Optimising psychological treatment for pain after breast cancer: a factorial design study protocol in Denmark.

INTRODUCTION: One in five breast cancer (BC) survivors are affected by persistent pain years after completing primary treatment. While the efficacy of psychological interventions for BC-related pain has been documented in several meta-analyses, reported effect sizes are generally modest, pointing to a need for optimisation. Guided by the Multiphase Optimization Strategy, the present study aims to optimise psychological treatment for BC-related pain by identifying active treatment components in a full factorial design. METHODS AND ANALYSIS: The study uses a 2×3 factorial design, randomising 192 women with BC-related pain (18-75 years) to eight experimental conditions. The eight conditions consist of three contemporary cognitive-behavioural therapy components, namely: (1) mindful attention, (2) decentring, and (3) values and committed action. Each component is delivered in two sessions, and each participant will receive either zero, two, four or six sessions. Participants receiving two or three treatment components will be randomised to receive them in varying order. Assessments will be conducted at baseline (T1), session by session, every day for 6 days following the first session in each treatment component, at post-intervention (T2) and at 12-week follow-up (T3). Primary outcomes are pain intensity (Numerical Rating Scale) and pain interference (Brief Pain Inventory interference subscale) from T1 to T2. Secondary outcomes are pain burden, pain quality, pain frequency, pain catastrophising, psychological distress, well-being and fear of cancer recurrence. Possible mediators include mindful attention, decentring, and pain acceptance and activity engagement. Possible moderators are treatment expectancy, treatment adherence, satisfaction with treatment and therapeutic alliance. ETHICS AND DISSEMINATION: Ethical approval for the present study was received from the Central Denmark Region Committee on Health Research Ethics (no: 1-10-72-309-40). Findings will be made available to the study funders, care providers, patient organisations and other researchers at international conferences, and published in international, peer-reviewed journals. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT05444101).

Overweight and prognosis in triple-negative breast cancer patients: a systematic review and meta-analysis.

We conducted a systematic review and meta-analysis investigating the association between overweight and outcome in triple-negative breast cancer (TNBC) patients. We searched PubMed and Embase using variations of the search terms triple-negative breast cancer (population), overweight and/or obesity (exposure), and prognosis (outcome). Based on the World Health Organization guidelines for defining overweight, we included longitudinal observational studies, which utilized survival statistics with hazard ratios (HRs) in our analysis. The included studies measured body mass index at the time of diagnosis of TNBC and reported disease-free survival and/or overall survival. Study quality was assessed with the Newcastle-Ottawa Scale and study data were extracted using the Meta-analysis of Observational Studies in Epidemiology (MOOSE) checklist, independently by two authors. Random-effects models were used to combine the effect sizes (HRs), and the results were evaluated and adjusted for possible publication bias. Thirteen studies of 8,944 TNBC patients were included. The meta-analysis showed that overweight was associated with both shorter disease-free survival (HR = 1.26; 95%CI: 1.09-1.46) and shorter overall survival (HR = 1.29; 95%CI: 1.11c1.51) compared to normal-weight. Additionally, our Bayesian meta-analyses suggest that overweight individuals are 7.4 and 9.9 times more likely to have shorter disease-free survival and overall survival, respectively. In conclusion, the available data suggest that overweight is associated with shorter disease-free and overall survival among TNBC patients. The results should be interpreted with caution due to possible publication bias.

Mindfulness-based interventions for psychological and physical health outcomes in cancer patients and survivors: A systematic review and meta-analysis of randomized controlled trials.

OBJECTIVE: Mindfulness-based interventions (MBIs) are increasingly used within psycho-oncology. Since the publication of the most recent comprehensive meta-analysis on MBIs in cancer in 2012, the number of published trials has more than doubled. We therefore conducted a systematic review and meta-analysis of randomized controlled trials (RCTs), testing the efficacy of MBIs on measures of psychological distress (primary outcome) and other health outcomes in cancer patients and survivors. METHODS: Two authors conducted independent literature searches in electronic databases from first available date to 10 October 2018, selected eligible studies, extracted data for meta-analysis, and evaluated risk of bias. RESULTS: Twenty-nine independent RCTs (reported in 38 papers) with 3274 participants were included. Small and statistically significant pooled effects of MBIs on combined measures of psychological distress were found at post-intervention (Hedges's g = 0.32; 95%CI: 0.22-0.41; P < .001) and follow-up (g = 0.19; 95%CI: 0.07-0.30; P < .002). Statistically significant effects were also found at either post-intervention or follow-up for a range of self-reported secondary outcomes, including anxiety, depression, fear of cancer recurrence, fatigue, sleep disturbances, and pain (g: 0.20 to 0.51; p: <.001 to.047). Larger effects of MBIs on psychological distress were found in studies (a) adhering to the original MBI manuals, (b) with younger patients, (c) with passive control conditions, and (d) shorter time to follow-up. Improvements in mindfulness skills were associated with greater reductions in psychological distress at post-intervention. CONCLUSIONS: MBIs appear efficacious in reducing psychological distress and other symptoms in cancer patients and survivors. However, many of the effects were of small magnitude, suggesting a need for intervention optimization research.

Mindfulness-based Cognitive Therapy and Persistent Pain in Women Treated for Primary Breast Cancer: Exploring Possible Statistical Mediators: Results From a Randomized Controlled Trial.

OBJECTIVES: The aim of this study was to investigate possible statistical mediators in a randomized controlled trial of mindfulness-based cognitive therapy (MBCT) on pain intensity in women treated for primary breast cancer. MATERIALS AND METHODS: The sample consisted of 129 women treated for breast cancer, presenting with persistent pain, who were randomly assigned to MBCT or a wait-list control. We previously reported a statistically significant and robust effect of MBCT on pain intensity (11-point numeric rating scale), which was included as the primary outcome. The proposed mediators were mindfulness (the Five Facet Mindfulness Questionnaire), self-compassion (the Short-Form Self-Compassion Scale), and pain catastrophizing (the Pain Catastrophizing Scale). Measurement points included baseline (T1), postintervention (T2), and 3- (T3) and 6-month (T4) follow-ups. All indirect effects of the mediators were tested in separate Multilevel Models, using the product-of-coefficients approach with bias-corrected confidence intervals (95% BSCI). The statistically significant mediators were then included in a multiple mediator model. RESULTS: Statistically significant indirect effects were found for mindfulness nonreactivity (B=-0.17, BSCI [-0.32 to -0.04]) and pain catastrophizing (B=-0.76, BSCI [-1.25 to -0.47]). No statistically significant indirect effect was found for self-compassion (B=-0.09, BSCI [-0.30 to 0.04]). In a multiple mediator model, including mindfulness nonreactivity and pain catastrophizing, only pain catastrophizing remained statistically significant (B=-0.72, BSCI [-1.19 to -0.33]), explaining 78% of the effect. DISCUSSION: The results of the present study may have clinical implications. An increased focus on the proposed mediators may optimize the clinical use of MBCT for persistent pain in women treated for breast cancer.

Efficacy of Mindfulness-Based Cognitive Therapy on Late Post-Treatment Pain in Women Treated for Primary Breast Cancer: A Randomized Controlled Trial.

PURPOSE: To assess the efficacy of mindfulness-based cognitive therapy (MBCT) for late post-treatment pain in women treated for primary breast cancer. METHODS: A randomized wait list-controlled trial was conducted with 129 women treated for breast cancer reporting post-treatment pain (score ≥ 3 on pain intensity or pain burden assessed with 10-point numeric rating scales). Participants were randomly assigned to a manualized 8-week MBCT program or a wait-list control group. Pain was the primary outcome and was assessed with the Short Form McGill Pain Questionnaire 2 (SF-MPQ-2), the Present Pain Intensity subscale (the McGill Pain Questionnaire), and perceived pain intensity and pain burden (numeric rating scales). Secondary outcomes were quality of life (World Health Organization-5 Well-Being Index), psychological distress (the Hospital Depression and Anxiety Scale), and self-reported use of pain medication. All outcome measures were assessed at baseline, postintervention, and 3-month and 6-month follow-up. Treatment effects were evaluated with mixed linear models. RESULTS: Statistically significant time × group interactions were found for pain intensity (d = 0.61; P = .002), the Present Pain Intensity subscale (d = 0.26; P = .026), the SF-MPQ-2 neuropathic pain subscale (d = 0.24; P = .036), and SF-MPQ-2 total scores (d = 0.23; P = .036). Only pain intensity remained statistically significant after correction for multiple comparisons. Statistically significant effects were also observed for quality of life (d = 0.42; P = .028) and nonprescription pain medication use (d = 0.40; P = .038). None of the remaining outcomes reached statistical significance. CONCLUSION: MBCT showed a statistically significant, robust, and durable effect on pain intensity, indicating that MBCT may be an efficacious pain rehabilitation strategy for women treated for breast cancer. In addition, the effect on neuropathic pain, a pain type reported by women treated for breast cancer, further suggests the potential of MBCT but should be considered preliminary.

Do postoperative psychotherapeutic interventions and support groups influence weight loss following bariatric surgery? A systematic review and meta-analysis of randomized and nonrandomized trials.

Bariatric surgery is currently considered the most effective treatment of severe obesity, but considerable individual variations in weight loss results have been reported. We therefore conducted a systematic review and meta-analysis of studies investigating the effect of psychotherapeutic interventions and support groups on weight loss following bariatric surgery. A literature search was conducted in the databases PubMed and PsycINFO, identifying nine eligible studies reporting results of the effect of psychotherapeutic interventions and support groups on weight loss following bariatric surgery. The results revealed a statistically significant overall effect of both psychotherapeutic interventions and support groups on weight loss (pooled effect size correlation (ESr) = 0.18; p < 0.0001). When comparing the effect sizes of psychotherapeutic interventions and support groups, no difference was found (p = 0.51). Higher quality studies had smaller effect sizes (0.16) than studies with low quality scores (0.22), but the difference did not reach statistical significance (p = 0.26). Patients attending psychotherapeutic interventions or support groups in combination with bariatric surgery appeared to experience greater weight loss results than patients treated with bariatric surgery only. However, research in this area is characterized by a lack of methodological rigor, and it is recommended that future study designs include randomization and active attention control conditions.