Optimizing electronic capture of patient-reported outcome measures in oncology clinical trials: lessons learned from a qualitative study.

Aim: To understand the impact of anticancer treatment on oncology patients' ability to use electronic solutions for completing patient-reported outcomes (ePRO). Materials & methods: Semi-structured interviews were conducted with seven individuals who had experienced a cancer diagnosis and treatment. Results: Participants reported that the following would impact the ability to interact with an ePRO solution: peripheral neuropathy of the hands (4/7), fatigue and/or concentration and memory issues (6/7), where they are in a treatment cycle (5/7). Approaches to improve usability included: larger, well-spaced buttons to deal with finger numbness, the ability to pause a survey and complete at a later point and presenting the recall period with every question to reduce reliance on memory. Conclusion: Symptoms associated with cancers and anticancer treatments can impact the use of technologies. The recommendations for optimizing the electronic implementation of patient-reported outcome instruments in this population provides the potential to improve data quality in oncology trials and places patient needs at the forefront to ensure 'fit-for-purpose' solutions.

Improvements in Stress, Affect, and Irritability Following Brief Use of a Mindfulness-based Smartphone App: A Randomized Controlled Trial.

Mindfulness training, which involves observing thoughts and feelings without judgment or reaction, has been shown to improve aspects of psychosocial well-being when delivered via in-person training programs such as mindfulness-based stress reduction (MBSR) and mindfulness-based cognitive therapy (MBCT). Less is known about the efficacy of digital training mediums, such as smartphone apps, which are rapidly rising in popularity. In this study, novice meditators were randomly allocated to an introductory mindfulness meditation program or to a psychoeducational audiobook control featuring an introduction to the concepts of mindfulness and meditation. The interventions were delivered via the same mindfulness app, were matched across a range of criteria, and were presented to participants as well-being programs. Affect, irritability, and two distinct components of stress were measured immediately before and after each intervention in a cohort of healthy adults. While both interventions were effective at reducing stress associated with personal vulnerability, only the mindfulness intervention had a significant positive impact on irritability, affect, and stress resulting from external pressure (between group Cohen's d = 0.44, 0.47, 0.45, respectively). These results suggest that brief mindfulness training has a beneficial impact on several aspects of psychosocial well-being, and that smartphone apps are an effective delivery medium for mindfulness training.

The efficacy of protein supplementation during recovery from muscle-damaging concurrent exercise.

This study investigated the effect of protein supplementation on recovery following muscle-damaging exercise, which was induced with a concurrent exercise design. Twenty-four well-trained male cyclists were randomised to 3 independent groups receiving 20 g protein hydrolysate, iso-caloric carbohydrate, or low-calorific placebo supplementation, per serve. Supplement serves were provided twice daily, from the onset of the muscle-damaging exercise, for a total of 4 days and in addition to a controlled diet (6 g·kg-1·day-1 carbohydrate, 1.2 g·kg-1·day-1 protein, remainder from fat). Following the concurrent exercise session at time-point 0 h, comprising a simulated high-intensity road cycling trial and 100 drop-jumps, recovery of outcome measures was assessed at 24, 48, and 72 h. The concurrent exercise protocol was deemed to have caused exercise-induced muscle damage (EIMD), owing to time effects (p < 0.001), confirming decrements in maximal voluntary contraction (peaking at 15% ± 10%) and countermovement jump performance (peaking at 8% ± 7%), along with increased muscle soreness, creatine kinase, and C-reactive protein concentrations. No group or interaction effects (p > 0.05) were observed for any of the outcome measures. The present results indicate that protein supplementation does not attenuate any of the indirect indices of EIMD imposed by concurrent exercise, when employing great rigour around the provision of a quality habitual diet and the provision of appropriate supplemental controls.

Effect of training on the response of plasma vascular endothelial growth factor to exercise in patients with peripheral arterial disease.

Expansion of the capillary network, or angiogenesis, occurs following endurance training. This process, which is reliant on the presence of VEGF (vascular endothelial growth factor), is an adaptation to a chronic mismatch between oxygen demand and supply. Patients with IC (intermittent claudication) experience pain during exercise associated with an inadequate oxygen delivery to the muscles. Therefore the aims of the present study were to examine the plasma VEGF response to acute exercise, and to establish whether exercise training alters this response in patients with IC. In Part A, blood was collected from patients with IC (n=18) before and after (+20 and +60 min post-exercise) a maximal walking test to determine the plasma VEGF response to acute exercise. VEGF was present in the plasma of patients (45.11+/-29.96 pg/ml) and was unchanged in response to acute exercise. Part B was a training study to determine whether exercise training altered the VEGF response to acute exercise. Patients were randomly assigned to a treatment group (TMT; n=7) that completed 6 weeks of high-intensity treadmill training, or to a control group (CON; n=6). All patients completed a maximal walking test before and after the intervention, with blood samples drawn as for Part A. Training had no effect on plasma VEGF at rest or in response to acute exercise, despite a significant increase in maximal walking time in the TMT group (915+/-533 to 1206+/-500 s; P=0.009) following the intervention. The absence of a change in plasma VEGF may reflect altered VEGF binding at the endothelium, although this cannot be confirmed by the present data.