1739 Self-management for chronic symptoms in the survivorship phase of illness: A randomised controlled trial of a group intervention for radiotherapy side effects versus usual care for men after treatment for prostate cancer

2015 ◽  
Vol 51 ◽  
pp. S260
Author(s):  
S. Faithfull ◽  
J. Cockle Hearne ◽  
H.E. Fairbanks ◽  
R. Laing
Keyword(s):  
Prostate Cancer ◽  
Side Effects ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Group Intervention ◽  
Controlled Trial ◽  
Self Management ◽  
Randomised Controlled

scholarly journals Evidence generation for the clinical impact of myCOPD in patients with mild, moderate and newly diagnosed COPD: a randomised controlled trial

2020 ◽  
Vol 6 (4) ◽  
pp. 00460-2020
Author(s):  
Michael G. Crooks ◽  
Jack Elkes ◽  
William Storrar ◽  
Kay Roy ◽  
Mal North ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Small Sample ◽  
Self Management ◽  
Open Label ◽  
Management Interventions ◽  
Randomised Controlled ◽  
The Impact

Self-management interventions in COPD aim to improve patients' knowledge, skills and confidence to make correct decisions, thus improving health status and outcomes. myCOPD is a web-based self-management app known to improve inhaler use and exercise capacity in individuals with more severe COPD.We explored the impact of myCOPD in patients with mild–moderate or recently diagnosed COPD through a 12-week, open-label, parallel-group, randomised controlled trial of myCOPD compared with usual care. The co-primary outcomes were between-group differences in mean COPD assessment test (CAT) score at 90 days and critical inhaler errors. Key secondary outcomes were app usage and patient activation measurement (PAM) score.Sixty patients were randomised (29 myCOPD, 31 usual care). Groups were balanced for forced expiratory volume in 1 s (FEV1 % pred) but there was baseline imbalance between groups for exacerbation frequency and CAT score. There was no significant adjusted mean difference in CAT score at study completion, −1.27 (95% CI −4.47–1.92, p=0.44) lower in myCOPD. However, an increase in app use was associated with greater CAT score improvement. The odds of ≥1 critical inhaler error was lower in the myCOPD arm (adjusted OR 0.30 (95% CI 0.09–1.06, p=0.061)). The adjusted odds ratio for being in a higher PAM level at 90 days was 1.65 (95% CI 0.46–5.85) in favour of myCOPD.The small sample size and phenotypic difference between groups limited our ability to demonstrate statistically significant evidence of benefit beyond inhaler technique. However, our findings provide important insights into associations between increased app use and clinically meaningful benefit warranting further study in real world settings.

scholarly journals Usual care and a self-management support programme versus usual care and a relaxation programme for people living with chronic headache disorders: a randomised controlled trial protocol (CHESS)

BMJ Open ◽  
2020 ◽  
Vol 10 (4) ◽  
pp. e033520 ◽  
Author(s):  
Shilpa Patel ◽  
Felix Achana ◽  
Dawn Carnes ◽  
Sandra Eldridge ◽  
David R Ellard ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Chronic Headache ◽  
Controlled Trial ◽  
Self Management ◽  
Management Support ◽  
Support Programme ◽  
Chronic Headaches ◽  
Randomised Controlled

IntroductionChronic headaches are poorly diagnosed and managed and can be exacerbated by medication overuse. There is insufficient evidence on the non-pharmacological approaches to helping people living with chronic headaches.Methods and analysisChronic Headache Education and Self-management Study is a pragmatic randomised controlled trial to test the effectiveness and cost-effectiveness of a self-management education support programme on top of usual care for patients with chronic headaches against a control of usual care and relaxation. The intervention is a 2-day group course based on education, personal reflection and a cognitive behavioural approach, plus a nurse-led one-to-one consultation and follow-up over 8 weeks. We aim to recruit 689 participants (356 to the intervention arm and 333 to the control) from primary care and self-referral in London and the Midlands. The trial is powered to show a difference of 2.0 points on the Headache Impact Test, a patient-reported outcome measure at 12 months post randomisation. Secondary outcomes include health related quality of life, self-efficacy, social activation and engagement, anxiety and depression and healthcare utilisation. Outcomes are being measured at 4, 8 and 12 months. Cost-effectiveness will be expressed in terms of incremental cost per quality-adjusted life year gained.Ethics and disseminationThis trial will provide data on effectiveness and cost-effectiveness of a self-management support programme for chronic headaches. The results will inform commissioning of services and clinical practice. North West – Greater Manchester East Research Ethics Committee have approved the trial. The current protocol version is 3.6 date 7 March 2019.Trial registration numberISRCTN79708100.

scholarly journals Randomised Controlled Trial To Investigate The Effectiveness of The Self-Management After Radiotherapy (SMaRT) Intervention To Ameliorate Lower Urinary Tract Symptoms in Men Treated for Prostate Cancer

2021 ◽  
Author(s):  
Sara Faithfull ◽  
Jane Cockle-Hearne ◽  
Agnieszka Lemanska ◽  
Sophie Otter ◽  
Simon Skene
Keyword(s):  
Prostate Cancer ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
The Self ◽  
Urinary Symptoms ◽  
Analysis Of Covariance ◽  
Self Management ◽  
Curative Radiotherapy ◽  
Eortc Qlq ◽  
Randomised Controlled

Abstract Purpose To evaluate the effectiveness of the self-management after radiotherapy (SMaRT) intervention to improve urinary symptoms in men with prostate cancer. Methods The randomised controlled trial (RCT) recruited men from one radiotherapy centre in the UK after curative radiotherapy or brachytherapy and moderate urinary symptoms defined as the International Prostate Symptom Score (IPSS) ≥ 8. 63 men were randomised either to SMaRT, a 10-week self-management intervention including group support, education, pelvic floor muscle exercises, or care-as-usual. The primary outcome was the IPSS at 6 months. Secondary outcomes were IPSS at 3 months, and International Continence Society Male Short Form (ICS), European Organisation for Research and Treatment of Cancer Quality of Life prostate scale (EORTC QLQ-PR25), EORTC QLQ-30 and Self-Efficacy for Symptom Control Inventory (SESCI) at 3 and 6 months. Analysis of covariance (ANCOVA) was used to analyse the effect of the intervention. Results SMaRT did not improve urinary symptoms as measured by IPSS at 6 months. The adjusted difference was − 2.5 [95%CI -5.0 to 0.0], p = 0.054. Significant differences were detected at 3 months in ICS voiding symptoms (-1.1 [-2.0 to -0.2], p = 0.017), ICS urinary incontinence (-1.0 [-1.8 to -0.1], p = 0.029) and SESCI managing symptoms domain (13.5 [2.5 to 24.4], p = 0.017). No differences were observed at 6 months. Conclusions SMaRT provided short-term benefit in urinary voiding and continence, and helped men manage symptoms but was not effective long-term. Face-to-face and supervised approaches may provide more benefit.

scholarly journals Effectiveness of a brief positive skills intervention to improve psychological adjustment in patients with end-stage kidney disease newly initiated on haemodialysis: protocol for a randomised controlled trial (HED-Start)

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e053588
Author(s):  
Konstadina Griva ◽  
Jace Ming Xuan Chia ◽  
Zack Zhong Sheng Goh ◽  
Yen Peng Wong ◽  
Job Loei ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Kidney Disease ◽  
Usual Care ◽  
Life Skills ◽  
Controlled Trial ◽  
Self Management ◽  
End Stage Kidney Disease ◽  
Research Activities ◽  
Randomised Controlled ◽  
End Stage

IntroductionInitiation onto haemodialysis is a critical transition that entails multiple psychosocial and behavioural demands that can compound mental health burden. Interventions guided by self-management and cognitive–behavioural therapy to improve distress have been variably effective yet are resource-intensive or delivered reactively. Interventions with a focus on positive affect for patients with end-stage kidney disease are lacking. This study will seek (1) to develop a positive life skills intervention (HED-Start) combining evidence and stakeholder/user involvement and (2) evaluate the effectiveness of HED-Start to facilitate positive life skills acquisition and improve symptoms of distress and adjustment in incident haemodialysis patients.Methods and analysisThis is a single/assessor-blinded randomised controlled trial (RCT) to compare HED-Start to usual care. In designing HED-Start, semistructured interviews, a codesign workshop and an internal pilot will be undertaken, followed by a two-arm parallel RCT to evaluate the effectiveness of HED-Start. A total of 148 incident HD patients will be randomised using a 1:2 ratio into usual care versus HED-Start to be delivered in groups by trained facilitators between January 2021 and September 2022. Anxiety and depression will be the primary outcomes; secondary outcomes will be positive and negative affect, quality of life, illness perceptions, self-efficacy, self-management skills, benefit finding and resilience. Assessments will be taken at 2 weeks prerandomisation (baseline) and 3 months postrandomisation (2 weeks post-HED-Start completion). Primary analyses will use an intention-to-treat approach and compare changes in outcomes from baseline to follow-up relative to the control group using mixed-effect models.Ethics and disseminationEthics approval was obtained from Nanyang Technological University Institutional Review Board (IRB-2019-01-010). Written informed consent will be obtained before any research activities. Trial results will be disseminated via publications in peer-reviewed journals and conference presentations and will inform revision(s) in renal health services to support the transition of new patients to haemodialysis.Trial registration numberNCT04774770.

scholarly journals Promoting Independence in Dementia (PRIDE): Protocol for a Feasibility Randomised Controlled Trial

2019 ◽  
Author(s):  
Aisha Shafayat ◽  
Emese Csipke ◽  
Lucy Bradshaw ◽  
Georgina Charlesworth ◽  
Florence Day ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Feasibility Trial ◽  
Self Management ◽  
Mild Dementia ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

Abstract Background Memory services often see people with early stage dementia who are largely independent and able to participate in community activities but who run the risk of reducing activities and social networks. PRIDE is a self-management intervention designed to promote living well and enhance independence for people with mild dementia. This study aims to examine the feasibility of conducting a definitive randomised trial comparing the clinical and cost-effectiveness of the PRIDE intervention offered in addition to usual care or with usual care alone. Methods/Design PRIDE is a parallel, two-arm, multicentre, feasibility, randomised controlled trial (RCT). Eligible participants aged 18 or over who have mild dementia (defined as a score of 0.5 or 1 on the Clinical Dementia Rating Scale) who can participate in the intervention and provide informed consent will be randomised (1:1) to treatment with the PRIDE intervention delivered in addition to usual care, or usual care only. Participants will be followed-up at three and six month’s post-randomisation. There will be an option for a supporter to join each participant. Each supporter will be provided with questionnaires at baseline and follow-ups at three to six months. Embedded qualitative research with both participants and supporters will explore their perspectives on the intervention investigating a range of themes including acceptability and barriers and facilitators to delivery and participation. The feasibility of conducting a full RCT associated with participant recruitment and follow-up of both conditions, intervention delivery including the recruitment, training, retention of PRIDE trained facilitators, clinical outcomes, intervention and resource use costs and the acceptability of the intervention and study related procedures will be examined. Discussion This study will assess whether a definitive randomised trial comparing the clinical and cost-effectiveness of whether the PRIDE intervention offered in addition to usual care is feasible in comparison to usual care alone, and if so will provide data to inform the design and conduct of a future trial. Trial Registration and protocol version ISRCTN, ISRCTN11288961, registered on 23 October 2019, http://www.isrctn.com/ISRCTN12345678 Protocol V2.1 dated 19 June 2019 Keywords Dementia, self-management, feasibility trial

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