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 Randomised controlled trial to investigate the effectiveness of the symptom management after radiotherapy (SMaRT) group 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 S. Skene
Keyword(s):  
Prostate Cancer ◽  
Randomised Controlled Trial ◽  
Symptom Management ◽  
Group Intervention ◽  
Controlled Trial ◽  
Urinary Symptoms ◽  
Analysis Of Covariance ◽  
Curative Radiotherapy ◽  
Eortc Qlq ◽  
Randomised Controlled

Abstract Purpose To evaluate the effectiveness of the symptom management after radiotherapy (SMaRT) group 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 with moderate to severe urinary symptoms defined as scores ≥ 8 on the International Prostate Symptom Score (IPSS) questionnaire. Sixty-three men were randomised either; to SMaRT, a 10-week symptom-management intervention including group support, education, pelvic floor muscle exercises, or a care-as-usual group. The primary outcome was the IPSS at 6 months from baseline assessment. 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 from baseline. Analysis of covariance (ANCOVA) was used to analyse the effect of the intervention. Results SMaRT group intervention 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 group intervention provided short-term benefit in urinary voiding and continence and helped men manage symptoms but was not effective long term.

scholarly journals Primary care randomised controlled trial of a tailored interactive website for the self-management of respiratory infections (Internet Doctor)

BMJ Open ◽  
2016 ◽  
Vol 6 (4) ◽  
pp. e009769 ◽  
Author(s):  
Paul Little ◽  
Beth Stuart ◽  
Panayiota Andreou ◽  
Lisa McDermott ◽  
Judith Joseph ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Respiratory Infections ◽  
Controlled Trial ◽  
The Self ◽  
Self Management ◽  
Randomised Controlled

Effects of transtheoretical model‐based intervention on the self‐management of patients with an ostomy: A randomised controlled trial

2019 ◽  
Vol 28 (9-10) ◽  
pp. 1936-1951 ◽  
Author(s):  
Sha‐Li Wen ◽  
Juan Li ◽  
An‐Ni Wang ◽  
Meng‐Meng Lv ◽  
Hui‐Yuan Li ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Transtheoretical Model ◽  
Controlled Trial ◽  
The Self ◽  
Self Management ◽  
Model Based ◽  
Randomised Controlled

scholarly journals Evaluation of an innovative mobile health programme for the self-management of chronic obstructive pulmonary disease (MH-COPD): protocol of a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e025381 ◽  
Author(s):  
Hang Ding ◽  
Mohan Karunanithi ◽  
Derek Ireland ◽  
Lisa McCarthy ◽  
Rekha Hakim ◽  
...  
Keyword(s):  
Physical Activity ◽  
Chronic Obstructive Pulmonary Disease ◽  
Randomised Controlled Trial ◽  
Patient Adherence ◽  
Controlled Trial ◽  
The Self ◽  
Self Management ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease ◽  
Randomised Controlled

IntroductionChronic obstructive pulmonary disease (COPD) is the fourth leading cause of death globally. In outpatient care, the self-management of COPD is essential, but patient adherence to this remains suboptimal. The objective of this study is to examine whether an innovative mobile health (mHealth)-enabled care programme (MH-COPD) will improve the patient self-management and relevant health outcomes.Methods and analysisA prospective open randomised controlled trial has been designed. In the trial, patients with COPD will be recruited from The Prince Charles Hospital, Brisbane, Australia. They will then be randomised to participate in either the MH-COPD intervention group (n=50 patients), or usual care control group (UC-COPD) (n=50 patients) for 6 months. The MH-COPD programme has been designed to integrate an mHealth system within a clinical COPD care service. In the programme, participants will use a mHealth application at home to review educational videos, monitor COPD symptoms, use an electronic action plan, modify the risk factors of cigarette smoking and regular physical activity, and learn to use inhalers optimally. All participants will be assessed at baseline, 3 months and 6 months. The primary outcomes will be COPD symptoms and quality of life. The secondary outcomes will be patient adherence, physical activity, smoking cessation, use of COPD medicines, frequency of COPD exacerbations and hospital readmissions, and user experience of the mobile app.Ethics and disseminationThe clinical trial has been approved by The Prince Charles Hospital Human Research Ethics Committee (HREC/16/QPCH/252). The recruitment and follow-up of the trial will be from January 2019 to December 2020. The study outcomes will be disseminated according to the Consolidated Standards of Reporting Trials statement through a journal publication, approximately 6 months after finishing data collection.Trial registration numberACTRN12618001091291.

scholarly journals Effectiveness of an eHealth self-management tool for older adults with multimorbidity (KeepWell): protocol for a hybrid effectiveness–implementation randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e048350
Author(s):  
Monika Kastner ◽  
Julie Makarski ◽  
Leigh Hayden ◽  
Jemila S Hamid ◽  
Jayna Holroyd-Leduc ◽  
...  
Keyword(s):  
Older Adults ◽  
Chronic Disease ◽  
Randomised Controlled Trial ◽  
Disease Management ◽  
Chronic Conditions ◽  
Controlled Trial ◽  
Management Tool ◽  
Self Management ◽  
Plain Language ◽  
Randomised Controlled

IntroductionIn response to the burden of chronic disease among older adults, different chronic disease self-management tools have been created to optimise disease management. However, these seldom consider all aspects of disease management are not usually developed specifically for seniors or created for sustained use and are primarily focused on a single disease. We created an eHealth self-management application called ‘KeepWell’ that supports seniors with complex care needs in their homes. It incorporates the care for two or more chronic conditions from among the most prevalent high-burden chronic diseases.Methods and analysisWe will evaluate the effectiveness, cost and uptake of KeepWell in a 6-month, pragmatic, hybrid effectiveness–implementation randomised controlled trial. Older adults age ≥65 years with one or more chronic conditions who are English speaking are able to consent and have access to a computer or tablet device, internet and an email address will be eligible. All consenting participants will be randomly assigned to KeepWell or control. The allocation sequence will be determined using a random number generator.Primary outcome is perceived self-efficacy at 6 months. Secondary outcomes include quality of life, health background/status, lifestyle (nutrition, physical activity, caffeine, alcohol, smoking and bladder health), social engagement and connections, eHealth literacy; all collected via a Health Risk Questionnaire embedded within KeepWell (intervention) or a survey platform (control). Implementation outcomes will include reach, effectiveness, adoption, fidelity, implementation cost and sustainability.Ethics and disseminationEthics approval has been received from the North York General Hospital Research and Ethics Board. The study is funded by the Canadian Institutes of Health Research and the Ontario Ministry of Health. We will work with our team to develop a dissemination strategy which will include publications, presentations, plain language summaries and an end-of-grant meeting.Trial registration numberNCT04437238.

scholarly journals Additional Treatments to the Local tumour for metastatic prostate cancer-Assessment of Novel Treatment Algorithms (IP2-ATLANTA): protocol for a multicentre, phase II randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e042953
Author(s):  
Martin John Connor ◽  
Taimur Tariq Shah ◽  
Katarzyna Smigielska ◽  
Emily Day ◽  
Johanna Sukumar ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Lymph Node ◽  
Androgen Receptor ◽  
Randomised Controlled Trial ◽  
Phase Ii ◽  
Metastatic Prostate Cancer ◽  
Controlled Trial ◽  
Pelvic Lymph Node ◽  
Study Results ◽  
Randomised Controlled

IntroductionSurvival in men diagnosed with de novo synchronous metastatic prostate cancer has increased following the use of upfront systemic treatment, using chemotherapy and other novel androgen receptor targeted agents, in addition to standard androgen deprivation therapy (ADT). Local cytoreductive and metastasis-directed interventions are hypothesised to confer additional survival benefit. In this setting, IP2-ATLANTA will explore progression-free survival (PFS) outcomes with the addition of sequential multimodal local and metastasis-directed treatments compared with standard care alone.MethodsA phase II, prospective, multicentre, three-arm randomised controlled trial incorporating an embedded feasibility pilot. All men with new histologically diagnosed, hormone-sensitive, metastatic prostate cancer, within 4 months of commencing ADT and of performance status 0 to 2 are eligible. Patients will be randomised to Control (standard of care (SOC)) OR Intervention 1 (minimally invasive ablative therapy to prostate±pelvic lymph node dissection (PLND)) OR Intervention 2 (cytoreductive radical prostatectomy±PLND OR prostate radiotherapy±pelvic lymph node radiotherapy (PLNRT)). Metastatic burden will be prespecified using the Chemohormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease (CHAARTED) definition. Men with low burden disease in intervention arms are eligible for metastasis-directed therapy, in the form of stereotactic ablative body radiotherapy (SABR) or surgery. Standard systemic therapy will be administered in all arms with ADT±upfront systemic chemotherapy or androgen receptor agents. Patients will be followed-up for a minimum of 2 years. Primary outcome: PFS. Secondary outcomes include predictive factors for PFS and overall survival; urinary, sexual and rectal side effects. Embedded feasibility sample size is 80, with 918 patients required in the main phase II component. Study recruitment commenced in April 2019, with planned follow-up completed by April 2024.Ethics and disseminationApproved by the Health Research Authority (HRA) Research Ethics Committee Wales-5 (19/WA0005). Study results will be submitted for publication in peer-reviewed journals.Trial registration numberNCT03763253; ISCRTN58401737

Sign in / Sign up

Export Citation Format

Share Document