agitation with risperidone compared with placebo between 24 and 48 hours (MD -0.05, 95% CI -0.19 to 0.09; 111 participants with mild- to moderate-severity delirium). Risperidone may increase extrapyramidal adverse effects compared with placebo (MD 0.73 95% CI 0.09 to 1.37; 111 participants with mild- to moderate-severity delirium). 5. Lorazepam plus haloperidol versus placebo plus haloperidol We are uncertain whether lorazepam plus haloperidol compared with placebo plus haloperidol improves delirium symptoms within 24 hours (MD 2.10, 95% CI -1.00 to 5.20; 50 participants with moderate to severe delirium), reduces agitation within 24 hours (MD 1.90, 95% CI 0.90 to 2.80; 52 participants), or increases adverse events (RR 0.70, 95% CI -0.19 to 2.63; 31 participants with moderate to severe delirium). 6. Haloperidol versus chlorpromazine We are uncertain whether haloperidol reduces delirium symptoms compared with chlorpromazine at 48 hours (MD 0.37, 95% CI -4.58 to 5.32; 24 participants). Agitation scores were not reported. We are uncertain whether haloperidol increases adverse events compared with chlorpromazine (MD 0.46, 95% CI -4.22 to 5.14; 24 participants). 7. Haloperidol versus lorazepam We are uncertain whether haloperidol reduces delirium symptoms compared with lorazepam at 48 hours (MD -4.88, 95% CI -9.70 to 0.06; 17 participants). Agitation scores were not reported. We are uncertain whether haloperidol increases adverse events compared with lorazepam (MD -6.66, 95% CI -14.85 to 1.53; 17 participants). 8. Lorazepam versus chlorpromazine We are uncertain whether lorazepam reduces delirium symptoms compared with chlorpromazine at 48 hours (MD 5.25, 95% CI 0.38 to 10.12; 19 participants), or increases adverse events (MD 7.12, 95% CI 1.08 to 15.32; 18 participants). Agitation scores were not reported. SECONDARY OUTCOMES: use of rescue medication, cognitive impairment, survival There were insufficient data to draw conclusions or assess GRADE. AUTHORS' CONCLUSIONS: We found no high-quality evidence to support or refute the use of drug therapy for delirium symptoms in terminally ill adults. We found low-quality evidence that risperidone or haloperidol may slightly worsen delirium symptoms of mild to moderate severity for terminally ill people compared with placebo. We found moderate- to low-quality evidence that haloperidol and risperidone may slightly increase extrapyramidal adverse events for people with mild- to moderate-severity delirium. Given the small number of studies and participants on which current evidence is based, further research is essential.

The (un)availability of prognostic information in the last days of life: a prospective observational study.

OBJECTIVES: The aims of this study were (1) to document the clinical condition of patients considered to be in the last 2 weeks of life and (2) to compare patients who did or did not survive for 72 hours. DESIGN: A prospective observational study. SETTING: Two sites in London, UK (a hospice and a hospital palliative care team). PARTICIPANTS: Any inpatient, over 18 years old, English speaking, who was identified by the palliative care team as at risk of dying within the next 2 weeks was eligible. OUTCOME MEASURES: Prognostic signs and symptoms were documented at a one off assessment and patients were followed up 7 days later to determine whether or not they had died. RESULTS: Fifty participants were recruited and 24/50 (48%) died within 72 hours of assessment. The most prevalent prognostic features observed were a decrease in oral food intake (60%) and a rapid decline of the participant's global health status (56%). Participants who died within 72 hours had a lower level of consciousness and had more care needs than those who lived longer. A large portion of data was unavailable, particularly that relating to the psychological and spiritual well-being of the patient, due to the decreased consciousness of the patient. CONCLUSIONS: The prevalence of prognostic signs and symptoms in the final days of life has been documented between those predicted to die and those who did not. How doctors make decisions with missing information is an area for future research, in addition to understanding the best way to use the available information to make more accurate predictions.

Manualised cognitive-behavioural therapy in treating depression in advanced cancer: the CanTalk RCT.

BACKGROUND: With a prevalence of up to 16.5%, depression is one of the commonest mental disorders in people with advanced cancer. Depression reduces the quality of life (QoL) of patients and those close to them. The National Institute for Health and Care Excellence (NICE) guidelines recommend treating depression using antidepressants and/or psychological treatments, such as cognitive-behavioural therapy (CBT). Although CBT has been shown to be effective for people with cancer, it is unclear whether or not this is the case for people with advanced cancer and depression. OBJECTIVES: To assess the clinical effectiveness and cost-effectiveness of treatment as usual (TAU) plus manualised CBT, delivered by high-level Improving Access to Psychological Therapy (IAPT) practitioners, versus TAU for people with advanced cancer and depression, measured at baseline, 6, 12, 18 and 24 weeks. DESIGN: Parallel-group, single-blind, randomised trial, stratified by whether or not an antidepressant was prescribed, comparing TAU with CBT plus TAU. SETTING: Recruitment took place in oncology, hospice and primary care settings. CBT was delivered in IAPT centres or/and over the telephone. PARTICIPANTS: Patients (N = 230; n = 115 in each arm) with advanced cancer and depression. Inclusion criteria were a diagnosis of cancer not amenable to cure, a DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) diagnosis of depressive disorder using the Mini-International Neuropsychiatric Interview, a sufficient understanding of English and eligibility for treatment in an IAPT centre. Exclusion criteria were an estimated survival of < 4 months, being at high risk of suicide and receiving, or having received in the last 2 months, a psychological intervention recommended by NICE for treating depression. INTERVENTIONS: (1) Up to 12 sessions of manualised individual CBT plus TAU delivered within 16 weeks and (2) TAU. OUTCOME MEASURES: The primary outcome was the Beck Depression Inventory, version 2 (BDI-II) score at 6, 12, 18 and 24 weeks. Secondary outcomes included scores on the Patient Health Questionnaire-9, the Eastern Cooperative Oncology Group Performance Status, satisfaction with care, EuroQol-5 Dimensions and the Client Services Receipt Inventory, at 12 and 24 weeks. RESULTS: A total of 80% of treatments (185/230) were analysed: CBT (plus TAU) (n = 93) and TAU (n = 92) for the BDI-II score at all time points using multilevel modelling. CBT was not clinically effective [treatment effect -0.84, 95% confidence interval (CI) -2.76 to 1.08; p = 0.39], nor was there any benefit for other measures. A subgroup analysis of those widowed, divorced or separated showed a significant effect of CBT on the BDI-II (treatment effect -7.21, 95% CI -11.15 to -3.28; p < 0.001). Economic analysis revealed that CBT has higher costs but produces more quality-adjusted life-years (QALYs) than TAU. The mean service costs for participants (not including the costs of the interventions) were similar across the two groups. There were no differences in EQ-5D median scores at baseline, nor was there any advantage of CBT over TAU at 12 weeks or 24 weeks. There was no statistically significant improvement in QALYs at 24 weeks. LIMITATIONS: Although all participants satisfied a diagnosis of depression, for some, this was of less than moderate severity at baseline, which could have attenuated treatment effects. Only 64% (74/115) took up CBT, comparable to the general uptake through IAPT. CONCLUSIONS: Cognitive-behavioural therapy (delivered through IAPT) does not achieve any clinical benefit in advanced cancer patients with depression. The benefit of CBT for people widowed, divorced or separated is consistent with other studies. Alternative treatment options for people with advanced cancer warrant evaluation. Screening and referring those widowed, divorced or separated to IAPT for CBT may be beneficial. Whether or not improvements in this subgroup are due to non-specific therapeutic effects needs investigation. TRIAL REGISTRATION: Current Controlled Trials ISRCTN07622709. FUNDING: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 19. See the NIHR Journals Library website for further project information.

There are high rates of depression in people with advanced (cannot-be-cured) cancer. Depression worsens a person's quality of life (QoL), may become a burden for carers and may prolong a patient's hospital stay. Cognitive­behavioural therapy (CBT) challenges unhelpful thinking and ways of doing things to help improve mood. CBT is effective for treating depression, but it is unclear if it works for depression in advanced cancer patients. Advanced cancer patients with depression were entered into a research trial to see if the addition of CBT to usual care was better at improving depressive symptoms than usual care alone. We also wished to evaluate whether or not CBT helped to save costs. We enrolled 230 participants from hospital clinics, general practitioner (GP) surgeries and the Marie Curie Hospice, Hampstead. A computer program randomly allocated people to one of two groups: (1) CBT plus usual care or (2) usual care alone. Everyone received usual care from their GPs and oncology teams. Patients who were offered the addition of CBT received up to 12 1-hour sessions delivered through a community service called Improving Access to Psychological Therapies. We measured depression using a questionnaire called the Beck Depression Inventory, version 2 collected at the start of, and at 6, 12, 18 and 24 weeks into, the trial. We also collected other measures, including those relating to health, QoL and resource costs at various times. Overall, there was no improvement in symptoms of low mood or cost savings with the addition of CBT to usual care compared with usual care alone. This means that CBT does not benefit people with depression and advanced cancer, and should not be routinely offered. However, those widowed, divorced or separated appeared to benefit from CBT over and above their usual care. CBT targeted to these people may be helpful and may ensure that resources are allocated in the best way.

Understanding care when cure is not likely for young adults who face cancer: a realist analysis of data from patients, families and healthcare professionals.

OBJECTIVES: To understand the experiences of young adults with cancer for whom cure is not likely, in particular what may be specific for people aged 16-40 years and how this might affect care. DESIGN: We used data from multiple sources (semi-structured interviews with people with cancer, nominated family members and healthcare professionals, and workshops) informed by a preliminary programme theory: realist analysis of data within these themes enabled revision of our theory. A realist logic of analysis explored contexts and mechanisms affecting outcomes of care. SETTING: Three cancer centres and associated palliative care services across England. PARTICIPANTS: We aimed for a purposive sample of 45 people with cancer from two groups: those aged 16-24 years for whom there may be specialist cancer centres and those 16-40 years cared for through general adult services; each could nominate for interview one family member and one healthcare professional. We interviewed three people aged 16-24 years and 30 people 25-40 years diagnosed with cancer (carcinomas; blood cancers; sarcoma; central nervous system tumours) with a clinician-estimated prognosis of <12 months along with nominated family carers and healthcare professionals. 19 bereaved family members and 47 healthcare professionals participated in workshops. RESULTS: Data were available from 69 interviews (33 people with cancer, 14 family carers, 22 healthcare professionals) and six workshops. Qualitative analysis revealed seven key themes: loss of control; maintenance of normal life; continuity of care; support for professionals; support for families; importance of language chosen by professionals; and financial concerns. CONCLUSIONS: Current care towards end of life for young adults with cancer and their families does not meet needs and expectations. We identified challenges specific to those aged 16-40 years. The burden that care delivery imposes on healthcare professionals must be recognised. These findings can inform recommendations for measures to be incorporated into services.

Acceptance and commitment therapy for adults with advanced cancer (CanACT): A feasibility randomised controlled trial.

OBJECTIVE: To understand the feasibility of recruiting people with advanced cancer into a randomised controlled trial of acceptance and commitment therapy (ACT) vs a standardised talking control (TC) and delivering ACT to this population; to explore the acceptability of outcome measures and generate normative data. METHODS: This was a feasibility two-arm randomised controlled trial. Participants were attendees with advanced cancer at one of three hospice-based day-therapy units in London, United Kingdom, who demonstrated low scores on the Functional Assessment of Cancer Therapies-General (FACT-G). The primary end point was 3 months. RESULTS: The recruitment target was 54 participants; 42 people were recruited and randomised to up to eight individual sessions of ACT (n = 20) or TC (n = 22). Eighteen out of 42 (43%) of participants completed the primary outcome at 3 months, and at least one follow-up was available in 30/42 (71%) participants. An exploratory analysis revealed a non-significant adjusted mean difference after 3 months in the main outcome FACT-G of -3.41 (CI = -18.61-11.79) with TC having better functioning. Over 6 months, the adjusted mean difference between trial arms was 2.25 (CI = -6.03-10.52) in favour of ACT. CONCLUSIONS: It is feasible to recruit people with advanced cancer in a trial of ACT versus TC. Future research should test the effectiveness of ACT in a fully powered trial.

How do palliative care doctors recognise imminently dying patients? A judgement analysis.

OBJECTIVES: To identify a group of palliative care doctors who perform well on a prognostic test and to understand how they make their survival predictions. DESIGN: Prospective observational study and two cross-sectional online studies. SETTING: Phase I: an online prognostic test, developed from a prospective observational study of patients referred to palliative care. Phase II: an online judgement task consisting of 50 hypothetical vignettes. PARTICIPANTS: All members of the Association of Palliative Medicine (APM) were eligible (n=~1100). 99 doctors completed the prognostic test and were included in the phase I analysis. The top 20% were invited to participate in phase II; 14/19 doctors completed the judgement task and were included in the phase II analysis. MEASURES: Phase I: participants were asked to give a probability of death within 72 hours (0%-100%) for all 20 cases. Accuracy on the prognostic test was measured with the Brier score which was used to identify the 'expert' group (scale range: 0 (expert)-1 (non-expert)). Phase II: participants gave a probability of death within 72 hours (0%-100%). A mixed model regression analysis was completed using the percentage estimate as the outcome and the patient information included in the vignettes as the predictors. RESULTS: The mean Brier score of all participants was 0.237 (95% CI 0.235 to 0.239). The mean Brier score of the 'experts' was 0.184 (95% CI 0.176 to 0.192). Six of the seven prognostic variables included in the hypothetical vignettes were significantly associated with clinician predictions of death. The Palliative Performance Score was identified as being the most influential in the doctors' prognostic decision making (ß=0.48, p<0.001). CONCLUSIONS: This study identified six clinical signs and symptoms which influenced the judgement policies of palliative care doctors. These results may be used to teach novice doctors how to improve their prognostic skills.

A review of specialist palliative care provision and access across London - mapping the capital.

Palliative care provision varies by diagnosis, geography, and setting. The Minimum Data-set provides high-level data on provision, but comprehensive comparative information about specialist palliative care (SPC) provision is lacking. The London Cancer Alliance - now RM Partners' Accountable Cancer Network - palliative care group (West/South London) and PallE8 (North/East London), with Marie Curie, sought to address this gap. The aim was to provide comparative data on SPC provision across London to support commissioners and providers to assess provision, identify gaps, and reduce inequity. A data-collection template was developed through expert consensus. Demographic, diagnostic, and service data was collected, plus models of care, staffing levels, and use of clinical outcome/experience measures. Results were collated by organisation and CCG. Cleaned data was provided back to each organisation for verification before final analyses. RESULTS: All 50 adult SPC providers in London participated, representing hospitals, hospices and community services. •Patients in all 32 CCGs have access to hospice beds, with 322 beds from 15 providers (4 NHS) for a population of 9,323,570 (with 47,583 deaths annually).•SPC in London sees more non-cancer patients than is reported nationally; 79% of hospital advisory, 74% of community, and 88% of hospice in-patient services have higher proportions of non-cancer patients.•Considerable variation in out-of-hours availability of both hospital SPC and community SPC services across London; only 9 of 30 hospital and 17 of 26 community services provide seven-day visiting.•Wide variation in the models of community-based SPC; proportions of community patients attending day services vary from 1 in 4, to 1 in 17, just 13 CCGs have H@H-type provision, with few Rapid Response or Care Coordination services. CONCLUSIONS: This detailed survey demonstrates important gaps in availability and provision of SPC services. Recommendations are made for commissioners and providers to join together to address these. It also gives a comprehensive view of rapidly changing models of community-based care, to inform innovation and service development.

'I am actually doing something to keep well. That feels really good': Experiences of exercise within hospice care.

Background: Patients with advanced cancer frequently experience functional impairment and reduced quality of life. Therapeutic exercise can provide benefit and be made accessible through the use of tailored programmes. Most studies examining exercise programmes for people with advanced cancer have used quantitative outcome measures and focussed on objective physical function, therefore offer a limited perspective on the experience of exercise participation. Methods: This qualitative study explored patients' experiences of an exercise programme within a palliative care setting. The interviews focussed on the perceived impact on all aspects of quality of life. Results: Nine people with advanced cancer, attending a hospice-based exercise programme, completed a one-to-one interview with a senior physiotherapist to explore the physical, emotional, and social impacts of their participation. Interviews were audiotaped, transcribed verbatim and analysed using interpretive phenomenological analysis. Patients reported an awareness of the positive physical, psychological, and social consequences of exercising. Their experiences reflected on all dimensions of quality of life, the impact of others and the sense of meaning gained through participation in exercise. Conclusion: Our findings highlight that exercise in palliative care should not be viewed solely a physical intervention, but one that has potential to enhance many aspects of patients' quality of life.

The clinical and cost effectiveness of cognitive behavioural therapy plus treatment as usual for the treatment of depression in advanced cancer (CanTalk): study protocol for a randomised controlled trial.

BACKGROUND: The prevalence of depressive disorder in adults with advanced cancer is around 20 %. Although cognitive behavioural therapy (CBT) is recommended for depression and may be beneficial in depressed people with cancer, its use for depression in those with advanced disease for whom cure is not likely has not been explored. METHODS: People aged 18 years and above with advanced cancer attending General Practitioner (GP), oncology or hospice outpatients from centres across England will be screened to establish a DSM-IV diagnosis of depression. Self-referral is also accepted. Eligible consenters will be randomised to a single blind, multicentre, randomised controlled trial of the addition to treatment as usual (TAU) of up to 12 one-hour weekly sessions of manualised CBT versus TAU alone. Sessions are delivered in primary care through Increasing Access to Psychological Care (IAPT) service, and the manual includes a focus on issues for people approaching the end of life. The main outcome is the Beck Depression Inventory-II (BDI-II). Subsidiary measures include the Patient Health Questionnaire, quality of life measure EQ-5D, Satisfaction with care, Eastern Cooperative Oncology Group-Performance Status and a modified Client Service Receipt Inventory. At 90 % power, we require 240 participants to enter the trial. Data will be analysed using multi-level (hierarchical) models for data collected at baseline, 6, 12, 18 and 24 weeks. Cost effectiveness analysis will incorporate costs related to the intervention to compare overall healthcare costs and QALYs between the treatment arms. We will conduct qualitative interviews after final follow-up on patient and therapist perspectives of the therapy. DISCUSSION: This trial will provide data on the clinical and cost effectiveness of CBT for people with advanced cancer and depression. We shall gain an understanding of the feasibility of delivering care to this group through IAPT. Our findings will provide evidence for policy-makers, commissioners and clinicians in cancer and palliative care, and in the community. TRIAL REGISTRATION: Controlled Trials ISRCTN07622709 , registered 15 July 2011.

Acceptance and commitment therapy for adults with advanced cancer (CanACT): study protocol for a feasibility randomised controlled trial.

BACKGROUND: One-third of people with cancer experience psychological distress and may suppress distressing thoughts, emotions, and concerns, leading to further problems. Conventional psychological treatments reduce distress by problem solving, but in advanced cancer, when ill health is progressive and death may be approaching, physical and psychological difficulties are complex and have no simple solutions. Acceptance and Commitment Therapy encourages acknowledgement and acceptance of mental experiences, increasing people's ability to work with problems that cannot be solved. Previous pilot work in advanced cancer confirms that distress can be associated with an avoidance of experiencing uncomfortable thoughts and emotions. METHODS/DESIGN: This feasibility randomised controlled trial of Acceptance Commitment Therapy aims to establish parameters for a larger trial. Fifty-four participants with advanced cancer will be randomly allocated to up to eight sessions (each 1 hour) of Acceptance Commitment Therapy or a talking control. Participants will be recruited from those attending outpatient services and hospice day care at three specialist palliative care units in North and East London, United Kingdom. The primary outcome is a measure of functioning in four areas of life (physical, social/family, emotional, and general activity) using the Functional Assessment of Cancer Therapies--General questionnaire at 3 months after randomisation. Secondary outcomes are (i) acceptance using the Acceptance and Action Questionnaire; (ii) psychological distress using the Kessler Psychological Distress Scale; (iii) physical functioning using a timed walk and sit-to-stand test; and (iv) quality of life measures including the Euroqol-5 Dimensions and ICECAP Supportive Care measures. Qualitative data will be collected at 3 months to explore the participants' experiences of the trial and therapy. Data will be collected on the costs of care. DISCUSSION: Data generated on the recruitment, retention, and experience of the interventions and the usefulness of the outcome measures will inform the adaptations required and whether changes in function are consistent with existing data when planning for a sufficiently powered randomised controlled trial. TRIAL REGISTRATION: ISRCTN13841211 (registered 22 July 2015).

Interventions for sexual dysfunction following treatments for cancer in women.

BACKGROUND: The proportion of people living with and surviving cancer is growing. This has led to increased awareness of the importance of quality of life, including sexual function, in those affected by cancer. Sexual dysfunction is a potential long-term complication of many cancer treatments. This includes treatments that have a direct impact on the pelvic area and genitals, and also treatments that have a more generalised (systemic) impact on sexual function.This is an update of the original Cochrane review published in Issue 4, 2007, on interventions for treating sexual dysfunction following treatments for cancer for men and women. Since publication in 2007, there has been an increase in the number of trials for both men and women and this current review critiques only those for women. A review in press will present those for men. OBJECTIVES: To evaluate the effectiveness of interventions for treating sexual dysfunction in women following treatments for cancer. To assess adverse events associated with interventions. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL 2015, Issue 9), MEDLINE, EMBASE, PsycINFO, AMED, CINAHL, Dissertation Abstracts and the NHS Research Register. The searches were originally run in January 2007 and we updated these to September 2015. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that assessed the effectiveness of a treatment for sexual dysfunction. The trial participants were women who had developed sexual dysfunction as a consequence of a cancer treatment. We sought evaluations of interventions that were pharmaceutical, mechanical, psychotherapeutic, complementary or that involved physical exercise. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted the data and assessed trial quality. We considered meta-analysis for trials with comparable key characteristics. MAIN RESULTS: Since the original version of this review we have identified 11 new studies in women. The one study identified in the earlier version of this review was excluded in this update as it did not meet our narrower inclusion criteria to include only interventions for the treatment, not prevention, of sexual dysfunction.In total 1509 female participants were randomised across 11 trials. All trials explored interventions following treatment either for gynaecological or breast cancer. Eight trials evaluated a psychotherapeutic or psycho-educational intervention. Two trials evaluated a pharmaceutical intervention and one pelvic floor exercises. All involved heterosexual women. Eight studies were at a high risk of bias as they involved a sample of fewer than 50 participants per trial arm. The trials varied not only in intervention content but in outcome measurements, thereby restricting combined analysis. In the trials evaluating a psychotherapeutic intervention the effect on sexual dysfunction was mixed; in three trials benefit was found for some measures of sexual function and in five trials no benefit was found. Evidence from the other three trials, two on different pharmaceutical applications and one on exercise, differed and was limited by small sample sizes. Only the trial of a pH-balanced vaginal gel found significant improvements in sexual function. The trials of pharmaceutical interventions measured harm: neither reported any. Only one psychological intervention trial reported that no harm occurred because of the intervention; the other trials of psychological support did not measure harm. AUTHORS' CONCLUSIONS: Since the last version of this review, the new studies do not provide clear information on the impact of interventions for sexual dysfunction following treatments for cancer in women. The sexual dysfunction interventions in this review are not representative of the range that is available for women, or of the wider range of cancers in which treatments are known to increase the risk of sexual problems. Further evaluations are needed.

Promoting lifestyle behaviour change and well-being in hospital patients: a pilot study of an evidence-based psychological intervention.

BACKGROUND: Lifestyle risk behaviours show an inverse social gradient, clustering in vulnerable groups. We designed and piloted an intervention to address barriers to lifestyle behaviour change among hospital patients. METHODS: We designed our intervention using effective components of behaviour change interventions informed by psychological theory. Delivered by a health psychologist based at the Royal Free London NHS Foundation Trust, the 4-week intervention included detailed baseline assessment, personalized goal setting, psychological skills development, motivation support and referral to community services. Primary outcomes were feasibility and patient acceptability. We also evaluated changes to health and well-being. RESULTS: From 1 July 2013 to 31 September 2014, 686 patients were referred, 338 (49.3%) attended a first appointment and 172 (25.1%) completed follow-up. Furthermore, 72.1% of attenders were female with the median age 55 years and poor self-reported baseline health. After 4 weeks, self-efficacy, health and well-being scores significantly improved: 63% of lifestyle goals and 89% of health management goals were fully achieved; 58% of referrals to community lifestyle behaviour change services and 79% of referrals to other services (e.g. Citizen's Advice Bureau) were accepted; 99% were satisfied/very satisfied with the service. CONCLUSIONS: Our hospital-based intervention was feasible, acceptable and showed preliminary health and well-being gains.

Laxatives for the management of constipation in people receiving palliative care.

BACKGROUND: This article describes the second update of a Cochrane review on the effectiveness of laxatives for the management of constipation in people receiving palliative care. Previous versions were published in 2006 and 2010 where we also evaluated trials of methylnaltrexone; these trials have been removed as they are included in another review in press. In these earlier versions, we drew no conclusions on individual effectiveness of different laxatives because of the limited number of evaluations. This is despite constipation being common in palliative care, generating considerable suffering due to the unpleasant physical symptoms and the availability of a wide range of laxatives with known differences in effect in other populations. OBJECTIVES: To determine the effectiveness and differential efficacy of laxatives used to manage constipation in people receiving palliative care. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library), MEDLINE, EMBASE, CINAHL and Web of Science (SCI & CPCI-S) for trials to September 2014. SELECTION CRITERIA: Randomised controlled trials (RCTs) evaluating laxatives for constipation in people receiving palliative care. DATA COLLECTION AND ANALYSIS: Two authors assessed trial quality and extracted data. The appropriateness of combining data from the studies depended upon clinical and outcome measure homogeneity. MAIN RESULTS: We identified five studies involving the laxatives lactulose, senna, co-danthramer, misrakasneham, docusate and magnesium hydroxide with liquid paraffin. Overall, the study findings were at an unclear risk of bias. As all five studies compared different laxatives or combinations of laxatives, it was not possible to perform a meta-analysis. There was no evidence on whether individual laxatives were more effective than others or caused fewer adverse effects. AUTHORS' CONCLUSIONS: This second update found that laxatives were of similar effectiveness but the evidence remains limited due to insufficient data from a few small RCTs. None of the studies evaluated polyethylene glycol or any intervention given rectally. There is a need for more trials to evaluate the effectiveness of laxatives in palliative care populations. Extrapolating findings on the effectiveness of laxatives evaluated in other populations should proceed with caution. This is because of the differences inherent in people receiving palliative care that may impact, in a likely negative way, on the effect of a laxative.

Spiritual beliefs near the end of life: a prospective cohort study of people with cancer receiving palliative care.

OBJECTIVES: Despite growing research interest in spirituality and health, and recommendations on the importance of spiritual care in advanced cancer and palliative care, relationships between spiritual belief and psychological health near death remain unclear. We investigated (i) relationships between strength of spiritual beliefs and anxiety and depression, intake of psychotropic/analgesic medications and survival in patients with advanced disease; and (ii) whether the strength of spiritual belief changes as death approaches. METHODS: We conducted a prospective cohort study of 170 patients receiving palliative care at home, 97% of whom had a diagnosis of advanced cancer. Data on strength of spiritual beliefs (Beliefs and Values Scale [BVS]), anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), psychotropic/analgesic medications, daily functioning, global health and social support were collected at recruitment then 3 and 10 weeks later. Mortality data were collected up to 34 months after the first patient was recruited. RESULTS: Regression analysis showed a slight increase in strength of spiritual belief over time approaching statistical significance (+0.16 BVS points per week, 95% CI [-0.01, 0.33], p = 0.073). Belief was unrelated to anxiety and depression (-0.15 points decrease in HADS for 10 points increased in BVS (95% CI [-0.57, 0.27], p = 0.49) or consumption of psychotropic medication). There was a non-significant trend for decreasing analgesic prescription with increasing belief. Mortality was higher over 6 months in participants with lower belief at recruitment. CONCLUSION: Results suggest that although religious and spiritual beliefs might increase marginally as death approaches, they do not affect levels of anxiety or depression in patients with advanced cancer.

Rehabilitation in advanced, progressive, recurrent cancer: a randomized controlled trial.

CONTEXT: Two million people across the U.K. are living with cancer, often experienced as a long-term condition. They may have unmet needs after active treatment. Rehabilitation aims to address these needs, maximize psychological and physical function, and enable minimum dependency regardless of life expectancy. OBJECTIVES: We aimed to test, in a randomized controlled trial, the clinical and cost effectiveness of a rehabilitation intervention for patients with advanced, recurrent cancer. METHODS: We conducted a two-arm, wait-list control, randomized trial of a complex rehabilitation intervention delivered by a hospice-based multidisciplinary team vs. usual care for active, progressive, recurrent hematological and breast malignancies, with a follow-up at three months. The primary outcome was the psychological subscale of the Supportive Care Needs Survey (SCNS). Secondary outcomes were other domains of the SCNS, psychological status, continuity of care, quality of life, and resource use. RESULTS: Forty-one participants were enrolled and 36 completed the trial. The primary outcome was significantly lower in the intervention arm (adjusted difference -16.8, 95% CI -28.34 to -5.3; P = 0.006). The SCNS physical and patient care subscales (-14.2, 95% CI -26.2 to -2.2; P = 0.02 and -7.4, 95% CI -13.7 to -1.1; P = 0.02, respectively) and self-reported health state (12.8, 95% CI 3.2 to 22.4; P = 0.01) also differed significantly. The incremental cost-effectiveness ratio was £19,390 per quality-adjusted life year. CONCLUSION: This intervention significantly reduced the unmet needs of cancer survivors and it is likely that it is cost-effective. Despite small numbers, the main effect size was robust. We recommend implementation alongside evaluation in wider clinical settings and patient populations.

Drug therapy for delirium in terminally ill adult patients.

BACKGROUND: Delirium is a syndrome characterised by a disturbance of consciousness (often fluctuating), cognition and perception. In terminally ill patients it is one of the most common causes of admission to clinical care. Delirium may arise from any number of causes and treatment should be directed at addressing these causes rather than the symptom cluster. In cases where this is not possible, or treatment does not prove successful, the use of drug therapy to manage the symptoms may become necessary. This is an update of the review published on 'Drug therapy for delirium in terminally ill adult patients' in The Cochrane Library 2004, Issue 2 ( Jackson 2004). OBJECTIVES: To evaluate the effectiveness of drug therapies to treat delirium in adult patients in the terminal phase of a disease. SEARCH METHODS: We searched the following sources: CENTRAL (The Cochrane Library 2012, Issue 7), MEDLINE (1966 to 2012), EMBASE (1980 to 2012), CINAHL (1982 to 2012) and PSYCINFO (1990 to 2012). SELECTION CRITERIA: Prospective trials with or without randomisation or blinding involving the use of drug therapies for the treatment of delirium in adult patients in the terminal phase of a disease. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial quality using standardised methods and extracted trial data. We collected outcomes related to efficacy and adverse effects. MAIN RESULTS: One trial met the criteria for inclusion. In the 2012 update search we retrieved 3066 citations but identified no new trials. The included trial evaluated 30 hospitalised AIDS patients receiving one of three agents: chlorpromazine, haloperidol and lorazepam. The trial under-reported key methodological features. It found overall that patients in the chlorpromazine group and those in the haloperidol group had fewer symptoms of delirium at follow-up (to below the diagnostic threshold using the Diagnostic and Statistical Manual of Mental Disorders (DSM-III) and that both were equally effective (at two days mean difference (MD) 0.37; 95% confidence interval (CI) -4.58 to 5.32; between two and six days MD -0.21; 95% CI -5.35 to 4.93). Chlorpromazine and haloperidol were found to be no different in improving cognitive status in the short term (at 48 hours) but at subsequent follow-up cognitive status was reduced in those taking chlorpromazine. Improvements from baseline to day two for patients randomised to lorazepam were not apparent. All patients on lorazepam (n = 6) developed adverse effects, including oversedation and increased confusion, leading to trial drug discontinuation. AUTHORS' CONCLUSIONS: There remains insufficient evidence to draw conclusions about the role of drug therapy in the treatment of delirium in terminally ill patients. Thus, practitioners should continue to follow current clinical guidelines. Further research is essential.