BE-WEL trial (breast: evaluation of weight and exercise for lymphoedema) testing weight control and exercise programmes for women with breast cancer related lymphoedema: a feasibility trial.

PURPOSE: A combined body weight loss and upper body/arm exercise programme is a potential strategy for managing Breast cancer related lymphoedema (BCRL), but there is limited data on the best method for delivery or its potential efficacy. METHODS: Fifty-seven women with overweight/obesity and BCRL were randomised to a 12 week supervised (n = 12) or home-based combined weight loss and upper body/arm exercise programme (n = 16), a home-based upper-body arm exercise only programme (n = 17) or standard care (n = 12). Primary outcomes were uptake, retention and changes in weight and change in Relative Arm Volume Increase (RAVI) using analysis of covariance (ANCOVA). RESULTS: Sixteen percent of women invited joined the study and 49 completed the trial (85% retention). Reductions in weight occurred in the supervised and home-based weight control and exercise programmes; Mean (95% CI) change compared to standard care - 1.68 (- 4.36 to - 1.00), - 2.47(- 4.99 to - 0.04) Kg. Reductions in perometer assessed RAVI were seen in the supervised and home-based combined weight control and arm exercise groups and the weight stable home-based arm exercise only group: mean (95% CI) change compared to standard care - 2.4 (- 5.0 to + 0.4),- 1.8 (- 4.3 to + 0.7), - 2.5(- 4.9 to - 0.05)%. CONCLUSION: Women with BCRL and overweight and obesity engaged in diet and exercise weight loss programmes. Both weight loss/arm exercise programmes led to modest changes in weight and BCRL. Comparable reductions in BCRL were reported in the weight stable group undertaking arm exercise only. The independent and combined effects of weight loss and exercise on BCRL need further study. TRIAL REGISTRATION: ISRCTN86789850 https://doi.org/10.1186/ISRCTN86789850 , registered 2011.

Randomised controlled trial of intermittent vs continuous energy restriction during chemotherapy for early breast cancer.

BACKGROUND: Excess adiposity at diagnosis and weight gain during chemotherapy is associated with tumour recurrence and chemotherapy toxicity. We assessed the efficacy of intermittent energy restriction (IER) vs continuous energy restriction (CER) for weight control and toxicity reduction during chemotherapy. METHODS: One hundred and seventy-two women were randomised to follow IER or CER throughout adjuvant/neoadjuvant chemotherapy. Primary endpoints were weight and body fat change. Secondary endpoints included chemotherapy toxicity, cardiovascular risk markers, and correlative markers of metabolism, inflammation and oxidative stress. RESULTS: Primary analyses showed non-significant reductions in weight (-1.1 (-2.4 to +0.2) kg, p = 0.11) and body fat (-1.0 (-2.1 to +0.1) kg, p = 0.086) in IER compared with CER. Predefined secondary analyses adjusted for body water showed significantly greater reductions in weight (-1.4 (-2.5 to -0.2) kg, p = 0.024) and body fat (-1.1 (-2.1 to -0.2) kg, p = 0.046) in IER compared with CER. Incidence of grade 3/4 toxicities were comparable overall (IER 31.0 vs CER 36.5%, p = 0.45) with a trend to fewer grade 3/4 toxicities with IER (18%) vs CER (31%) during cycles 4-6 of primarily taxane therapy (p = 0.063). CONCLUSIONS: IER is feasible during chemotherapy. The potential efficacy for weight control and reducing toxicity needs to be tested in future larger trials. CLINICAL TRIAL REGISTRATION: ISRCTN04156504.

The effectiveness of home versus community-based weight control programmes initiated soon after breast cancer diagnosis: a randomised controlled trial.

BACKGROUND: Breast cancer diagnosis may be a teachable moment for lifestyle behaviour change and to prevent adjuvant therapy associated weight gain. We assessed the acceptability and effectiveness of two weight control programmes initiated soon after breast cancer diagnosis to reduce weight amongst overweight or obese women and prevent gains in normal-weight women. METHODS: Overweight or obese (n = 243) and normal weight (n = 166) women were randomised to a three-month unsupervised home (home), a supervised community weight control programme (community) or to standard written advice (control). Primary end points were change in weight and body fat at 12 months. Secondary end points included change in insulin, cardiovascular risk markers, quality of life and cost-effectiveness of the programmes. RESULTS: Forty-three percent of eligible women were recruited. Both programmes reduced weight and body fat: home vs. control mean (95% CI); weight -2.3 (-3.5, -1.0) kg, body fat -1.6 (-2.6, -0.7) kg, community vs. control; weight -2.4 (-3.6, -1.1) kg, body fat -1.4 (-2.4, -0.5) kg (all p < 0.001). The community group increased physical activity, reduced insulin, cardiovascular disease risk markers, increased QOL and was cost-effective. CONCLUSIONS: The programmes were equally effective for weight control, but the community programme had additional benefits. CLINICAL TRIAL REGISTRATION: ISRCTN68576140.

An exploration of emotion regulation in psychosis.

UNLABELLED: The emotional experience of individuals who experience psychosis has historically been neglected, possibly due to the divide between the psychoses and neuroses. This study examined emotional experience and regulation in individuals who had experienced psychosis, individuals experiencing anxiety or mood disorders, and non-patient controls. Participants completed validated measures of emotional experience and emotion regulation. Both clinical groups were found to experience similar levels of emotions, and in comparison to the non-patient controls, they experienced greater levels of negatively valenced emotions and lower levels of happiness. Both clinical groups also used similar emotion regulation strategies, and in comparison to non-patient controls, they used significantly more dysfunctional and less functional strategies, suggesting that the emotional experience and emotion regulation strategies of people who have experienced psychosis are more similar to non-psychotic disorders than have previously been thought to be the case. The theoretical and clinical implications of these findings are discussed. KEY PRACTITIONER MESSAGE: *Individuals with psychosis experience similar emotions as individuals with anxiety and mood disorders, namely more unhappiness, fear and less happiness. *People with psychosis attempt to regulate these emotions in similar ways to people with mood and anxiety problems, by using more dysfunctional emotional regulation strategies such as ruminating. *Clinicians may want to pay closer attention to assessing the emotion regulation strategies of those who experience psychosis and consider the implications of these in therapy. *They may also want to consider the role emotional dysregulation may play in the development, maintenance and course of psychosis. *An emotion regulation approach to psychosis may be characterised by focussing on emotional experiences and the individual's response to these, as opposed to psychotic symptoms.

The Effect of Reducing the "Jumping to Conclusions" Bias on Treatment Decision-Making Capacity in Psychosis: A Randomized Controlled Trial With Mediation Analysis.

BACKGROUND: Evidence-based psychological interventions to support treatment decision-making capacity (capacity) in psychosis do not currently exist. This study sought to establish whether reducing the extent to which this group form conclusions based on limited evidence, also known as the "jumping-to-conclusions" (JTC) bias, could improve capacity. METHODS: In a randomized controlled open trial, 37 patients aged 16-65 years diagnosed with schizophrenia-spectrum disorders were randomly assigned (1:1) to receive a single-session intervention designed to reduce the JTC bias (MCT-JTC; adapted from Metacognitive Training [MCT]) or an attention control (AC) condition designed to control for therapist attention, duration, modality, and face validity. Primary outcomes were treatment decision-making capacity measured by the MacArthur Competency Assessment Tool for Treatment (MacCAT-T) and the jumping-to-conclusions reasoning bias measured by draws to decision on the beads task, each of which were administered by the psychologist delivering the intervention. RESULTS: Those receiving MCT-JTC had large improvements in overall capacity (d = 0.96, P < .05) and appreciation (d = 0.87, P < .05) compared to those receiving AC. Reduction in JTC mediated a large proportion of the effect of group allocation on understanding, appreciation, reasoning, and overall MacCAT-T scores. CONCLUSION: This is the first experimental investigation of the effect of a psychological intervention on treatment decision-making capacity in psychosis. It provides early evidence that reducing the JTC bias is associated with large and rapid improvements in capacity. Due to limited resources, assessments were administered by the researchers delivering the intervention. Results should therefore be considered preliminary and a larger, definitive trial addressing methodological limitations is warranted.