scholarly journals Randomised controlled trial protocol (GRIP study): examining the effect of involvement of a general practitioner and home care oncology nurse after a cancer diagnosis on patient reported outcomes and healthcare utilization

BMC Cancer ◽  
2018 ◽  
Vol 18 (1) ◽  
Author(s):  
I. A. A. Perfors ◽  
C. W. Helsper ◽  
E. A. Noteboom ◽  
E. van der Wall ◽  
N. J. de Wit ◽  
...  
Keyword(s):  
General Practitioner ◽  
Randomised Controlled Trial ◽  
Home Care ◽  
Cancer Diagnosis ◽  
Patient Reported Outcomes ◽  
Controlled Trial ◽  
Trial Protocol ◽  
Oncology Nurse ◽  
Patient Reported ◽  
Randomised Controlled

scholarly journals An App With Brief Behavioural Support to Promote Physical Activity After a Cancer Diagnosis (APPROACH): Study Protocol for a Pilot Randomised Controlled Trial

2021 ◽  
Author(s):  
Phillippa Lally ◽  
Natalie Miller ◽  
Anna Roberts ◽  
Rebecca J Beeken ◽  
Diana M Greenfield ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Cancer Diagnosis ◽  
Controlled Trial ◽  
Sample Size Calculation ◽  
Self Report ◽  
Brisk Walking ◽  
Behavioural Support ◽  
Patient Reported ◽  
Randomised Controlled

Abstract BackgroundThere are multiple health benefits from participating in physical activity after a cancer diagnosis, but many people living with and beyond cancer (LWBC) are not meeting physical activity guidelines. App-based interventions offer a promising platform for intervention delivery. This trial aims to pilot a theory-driven, app-based intervention that promotes brisk walking among people living with and beyond cancer. The primary aim is to investigate the feasibility and acceptability of study procedures before conducting a larger randomised controlled trial (RCT).MethodsThis is an individually randomised, two-armed pilot RCT. Patients with localised or metastatic breast, prostate or colorectal cancer, who are aged 16 years or over, will be recruited from a single hospital site in South Yorkshire in the UK. The intervention includes an app designed to encourage brisk walking (Active 10) supplemented with habit-based behavioural support in the form of two brief telephone/video calls, an information leaflet and walking planners. The primary outcomes will be feasibility and acceptability of the study procedures. Demographic and medical characteristics will be collected at baseline, through self-report and hospital records. Secondary outcomes for the pilot (assessed at 0 and 3 months) will be accelerometer measured and self-reported physical activity, body mass index (BMI) and waist circumference, and patient reported outcomes of quality of life, fatigue, sleep, anxiety, depression, self-efficacy, and habit strength for walking. Qualitative interviews will explore experiences of participating or reasons for declining to participate. Parameters for the intended primary outcome measure (accelerometer measured average daily minutes of brisk walking (>100 steps/minute)) will inform a sample size calculation for the future RCT and a preliminary economic evaluation will be conducted. DiscussionThis pilot study will inform the design of a larger RCT to investigate the efficacy and cost-effectiveness of this intervention in people LWBC. Trial registrationISRCTN registry, ISRCTN18063498. Registered 16 April 2021. http://isrctn.com/ISRCTN18063498

scholarly journals Bladder cancer and exeRcise trAining during intraVesical thErapy—the BRAVE trial: a study protocol for a prospective, single-centre, phase II randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e055782
Author(s):  
Fernanda Z. Arthuso ◽  
Adrian S. Fairey ◽  
Normand G. Boulé ◽  
Kerry S. Courneya
Keyword(s):  
Bladder Cancer ◽  
Randomised Controlled Trial ◽  
Exercise Training ◽  
Patient Reported Outcomes ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Intravesical Therapy ◽  
Patient Reported ◽  
Health Related ◽  
Randomised Controlled

IntroductionNon-muscle invasive bladder cancer (NMIBC) accounts for about 75% of newly diagnosed bladder cancers. The treatment for NMIBC involves surgical removal of the tumour followed by 6 weekly instillations of immunotherapy or chemotherapy directly into the bladder (ie, intravesical therapy). NMIBC has a high rate of recurrence (31%–78%) and progression (15%). Moreover, bladder cancer and its treatment may affect patient functioning and quality of life. Exercise is a safe and effective intervention for many patient with cancer groups, however, no studies have examined exercise during intravesical therapy for NMIBC. The primary objective of the Bladder cancer and exeRcise trAining during intraVesical thErapy (BRAVE) trial is to examine the safety and feasibility of an exercise intervention in patients with bladder cancer undergoing intravesical therapy. The secondary objectives are to investigate the preliminary efficacy of exercise on health-related fitness and patient-reported outcomes; examine the social cognitive predictors of exercise adherence; and explore the potential effects of exercise on tumour recurrence and progression.Methods and analysisBRAVE is a phase II randomised controlled trial that aims to include 66 patients with NMIBC scheduled to receive intravesical therapy. Participants will be randomly assigned to the exercise intervention or usual care. The intervention consists of three supervised, high-intensity interval training sessions per week for 12 weeks. Feasibility will be evaluated by eligibility, recruitment, adherence and attrition rates. Preliminary efficacy will focus on changes in cardiorespiratory fitness and patient-reported outcomes from baseline (prior to intravesical therapy) to pre-cystoscopy (3 months). Cancer outcomes will be tracked at 3 months, and 1-year follow-up by cystoscopy. Analysis of covariance will compare between-group differences at post-intervention (pre-cystoscopy) for all health-related fitness and patient-reported outcomes.Ethics and disseminationThe study was approved by the Health Research Ethics Board of Alberta-Cancer Committee (#20–0184). Dissemination will include publication and presentations at scientific conferences and public channels.Trial registration numberNCT04593862; Pre-results.

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