Recruitment, adherence, and retention of endometrial cancer survivors in a behavioural lifestyle programme: the Diet and Exercise in Uterine Cancer Survivors (DEUS) parallel randomised pilot trial

Objective: Healthy eating and physical activity may help endometrial cancer survivors (ECS) improve their quality of life. However, most ECS do not meet the relevant guidelines. This pilot trial aimed to test the study feasibility procedures for a definitive trial of a behavioural lifestyle programme. Design and setting: This 24-week parallel two-arm randomised pilot trial took place in two hospitals in London, UK (April 2015–June 2016). Participants: Sixty disease-free ECS within 3 years of diagnosis. Interventions: Participants were randomised using minimisation to receive the intervention or care as usual. The ‘Shape-Up following cancer treatment’ programme used self-monitoring, goal-setting, self-incentives, problem-solving and group social support for 12 hours over 8 weeks to help survivors improve their eating and physical activity. Outcome measures: The main outcome measures were recruitment, adherence, and retention rates. Further outcomes included barriers to participation and feedback on programme satisfaction. Results: Of the 296 potentially eligible ECS, 20% (n=60) were randomly allocated to the active intervention (n=29) or control group (n=31). Three participants in each arm were deemed ineligible after randomisation and excluded from analysis. Twenty participants (77%; 95% CI 61% to 93%) adhered to the intervention and provided generally favourable feedback. At 24 weeks, 25/26 (96%; 95% CI 89% to 100%) intervention and 24/28 (86%; 95% CI 73% to 99%) control participants completed their assessment. No intervention-related adverse events were reported. Among eligible survivors who declined study participation (n=83), inconvenience (78%; 95% CI 69% to 87%) was the most common barrier. Conclusions: The trial was feasible to deliver based on the a priori feasibility criteria. Enhancing recruitment and adherence in a definitive trial will require designs that promote convenience and consider ECS-reported barriers. Trial registration number: NCT02433080; Pre-results. Trial funding: University College London, St. Bartholomew’s Hospital Nurses League, and NIHR University College London Hospitals Biomedical Research Centre

Use of intervention mapping to adapt a health behavior change intervention for endometrial cancer survivors: The shape-up following cancer treatment program

Background: About 80% of endometrial cancer survivors (ECS) are overweight or obese and have sedentary behaviors. Lifestyle behavior interventions are promising for improving dietary and physical activity behaviors, but the constructs associated with their effectiveness are often inadequately reported. The aim of this study was to systematically adapt an evidence-based behavior change program to improve healthy lifestyle behaviors in ECS. Methods: Following a review of the literature, focus groups and interviews were conducted with ECS (n = 16). An intervention mapping protocol was used for the program adaptation, which consisted of six steps: a needs assessment, formulation of matrices of change objectives, selection of theoretical methods and practical applications, program production, adoption and implementation planning, and evaluation planning. Social Cognitive Theory and Control Theory guided the adaptation of the intervention. Results: The process consisted of eight 90-min group sessions focusing on shaping outcome expectations, knowledge, self-efficacy, and goals about healthy eating and physical activity. The adapted performance objectives included establishment of regular eating, balanced diet, and portion sizes, reduction in sedentary behaviors, increase in lifestyle and organized activities, formulation of a discrepancy-reducing feedback loop for all above behaviors, and trigger management. Information on managing fatigue and bowel issues unique to ECS were added. Conclusions: Systematic intervention mapping provided a framework to design a cancer survivor-centered lifestyle intervention. ECS welcomed the intervention and provided essential feedback for its adaptation. The program has been evaluated through a randomized controlled trial

Breast, Prostate, and Colorectal Cancer Survivors' Experiences of Using Publicly Available Physical Activity Mobile Apps: Qualitative Study

BACKGROUND: Physical activity (PA) can improve a range of outcomes following a cancer diagnosis. These include an improvement in experience of side effects of treatment (eg, fatigue) and management of comorbid conditions. PA might also increase survival and reduce recurrence. Digital interventions have shown potential for PA promotion among cancer survivors, but most in a previous review were Web-based, and few studies used mobile apps. There are many PA apps available for general public use, but it is unclear whether these are suitable as a PA intervention after a cancer diagnosis. OBJECTIVE: This study sought posttreatment nonmetastatic breast, prostate, and colorectal cancer survivors' opinions of using smartphone apps to promote PA and gathered their views on existing publicly available PA apps to inform a future intervention. METHODS: Each participant was randomly assigned to download 2 of 4 apps (Human, The Walk, The Johnson & Johnson Official 7 Minute Workout, and Gorilla Workout). Participants used each app for 1 week consecutively. In-depth semistructured telephone interviews were then conducted to understand participants' experiences of using the apps and how app-based PA interventions could be developed for cancer survivors. The interviews were analyzed using thematic analysis. RESULTS: Thirty-two participants took part: 50% (16/32) had prostate cancer, 25% (8/32) had breast cancer, and 25% (8/32) had colorectal cancer. Three core themes were identified. The first theme was that multiple factors affect engagement with PA apps and this is highly personalized. Factors affecting engagement included participants' perceptions of (1) the advantages and disadvantages of using apps to support PA, (2) the relevance of the app to the user (eg, in terms of cancer-related factors, their PA goals, the difficulty level of the app, the way in which they interact with their mobile phone, and the extent to which the app fits with their self-identity), (3) the quality of the app (eg, usability, accuracy, quality of production, and scientific evidence-base), and (4) the behavior change techniques used to promote PA. In the second theme, participants recommended that apps that promote walking are most appealing, as walking removes many barriers to PA. Finally, the participants suggested that PA apps should be integrated into cancer care, as they valued guidance and recommendations from health care professionals. CONCLUSIONS: This sample of breast, prostate, and colorectal cancer survivors was receptive to the use of apps to promote PA. Although no publicly available PA app was deemed wholly suitable, many suggestions for adaptation and intervention development were provided. The results can inform the development of an app-based PA intervention for cancer survivors. They also highlight the wide-ranging and dynamic influences on engagement with digital interventions, which can be applied to other evaluations of mobile health products in other health conditions and other health behaviors

The adapted Zelen was a feasible design to trial exercise in myeloma survivors

OBJECTIVE: We utilised a method rarely seen in cancer behavioural trials to explore methods of overcoming difficulties often seen in randomised controlled trials. We report our experiences of the adapted-Zelen design, so that other researchers can consider this approach for behavioural trials. STUDY DESIGN: & Setting:The adapted-Zelen design was used to explore the effects of exercise on multiple myeloma patients fatigue, quality of life and physical outcomes. All participants consented to an observational cohort study of lifestyle factors, but were unaware of subsequent randomisation to remain in cohort only group or be offered an exercise intervention requiring second consent. RESULTS: Due to lower than expected uptake rate to the exercise offered group (57%), the length of recruitment increased from 24 to 29 months to ensure power was reached. At enrolment patients were unaware of the potential increased commitment and as a result 62% of participants allocated to the intervention declined due to the extra time/travel commitment required. This emulates clinical settings and suggests improvements in intervention delivery are required. Dropout rates from the cohort only group were similar to designs that provide the control with the intervention. Our results from the main study do not suggest contamination occurred despite some anecdotal evidence. CONCLUSION: Future use of this design warrants careful consideration of the study resources and recruitment time frames required but holds potential value in reducing contamination, control group dissatisfaction and resulting drop out. Adapted-Zelen design reduces selection bias and therefore gives clinicians a better understanding of acceptability in clinical settings. Future studies should evaluate control group experiences of the design and formally record contamination throughout the study to confirm its acceptability

Fatigue, quality of life and physical fitness following an exercise intervention in multiple myeloma survivors (MASCOT): an exploratory randomised Phase 2 trial utilising a modified Zelen design

Background: Exercise may improve fatigue in multiple myeloma survivors, but trial evidence is limited, and exercise may be perceived as risky in this older patient group with osteolytic bone destruction. / Methods: In this Phase 2 Zelen trial, multiple myeloma survivors who had completed treatment at least 6 weeks ago, or were on maintenance only, were enrolled in a cohort study and randomly assigned to usual care or a 6-month exercise programme of tailored aerobic and resistance training. Outcome assessors and usual care participants were masked. The primary outcome was the FACIT-F fatigue score with higher scores denoting less fatigue. / Results: During 2014–2016, 131 participants were randomised 3:1 to intervention (n = 89) or usual care (n = 42) to allow for patients declining allocation to the exercise arm. There was no difference between groups in fatigue at 3 months (between-group mean difference: 1.6 [95% CI: −1.1–4.3]) or 6 months (0.3 [95% CI: −2.6–3.1]). Muscle strength improved at 3 months (8.4 kg [95% CI: 0.5–16.3]) and 6 months (10.8 kg [95% CI: 1.2–20.5]). Using per-protocol analysis, cardiovascular fitness improved at 3 months (+1.2 ml/kg/min [95% CI: 0.3–3.7]). In participants with clinical fatigue (n = 17), there was a trend towards less fatigue with exercise over 6 months (6.3 [95% CI: −0.6–13.3]). There were no serious adverse events. / Conclusions: Exercise appeared safe and improved muscle strength and cardiovascular fitness, but benefits in fatigue appeared limited to participants with clinical fatigue at baseline. Future studies should focus on patients with clinical fatigue. / Clinical trial registration: The study was registered with ISRCTN (38480455) and is completed

Applied Interventions in the Prevention and Treatment of Obesity Through the Research of Professor Jane Wardle

Purpose of Review Obesity presents a challenge for practitioners, policy makers, researchers and for those with obesity themselves. This review focuses on psychological approaches to its management and prevention in children and adults. Recent Findings Through exploring the work of the late Professor Jane Wardle, we look at the earliest behavioural treatment approaches and how psychological theory has been used to develop more contemporary approaches, for example incorporating genetic feedback and habit formation theory into interventions. We also explore how Jane has challenged thinking about the causal pathways of obesity in relation to eating behaviour. Beyond academic work, Jane was an advocate of developing interventions which had real-world applications. Summary Therefore, we discuss how she not only developed new interventions but also made these widely available and the charity that she established

Nutrition and physical activity recommendations for cancer survivors in Scotland: feasibility of a short course to promote behaviour change.

More people are living for longer following a cancer diagnosis, however long-term survivors are more likely to experience chronic illnesses. Improving their diet and physical activity behaviours may increase survival and reduce the risk of cancer recurrence and other non-communicable diseases. The World Cancer Research Fund and American Institute for Cancer Research recommend that cancer survivors aim to be a healthy weight and physically active; eat a diet rich in wholegrains, vegetables, fruits and beans; limit consumption of ‘fast foods’, red and processed meat, sugar sweetened drinks and alcohol; and meet nutritional needs through diet alone rather than relying on supplements. Evidence suggests that cancer survivors are receptive to receiving advice and making dietary and physical activity changes, but barriers to improving the diet and being physically active need to be explored and addressed. We collaborated with CLAN Cancer Support (an independent charity) to assess the feasibility of a two-day course designed to improve diet and physical activity in cancer survivors in Scotland. Further, it explored the barriers and facilitators that cancer survivors identify in relation to eating a healthy diet and being physically active. The course included presentations, practical activities and group discussions. Initial analysis indicates that factors specific to this population need to be designed into the delivery of the course to enhance recruitment and promote behaviour change. Research then needs to be translated into sustainable support programmes accessible by all cancer survivors. This article describes the rationale behind the study, its design and expected outcomes

Cancer specialist nurses’ perspectives of physical activity promotion and the potential role of physical activity apps in cancer care

Purpose: The purpose of this study was to understand breast, prostate and colorectal cancer Clinical Nurse Specialists’ (CNSs) perspectives on physical activity (PA) promotion and the role of smartphone apps to support PA promotion in cancer care. Methods: CNSs working in breast, prostate or colorectal cancer were recruited via advertisements distributed by professional organisations. In-depth semi-structured telephone interviews were conducted and analysed using thematic analysis. Results: 19 CNSs participated. The analysis resulted in 4 themes regarding CNSs’ perspectives of PA promotion within cancer care: i) policy changes in survivorship care have influenced CNSs’ promotion of PA; ii) CNSs recognise their role in supporting PA but sit within a wider system necessary for effective PA promotion; iii) CNSs use several techniques to promote PA within their consultations; iv) remaining challenges in PA promotion. The analysis resulted in 3 themes regarding CNSs’ perspectives on the use of apps to promote PA within cancer care: i) the influence of apps on access to PA support; ii) the role of apps in self-directed PA; iii) implementing apps in cancer care. Conclusions: The results of this study provide valuable insight into the CNS role and provide a number of important considerations for the development and implementation of PA interventions within cancer care, with a specific focus on smartphone-based interventions. Implications for cancer survivors: CNSs play an important role in PA promotion in cancer care and this research can inform the development of PA interventions delivered via smartphone app for people affected by cancer