scholarly journals Healthy Eating and Active Lifestyle After Bowel Cancer (HEAL ABC): feasibility randomised controlled trial protocol

2020 ◽  
Vol 6 (1) ◽  
Author(s):  
Jana Sremanakova ◽  
Anne Marie Sowerbutts ◽  
Chris Todd ◽  
Richard Cooke ◽  
Sorrel Burden

Abstract Background Targeting modifiable lifestyle factors including diet and physical activity represents a potentially cost-effective strategy that could support a growing population of colorectal cancer survivors and improve their health outcomes. Currently, effective, evidence-based interventions and resources helping people after bowel cancer to adopt new lifestyle habits are lacking. The aim of this trial is to test the Healthy Eating and Active Lifestyle After Bowel Cancer (HEAL-ABC) intervention to inform a future definitive randomised controlled trial. Methods/design This is a feasibility randomised controlled trial. A total of 72 survivors who have completed surgery and all anticancer treatments will be recruited. The intervention group will receive HEAL-ABC resources based on behaviour change theory combined with supportive telephone calls informed by motivational interviewing every 2 weeks during the 3-month intervention, and once a month for 6 months to follow-up. Participants in the control group will follow usual care and have access to resources available in the public domain. The study is testing feasibility of the intervention including adherence and ability to collect data on anthropometry, body composition, diet, physical activity, behaviour change, quality of life, blood markers, contact with healthcare services, morbidities and overall survival. Discussion The proposed study will add to the evidence base by addressing an area where there is a paucity of data. This study on lifestyle interventions for people after colorectal cancer follows the Medical Research Council guidance on evaluating complex interventions in clinical practice. It focuses on people living after treatment for colorectal cancer and targets an important research area identified by cancer survivors as a research priority reported by the National Cancer Institute and James Lind Alliance UK. Trial registration ClinicalTrials.gov NCT04227353 approved on the 13th of January 2020

BMJ Open ◽  
2020 ◽  
Vol 10 (3) ◽  
pp. e029831 ◽  
Author(s):  
Jennifer Fortune ◽  
Meriel Norris ◽  
Andrea Stennett ◽  
Cherry Kilbride ◽  
Grace Lavelle ◽  
...  

ObjectivesThe purpose of this study was to explore the experiences of people with multiple sclerosis (MS) who participated in iStep-MS, a feasibility randomised controlled trial of a behaviour change intervention that aimed to increase physical activity and reduce sedentary behaviour.DesignA qualitative approach was undertaken embedded in the feasibility randomised controlled trial. One-to-one semi-structured interviews were conducted and analysed using Framework analysis.SettingParticipants were recruited from a single MS therapy centre in the southeast of England, UK.ParticipantsSixty people with MS were randomly allocated in a 1:1 ratio to the intervention or usual care. Following a purposive sampling strategy, 15 participants from the intervention arm undertook 1:1 semi-structured interviews.InterventionsThe iStep-MS intervention consisted of four therapist-led sessions over 12 weeks, supported by a handbook and pedometer.ResultsThree themes were identified from the data.“I can do this”: developing competence in physical activityhighlights the enhanced physical activity confidence gained through goal setting and accomplishment. “I felt valued”: the nurturing cultureprovides an overview of the supportive and non-judgemental environment created by the programme structure and therapeutic relationship. Finally, “What can I do?”: empowered enactmentdescribes the transition from the supported iStep-MS intervention to intrinsically motivated physical activity enactment.ConclusionsOverall, this study supports the acceptability of the iStep-MS intervention and identified key areas that supported participants to be physically active.Trial registration numberISRCTN15343862.


Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Aron Onerup ◽  
Eva Angenete ◽  
David Bock ◽  
Mats Börjesson ◽  
Monika Fagevik Olsén ◽  
...  

An amendment to this paper has been published and can be accessed via the original article.


2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Ellie Shingler ◽  
Claire Perks ◽  
Georgia Herbert ◽  
Andy Ness ◽  
Charlotte Atkinson

Abstract Background Capecitabine and oxaliplatin (CAPOX) chemotherapy is a standard treatment for stage 2/3 colorectal cancer. Treatment is associated with dose-limiting toxicities such as neutropenia, vomiting, diarrhoea, and stomatitis. Short-term fasting prior to chemotherapy may help protect normal cells from the toxic effects of chemotherapy by allowing them to conserve energy for maintenance and repair. However, there is a lack of evidence to support the efficacy of short-term fasting in protecting against chemotherapy-related toxicities in humans, and it is not known whether people due to undergo chemotherapy will be willing and able to follow a short-term fast. Preliminary data confirming this is feasible are required before adequately powered trials can be designed and conducted. Methods The short-term, water only, fasting trial (SWiFT) is a two-armed feasibility randomised controlled trial, aiming to recruit 30 people scheduled to begin routine treatment with CAPOX chemotherapy for stage 2/3 colorectal cancer. Participants will be randomly allocated, in a 1:1 ratio, to either a 36-h fast or standard dietary advice prior to chemotherapy administration for the first 3 cycles of chemotherapy. The primary outcome measures will assess the feasibility of the trial and include: adherence to intervention, recruitment, retention, and data completion rates as well as the acceptability of the intervention which will be qualitatively assessed. The secondary outcome measures aim to provide further information on possible outcomes of interest for a definitive trial and include side effects of chemotherapy, quality of life, markers of cellular metabolism and inflammation, appetite, and sarcopenia. Discussion It is not known whether it is possible to recruit to a trial of short-term fasting in this population, or whether participants would be able to adhere to the intervention. Therefore, we aim to test the feasibility of a pre-chemotherapy, 36-h, water-only fast in people receiving CAPOX chemotherapy for stage 2/3 colorectal cancer. Trial registration This trial has been registered with the ISRCTN Registry. Trial registration no: ISRCTN17994717. Date of registration: 23 October 2018. URL: http://www.isrctn.com/ISRCTN17994717


Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Farren L. Goulding ◽  
Charity D. Evans ◽  
Katherine B. Knox ◽  
Hyun J. Lim ◽  
Michael C. Levin ◽  
...  

Abstract Background Multiple sclerosis (MS) is a chronic, degenerative disease of the central nervous system. Because of the long-term and unpredictable nature of the disease, the burden of MS is significant from both a patient and societal perspective. Despite a recent influx of disease-modifying therapies to treat MS, many individuals continue to experience disability that negatively affects productivity and quality of life. Previous research indicates that physical activity has a positive impact on walking function in individuals with MS, in addition to the usual beneficial effects on overall health. However, most people with MS are not active enough to gain these benefits, and a lack of support to initiate and maintain physical activity has been identified as a major barrier. This study will evaluate the impact of a novel intervention involving individualised behaviour change strategies delivered by neurophysiotherapists on increasing physical activity levels in individuals with MS who are currently inactive. Methods/design This single-blind, parallel-group, randomised controlled trial will be conducted in Saskatchewan, Canada. Eligible participants include individuals with MS who are ambulatory but identified as currently inactive by the self-reported Godin Leisure-Time Exercise Questionnaire (GLTEQ). The intervention will be delivered by neurophysiotherapists and includes individualised behaviour change strategies aimed at increasing physical activity over a 12-month period. The control group will receive usual care during the 12-month study period. The primary outcome is the change in physical activity level, as measured by the change in the GLTEQ score from baseline to 12 months. Secondary outcomes include the change in patient-reported outcome measures assessing MS-specific symptoms, confidence and quality of life. Discussion Physical activity has been identified as a top research priority by the MS community. Findings from this novel study may result in new knowledge that could significantly impact the management and overall health of individuals with MS. Trial registration ClinicalTrials.gov, NCT04027114. Registered on 10 July 2019.


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