Trial of Optimal Personalised Care After Treatment-Gynaecological Cancer (TOPCAT-G): A Randomized Feasibility Trial.

OBJECTIVE: This study aimed to evaluate the feasibility of completing a parallel-group randomized controlled trial to compare usual follow-up care for women who have completed treatment of gynecological cancer against a nurse-led telephone intervention, known as Optimal Personalised Care After Treatment-Gynaecological. METHODS: The unblinded trial aimed to recruit patients who had completed treatment of cervical, endometrial, epithelial ovarian, or vulval cancer within the previous 3 months at 3 North Wales hospitals. We randomized participants to either usual hospital-based follow-up or specialist nurse-led telephone education, empowerment, and structured needs assessment follow-up. The primary outcomes assessed the feasibility of running a larger trial including patient eligibility, recruitment and retention rates, and outcome measure completion. Secondary outcomes were generic and health-related quality of life and a patient self-report health service use (Client Service Receipt Inventory) data collected at 3 time points (baseline, 3 months, and 6 months). RESULTS: Of the 58 women screened, 44 were eligible (76%) and 24 (55%) were recruited and randomized (12:12 to control and intervention, respectively). One participant was lost to follow-up. Recruited participants had a mean (SD) age of 60 (11.2) years and were approximately 5 months from their initial diagnosis (mean [SD], 159 [58] days). Seventeen (71%) of the participants had an endometrial cancer diagnosis. All outcome measure completion rates exceeded 96%. Although not a core feasibility objective, analyses of outcome measures indicated positive changes in quality of life and well-being within the Optimal Personalised Care After Treatment-Gynaecological group; exploratory cost consequence analysis indicated that the nurse-led intervention had a mean total service use cost of £27 per patient (bootstrapped 95% confidence interval, -£290 to £240) lower than did the standard care group. CONCLUSION: Eligibility, recruitment, and retention rates as well as outcome measure completion showed that the trial is feasible.

The effects of lifelong cognitive lifestyle on executive function in older people with Parkinson's disease.

OBJECTIVE: Active lifelong cognitive lifestyles increase cognitive reserve and have beneficial effects on global cognition, cognitive decline and dementia risk in Parkinson's disease (PD). Executive function is particularly impaired even in early PD, and this impacts on quality of life. The effects of lifelong cognitive lifestyle on executive function in PD have not been studied previously. This study examined the association between lifelong cognitive lifestyle, as a proxy measure of cognitive reserve, and executive function in people with PD. METHODS: Sixty-nine people diagnosed with early PD without dementia were recruited as part of the Bilingualism as a protective factor in Age-related Neurodegenerative Conditions study. Participants completed a battery of tests of executive function. The Lifetime of Experiences Questionnaire was completed as a comprehensive assessment of lifelong cognitive lifestyle. Non-parametric correlations compared clinical measures with executive function scores. Cross-sectional analyses of covariance were performed comparing the performance of low and high cognitive reserve groups on executive function tests. RESULTS: Correlational analyses showed that better executive function scores were associated with younger age, higher levodopa dose and higher Lifetime of Experiences Questionnaire scores. Higher cognitive reserve was associated with better motor function, but high and low cognitive reserve groups did not differ in executive function. CONCLUSIONS: Cognitive reserve, although associated with global cognition, does not appear to be associated with executive function. This differential effect may reflect the specific cognitive profile of PD. The long-term effects of cognitive reserve on executive function in PD require further exploration. Copyright © 2017 John Wiley & Sons, Ltd.

Improving the oral health of older people in care homes (TOPIC): a protocol for a feasibility study.

BACKGROUND: Evidence for interventions promoting oral health amongst care home residents is weak. The National Institute for Health and Care Excellence (NICE) guideline NG48 aims to maintain and improve the oral health of care home residents. A co-design process that worked with residents and care home staff to understand how the NG48 guideline could be best implemented in practice has been undertaken to refine a complex intervention. The aim of this study is to assess the feasibility of the intervention to inform a future larger scale definitive trial. METHODS: This is a protocol for a pragmatic cluster randomised controlled trial with a 12-month follow-up that will be undertaken in 12 care homes across two sites (six in London, six in Northern Ireland). Care homes randomised to the intervention arm (n = 6) will receive the complex intervention based on the NG48 guideline, whilst care homes randomised to the control arm (n = 6) will continue with routine practice. The intervention will include a training package for care home staff to promote knowledge and skills in oral health promotion, the use of the Oral Health Assessment Tool on residents by trained care home staff, and a 'support worker assisted' daily tooth-brushing regime with toothpaste containing 1500 ppm fluoride. An average of ten residents, aged 65 years or over who have at least one natural tooth, will be recruited in each care home resulting in a recruited sample of 120 participants. Assessments will be undertaken at baseline, 6 months and 12 months, and will include a dental examination and questionnaires on general health and oral health administered by a research assistant. A parallel process evaluation involving semi-structured interviews will be undertaken to explore how the intervention could be embedded in standard practice. Rates of recruitment and retention, and intervention fidelity will also be recorded. A cost-consequence model will determine the relevance of different outcome measures in the decision-making context. DISCUSSION: The study will provide valuable information for trialists, policymakers, clinicians and care home staff on the feasibility and associated costs of oral health promotion in UK care homes. TRIAL REGISTRATION: ISRCTN10276613. Registered on 17th April 2020. http://www.isrctn.com/ISRCTN10276613 .

Trial of Optimal Personalised Care After Treatment for Gynaecological cancer (TOPCAT-G): a study protocol for a randomised feasibility trial.

BACKGROUND: Gynaecological cancers are diagnosed in over 1000 women in Wales every year. We estimate that this is costing the National Health Service (NHS) in excess of £1 million per annum for routine follow-up appointments alone. Follow-up care is not evidence-based, and there are no definitive guidelines from The National Institute for Health and Care Excellence (NICE) for the type of follow-up that should be delivered. Standard care is to provide a regular medical review of the patient in a hospital-based outpatient clinic for a minimum of 5 years. This study is to evaluate the feasibility of a proposed alternative where the patients are delivered a specialist nurse-led telephone intervention known as Optimal Personalised Care After Treatment for Gynaecological cancer (OPCAT-G), which comprised of a protocol-based patient education, patient empowerment and structured needs assessment. METHODS: The study will recruit female patients who have completed treatment for cervical, endometrial, epithelial ovarian or vulval cancer within the previous 3 months in Betsi Cadwaladr University Health Board (BCUHB) in North Wales. Following recruitment, participants will be randomised to one of two arms in the trial (standard care or OPCAT-G intervention). The primary outcomes for the trial are patient recruitment and attrition rates, and the secondary outcomes are quality of life, health status and capability, using the EORTC QLQ-C30, EQ-5D-3L and ICECAP-A measures. Additionally, a client service receipt inventory (CSRI) will be collected in order to pilot an economic evaluation. DISCUSSION: The results from this feasibility study will be used to inform a fully powered randomised controlled trial to evaluate the difference between standard care and the OPCAT-G intervention. TRIAL REGISTRATION: ISRCTN45565436.

Bilingualism, executive control, and age at diagnosis among people with early-stage Alzheimer's disease in Wales.

The observation of a bilingual advantage in executive control tasks involving inhibition and management of response conflict suggests that being bilingual might contribute to increased cognitive reserve. In support of this, recent evidence indicates that bilinguals develop Alzheimer's disease (AD) later than monolinguals, and may retain an advantage in performance on executive control tasks. We compared age at the time of receiving an AD diagnosis in bilingual Welsh/English speakers (n = 37) and monolingual English speakers (n = 49), and assessed the performance of bilinguals (n = 24) and monolinguals (n = 49) on a range of executive control tasks. There was a non-significant difference in age at the time of diagnosis, with bilinguals being on average 3 years older than monolinguals, but bilinguals were also significantly more cognitively impaired at the time of diagnosis. There were no significant differences between monolinguals and bilinguals in performance on executive function tests, but bilinguals appeared to show relative strengths in the domain of inhibition and response conflict. Bilingual Welsh/English speakers with AD do not show a clear advantage in executive function over monolingual English speakers, but may retain some benefits in inhibition and management of response conflict. There may be a delay in onset of AD in Welsh/English bilinguals, but if so, it is smaller than that found in some other clinical populations. In this Welsh sample, bilinguals with AD came to the attention of services later than monolinguals, and reasons for this pattern could be explored further.

Cognitive reserve in Parkinson's disease: the effects of welsh-english bilingualism on executive function.

Objective. Bilingualism has been shown to benefit executive function (EF) and delay the onset of Alzheimer's disease. This study aims at examining whether a bilingual advantage applies to EF in Parkinson's disease (PD). Method. In a cross-sectional outpatient cohort of monolingual English (n = 57) and bilingual Welsh/English (n = 46) speakers with PD we evaluated the effects of bilingualism compared with monolingualism on performance on EF tasks. In bilinguals we also assessed the effects of the degree of daily usage of each language and the degree of bilingualism. Results. Monolinguals showed an advantage in performance of language tests. There were no differences in performance of EF tests in monolinguals and bilinguals. Those who used Welsh less in daily life had better performance on one test of English vocabulary. The degree of bilingualism correlated with one test of nonverbal reasoning and one of working memory but with no other tests of EF. Discussion. The reasons why the expected benefit in EF in Welsh-English bilinguals with PD was not found require further study. Future studies in PD should include other language pairs, analysis of the effects of the degree of bilingualism, and longitudinal analysis of cognitive decline or dementia together with structural or functional neuroimaging.