North of England Women's Diet and ActivitY After Breast Cancer RCT
Research type
Research Study
Full title
North of England Women's Diet and ActivitY After Breast Cancer: Randomised Controlled Trial (NEW DAY-ABC)
IRAS ID
253794
Contact name
John Saxton
Contact email
Sponsor organisation
Northumbria University
ISRCTN Number
ISRCTN15088551
Duration of Study in the UK
3 years, 5 months, 30 days
Research summary
Research Summary:
Being overweight after hormone positive breast cancer treatment increases the chance of cancer returning: extra weight (mainly fat) leads to higher levels of oestrogen/harmful substances in the blood. There is a lack of lifestyle support for overweight women after breast cancer. This study has designed a practical way to provide individually tailored lifestyle support to help them lose weight. This overall project has three phases, the first phase of which has already been completed and was a qualitative co-design process, working with patients and clinicians to develop an intervention.The second and third phases are to complete the internal pilot of this intervention to test the feasibility of the study before going into the full trial. For the 10 month internal pilot, we will recruit 66 hormone positive breast cancer patients from four NHS Trusts (Gateshead, Newcastle, Northumbria and Sheffield) and will be randomised to either the control or the intervention group.
Intervention patients will be enrolled in a lifestyle intervention programme in either Sheffield or Newcastle designed to help the women become more active and lose weight; control patients will continue on their usual care pathway. Lifestyle advisors at each site will be trained to deliver the intervention which will incorporate diet, exercise and general lifestyle advice and will be a combination of group sessions and personalised telephone counselling sessions with the lifestyle advisors. All patients will complete baseline, 6 months and 12 months testing that will be carried out by members of the research team, who will be blinded to group allocation. Data will be collected at each time point on weight, body composition, activity, diet, quality of life and cancer specific symptoms and fears.
Providing the trial is feasible, we will add a further four trusts to the Pilot sites with the target to recruit 454 patients.
Summary of Research:
The first phase of the development work was a qualitative study designed to investigate the experiences and perceptions of hormone-positive female breast cancer patients (BCPs) regarding weight management behaviours during and after treatment. Secondly, to gain insight into the experiences of healthcare professionals (HCPs) regarding the provision of weight management advice to patients undergoing treatment. Four focus groups involving 16 BCPs having a median (range) age of 51 (35–70 y) and three focus groups involving 21 HCPs aged 46 (29–62) were held at a university campus, local cancer support centre or clinical site. Data were analysed using Framework analysis and four overarching themes (and 10 subthemes) were identified: (1) Treatment; (2) Support for lifestyle behav- iour change; (3) Information availability for BCPs; (4) Knowledge of current evidence amongst HCPs. The physical and psychological consequences of treatment influenced motivation for weight management amongst BCPs. Social support for health promoting behaviours was viewed as important but was conflicting, requiring context-specific consid- erations. BCPs said they would have welcomed access to credible information (guided by HCPs) about the potential detrimental health effects of excess body weight and weight gain, together with advice on weight management via healthy eating and physical activity. HCPs felt that they had insufficient knowledge of public health dietary and physical activity recommendations or evidence-based interventions to confidently offer such advice. HCPs expressed concern that raising weight management issues would exacerbate distress or invoke feelings of guilt amongst BCPs, and cited time pressures on patient consultations as additional barriers to providing weight management support. The study yielded novel insights into factors influencing weight management behaviours amongst overweight BCPs. The results suggest that evidence-based information and support, which addresses key physical and psychological challenges to physical activity and dietary behaviours, offers the best route to sustainable weight management in this population.
The second phase of the development work was to co-design (with patients) a programme of tailored, personalised support (intervention), including high-quality support materials, to help female breast cancer patients (BCPs) to develop the skills and confidence needed for sustainable weight loss. Hormone-positive breast cancer patients were recruited from two UK National Health Service (NHS) Trusts. The selection criteria included (i) recent experience of breast cancer treatment (within 36 months of completing primary treatment); (ii) participation in a recent focus group study investigating weight management perceptions and experiences; (iii) willingness to share experiences and contribute to discussions on the support structures needed for sustainable dietary and physical activity behaviour change. Co-design workshops included presentations and interactive activities and were facilitated by an experienced co-design researcher (HH), assisted by other members of the research team. Two groups of BCPs from the North of England (N = 4) and South Yorkshire (N = 5) participated in a two- stage co-design process. The stage 1 and stage 2 co-design workshops were held two weeks apart and took place between Jan–March 2019, with each workshop being approximately 2 h in duration. Guided by the Behaviour Change Wheel, a theoretically-informed weight management intervention was developed on the basis of co- designed strategies to overcome physical and emotional barriers to dietary and physical activity behaviour change. BCPs were instrumental in designing all key features of the intervention, in terms of Capability (e.g., evidence-based information, peer-support and shared experiences), Opportunity (e.g., flexible approach to weight management based on core principles) and Motivation (e.g., appropriate use of goal-setting and high-quality resources, including motiva- tional factsheets) for behaviour change. This co-design approach enabled the development of a theoretically-informed intervention with a content, structure and delivery model that has the potential to address the weight management challenges faced by BCPs. Future research is required to evaluate the effectiveness of the intervention for eliciting clinically-important and sustainable weight loss in this population.
The third phase of the development work was to pilot the intervention in BCPs. A two arm, parallel group, randomised controlled external pilot study recruited early-stage breast cancer patients with a body mass index (BMI) >25, within 3 years of completing primary treatment (excluding endocrine therapy) from oncology centres in hospitals in the north of England. Participants were randomly allocated (2:1) to the NEWDAY-ABC co-designed lifestyle intervention (bespoke support for healthy eating and regular physical activity) or usual care control group. The main feasibility outcomes were rates of recruitment, data quality, intervention acceptability and adherence. Secondary outcomes were the candidate outcomes for a definitive trial including weight loss, anthropometric measures, dietary behaviour change, physical activity and patient-reported outcomes (PROMs) relevant to the physical and psychological health challenges experienced by this population and were assessed at baseline and 6-months. Although recruitment to this pilot study was thwarted by the Covid-19 pandemic, the intervention was shown to be feasible in a small group of patients and demonstrated clear signals of efficacy for weight loss, health behaviour change and other patient-reported outcomes. This suggests that the intervention has much potential to elicit meaningful improvements in a range of important health outcomes at 6 months. Further research is needed to translate these findings to the broader UK breast cancer population and to evaluate sustainability of weight loss beyond 6 months.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
19/NE/0358
Date of REC Opinion
7 Jan 2020
REC opinion
Further Information Favourable Opinion