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 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 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

scholarly journals Exercise duRing Active Surveillance for prostatE cancer—the ERASE trial: a study protocol of a phase II randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e026438 ◽  
Author(s):  
Dong-Woo Kang ◽  
Adrian S Fairey ◽  
Normand G Boulé ◽  
Catherine J Field ◽  
Kerry S Courneya
Keyword(s):  
Prostate Cancer ◽  
Randomised Controlled Trial ◽  
Disease Progression ◽  
Active Surveillance ◽  
Cancer Progression ◽  
Phase Ii ◽  
Controlled Trial ◽  
Exercise Group ◽  
Fear Of Cancer ◽  
Randomised Controlled

IntroductionActive surveillance (AS) is the preferred primary treatment strategy for men with low-risk clinically localised prostate cancer (PCa); however, the majority of these men still receive radical treatment within 10 years due to disease progression and/or fear of cancer progression. Interventions designed to suppress tumour growth, mitigate fear of cancer progression and precondition men for impending radical treatments are an unmet clinical need. Exercise has been shown to delay the progression of prostate tumours in animal models, improve physical and functional health and manage psychological outcomes in cancer patients; however, these outcomes have not been demonstrated in PCa patients undergoing AS.Methods and analysisThis phase II randomised controlled trial will randomise 66 men undergoing AS to either an exercise group or a usual care group. The exercise group will perform a 12-week, supervised, high-intensity interval training programme, consisting of 3 sessions/week for 28–40 min/session. The primary outcome will be cardiorespiratory fitness. Secondary outcomes will include immunosurveillance and cancer-related biomarkers, psychosocial outcomes including fear of cancer progression and quality of life and physical function. Exploratory outcomes will include clinical indicators of disease progression. The trial has 80% power to detect a significant between-group difference in VO2peakof 3.5 mL/kg/min with a two-tailed alpha level <0.05 and a 10% dropout rate.Ethics and disseminationThe study has received full ethical approval from the Health Research Ethics Board of Alberta – Cancer Committee (Protocol Number: HREBA.CC-17–0248). The findings of the study will be disseminated through public and scientific channels.Trial registration numberNCT03203460; Pre-results.

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