scholarly journals Vocational rehabilitation services for patients with cancer: design of a feasibility study incorporating a pilot randomised controlled trial among women with breast cancer following surgery

Trials ◽  
2011 ◽  
Vol 12 (1) ◽  
Author(s):  
Richard G Kyle ◽  
Bill Culbard ◽  
Josie Evans ◽  
Nicola M Gray ◽  
Dolapo Ayansina ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Randomised Controlled Trial ◽  
Vocational Rehabilitation ◽  
Feasibility Study ◽  
Controlled Trial ◽  
Rehabilitation Services ◽  
Pilot Randomised Controlled Trial ◽  
Vocational Rehabilitation Services ◽  
Patients With Cancer ◽  
Randomised Controlled

scholarly journals A Feasibility Study of the Mistletoe and Breast Cancer (MAB) Trial: A Protocol for a Randomised Double-blind Controlled Trial

2020 ◽  
Author(s):  
Susan Bryant ◽  
Lorna Duncan ◽  
Gene Feder ◽  
Alyson Huntley
Keyword(s):  
Breast Cancer ◽  
Randomised Controlled Trial ◽  
Feasibility Study ◽  
Controlled Trial ◽  
Locally Advanced ◽  
Cochrane Review ◽  
Double Blind ◽  
Randomised Controlled ◽  
The Uk ◽  
Mistletoe Therapy

Abstract Background: A Cochrane review of mistletoe therapy concludes that there is some evidence that mistletoe extracts may offer benefits on measures of quality of life during chemotherapy for breast cancer, but these results need replication. Our aim was to test the feasibility of a placebo controlled, double blind randomised controlled trial of mistletoe therapy in patients with breast cancer undergoing chemotherapy with or without radiotherapy. Methods/design: A placebo controlled, double blind randomised controlled trial of mistletoe therapy in patients with breast cancer. There will be three arms (groups) in the trial: Iscador M, Iscador P, with physiological saline as the placebo. The aim is to recruit 45 adult patients with a new diagnosis of early or locally advanced breast cancer, up to 12 weeks following definitive breast surgery whose standard treatment plan includes chemotherapy with or without radiotherapy. They will be taught to administer the MAB therapies subcutaneously and will titrate up to their optimal dose. MAB therapy will continue throughout their standard chemotherapy and radiotherapy and one month beyond. The main outcome of the MAB study is the feasibility of conducting such a trial within the NHS in order to inform a future fully powered investigative trial. Feasibility will be measured through recruitment, retention and patient experience using clinical research forms, patient diaries, cancer-related questionnaires and qualitative interviews conducted with both patients and oncology staff.Discussion: This trial is the first of its kind in the UK. Currently mistletoe therapy is mostly available through private practice in the UK. Completion of this feasibility study will support applications for further funding for a fully powered randomised controlled trial which will measure effectiveness and cost-effectiveness of this herbal therapy.

scholarly journals Tourniquet use in total knee replacement surgery: a feasibility study and pilot randomised controlled trial (SAFE-TKR study)

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e043564
Author(s):  
Peter David Henry Wall ◽  
Imran Ahmed ◽  
Claire Edwin ◽  
Muhamed M Farhan-Alanie ◽  
Helen Parsons ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Total Knee Replacement ◽  
Feasibility Study ◽  
Knee Replacement ◽  
Controlled Trial ◽  
Brain Mri ◽  
Thigh Pain ◽  
Pilot Randomised Controlled Trial ◽  
Total Knee ◽  
Randomised Controlled

IntroductionTourniquets are routinely used during total knee replacement (TKR) surgery. They could increase the risk of thromboembolic events including cerebral emboli, cognitive decline, pain and other adverse events (AEs). A randomised controlled trial to assess whether tourniquet use might safely be avoided is therefore warranted but it is unclear whether such a trial would be feasible.MethodsIn a single-site feasibility study and pilot randomised controlled trial, adults having a TKR were randomised to surgery with an inflated tourniquet versus a non-inflated tourniquet. Participants underwent brain MRI preoperatively and within 2 days postoperatively. We assessed cognition using the Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA) and Oxford Cognitive Screen (OCS) and thigh pain using a Visual Analogue Scale at baseline and days 1 and 2, and 1 week postsurgery. AEs related to surgery were recorded up to 12 months.ResultsWe randomised 53 participants (27 tourniquet inflated and 26 tourniquet not inflated). Fifty-one participants received care per-protocol (96%) and 48 (91%) were followed up at 12 months. One new ischaemic brain lesion was detected. Of the cognitive tests, MoCA was easy to summarise, sensitive to change with lower ceiling effects compared with OCS and MMSE. There was a trend towards more thigh pain (mean 49.6 SD 30.4 vs 36.2 SD 28 at day 1) and more AEs related to surgery (21 vs 9) in participants with an inflated tourniquet compared with those with a tourniquet not inflated.ConclusionA full trial is feasible, but using MRI as a primary outcome is unlikely to be appropriate or feasible. Suitable primary outcomes would be cognition measured using MoCA, pain and AEs, all of which warrant investigation in a large multicentre trial.Trial registration numberISRCTN20873088.

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