Results of DUET: A Web-Based Weight Loss Randomized Controlled Feasibility Trial among Cancer Survivors and Their Chosen Partners.

(1) Background: A healthful diet, regular physical activity, and weight management are cornerstones for cancer prevention and control. Yet, adherence is low in cancer survivors and others, calling for innovative solutions. Daughters, dUdes, mothers, and othErs fighting cancer Together (DUET) is a 6-month, online, diet-and-exercise, weight-loss intervention to improve health behaviors and outcomes among cancer survivor-partner dyads. (2) Methods: DUET was tested in 56 dyads (survivors of obesity-related cancers and chosen partners) (n = 112), both with overweight/obesity, sedentary behavior, and suboptimal diets. After baseline assessment, dyads were randomized to DUET intervention or waitlist control arms; data were collected at 3- and 6-months and analyzed using chi-square, t-tests, and mixed linear models (α < 0.05). (3) Results: Retention was 89% and 100% in waitlisted and intervention arms, respectively. Dyad weight loss (primary outcome) averaged -1.1 (waitlist) vs. -2.8 kg (intervention) (p = 0.044/time-by-arm interaction p = 0.033). Caloric intake decreased significantly in DUET survivors versus controls (p = 0.027). Evidence of benefit was observed for physical activity and function, blood glucose, and c-reactive protein. Dyadic terms were significant across outcomes, suggesting that the partner-based approach contributed to intervention-associated improvements. (4) Conclusions: DUET represents a pioneering effort in scalable, multi-behavior weight management interventions to promote cancer prevention and control, calling for studies that are larger in size, scope, and duration.

Association between Presurgical Weight Status and Urinary and Sexual Function in Prostate Cancer Patients Treated by Radical Prostatectomy: A Prospective Cohort Study.

OBJECTIVE: To prospectively examine the influence of weight status on urinary and sexual function in clinically localized prostate cancer patients treated by radical prostatectomy (RP). METHODS: The Prostatectomy, Incontinence and Erectile dysfunction study recruited patients at 2 US institutions between 2011 and 2014. At baseline, height and weight were measured, and urinary and sexual function were collected by the modified Expanded Prostate Cancer Index Composite-50. This index was repeated at the 5-week, 6-month, and 12-month postsurgical assessments and compared to baseline using linear generalized estimating equations. Logistic equations were used to evaluate the likelihood of functional recovery at the 6- and 12-month assessments. RESULT: Presurgery, nonobese patients (68.8% of 407 patients) had similar urinary function as those with obesity (P = .217), but better sexual function (P = .006). One year after surgery, 50.5% and 28.9% patients had recovered to baseline levels for urinary and sexual function, respectively. Recovery was not, however, uniform by obesity. Compared to those with obesity, nonobese patients had better urinary function at the 6- (P < .001) and 12-month postsurgical assessments (P = .011) and were more likely to recover their function by the 6-month assessment (OR = 2.55, 95% CI = 1.36-4.76). For sexual function, nonobese patients had better function at the 6- (P = .028) and 12-month (P = .051) assessments, but a similar likelihood of recovery 1-year postsurgery. CONCLUSION: Nonobese prostate cancer patients had better and likely earlier recovery in urinary function postsurgery, and better sexual function both pre- and postsurgery. These findings support the potential for tailored presurgical counseling about RP side-effects and prehabilitation to improve these side-effects.

Efficacy of a Digital Personalized Elimination Diet for the Self-Management of Irritable Bowel Syndrome and Comorbid Irritable Bowel Syndrome and Inflammatory Bowel Disease.

INTRODUCTION: Most patients with irritable bowel syndrome (IBS) and dual-diagnosis IBS and inflammatory bowel disease (IBD) report that symptoms originate from or are exacerbated by trigger foods. Despite patient interest and need, there is no consensus on what diet is optimal. Popular diets have notable limitations including cost, length, implementation complexity, and lack of personalization. METHODS: This pilot study evaluated the feasibility, desirability, and effect on gastrointestinal symptoms of a digitally delivered personalized elimination diet for patients with IBS and comorbid IBS/IBD, powered by machine learning. Participants were recruited online and were provided access to a digital personalized nutrition tool for 9 weeks (N = 37; IBS only = 16, Crohn's disease and IBS = 9, and ulcerative colitis and IBS = 12). RESULTS: Significant symptom improvement was seen for 81% of participants at study midpoint and persisted for 70% at end point, measured by the relevant symptom severity score (IBS symptom severity score, Patient Simple Clinical Colitis Activity Index, or Mobile Health Index for Crohn's disease). Clinically significant symptom improvement was observed in 78% of participants at midpoint and 62% at end point. Twenty-five participants (67.6%) achieved total symptomatic resolution by the end of study. Patient-reported quality of life improved for 89% of participants. Ninety-five percentage daily engagement, 95% retention, 89% adherence and 92% satisfaction with the program were reported. DISCUSSION: Dietary elimination can improve symptoms and quality of life in patients with IBS and comorbid IBS/IBD. Digital technology can personalize dietary interventions and improve adherence. Randomized controlled trials are warranted.

Correction: Pekmezi et al. Rationale and Methods for a Randomized Controlled Trial of a Dyadic, Web-Based, Weight Loss Intervention among Cancer Survivors and Partners: The DUET Study. Nutrients 2021, 13, 3472.

The authors would like to correct errors in their prior publication [...].

Rationale and Methods for a Randomized Controlled Trial of a Dyadic, Web-Based, Weight Loss Intervention among Cancer Survivors and Partners: The DUET Study.

Scalable, effective interventions are needed to address poor diet, insufficient physical activity, and obesity amongst rising numbers of cancer survivors. Interventions targeting survivors and their friends and family may promote both tertiary and primary prevention. The design, rationale, and enrollment of an ongoing randomized controlled trial (RCT) (NCT04132219) to test a web-based lifestyle intervention for cancer survivors and their supportive partners are described, along with the characteristics of the sample recruited. This two-arm, single-blinded RCT randomly assigns 56 dyads (cancer survivor and partner, both with obesity, poor diets, and physical inactivity) to the six-month DUET intervention vs. wait-list control. Intervention delivery and assessment are remotely performed with 0-6 month, between-arm tests comparing body weight status (primary outcome), and secondary outcomes (waist circumference, health indices, and biomarkers of glucose homeostasis, lipid regulation and inflammation). Despite COVID-19, targeted accrual was achieved within 9 months. Not having Internet access was a rare exclusion (<2%). Inability to identify a support partner precluded enrollment of 42% of interested/eligible survivors. The enrolled sample is diverse: ages 23-81 and 38% racial/ethnic minorities. Results support the accessibility and appeal of web-based lifestyle interventions for cancer survivors, though some cancer survivors struggled to enlist support partners and may require alternative strategies.

One-year urinary and sexual outcome trajectories among prostate cancer patients treated by radical prostatectomy: a prospective study.

BACKGROUND: To examine one-year trajectories of urinary and sexual outcomes, and correlates of these trajectories, among prostate cancer patients treated by radical prostatectomy (RP). METHODS: Study participants were recruited from 2011 to 2014 at two US institutions. Self-reported urinary and sexual outcomes were measured at baseline before surgery, and 5 weeks, 6 months and 12 months after surgery, using the modified Expanded Prostate Cancer Index Composite-50 (EPIC-50). Changes in EPIC-50 scores from baseline were categorized as improved (beyond baseline), maintained, or impaired (below baseline), using previously-reported minimum clinically important differences. RESULTS: Of the 426 eligible participants who completed the baseline survey, 395 provided data on at least one EPIC-50 sub-scale at 5 weeks and 12 months, and were analyzed. Although all mean EPIC-50 scores declined markedly 5 weeks after surgery and then recovered to near (incontinence-related outcomes) or below (sexual outcomes) baseline levels by 12 months post-surgery, some men experienced improvement beyond their baseline levels on each sub-scale (3.3-51% depending on the sub-scale). Having benign prostatic hyperplasia (BPH) at baseline (prostate size ≥ 40 g; an International Prostate Symptom Index Score ≥ 8; or using BPH medications) was associated with post-surgical improvements in voiding dysfunction-related bother at 5 weeks (OR = 3.9, 95% CI: 2.1-7.2) and 12 months (OR = 3.3, 95% CI: 2.0-5.7); and in sexual bother at 5 weeks (OR = 5.7, 95% CI:1.7-19.3) and 12 months (OR = 3.0, 95% CI: 1.2-7.1). CONCLUSIONS: Our findings provide additional support for considering baseline BPH symptoms when selecting the best therapy for early-stage prostate cancer.

The association of marital status and mortality among men with early-stage prostate cancer treated with radical prostatectomy: insight into post-prostatectomy survival strategies.

PURPOSE: The purpose of this study was to determine the association of marital status, a marker of social support, with all-cause and prostate cancer-specific mortality in a cohort of men with early-stage prostate cancer treated with radical prostatectomy. METHODS: We conducted a retrospective cohort study of 3,579 men treated for localized (stage 1-2) prostate cancer with radical prostatectomy at a single institution between 1994 and 2004. Marital status (not married vs. married) and marital history (never married, divorced, widowed vs. married) at the time of prostatectomy were examined in relation to (1) all-cause mortality and (2) prostate cancer-specific mortality using Cox proportional hazards regression. RESULTS: Not being married (vs. married) at the time of radical prostatectomy was associated with an increased risk of all-cause mortality [Hazard Ratio (HR) 1.42; 95% Confidence Interval (CI) 1.10, 1.85]. Similarly, in analyses of marital history, never-married men were at highest risk of all-cause mortality (HR 1.77, 95% CI 1.19, 2.63). Unmarried status (vs. married) was also associated with an increased risk of prostate cancer-specific mortality (HR 1.97; 95% CI 1.01, 3.83). CONCLUSIONS: Unmarried men with prostate cancer were at greater risk for death after radical prostatectomy. Among married men with prostate cancer, marriage likely serves as a multi-faceted proxy for many protective factors including social support. Future studies should explore the mechanisms underlying these findings to inform the development of novel prostate cancer survival interventions for unmarried men and those with low social support.

Adult weight gain accelerates the onset of breast cancer.

PURPOSE: Weight gain in adulthood is a risk factor for breast cancer; however, the impact on age of onset is unknown. The objective of this study was to investigate whether weight gain from early- to mid-adulthood influenced the timing of breast cancer onset. METHODS: Increase in body mass index (BMI) from lowest adult BMI to BMI at diagnosis and age at which these events occurred were calculated from breast cancer survivors enrolled in a weight loss trial (n = 660). Quartiles (Q) of the average increase in BMI were determined and associations between weight gain and age at disease onset were analyzed using analysis of covariance and spline regression models. RESULTS: A significant linear trend was observed across the quartiles of BMI change for earlier age at diagnosis [Q1 52.3 (± 0.73), Q2 51.9 (± 0.70), Q3 49.6 (± 0.66), Q4 47.3 (± 0.67), p < 0.0001] after adjusting for potential confounders. In analyses that stratified by tumor subtype and menopausal status, significant linear trends continued to be observed for earlier age at diagnosis across quartiles of BMI for ER ± , PR ± , HER2 + , as well as pre- and postmenopausal status (p-values < 0.001). CONCLUSIONS: Women who gain excess weight during adulthood are not only at risk for breast cancer, but also may experience earlier onset of disease and reduced cancer-free years.

Levels and patterns of self-reported and objectively-measured free-living physical activity among prostate cancer survivors: A prospective cohort study.

BACKGROUND: No prior study has measured or compared self-reported and objectively measured physical activity trajectories in prostate cancer survivors before and after treatment. METHODS: Clinically localized prostate cancer patients treated with radical prostatectomy were recruited between 2011 and 2014. Of the 350 participants enrolled at the main site, 310 provided self-reported physical activity at baseline before radical prostatectomy, and 5 weeks, 6 months, and 12 months after radical prostatectomy. A subset of participants (n = 81) provided objectively measured physical activity at all study time points by wearing an accelerometer for 7 days each. Changes in activity over time were compared using Friedman's test. Agreement between self-reported and objective measures was evaluated using Spearman's rank correlation coefficient. RESULTS: Self-reported moderate-to-vigorous physical activity was high at baseline (median, 32.1 min/day), followed by a decline at 5 weeks (median, 15.0 min/day) and a recovery at 6 and 12 months (median, 32.1-47.1 min/day). In contrast, objectively measured moderate-to-vigorous physical activity was low at all 4 time points (median, 0.0-5.2 min/day), with no overall change across study assessments (global P = .29). Self-reported moderate-to-vigorous physical activity tended to be more closely related to objectively measured light-intensity physical activity (ρ = 0.29-0.42) than to objectively measured moderate-to-vigorous physical activity (ρ = 0.07-0.27, P = .009-.32). CONCLUSIONS: In our population of prostate cancer survivors with critically low moderate-to-vigorous physical activity levels, self-reported measures greatly overestimated moderate-to-vigorous physical activity and may have been more reflective of light-intensity physical activity. Because cancer survivor guidelines are derived from self-reported data, our findings may imply that intensities of physical activity below moderate, such as light intensity, still have health benefits.

Weight management and physical activity throughout the cancer care continuum.

Mounting evidence suggests that weight management and physical activity (PA) improve overall health and well being, and reduce the risk of morbidity and mortality among cancer survivors. Although many opportunities exist to include weight management and PA in routine cancer care, several barriers remain. This review summarizes key topics addressed in a recent National Academies of Science, Engineering, and Medicine workshop entitled, "Incorporating Weight Management and Physical Activity Throughout the Cancer Care Continuum." Discussions related to body weight and PA among cancer survivors included: 1) current knowledge and gaps related to health outcomes; 2) effective intervention approaches; 3) addressing the needs of diverse populations of cancer survivors; 4) opportunities and challenges of workforce, care coordination, and technologies for program implementation; 5) models of care; and 6) program coverage. While more discoveries are still needed for the provision of optimal weight-management and PA programs for cancer survivors, obesity and inactivity currently jeopardize their overall health and quality of life. Actionable future directions are presented for research; practice and policy changes required to assure the availability of effective, affordable, and feasible weight management; and PA services for all cancer survivors as a part of their routine cancer care. CA Cancer J Clin 2018;68:64-89. © 2017 American Cancer Society.

A Case-Crossover Study of Urological Chronic Pelvic Pain Syndrome Flare Triggers in the MAPP Research Network.

PURPOSE: Although many factors have been proposed to trigger symptom exacerbations (flares) in patients with interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome, few studies have investigated these factors empirically. Therefore, we embedded a case-crossover study in the Multidisciplinary Approach to the Study of Chronic Pelvic Pain longitudinal study to evaluate a range of patient reported triggers. MATERIALS AND METHODS: We assessed exposure to proposed triggers, including diet, physical activities, sedentary behaviors, stress, sexual activities, infection-like symptoms and allergies, by questionnaire a maximum of 3 times when participants reported flares and at 3 randomly selected times. We compared participant preflare to nonflare exposures by conditional logistic regression. RESULTS: In our full analytical sample of 292 participants only 2 factors, including recent sexual activity (OR 1.44, 95% CI 1.06-1.96) and urinary tract infection symptoms (OR 3.39, 95% CI 2.02-5.68), which may overlap with those of flares, were associated with flare onset. On subanalyses restricted to flares with specific suspected triggers additional positive associations were observed for some factors such as certain dietary factors, abdominal muscle exercises, and vaginal infection-like symptoms and fever, but not for other factors (eg stress). CONCLUSIONS: Except for sexual activity our findings suggest that patient reported triggers may be individual or group specific, or they may not contribute to flares. These findings suggest caution in following rigid, global flare prevention strategies and support additional research to develop evidence-based strategies.

Caution with Use of the EPIC-50 Urinary Bother Scale: How Voiding Dysfunction Modifies its Performance.

PURPOSE: We evaluated agreement between patient reported urinary function and bother, and sexual function and bother in patients treated with radical prostatectomy to help inform possible nonfunctional, modifiable mechanisms for patient bother. MATERIALS AND METHODS: Patients were recruited from 2011 to 2014 at Washington University, and Brigham and Women's Hospital. Urinary and sexual outcomes were assessed by EPIC-50 (Expanded Prostate Cancer Index Composite-50) before, 5 weeks and 12 months after radical prostatectomy. Spearman rank correlation coefficients and agreement/disagreement categories were used to describe the relation between function and bother. RESULTS: Despite moderate to good agreement between function and bother (urinary r = 0.51-0.69 and sexual r = 0.65-0.80) discordant groups were observed. In the urinary domain these groups were men disproportionately bothered by function at baseline (16.9%) and 12 months after radical prostatectomy (6.1%) and men less bothered by function 5 weeks (26.8%) and 12 months (9.9%) after radical prostatectomy. Discordant groups in the sexual domain were men less bothered by function at baseline (20.8%), and 5 weeks (21.1%) and 12 months (15.7%) after radical prostatectomy. Splitting the urinary bother scale into 2 subscales, including one for incontinence related bother to complement the urinary function scale which measures only incontinence, and one for voiding dysfunction related bother yielded considerably better agreement (urinary function and incontinence related bother r = 0.78-0.83). Factors contributing to the group less bothered by sexual function were unclear. CONCLUSIONS: When using EPIC-50, investigators should consider splitting the urinary bother scale by the relation to incontinence to prevent distortions of function-bother and comparisons before vs after radical prostatectomy by coexisting voiding dysfunction.

Gender-varying associations between physical activity intensity and mental quality of life in older cancer survivors.

PURPOSE: Physical activity can enhance quality of life in cancer survivors, but this conclusion is based largely on research linking moderate-to-vigorous physical activity with quality of life. Light-intensity physical activity may be more feasible than more strenuous exercise for many older cancer survivors. This study reports a secondary analysis of baseline data from a lifestyle behavior intervention trial and examines the hypothesis that older cancer survivors who engage in more light-intensity physical activity, independent of moderate-to-vigorous activity, will report better mental quality of life. METHODS: Older (≥65 years), overweight or obese breast, prostate, or colorectal cancer survivors (n = 641, 54% female) self-reported their physical activity and mental quality of life (i.e., mental health, emotional role functioning, vitality, and social role functioning from the Short-Form 36 Health Status Survey) as a part of the RENEW trial baseline assessment. Analysis of covariance was used to test hypotheses. RESULTS: For older women (but not men), light physical activity was positively associated with mental quality of life after adjusting for moderate-to-vigorous physical activity. Light physical activity that involved social participation appeared to be responsible for this association. For older men (but not women), moderate-to-vigorous physical activity was positively associated with mental quality of life. CONCLUSIONS: Some activity appears to be better than none for important dimensions of mental quality of life. Experimental research is needed to test the hypothesis that older cancer survivors should strive to avoid inactivity regardless of whether they are able to engage in moderate-to-vigorous physical activity.

Impact of a behavioral weight loss intervention on comorbidities in overweight and obese breast cancer survivors.

PURPOSE: Comorbid medical conditions are common among breast cancer survivors, contribute to poorer long-term survival and increased overall mortality, and may be ameliorated by weight loss. This secondary analysis evaluated the impact of a weight loss intervention on comorbid medical conditions immediately following an intervention (12 months) and 1-year postintervention (24 months) using data from the Exercise and Nutrition to Enhance Recovery and Good health for You (ENERGY) trial-a phase III trial which was aimed at and successfully promoted weight loss. METHODS: ENERGY randomized 692 overweight/obese women who had completed treatment for early stage breast cancer to either a 1-year group-based behavioral intervention designed to achieve and maintain weight loss or to a less intensive control intervention. Minimal support was provided postintervention. New medical conditions, medical conditions in which non-cancer medications were prescribed, hospitalizations, and emergency room visits, were compared at baseline, year 1, and year 2. Changes over time were analyzed using chi-squared tests, Kaplan-Meier, and logistic regression analyses. RESULTS: At 12 months, women randomized to the intervention had fewer new medical conditions compared to the control group (19.6 vs. 32.2 %, p < 0.001); however, by 24 months, there was no longer a significant difference. No difference was observed in each of the four conditions for which non-cancer medications were prescribed, hospital visits, or emergency visits at either 12 or 24 months. CONCLUSIONS: These results support a short-term benefit of modest weight loss on the likelihood of comorbid conditions; however, recidivism and weight regain likely explain no benefit at 1-year postintervention follow-up.

Sexually transmitted infections, benign prostatic hyperplasia and lower urinary tract symptom-related outcomes: results from the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial.

OBJECTIVE: To examine whether a history of sexually transmitted infections (STIs) or positive STI serology is associated with prevalent and incident benign prostatic hyperplasia (BPH)/lower urinary tract symptoms (LUTS)-related outcomes in the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial. METHODS: Self-reported history of STIs (gonorrhoea, syphilis) was ascertained at baseline, and serological evidence of STIs (Chlamydia trachomatis, Trichomonas vaginalis, human papillomavirus (HPV)-16, HPV-18, herpes simplex virus type 2, human herpesvirus type 8 and cytomegalovirus) was detected in baseline serum specimens. We used data collected on the baseline questionnaire, as well as results from the baseline prostate-specific antigen (PSA) test and digital rectal examination (DRE), to define prevalent BPH/LUTS-related outcomes as evidence of LUTS (self-reported diagnosis of an enlarged prostate/BPH, BPH surgery or nocturia [waking ≥2 times/night to urinate]) and evidence of prostate enlargement (PSA > 1.4 ng/mL or prostate volume ≥30 mL) in men without prostate cancer. We created a similar definition of incident BPH using data from the follow-up questionnaire completed 5-13 years after enrolment (self-reported diagnosis of an enlarged prostate/BPH or nocturia), data on finasteride use during follow-up, and results from the follow-up PSA tests and DREs. We used Poisson regression with robust variance estimation to calculate prevalence ratios (PRs) in our cross-sectional analysis of self-reported (n = 32 900) and serologically detected STIs (n = 1 143) with prevalent BPH/LUTS, and risk ratios in our prospective analysis of self-reported STIs with incident BPH/LUTS (n = 5 226). RESULTS: Generally null results were observed for associations of a self-reported history of STIs and positive STI serologies with prevalent and incident BPH/LUTS-related outcomes, with the possible exception of T. vaginalis infection. This STI was positively associated with prevalent nocturia (PR 1.36, 95% confidence interval (CI) 1.18-1.65), prevalent large prostate volume (PR 1.21 95% CI 1.02-1.43), and any prevalent BPH/LUTS (PR 1.32 95% CI 1.09-1.61); too few men had information on both STI serologies and incident BPH/LUTS to investigate the associations between T. vaginalis infection and incident BPH/LUTS-related outcomes. CONCLUSIONS: Our findings do not support associations of several known STIs with BPH/LUTS-related outcomes, although T. vaginalis infection may warrant further study.

Physical activity levels of overweight or obese breast cancer survivors: correlates at entry into a weight loss intervention study.

PURPOSE: Physical activity is associated with reduced risk and progression of breast cancer, and exercise can improve physical function, quality of life, and fatigue in cancer survivors. Evidence on factors associated with cancer survivors' adherence to physical activity guidelines from the American Cancer Society and the U.S. Department of Health and Human Services is mixed. This study seeks to help fill this gap in knowledge by examining correlates with physical activity among breast cancer survivors. METHODS: Overweight or obese breast cancer survivors (N = 692) were examined at enrollment into a weight loss intervention study. Questionnaires and medical record review ascertained data on education, race, ethnicity, menopausal status, physical activity, and medical history. Measures of anthropometrics and fitness level were conducted. Regression analysis examined associations between physical activity and demographic, clinical, and lifestyle factors. RESULTS: Overall, 23% of women met current guidelines. Multivariate analysis revealed that body mass index (p = 0.03), emergency room visits in the past year (p = 0.04), and number of comorbidities (p = 0.02) were associated with less physical activity. Geographic region also was associated with level of physical activity (p = 0.02), with women in Alabama reporting significantly less activity than those in other participating regions. CONCLUSIONS: The majority of overweight/obese breast cancer survivors did not meet physical activity recommendations. Physical activity levels were associated with degree of adiposity, geographic location, and number of comorbidities. The majority of overweight breast cancer survivors should be encouraged to increase their level of physical activity. Individualizing exercise prescriptions according to medical comorbidities may improve adherence.

Correlates of quality of life in overweight or obese breast cancer survivors at enrollment into a weight loss trial.

OBJECTIVE: The purpose of this analysis was to examine the correlates of the physical and psychosocial domains of quality of life (QOL) in a cohort of breast cancer survivors participating in a weight loss intervention trial. METHODS: Correlates of QOL and psychosocial functioning were examined in 692 overweight or obese breast cancer survivors at entry into a weight loss trial. QOL was explored with three measures: Short-form 36 (SF-36), Impact of Cancer scale (IOC), and the Breast Cancer Prevention Trial (BCPT) symptom scales. Available data included information on weight and physical activity, as well as demographic and medical characteristics. Multivariate analyses were used to identify associations adjusted for other characteristics. RESULTS: In multivariate analysis, younger age was associated with higher negative impact scores (p < 0.0001). Hispanic, African-American, and Asian women had higher positive IOC impact scores compared with White non-Hispanic women (p < 0.01). Increased number of comorbidities was associated with lower physical and mental QOL scores (p < 0.01). Body mass index was not independently associated with QOL measures. Physical activity was directly associated with physical and mental QOL and IOC positive impact, and inversely related to IOC negative impact and Breast Cancer Prevention Trial symptom scales. CONCLUSIONS: Quality-of-life measures in breast cancer survivors are differentially associated with demographic and other characteristics. When adjusted for these characteristics, degree of adiposity among overweight or obese women does not appear to be independently associated with QOL. Among overweight or obese breast cancer survivors, higher level of physical activity is associated with higher QOL across various scales and dimensions.

Quality of life outcomes from the Exercise and Nutrition Enhance Recovery and Good Health for You (ENERGY)-randomized weight loss trial among breast cancer survivors.

Obesity is a poor prognostic factor and is negatively related to quality of life (QOL) in breast cancer survivors. Exercise and Nutrition to Enhance Recovery and Good Health for You is the largest weight loss trial completed among cancer survivors. Percent losses in body weight with an intensive group-based intervention versus an attention control were 6.0 versus 1.5 % (p < 0.0001) and 3.7 versus 1.3 % (p < 0.0001) at 12 and 24 months, respectively. ENERGY also was designed to answer the research question: Does weight loss significantly improve vitality and physical function (key components of QOL)? 692 breast cancer survivors (BMI: 25-45 kg/m(2)) at 4 US sites were randomized to a year-long intensive intervention of 52 group sessions and telephone counseling contacts versus a non-intensive (control) of two in-person counseling sessions. Weight, self-reported QOL, and symptoms were measured semi-annually for two years. Significant decreases in physical function and increases in symptoms were observed among controls from baseline to 6 months, but not in the intervention arm, -3.45 (95 % Confidence Interval [CI] -6.10, -0.79, p = 0.0109) and 0.10 (95 %CI 0.04, 0.16, p = 0.0021), respectively. Improvements in vitality were seen in both arms but trended toward greater improvement in the intervention arm -2.72 (95 % CI -5.45, 0.01, p = 0.0508). These differences diminished over time; however, depressive symptoms increased in the intervention versus control arms and became significant at 24 months, -1.64 (95 % CI -3.13, -0.15, p = 0.0308). Increased QOL has been reported in shorter term diet and exercise trials among cancer survivors. These longer term data suggest that diet and exercise interventions improve some aspects of QOL, but these benefits may diminish over time.

Results of the Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial: A Behavioral Weight Loss Intervention in Overweight or Obese Breast Cancer Survivors.

PURPOSE: Obesity increases risk for all-cause and breast cancer mortality and comorbidities in women who have been diagnosed and treated for breast cancer. The Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) study is the largest weight loss intervention trial among survivors of breast cancer to date. METHODS: In this multicenter trial, 692 overweight/obese women who were, on average, 2 years since primary treatment for early-stage breast cancer were randomly assigned to either a group-based behavioral intervention, supplemented with telephone counseling and tailored newsletters, to support weight loss or a less intensive control intervention and observed for 2 years. Weight and blood pressure were measured at 6, 12, 18, and 24 months. Longitudinal mixed models were used to analyze change over time. RESULTS: At 12 months, mean weight loss was 6.0% of initial weight in the intervention group and 1.5% in the control group (P<.001). At 24 months, mean weight loss in the intervention and control groups was 3.7% and 1.3%, respectively (P<.001). Favorable effects of the intervention on physical activity and blood pressure were observed. The weight loss intervention was more effective among women older than 55 years than among younger women. CONCLUSION: A behavioral weight loss intervention can lead to clinically meaningful weight loss in overweight/obese survivors of breast cancer. These findings support the need to conduct additional studies to test methods that support sustained weight loss and to examine the potential benefit of intentional weight loss on breast cancer recurrence and survival.

Effect of weight loss on bone health in overweight/obese postmenopausal breast cancer survivors.

Current guidelines recommend weight loss in obese cancer survivors. Weight loss, however, has adverse effects on bone health in obese individuals without cancer but this has not been evaluated in breast cancer survivors. We investigated the associations of intentional weight loss with bone mineral density (BMD) and bone turn-over markers in overweight/obese postmenopausal breast cancer survivors. Participants were overweight/obese breast cancer survivors (N = 81) with stage I, II or IIIA disease enrolled in the St. Louis site of a multi-site Exercise and Nutrition to Enhance Recovery and Good health for You (ENERGY) study; a randomized-controlled clinical trial designed to achieve a sustained ≥7 % loss in body weight at 2 years. Weight loss was achieved through dietary modification with the addition of physical activity. Generalized estimating equations were used to assess differences in mean values between follow-up and baseline. Mean weight decreased by 3 and 2.3 % between baseline and 6-month follow-up, and 12-month follow-up, respectively. There were decreases in osteocalcin (10.6 %, p value < 0.001), PINP (14.5 %, p value < 0.001), NTx (19.2 % p value < 0.001), and RANK (48.5 %, p value < 0.001), but not BALP and CTX-1 levels between baseline and 12-month follow-up. No significant changes occurred in mean T-scores, pelvis and lumbar spine BMD between baseline and 12-month follow-up. A 2.3 % weight loss over 12 months among overweight/obese women with early-stage breast cancer does not appear to have deleterious effect on bone health, and might even have beneficial effect. These findings warrant confirmation, particularly among breast cancer survivors with a larger magnitude of weight loss.