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Background Exercise is an effective strategy to improve quality of life and physical fitness in breast cancer survivors; however, few studies have focused on the early survivorship period, minorities, physically inactive and obese women, or tested a combined exercise program and measured bone health. Here, we report the effects of a 16-week aerobic and resistance exercise intervention on patient-reported outcomes, physical fitness, and bone health in ethnically diverse, physically inactive, overweight or obese breast cancer survivors. Methods One hundred breast cancer survivors within 6 months of completing adjuvant treatment were assessed at baseline, post-intervention, and 3-month follow-up (exercise group only) for physical fitness, bone mineral density, serum concentrations of bone biomarkers, and quality of life. The exercise intervention consisted of moderate-vigorous (65–85% heart rate maximum) aerobic and resistance exercise thrice weekly for 16 weeks. Differences in mean changes for outcomes were evaluated using mixed-model repeated measure analysis. Results At post-intervention, the exercise group was superior to usual care for quality of life (between group difference: 14.7, 95% CI: 18.2, 9.7; p  < 0.001), fatigue (p < 0.001), depression (p < 0.001), estimated VO 2max (p < 0.001), muscular strength (p < 0.001), osteocalcin ( p  = 0.01), and BSAP ( p  = 0.001). At 3-month follow-up, all patient-reported outcomes and physical fitness variables remained significantly improved compared to baseline in the exercise group ( p  < 0.01). Conclusions A 16-week combined aerobic and resistance exercise program designed to address metabolic syndrome in ethnically-diverse overweight or obese breast cancer survivors also significantly improved quality of life and physical fitness. Our findings further support the inclusion of supervised clinical exercise programs into breast cancer treatment and care. Trial registration This trial is registered on ClinicalTrials.gov: NCT01140282 as of June 9, 2010.

Purpose Our study provides data on depression and anxiety in long-term cancer survivors, in men, women and various age groups, as well as identifies associated factors and coping-related resources. Methods We present data obtained from 1002 cancer survivors across a large variety of tumour entities 5 years (cohort 1) and 10 years (cohort 2) after diagnosis, in a cross-sectional study. We analysed depression (PHQ-9) and anxiety (GAD-7) symptomatology in comparison with two large age- and sex-matched samples randomly selected from the general population. Results Moderate to severe depression and anxiety were reported in 17% and 9% of cancer survivors, respectively. There were no significant differences between the 5 years and 10 years after diagnosis cohorts ( p  = 0.232). In both cohorts, we found higher depression and anxiety in women than in men ( p  < 0.001), and lower depression and anxiety in elderly patients ( p  < 0.001). Cancer survivors younger than 60 years of age were more depressed and anxious than the general population ( p  < 0.001). The variables, financial problems (Beta = 0.16, p  < 0.001), global quality of life (Beta = − 0.21, p  < 0.001) and cognitive function (Beta = − 0.30, p  < 0.001), had the strongest association with depression and anxiety. Conclusions For the prevention of depression and anxiety in long-term cancer survivors, individual treatment of physical and psychological symptoms is as important as social support and professional counselling. Post-treatment, cognitive limitations should be carefully assessed in long-term cancer survivorship to distinguish them from symptoms of a mental disorder, especially since younger cancer survivors of working age and female survivors seem to be more affected by depression and anxiety.

Background Breast cancer-related lymphedema (BCRL) represents a major source of morbidity among breast cancer survivors. Increasing data support early detection of subclinical BCRL followed by early intervention. A randomized controlled trial is being conducted comparing lymphedema progression rates using volume measurements calculated from the circumference using a tape measure (TM) or bioimpedance spectroscopy (BIS). Methods Patients were enrolled and randomized to either TM or BIS surveillance. Patients requiring early intervention were prescribed a compression sleeve and gauntlet for 4 weeks and then re-evaluated. The primary endpoint of the trial was the rate of progression to clinical lymphedema requiring complex decongestive physiotherapy (CDP), with progression defined as a TM volume change in the at-risk arm ≥ 10% above the presurgical baseline. This prespecified interim analysis was performed when at least 500 trial participants had ≥ 12 months of follow-up. Results A total of 508 patients were included in this analysis, with 109 (21.9%) patients triggering prethreshold interventions. Compared with TM, BIS had a lower rate of trigger (15.8% vs. 28.5%, p   <  0.001) and longer times to trigger (9.5 vs. 2.8 months, p   =  0.002). Twelve triggering patients progressed to CDP (10 in the TM group [14.7%] and 2 in the BIS group [4.9%]), representing a 67% relative reduction and a 9.8% absolute reduction ( p   =  0.130). Conclusions Interim results demonstrated that post-treatment surveillance with BIS reduced the absolute rates of progression of BCRL requiring CDP by approximately 10%, a clinically meaningful improvement. These results support the concept of post-treatment surveillance with BIS to detect subclinical BCRL and initiate early intervention.

Purpose Multi-gene signatures provide biological insight and risk stratification in breast cancer. Intrinsic molecular subtypes defined by mRNA expression of 50 genes (PAM50) are prognostic in hormone-receptor positive postmenopausal breast cancer. Yet, for 25–40% in the PAM50 intermediate risk group, long-term risk remains uncertain. Our study aimed to (i) test the long-term prognostic value of the PAM50 signature in pre- and post-menopausal breast cancer; (ii) investigate if the PAM50 model could be improved by addition of other mRNAs implicated in oncogenesis. Methods We used archived FFPE samples from 1723 breast cancer survivors; high quality reads were obtained on 1253 samples. Transcript expression was quantified using a custom codeset with probes for > 100 targets. Cox models assessed gene signatures for breast cancer relapse and survival. Results Over 15 + years of follow-up, PAM50 subtypes were ( P  < 0.01) associated with breast cancer outcomes after accounting for tumor stage, grade and age at diagnosis. Results did not differ by menopausal status at diagnosis. Women with Luminal B (versus Luminal A) subtype had a > 60% higher hazard. Addition of a 13-gene hypoxia signature improved prognostication with > 40% higher hazard in the highest vs lowest hypoxia tertiles. Conclusions PAM50 intrinsic subtypes were independently prognostic for long-term breast cancer survival, irrespective of menopausal status. Addition of hypoxia signatures improved risk prediction. If replicated, incorporating the 13-gene hypoxia signature into the existing PAM50 risk assessment tool, may refine risk stratification and further clarify treatment for breast cancer.

Cancer related cognitive impairments have been subjectively reported and objectively detected in breast cancer patients treated with chemotherapy and are known to have a profound negative impact on productivity, psychosocial well-being and overall quality of life. Moderate levels of walking are known to be of benefit to the psychosocial well-being of those affected by breast cancer and for managing cognitive impairment in healthy adults, children, and the elderly. The purpose of this study is to investigate the effects of a home-based, self-managed, moderate intensity walking intervention on subjective and objective cognitive functioning in breast cancer patients undergoing chemotherapy. A home-based, self-managed intervention that consisted of moderate levels of walking was compared to usual care among breast cancer patients treated with chemotherapy in a randomised controlled trial. Outcome measures included changes in subjective (CFQ) and objectively detected cognitive functioning (Stroop, SART and two subscales from the WAIS- Digit Span and Block Design). Fifty participants were randomised to either the intervention group (n = 25), who completed 12 weeks of moderate intensity walking, or to the control group (n = 25) mid-way through chemotherapy. Compared with the control group, the self-managed walking intervention had positive effects on perceived cognitive function but not on sustained attention, executive function, memory or visual spatial skills when assessed objectively using neuropsychological measures. This home-based, self-managed intervention is beneficial for protecting against perceived cognitive decline in breast cancer patients treated with chemotherapy. There is a need for further research to objectively assess cognitive decline within this population with larger sample sizes of patients. Current Controlled Trials ISRCTN50709297.

Background Cardiovascular disease (CVD) remains the largest cause of death in breast cancer survivors. The aim of this study was to explore the impact of exercise intensity on aerobic fitness and autonomic cardiac regulation (heart rate variability (HRV)) and salivary biomarkers of the stress systems (HPA-axis, cortisol; sympathetic nervous system, α-amylase) and mucosal immunity (secretory(s)-IgA), markers of increased risk of CVD in breast cancer survivors. Methods Participants were randomly assigned to; 1) high intensity interval training (HIIT); 2) moderate-intensity, continuous aerobic training (CMIT); or 3) a wait-list control (CON) for a 12-week (36 session) stationary cycling intervention. Cardiorespiratory fitness (VO 2peak ), resting HRV and salivary biomarkers were measured at baseline 2–4 d pre-intervention and 2–4 d post the last exercise session. Results Seventeen participants were included in this study (62 ± 8 years, HIIT; n  = 6, CMIT; n  = 5, CON; n = 6). A significant improvement ( p  ≤ 0.05) was observed for VO 2peak in the HIIT group; 19.3% (B = 3.98, 95%CI = [1.89; 4.02]) and a non-significant increase in the CMIT group; 5.6% (B = 1.96, 95%CI = [− 0.11; 4.03]), compared with a 2.6% (B = − 0.64, 95%CI = [− 2.10; 0.82]) decrease in the CON group. Post intervention improvements in HRV markers of vagal activity (log (ln)LF/HF, LnRMSSD) and sympathetic nervous system (α-amylase waking response) occurred for individuals exhibiting outlying (> 95% CI) levels at baseline compared to general population. Conclusion High intensity interval training improved cardiovascular fitness in breast cancer survivors and improved cardiac regulation, and sympathetic nervous system (stress) responses in some individuals. High-intensity interval training was safe and effective for breast cancer survivors to participate in with promising results as a time efficient intensity to improve physical health and stress, reducing CVD risk. Trial registration This pilot study was retrospectively registered through the Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12620000684921 .

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. 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. 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. 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. 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.

This is a report of the 5-year quality of life (QoL) findings of the BREX-study (n=444). A 12-month exercise intervention was arranged shortly after adjuvant treatments. Physical activity (PA) was assessed by PA diary, physical performance by a 2- km walking test, QoL by the EORTC QLQC30 and BR-23 questionnaires, fatigue by the FACIT-Fatigue scale and depression by the Beck's 13-item depression scale (BDI). Participants who improved their PA from baseline to 5-year follow-up were more likely to improve their global health score (RRR=1.02, p=0.016), physical (RRR=1.02, p=0.009), social (RRR=1.03, p=0.013), role functioning (RRR=1.03, p=0.005), and fatigue (RRR=1.02, p=0.002). An improved 2-km walking test was associated to improved global health, physical and role functioning, body image, future perspectives, and fatigue (p=0.011, p<0.001, p=0.001, p=0.021, p=0.012 and p=0.003). No significant difference between the groups was found. Improvement in PA or physical performance yields a positive change in QoL of breast cancer patients.

Study Objectives: The current archival analyses examine the direct and indirect effects of cognitive behavioral therapy for insomnia (CBT-I) on depression in cancer survivors. Methods: We report on 67 cancer survivors from a 2 × 2 randomized controlled trial of CBT-I and armodafinil for insomnia, after collapsing across the noneffective study medication conditions (armodafinil/placebo) to create CBT-I (yes/no). Depression and insomnia were assessed before, during the 7-week CBT-I intervention, at postintervention, and 3 months later by the Patient Health Questionnaire and the Insomnia Severity Index, respectively. Results: Mean depression at baseline for all participants was 6.44 (standard error = 0.41, range 0–15). Paired t tests showed that depression improved from baseline to postintervention by 48% ( P < .001) in the CBT-I group versus 15% ( P = .016) in the non-CBT-I group. Analysis of covariance controlling for baseline found that participants receiving CBT-I had significantly less depression at postintervention (effect size = −0.62; P = .001), compared to those who did not receive CBT-I. These benefits were maintained at the 3-month follow-up. Spearman rank correlations showed that changes in insomnia severity from baseline to postintervention were significantly correlated with concurrent changes in depression ( r = .73; P < .001). Path analysis revealed that improvement in depression was mediated by improvement in insomnia severity ( P < .001). Conclusions: Our findings provide preliminary support that in cancer survivors, CBT-I reduces depression via improvement in insomnia. Further, this reduction in depression remained stable 3 months after completing CBT-I. This suggests that a CBT-I intervention has a meaningful effect on depression. Clinical Trial Registration: Registry: ClinicalTrials.gov; Title: Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy; Identifier: NCT01091974; URL: https://clinicaltrials.gov/ct2/show/record/NCT01091974 Citation: Peoples AR, Garland SN, Pigeon WR, Perlis ML, Wolf JR, Heffner KL, Mustian KM, Heckler CE, Peppone LJ, Kamen CS, Morrow GR, Roscoe JA. Cognitive behavioral therapy for insomnia reduces depression in cancer survivors. J Clin Sleep Med 2019;15(1):129–137.

Digital health care apps, including digital therapeutics, have the potential to increase accessibility and improve patient engagement by overcoming the limitations of traditional facility-based medical treatments. However, there are no established tools capable of quantitatively measuring long-term engagement at present. This study aimed to evaluate an existing engagement index (EI) in a commercial health management app for long-term use and compare it with a newly developed EI. Participants were recruited from cancer survivors enrolled in a randomized controlled trial that evaluated the impact of mobile health apps on recovery. Of these patients, 240 were included in the study and randomly assigned to the Noom app (Noom Inc). The newly developed EI was compared with the existing EI, and a long-term use analysis was conducted. Furthermore, the new EI was evaluated based on adapted measurements from the Web Matrix Visitor Index, focusing on click depth, recency, and loyalty indices. The newly developed EI model outperformed the existing EI model in terms of predicting EI of a 6- to 9-month period based on the EI of a 3- to 6-month period. The existing model had a mean squared error of 0.096, a root mean squared error of 0.310, and an R of 0.053. Meanwhile, the newly developed EI models showed improved performance, with the best one achieving a mean squared error of 0.025, root mean squared error of 0.157, and R of 0.610. The existing EI exhibited significant associations: the click depth index (hazard ratio [HR] 0.49, 95% CI 0.29-0.84; P<.001) and loyalty index (HR 0.17, 95% CI 0.09-0.31; P<.001) were significantly associated with improved survival, whereas the recency index exhibited no significant association (HR 1.30, 95% CI 1.70-2.42; P=.41). Among the new EI models, the EI with a menu combination of menus available in the app's free version yielded the most promising result. Furthermore, it exhibited significant associations with the loyalty index (HR 0.32, 95% CI 0.16-0.62; P<.001) and the recency index (HR 0.47, 95% CI 0.30-0.75; P<.001). The newly developed EI model outperformed the existing model in terms of the prediction of long-term user engagement and compliance in a mobile health app context. We emphasized the importance of log data and suggested avenues for future research to address the subjectivity of the EI and incorporate a broader range of indices for comprehensive evaluation.