Long-term effect of a nurse-led psychosocial intervention on health-related quality of life in patients with head and neck cancer: a randomised controlled trial.
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SUBMITTER: van der Meulen IC
PROVIDER: S-EPMC3915114 | biostudies-other | 2014 Feb
REPOSITORIES: biostudies-other
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Project description:BACKGROUND: Many patients with head and neck cancer (HNC) experience depressive symptoms after treatment. This randomized controlled trial investigated the effects of a psychosocial nurse counseling and after intervention (NUCAI) versus usual care on the depressive and HNC-related physical symptoms of patients with HNC at 1 year after diagnosis. METHODS: A total of 205 patients with HNC were randomly assigned to either intervention (n = 103) or usual care (n = 102), with stratification for gender and tumor stage. The NUCAI, which consisted of six bimonthly 45-minute counseling sessions, was a problem-focused intervention aimed at helping patients to manage the physical, psychological, and social consequences of HNC and its treatment. It was nurse-led and offered in combination with regular medical follow-up visits at the University Medical Center Utrecht, the Netherlands. Depressive symptoms at 1 year after diagnosis were the primary outcome. Analyses were performed on an intention-to-treat basis for the total sample and for a predefined subgroup of patients with raised levels of depressive symptoms (Center for Epidemiologic Studies-Depression score ? 12; n = 91) at baseline using mixed-effect models. RESULTS: One year after HNC treatment, levels of depressive symptoms were significantly lower in the intervention group than in the control group in the total sample and in the subgroup of patients with raised levels of depressive symptoms. CONCLUSION: The NUCAI was feasible and effective in reducing depressive symptoms in patients with HNC 1 year after HNC treatment, and especially in patients with raised levels of depressive symptoms. The results of this study need to be confirmed in future studies before the NUCAI can be used in daily clinical practice.
| S-EPMC3607532 | biostudies-other
Project description:BackgroundIndigenous Maya women in Guatemala show some of the worst maternal health indicators worldwide. Our objective was to test acceptability, feasibility and impact of a co-designed group psychosocial intervention (Women's Circles) in a population with significant need but no access to mental health services.MethodsA parallel group pilot randomised study was undertaken in five rural Mam and three periurban K'iche' communities. Participants included 84 women (12 per community, in seven of the communities) randomly allocated to intervention and 71 to control groups; all were pregnant and/or within 2 years postpartum. The intervention consisted of 10 sessions co-designed with and facilitated by 16 circle leaders. Main outcome measures were: maternal psychosocial distress (HSCL-25), wellbeing (MHC-SF), self-efficacy and engagement in early infant stimulation activities. In-depth interviews also assessed acceptability and feasibility.ResultsThe intervention proved feasible and well accepted by circle leaders and participating women. 1-month post-intervention, wellbeing scores (p-value 0.008) and self-care self-efficacy (0.049) scores were higher among intervention compared to control women. Those women who attended more sessions had higher wellbeing (0.007), self-care and infant-care self-efficacy (0.014 and 0.043, respectively), and early infant stimulation (0.019) scores.ConclusionsThe pilot demonstrated acceptability, feasibility and potential efficacy to justify a future definitive randomised controlled trial. Co-designed women's groups provide a safe space where indigenous women can collectively improve their functioning and wellbeing.Trial registrationISRCTN13964819 . Registered 26 June 2018, retrospectively registered.
| S-EPMC6448212 | biostudies-literature
Project description:INTRODUCTION:India has high prevalence of hypertension but low awareness, treatment and control rate. A cluster randomised trial entitled 'm-Power Heart Project' is being implemented to test the effectiveness of a nurse care coordinator (NCC) led complex intervention to address uncontrolled hypertension in the community health centres (CHCs). The trial's process evaluation will assess the fidelity and quality of implementation, clarify the causal mechanisms and identify the contextual factors associated with variation in the outcomes. The trial will use a theory-based mixed-methods process evaluation, guided by the Consolidated Framework for Implementation Research. METHODS AND ANALYSIS:The process evaluation will be conducted in the CHCs of Visakhapatnam (southern India). The key stakeholders involved in the intervention development and implementation will be included as participants. In-depth interviews will be conducted with intervention developers, doctors, NCCs and health department officials and focus groups with patients and their caregivers. NCC training will be evaluated using Kirkpatrick's model for training evaluation. Key process evaluation indicators (number of patients recruited and retained; concordance between the treatment plans generated by the electronic decision support system and treatment prescribed by the doctor and so on) will be assessed. Fidelity will be assessed using Borrelli et al's framework. Qualitative data will be analysed using the template analysis technique. Quantitative data will be summarised as medians (IQR), means (SD) and proportions as appropriate. Mixed-methods analysis will be conducted to assess if the variation in the mean reduction of systolic blood pressure between the intervention CHCs is influenced by patient satisfaction, training outcome, attitude of doctors, patients and NCCs about the intervention, process indicators etc. ETHICS AND DISSEMINATION: Ethical approval for this study was obtained from the ethics committees at Public Health Foundation of India and Deakin University. Findings will be disseminated via peer-reviewed publications, national and international conference presentations. TRIAL REGISTRATION NUMBER:NCT03164317; Pre-results.
| S-EPMC6530308 | biostudies-literature
Project description:Between January 2004 and February 2006, 109 patients after intentionally curative surgery for oesophageal or gastric cardia cancer were randomised to standard follow-up of surgeons at the outpatient clinic (standard follow-up; n=55) or by regular home visits of a specialist nurse (nurse-led follow-up; n=54). Longitudinal data on generic (EuroQuol-5D, European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30) and disease-specific quality of life (EORTC QLQ-OES18), patient satisfaction and costs were collected at baseline and at 6 weeks and 4, 7 and 13 months afterwards. We found largely similar quality-of-life scores in the two follow-up groups over time. At 4 and 7 months, slightly more improvement on the EQ-VAS was noted in the nurse-led compared with the standard follow-up group (P=0.13 and 0.12, respectively). Small differences were also found in patient satisfaction between the two groups (P=0.14), with spouses being more satisfied with nurse-led follow-up (P=0.03). No differences were found in most medical outcomes. However, body weight of patients of the standard follow-up group deteriorated slightly (P=0.04), whereas body weight of patients of the nurse-led follow-up group remained stable. Medical costs were lower in the nurse-led follow-up group (2600 euro vs 3800 euro), however, due to the large variation between patients, this was not statistically significant (P=0.11). A cost effectiveness acceptability curve showed that the probability of being cost effective for costs per one point gain in general quality-of-life exceeded 90 and 75% after 4 and 13 months of follow-up, respectively. Nurse-led follow-up at home does not adversely affect quality of life or satisfaction of patients compared with standard follow-up by clinicians at the outpatient clinic. This type of care is very likely to be more cost effective than physician-led follow-up.
| S-EPMC2634677 | biostudies-other
Project description:ObjectiveTo examine the cost-effectiveness of nurse-led stroke aftercare addressing psychosocial outcome at 6 months post stroke, compared with care-as-usual.DesignEconomic evaluation within a comparative effectiveness research design.SettingPrimary care (2016-2017) and community settings (2011-2013) in the Netherlands.ParticipantsPersons who suffered from ischaemic or haemorrhagic stroke, or a transient ischaemic attack and were discharged home after visiting the emergency department, hospitalisation or inpatient rehabilitation.InterventionsNurse-led stroke aftercare at 6 months post stroke addressing psychosocial functioning by providing screening, psycho-education, emotional support and referral to specialist care when needed. Care-as-usual concerned routine follow-up care including secondary prevention programmes and a consultation with the neurologist at 6 weeks post stroke.Primary and secondary outcome measuresMain outcome measure of cost-effectiveness was quality-adjusted life years (QALYs) estimated by the quality of life measured by the five-dimensional, three-level EuroQol. Costs were assessed using a cost-questionnaire. Secondary outcomes were mood (Hospital Anxiety and Depression Scale) and social participation (Utrecht Scale for Evaluation of Rehabilitation-Participation) restrictions subscale.ResultsHealth outcomes were significantly better in stroke aftercare for QALYs (Δ=0.05; 95% CI 0.01 to 0.09) and social participation (Δ=4.91; 95% CI 1.89 to 7.93) compared with care-as-usual. Total societal costs were €1208 higher in stroke aftercare than in care-as-usual (95% CI -€3881 to €6057). Healthcare costs were in total €1208 higher in stroke aftercare than in care-as-usual (95% CI -€3881 to €6057). Average costs of stroke aftercare were €91 (SD=€3.20) per person. Base case cost-effectiveness analyses showed an incremental cost-effectiveness ratio of €24 679 per QALY gained. Probability of stroke aftercare being cost-effective was 64% on a €50 000 willingness-to-pay level.ConclusionsNurse-led stroke aftercare addressing psychosocial functioning showed to be a low-cost intervention and is likely to be a cost-effective addition to care-as-usual. It plays an important role by screening and addressing psychosocial problem, not covered by usual care.
| S-EPMC7908908 | biostudies-literature
Project description:IntroductionAcute psychological stress, as well as unusual experiences including hallucinations and delusions, are common in critical care unit patients and have been linked to post-critical care psychological morbidity such as post-traumatic stress disorder (PTSD), depression and anxiety. Little high-quality research has been conducted to evaluate psychological interventions that could alleviate longer-term psychological morbidity in the critical care unit setting. Our research team developed and piloted a nurse-led psychological intervention, aimed at reducing patient-reported PTSD symptom severity and other adverse psychological outcomes at 6 months, for evaluation in the POPPI trial.Methods and analysisThis is a multicentre, parallel group, cluster-randomised clinical trial with a staggered roll-out of the intervention. The trial is being carried out at 24 (12 intervention, 12 control) NHS adult, general, critical care units in the UK and is evaluating the clinical effectiveness and cost-effectiveness of a nurse-led preventative psychological intervention in reducing patient-reported PTSD symptom severity and other psychological morbidity at 6 months. All sites deliver usual care for 5 months (baseline period). Intervention group sites are then trained to carry out the POPPI intervention, and transition to delivering the intervention for the rest of the recruitment period. Control group sites deliver usual care for the duration of the recruitment period. The trial also includes a process evaluation conducted independently of the trial team.Ethics and disseminationThis protocol was reviewed and approved by the National Research Ethics Service South Central - Oxford B Research Ethics Committee (reference: 15/SC/0287). The first patient was recruited in September 2015 and results will be disseminated in 2018. The results will be presented at national and international conferences and published in peer reviewed medical journals.Trial registration numberISRCTN53448131; Pre-results.
| S-EPMC5879925 | biostudies-literature
Project description:BackgroundTo understand better the success of self-management interventions and to enable tailoring of such interventions at specific subgroups of patients, the nurse-led Activate intervention is developed targeting one component of self-management (physical activity) in a heterogeneous subgroup (patients at risk of cardiovascular disease) in Dutch primary care.AimThe aim of this study was to evaluate the effectiveness of the Activate intervention and identifying which patient-related characteristics modify the effect.MethodsA two-armed cluster-randomised controlled trial was conducted comparing the intervention with care as usual. The intervention consisted of four nurse-led behaviour change consultations within a 3-month period. Data were collected at baseline, 3 months and 6 months. Primary outcome was the daily amount of moderate to vigorous physical activity at 6 months. Secondary outcomes included sedentary behaviour, self-efficacy for physical activity, patient activation for self-management and health status. Prespecified effect modifiers were age, body mass index, level of education, social support, depression, patient provider relationship and baseline physical activity.ResultsThirty-one general practices (n?=?195 patients) were included (intervention group n?=?93; control group n?=?102). No significant between-group difference was found for physical activity (mean difference 2.49 minutes; 95% confidence interval -2.1; 7.1; P?=?0.28) and secondary outcomes. Patients with low perceived social support (P?=?0.01) and patients with a low baseline activity level (P?=?0.02) benefitted more from the intervention.ConclusionThe Activate intervention did not improve patients' physical activity and secondary outcomes in primary care patients at risk of cardiovascular disease. To understand the results, the intervention fidelity and active components for effective self-management require further investigation.Trial registration: ClinicalTrials.gov NCT02725203.
| S-EPMC7817988 | biostudies-literature
Project description:IntroductionIt has been suggested that palliative care integrated into standard cancer treatment from the early phase of the disease can improve the quality of life of patients with cancer. In this paper, we present the protocol for a multicentre randomised controlled trial to examine the effectiveness of a nurse-led, screening-triggered, early specialised palliative care intervention programme for patients with advanced lung cancer.Methods and analysisA total of 206 patients will be randomised (1:1) to the intervention group or the control group (usual care). The intervention, triggered with a brief self-administered screening tool, comprises comprehensive need assessments, counselling and service coordination by advanced-level nurses. The primary outcome is the Trial Outcome Index of the Functional Assessment of Cancer Therapy (FACT) at 12 weeks. The secondary outcomes include participants' quality of life (FACT-Lung), depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder-7), illness perception (Prognosis and Treatment Perceptions Questionnaire), medical service use and survival. A mixed-method approach is expected to provide an insight about how this intervention works.Ethics and disseminationThis study has been approved by the Institutional Review Board of the National Cancer Center Japan (approval number: 2016-235). The findings will be disseminated through peer-reviewed publications and conference presentations and will be reflected on to the national healthcare policy.Trial registration numberUMIN000025491.
| S-EPMC7692832 | biostudies-literature
Project description:INTRODUCTION:Liver cirrhosis affects health-related quality of life (HRQoL) even in its early stages. Morbidity is especially high when the disease decompensates and self-care actions become essential. Nurse involvement in secondary prevention in other chronic diseases has contributed to better symptom control, less need of inpatient care and improved HRQoL. In order to evaluate the impact of nurse involvement in the follow-up of patients with liver cirrhosis, we decided to compare structured nurse-led clinics, inspired by Dorothea Orem's nursing theory and motivational strategies, with a group of patients receiving standard care. The primary outcome is HRQoL and the secondary outcomes are quality of care, visits to outpatient clinics or hospitals, disease progress and health literacy. METHODS AND ANALYSIS:This is a pragmatic, multicentre randomised controlled study conducted at six Swedish hepatology departments. Eligible patients are adults with diagnosed cirrhosis of the liver (n=500). Participants are randomised into either an intervention with nurse-led follow-up group or into a standard of care group. Recruitment started in November 2016 and is expected to proceed until 2020. Primary outcomes are physical and mental HRQoL measured by RAND-36 at enrolment, after 1 and 2?years. ETHICS AND DISSEMINATION:The study is ethically approved by the Regional Ethical Review Board in Uppsala. The results shall be disseminated in international conferences and peer-reviewed articles. TRIAL REGISTRATION NUMBER:NCT02957253; Pre-results.
| S-EPMC6196856 | biostudies-literature
Project description:Objectives Robust research of complex interventions designed to promote mental well-being in later life is required to inform service development. An essential component is ensuring that such interventions are delivered as intended. We present a detailed description of the design and implementation of a fidelity assessment within a trial of one such intervention (Lifestyle Matters). The findings help to explain the trial results and also inform the design of embedded fidelity assessments within future evaluations of complex interventions. Design We conducted a mixed-method fidelity assessment embedded as part of a multicentre pragmatic randomised controlled trial. A conceptual fidelity framework was developed from the Behaviour Change Consortium framework. From this the fidelity assessment was designed. The resulting instrument assessed the following parameters: intervention design, training, supervision; and delivery, receipt and enactment of the intervention. Intervention The Lifestyle Matters intervention was designed to assist older people to improve and sustain mental well-being through participation in meaningful activity. The aim is to enable participants to engage in both new and neglected activities through a mix of facilitated group meetings and individual sessions. Results The fidelity assessment demonstrated that the intervention was delivered as per protocol for the group component and was tailored to meet individual needs. There was substantial inter-rater agreement for training; and group member performance 0.72; and moderate agreement for facilitator performance 0.55. It was not possible to determine whether small declines seen in facilitator performance were due to facilitator drift or moderating factors such as group dynamics or participant characteristics. Conclusions The assessment methods adequately measured criteria identified as being significant indicators of fidelity. Adherence during training, delivery and supervision was good. The subjective nature of identification and rating observed behaviours was the main challenge. Future research should explore alternative methods of assessing fidelity in trials of complex interventions. Trial registration number ISRCTN67209155.
| S-EPMC8039267 | biostudies-literature