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Background Many of the 3.8 million breast cancer survivors in the United States experience long‐term side effects of cancer therapy including peripheral neuropathy (PN). We assessed the prevalence and predictors of PN among women with breast cancer followed in the Women's Health Initiative's Life and Longevity After Cancer survivorship cohort. Methods The study population included 2420 women with local (79%) or regional (21%) stage disease. Presence of PN was based on the reports of “nerve problems and/or tingling sensations” after treatment and PN severity was assessed using the Functional Assessment of Cancer Therapy‐Gynecologic Oncology Group/Neurotoxicity instrument. Logistic regression analysis was used to evaluate the socio‐demographic and clinical factors associated with PN prevalence and severity. Results Initial breast cancer treatment included surgery‐only (21%), surgery and radiation (53%), or surgery and chemotherapy (±radiation) (26%). Overall, 17% of women reported PN occurring within days (30%), months (46%), or years (24%) after treatment and 74% reported ongoing symptoms at a median of 6.5 years since diagnosis. PN was reported by a larger proportion of chemotherapy recipients (33%) compared to those who had surgery alone (12%) or surgery+radiation (11%) (p

Background: Results of observational studies of the association between dietary fat and risk of invasive breast cancer have been inconsistent. In the Women's Health Initiative dietary modification (DM) randomized trial designed to lower fat intake, the intervention was not associated with a statistically significant reduction of overall breast cancer risk. However, the DM association with risk of ductal carcinoma in situ (DCIS) of the breast, a putative breast cancer precursor, has not been reported. Methods: A total of 48,835 postmenopausal women, ages 50–79 years at enrollment, with no breast cancer history and ≥32% of total energy intake from fat, were randomly assigned either to a dietary intervention (n = 19,541) designed to reduce total fat intake to 20% of energy and to increase vegetable, fruit, and grain consumption, or to a comparison group (n = 29,294). Cox proportional hazards models were used to estimate HRs and 95% confidence intervals for the association between the intervention and DCIS risk. Results: During 18.7 years (median) cumulative follow-up, including intervention (∼8.7 years) and post-intervention phases (∼13.0 years), 817 DCIS cases were ascertained. No evidence of an association between the DM intervention and DCIS risk was observed overall, or by trial phase (intervention and post-intervention). Similarly, no associations were found in subgroups defined by potential risk factors for DCIS. Conclusions: DM aiming to reduce fat intake was not associated with altered risk of DCIS. Impact: These results do not provide evidence of an association between dietary fat reduction and the risk of DCIS among postmenopausal women.

AIM: To investigate the association between dietary patterns and total and obesity-related cancers risk. Additionally, to examine if acculturation modifies this relationship. SUBJECT AND METHODS: Dietary intake of postmenopausal Hispanic women (N=5,482) enrolled in the Women’s Health Initiative was estimated from a Food Frequency Questionnaire and used to calculate dietary pattern scores; Healthy Eating Index-2015 (HEI-2015), Mexican Diet (MexD) score, alternate Mediterranean Diet Score (aMED), and the energy adjusted-Dietary Inflammatory Index (E-DII™). Associations were evaluated using Cox proportional hazards regression models. RESULTS: 631 cancers and 396 obesity-related cancers were diagnosed over a mean-follow up of 12 years. Across dietary scores, there were no significant associations with cancer risk or mortality. Trend analysis suggest a potentially lower risk for total cancer related to the highest MexD score (HR 0.68, 95% CI 0.45–1.04, P-trend=0.03), and lower risk for obesity-related cancer mortality related to the highest score category for MexD (HR 0.65, 95% CI 0.37–1.16, P-trend=0.02), and aMED (HR 0.87, 95% CI 0.45–1.67, P-trend=0.04). Further analysis suggests less acculturated women with higher MexD scores had 56% lower risk for any cancer (HR 0.44, 95% CI 0.22–0.88, P-trend=0.03) and 83% lower risk for cancer mortality (HR 0.17, 95% CI 0.04–0.76, P-trend=0.01) compared to more acculturated Hispanic women. CONCLUSIONS: Dietary patterns were not associated with cancer risk and mortality in postmenopausal Hispanic women. Less-acculturated, Spanish-preferred speakers, who reported consuming a more traditional Mexican diet may experience a lower risk for cancer and cancer mortality.

Objective Little is understood about patient expectations and use of complementary therapies (CT) during cancer treatment. A secondary analysis of an 11-week reflexology trial among women with breast cancer was conducted. We examined factors that predicted women's expectations about reflexology for symptom relief, factors that predicted utilisation of reflexology, and whether by the end of the trial they believed that reflexology had helped with symptom management. Methods Women (N = 256) were interviewed at baseline and week 11. Friend or family caregivers in the reflexology group were trained to deliver standardised sessions to patients at least once a week for 4 weeks. Baseline and week-11 reflexology expectations were analysed using general linear models. Reflexology utilisation was analysed with generalised linear mixed effects models. Results Patients who expected benefits from reflexology ("higher expectancy") at baseline were younger, had lower anxiety, higher education, higher spirituality, and greater CT use. Worsening symptoms over time were associated with greater utilisation of reflexology, but only when baseline expectancy was low. At week 11, expectancy was higher for those with greater symptom improvement. Conclusions Assessing patterns of patient factors, expectancy, and change in symptoms can help determine who is likely to use reflexology, and when.

Objective:This study examined associations between diet quality and disease activity in adults with rheumatoid arthritis (RA). Perceived stress was also compared to diet and disease activity. Methods: In a cross-sectional design, 50 adults with RA were recruited. The Arizona Food Frequency Questionnaire was used to measure dietary intake (four weeks) and diet quality scores were calculated with the Healthy Eating Index – 2015. Perceived stress was measured with the Perceived Stress Scale. Disease activity was measured with the Health Assessment Questionnaire-Disability Index and Pain Scale, erythrocyte sedimentation rate (ESR), high-sensitivity C-reactive protein, and Disease Activity Score Including 28 Joints-ESR. Results: Diet quality (56; SD ± 12) in participants was lower than the national mean (59). Age ( p = 0.015) and gender ( p = 0.003) were associated with higher diet quality. The belief that diet affects RA disease activity was reported by 44% of the participants, and these participants were significantly more likely to report dietary changes ( p

Nutrition and exercise interventions are strongly recommended for most cancer patients; however, much debate exists about the best prescription. Combining fasting with exercise is relatively untouched within the oncology setting. Separately, fasting has demonstrated reductions in chemotherapy-related side effects and improved treatment tolerability and effectiveness. Emerging evidence suggests fasting may have a protective effect on healthy cells allowing chemotherapy to exclusively target cancer cells. Exercise is commonly recommended and attenuates treatment- and cancer-related adverse changes to body composition, quality of life, and physical function. Given their independent benefits, in combination, fasting and exercise may induce synergistic effects and further improve cancer-related outcomes. In this narrative review, we provide a critical appraisal of the current evidence of fasting and exercise as independent interventions in the cancer population and discuss the potential benefits and mechanisms of combined fasting and exercise on cardiometabolic, body composition, patient-reported outcomes, and cancer-related outcomes. Our findings suggest that within the non-cancer population combined fasting and exercise is a viable strategy to improve health-related outcomes, however, its safety and efficacy in the oncology setting remain unknown. Therefore, we also provide a discussion on potential safety issues and considerations for future research in the growing cancer population.

The COVID-19 pandemic is among the most significant public health challenges of our time. The virus has left communities in a constant state of flux, creating tremendous uncertainty and concern amo...

Several studies have assessed the relationship between sleep duration and ovarian cancer risk, but the results are conflicting. Importantly, no studies addressed the relationship between sleep disturbance or sleep quality and ovarian cancer incidence. Moreover, few studies have examined the relationships between sleep measures and subtypes of ovarian cancer. This study included 109,024 postmenopausal women ages 50–79 from the Women's Health Initiative during 1993–1998 and followed through 2018. The Cox proportional hazards model was used to estimate adjusted HRs for the associations between sleep habits and the incidence of ovarian cancer and its subtypes. No association was observed between sleep duration, sleep quality, sleep disturbance, or insomnia and risk of overall ovarian cancer, serous/nonserous, or type I/type II ovarian cancer subtype. However, compared with women with average sleep quality, women with restful or very restful sleep quality had a significantly lower risk of invasive serous subtype [HR: 0.73, 95% confidence interval (CI): 0.60–0.90] while insomnia was associated with a higher risk of invasive serous subtype (HR: 1.36, 95% CI: 1.12–1.66). Associations with insomnia differed significantly by serous and nonserous subtypes, and type I and type II subtypes (Pheterogeneity = 0.001 and Pheterogeneity Prevention Relevance: This study shows no association between sleep duration, sleep quality, or insomnia with the risk of overall ovarian cancer among postmenopausal women. However, restful sleep quality was associated with a lower risk of invasive serous ovarian cancer, and insomnia was associated with a higher risk of invasive serous ovarian cancer.

Background The collection of self-reported physical activity using validated questionnaires has known bias and measurement error. Objective Accelerometry, an objective measure of daily activity, increases the rigor and accuracy of physical activity measurements. Here, we describe the methodology and related protocols for accelerometry data collection and quality assurance using the Actigraph GT9X accelerometer data collection in a convenience sample of ovarian cancer survivors enrolled in GOG/NRG 0225, a 24-month randomized controlled trial of diet and physical activity intervention versus attention control. Methods From July 2015 to December 2019, accelerometers were mailed on 1337 separate occasions to 580 study participants to wear at 4 time points (baseline, 6, 12, and 24 months) for 7 consecutive days. Study staff contacted participants via telephone to confirm their availability to wear the accelerometers and reviewed instructions and procedures regarding the return of the accelerometers and assisted with any technology concerns. Results We evaluated factors associated with wear compliance, including activity tracking, use of a mobile app, and demographic characteristics with chi-square tests and logistic regression. Compliant data, defined as ≥4 consecutive days with ≥10 hours daily wear time, exceeded 90% at all study time points. Activity tracking, but no other characteristics, was significantly associated with compliant data at all time points (P Conclusions The high compliance and data quality associated with this protocol suggest that it could be disseminated to support researchers who seek to collect robust objective activity data in cancer survivors residing in a wide geographic area.

BACKGROUND Symptom research among Latinas with breast cancer is limited-especially as it relates to multiple co-occurring symptoms. OBJECTIVE The aim of the study was to identify subgroups (latent classes) of Latinas who have distinct symptom profiles while receiving radiation, chemotherapy, and/or hormonal therapy for breast cancer. METHODS This secondary analysis included intake data from three randomized trials of supportive care psychosocial interventions for Latinas treated for breast cancer (n = 290). Prevalence of 12 symptoms-measured using the General Symptom Distress Scale-was entered into the latent class analysis to identify classes of women with different symptom profiles. RESULTS Most of the participants had Stage II or III disease, and 81% reported receiving chemotherapy. On average, women reported 4.2 (standard deviation [SD] = 3) symptoms with an overall symptom distress score of 6.4 (SD = 2.5) on a 1-10 scale, with 10 being most distressing. Latent class analysis resulted in three classes that were labeled based on symptoms with the highest prevalence. Class 1 (n = 192) was "Disrupted Sleep and Tired," Class 2 (n = 74) was "Tired," and Class 3 (n = 24) was "Pain, Disrupted Sleep, and Tired." Depression, anxiety, and difficulty concentrating had moderate prevalence in each of the three classes. DISCUSSION Beyond the core six symptoms (depression, anxiety, fatigue, pain, disrupted sleep, difficulty concentration), the classes differed in the prevalence of other burdensome symptoms (e.g., nausea, vomiting, constipation), which provide implications for treatment. Thus, it is important to assess for the full range of symptoms so that supportive care interventions can be tailored for the distinct symptom profiles of Latinas with breast cancer.

Breast cancer survivors frequently report sleep problems, but little research has studied sleep patterns longitudinally. We examined trends in sleep quality and duration up to 15 years before and 20 years after a diagnosis of breast cancer, over time among postmenopausal women participating in the Women’s Health Initiative (WHI). We included 12,098 participants who developed invasive breast cancer after study enrollment. A linear mixed-effects model was used to determine whether the time trend in sleep quality, as measured by the WHI Insomnia Rating Scale (WHIIRS), a measure of perceived insomnia symptoms from the past 4 weeks, changed following a cancer diagnosis. To examine sleep duration, we fit a logistic regression model with random effects for both short (, Epidemiology: Long-term sleep patterns unaffected by breast cancer diagnosis Despite frequent reports of poor sleep among survivors of breast cancer, a large epidemiological study has found no evidence that diagnosis of invasive breast cancer long-term sleep problems. Chloe Beverly of The Ohio State University in Columbus, USA, and colleagues examined long-term patterns in sleep quality, sleep duration and symptoms of depression among more than 12,000 participants of the Women’s Health Initiative who were diagnosed with breast cancer. On the whole, they found that women developed insomnia at a slightly slower rate after their diagnosis and the prevalence of depression went down, with little change in sleep duration. Although some women may experience cancer-related sleep disturbances shortly after their diagnosis and treatment, the findings suggest that, over the long term, most sleep issues remain consistent compared to before diagnosis.

Improved cancer treatments and cancer detection methods are not likely to completely eradicate the burden of cancer. Primary prevention of cancer is a logical strategy to use to control cancer while also seeking novel treatments and earlier detection. Lifestyle modification strategies to improve primary prevention and risk reduction for the development of cancer include choosing a healthy diet with an emphasis on plant sources, maintaining a healthy weight throughout life, being physically active, regularly using sunscreen and wearing protective clothing, limiting sun exposure during the hours of 10 AM to 2 PM, avoiding indoor tanning, and reducing or eliminating alcohol use. In addition to continued use of ongoing education of the public, health care providers, and cancer support communities, other policy and public health efforts should be pursued as well. Examples of supported and successful policy approaches are included in this article, including efforts to limit indoor tanning and improve community-wide interventions to reduce ultraviolet radiation exposure as well as to formally support various alcohol policy strategies including increasing alcohol taxes, reducing alcohol outlet density, improving clinical screening for alcohol use disorders, and limiting youth exposure to alcohol marketing and advertising. These prevention strategies are expected to have the largest impact on the development of melanoma as well as breast, colorectal, head and neck, liver, and esophageal cancers. The impact of these strategies as secondary prevention is less well understood. Areas of additional needed research and implementation are also highlighted. Future areas of needed research are the effects of these modifications after the diagnosis of cancer (as secondary prevention).

Purpose Bowel dysfunction is a common, persistent long-term effect of treatment for rectal cancer survivors. Survivors often use dietary modifications to maintain bowel control. There are few evidence-based interventions to guide survivors on appropriate diet modifications for bowel symptom management. The purpose of this paper is to describe the development and design of the Altering Intake, Managing Symptoms (AIMS) intervention to support bowel dysfunction management in rectal cancer survivors. Methods The AIMS intervention is a ten-session, telephone-based diet behavior change intervention delivered by trained health coaches. It uses dietary recall, participant-completed food and symptom diaries, and health coaching guided by motivational interviewing to promote bowel symptom management and improved diet quality. Based on the Chronic Care Self-Management Model (CCM), the AIMS Intervention is designed to improve self-efficacy and self-management of bowel symptoms by coaching survivors to appropriately modify their diets through goal setting, self-monitoring, and problem-solving. The intervention targets survivors with stage I-III rectosigmoid colon/rectum cancer who are 6 months post-treatment, 21 years and older, and English-speaking. Conclusions The design and development process described in this paper provides an overview and underscores the potential of the AIMS intervention to positively impact the quality of long-term survivorship for rectal cancer survivors. An ongoing pilot study will inform the design and development of future multi-site Phase II and III randomized trials.

BACKGROUND: Dietary energy density (DED) is the ratio of energy [kilocalories (kcal) or kilojoules (kJ)] intake to food weight (grams, g) and is a measure of diet quality. Consumption of foods high in DED has been associated with weight gain in adults. OBJECTIVE: To investigate the association between baseline DED and incident obesity-associated cancers in the Women’s Health Initiative (WHI). DESIGN: Prospective cohort study of clinical trial and observational study participants. PARTICIPANTS/SETTING: Postmenopausal women ages 50–79 years (n = 92,295) enrolled in the observational study or the calcium and vitamin D trial and hormone replacement therapy trials. MAIN OUTCOME MEASURES: Incident, medical record-adjudicated, obesity-related cancers during follow-up. Exposure variable was DED (kcal/g for the total diet) from self-reported dietary intake at baseline using a food frequency questionnaire. STATISTICAL ANALYSES PERFORMED: The associations between DED and each incident cancer, or any obesity-related cancer, were examined using competing-risks regression models, with death as a competing risk. Body mass index (BMI)-stratified models were generated to investigate BMI as a potential modifying factor. RESULTS: DED was associated with higher BMI (mean ± standard deviation: 28.9 ± 6.0 versus 26.3 ± 4.9 kg/m(2)) and waist circumference (89.3 ± 14.2 versus 82.4 ± 12.4 cm) for DED quintiles 5 versus 1, respectively. DED was associated with a 10% increased risk of any obesity-related cancer (subhazard ratio(Q5 vs Q1): 1.1; 95% confidence interval, 1.03–1.2; P = 0.004). This increased risk appeared limited to women who were normal-weight at enrollment. CONCLUSIONS: Higher DED may be a contributing factor for obesity-related cancers, especially among normal-weight postmenopausal women and, as such, could serve as a modifiable behavior for dietary intervention to reduce obesity-associated cancer risk.

Background Most Latina breast cancer survivors do not meet diet and physical activity (PA) guidelines for cancer survivors and effective lifestyle interventions to adopt and maintain these recommendations are limited, especially among underserved populations. Here we describe the design, methods and enrollment of a 2 × 2 factorial-designed trial testing the separate effects of the iMi Vida Saludable! (My Healthy Life!) intervention program on changes in diet and PA behaviors among Latina breast cancer survivors. Methods Latinas with a history of stage 0-III breast cancer, no evidence of recurrent/metastatic disease, and > 90 days post-treatment were primarily identified via cancer registries and physician referral. Participants were randomized to four arms: 1) 4 weeks of in-person group sessions plus 11 months of eHealth communication, 2) in-person group sessions alone, 3) eHealth alone, or 4) control. All participants received a Fitbit to self-monitor PA. Assessments at baseline, 6 and 12 months include diet, PA, anthropometrics, predictors and mediators of behavior change, psychosocial and quality of life outcomes, and blood draw. Results Of 884 women screened between January 2016 and September 2018, 27% were eligible. Primary reasons for ineligibility included not being willing/able to participate due to work/life responsibilities, health reasons, or transportation. Of 241 eligible women, 167 completed baseline assessment and enrolled. Conclusions We successfully enrolled a diverse group of breast cancer survivors representing more than 15 Latin American nationalities to a diet and physical activity trial. If effective, the iMi Vida Saludable! program can be implemented by community groups and medical centers. Trial registration: ClinicalTrials.gov , NCT02780271 , registered May 2016.

In caregivers of Latina breast cancer survivors, contextual factors such as informational support, Anglo-orientation, and spiritual well-being may affect physical and mental health. The purpose of this study was to test if caregiver self-efficacy moderated relationships between contextual factors and health outcomes. A model, derived from Bandura’s Social Cognitive Theory, included self-efficacy cancer knowledge (survivor) and self-efficacy symptom management (caregiver) as moderators of relationships between contextual factors and global health and depression. Secondary analysis of baseline caregiver data from an experimental study testing two psychoeducational interventions with Latina breast cancer survivors and their caregivers was conducted. Both self-efficacy measures were tested as moderators for relationships between contextual factors and health outcomes with fixed cutoffs (medium: mean, low/high: ±1 SD). Caregiver participants (N=233) were 43 years on average (SD=13), primarily women (70%), low-income (78%), and of Mexican-American ethnicity (55%). Anglo-orientation was significantly associated with global health (r(233)=.27, p

Objective To describe the study protocol of SWOG S1820, a trial of the Altering Intake, Managing Symptoms intervention for bowel dysfunction in survivors of R ectal C ancer (AIMS-RC). Design SWOG S1820 is a multi-site, randomized trial of 94 post-treatment survivors of rectal cancer, comparing the intervention and attention control arms. Setting Affiliated institutions of the National Cancer Institute (NCI)-supported National Community Oncology Research Program (NCORP) and the National Clinical Trial Network (NCTN). Participants Survivors of rectal cancer who are between 6 and 24 months after treatment completion. Intervention AIMS-RC is a 17-week, 10 session telephone coaching program to help survivors of rectal cancer track their symptoms and improve their diets for better health and bowel function. It includes telephone-based coaching, resource manual, and personalized text/email messaging for motivation in between the telephone sessions. Main outcome measures Bowel function, low anterior resection syndrome score, quality of life (QOL), dietary quality, motivation, self-efficacy, positive/negative affect, feasibility, adherence, retention, acceptability. Analysis Thirty-seven participants per arm (74 total) provide 80% power to detect this 0.5 standard deviation effect size, based on a two-sample t-test with a 1-sided alpha = 0.1. A total of 94 randomized participants will be accrued to account for 7% ineligibility and 15% attrition at 6 months.

Background: Fiber-based prebiotic supplements are marketed for maintaining bowel health and promoting beneficial gut bacteria. However, the association between prebiotic supplement use and colorectal cancer risk and mortality is unknown. Methods: The association between prebiotic use and colorectal cancer risk and mortality was evaluated in postmenopausal women in the Women's Health Initiative study. Self-reported prebiotic use was documented at study enrollment. Adjudicated colorectal cancer cases and mortality were captured using medical and death records. Cox proportional hazards models were used to estimate the HR related to prebiotic use and colorectal cancer risk and mortality. Results: In total, 3,032 colorectal cancer cases were diagnosed during an average 15.4 years of follow-up. Overall, 3.7% of women used a prebiotic with psyllium, the major fiber type. Use of any prebiotic supplement was not associated with colorectal cancer risk or mortality. The type of prebiotic supplement (none vs. insoluble or soluble) was not associated with colorectal cancer risk; however, use of insoluble fiber prebiotics compared with none was associated with higher colorectal cancer mortality [HR, 2.79; 95% confidence interval (CI), 1.32–5.90; P = 0.007]. Likelihood ratio tests indicated no significant interactions between prebiotic use and other colorectal cancer risk factors, including metabolic syndrome. Conclusions: Prebiotic fiber supplement use was not associated with colorectal cancer risk. Insoluble, but not soluble, prebiotic fiber use was associated with higher colorectal cancer mortality. These findings do not support the promotion of prebiotic fiber supplements to reduce colorectal cancer risk or colorectal cancer mortality. Impact: Further investigation is warranted for findings regarding insoluble prebiotic fiber and higher colorectal cancer mortality in postmenopausal women.

10549 Background: Obesity and related factors are increasingly associated with increased risk of developing and dying from cancer. The American Society of Clinical Oncology (ASCO) conducted a survey of cancer patients to assess their experience in receiving recommendations and referrals related to weight, diet and exercise as a part of their cancer care. Methods: An online survey was distributed to potential participants between March and June 2020 via ASCO channels and patient advocacy organizations, with an estimated reach of over 25,000 individuals. Eligibility criteria included being 18 years, living in the US, and having been diagnosed with cancer. Logistic regression was used to determine factors associated with recommendation and referral patterns. Results: In total, 2419 individuals responded to the survey. Most respondents were female (75.5%), 61.8% had an early-stage malignancy, 38.2% had advanced disease, and 49.0% were currently receiving treatment. Breast cancer was the most common cancer type (36.0%). Average BMI was 25.8 kg/m2. The majority of respondents consumed £2 servings of fruits and vegetables per day (50.9%) and exercised £2 times per week (50.4%). Exercise was addressed at most or some oncology visits in 57.5% of respondents, diet in 50.7%, and weight in 28.4%. Referrals were less common: 14.9% of respondents were referred to an exercise program, 25.6% to a dietitian and 4.5% to a weight management program. In multiple regression analyses, racial and ethnicity minority respondents were more likely to receive advice about diet (Odds Ratio [OR] 1.92, 95% CI 1.56-2.38) and weight (OR 1.64, 95% CI 1.23-2.17) compared to non-Hispanic whites, individuals diagnosed with cancer in the past 5 yrs (vs > 5 yrs) were more likely to receive advice about exercise (OR 1.48, 95% CI 1.23-1.79), and breast cancer patients were more likely to receive advice about exercise (OR 1.37, 95% CI 1.11-1.68) and weight (OR 1.46, 95% CI 1.03-2.07) than other cancer patients. Overall, 74% of survey respondents had changed their diet or exercise after cancer diagnosis. Respondents reporting that their oncologist spoke to them about increasing exercise or eating healthier foods were more likely to report a change in behavior than those whose oncologists did not (exercise: 79.6% vs 69.0%, P < 0.001; diet 81.1% vs 71.4%, P < 0.001). Respondents whose oncologist had spoken to them about exercise were more likely to exercise > 2 times per week compared to respondents whose oncologists did not address exercise (53.5% vs 44.1%, P < 0.001). Conclusions: In a national survey of oncology patients, slightly more than half of respondents reported attention to diet and exercise during oncology visits. Provider recommendations for diet and exercise were associated with positive changes in these behaviors. Additional attention to diet and exercise as part of oncology visits is needed to help support healthy lifestyle change in cancer patients.

Rationale: Overweight and obesity are highly prevalent among BC patients and are linked to poorer prognosis and worse patient-reported outcomes (PROs). Weight loss interventions, based on caloric restriction, increased physical activity (PA) and behavioral counselling, are safe and feasible among BC survivors and hold the promise to improve BC-specific outcomes. MEDEA: Motivating to Exercise and Diet, and Educating to healthy behaviors After breast cancer (ClinicalTrials.gov NCT04304924) will evaluate the impact of weight loss on CRF. Trial design: French multi-center 1:1 randomized controlled trial comparing a 12-month personalized, telephone-based weight loss program + health education intervention vs health education alone in overweight or obese BC patients. Endpoints and measures: Primary endpoint: difference in self-reported CRF 12 months post-randomization between arms, measured using the EORTC QLQ-C30 CRF subscale. Secondary endpoints: 1) PROs (EORTC QLQ-C30, -B45, -FA12), anxiety and depression (Hospital Anxiety and Depression Scale); 2) weight and body mass index (BMI), diet habits and quality, PA, sleep; 3) cost-effectiveness (number and length of hospital-admissions, all-drug consumption, number and duration of sick leaves). Accelerometer data will be collected to track PA and sleep measures. Qualitative analyses will evaluate patient motivation and satisfaction. Main eligibility criteria: stage I-II-III BC, primary BC treatment completed within the prior 12 months (definitive surgery, adjuvant chemo-, and/or radio-therapy, if administered), BMI ≥25 kg/m2, ability to walk at least 400 meters at any pace, ECOG PS 0-1, not participating in another weight loss, dietary or PA intervention clinical trial. Intervention and Control arms: The intervention and health education program are adapted from the BWEL: Breast Cancer WEight Loss study (ClinicalTrials.gov NCT02750826; PI Ligibel JA). The behavior change program is based on the Social Cognitive Theory. Patients in the intervention arm are paired with an individual lifestyle coach, who delivers the intervention through 24 semi-structured telephone calls of 30-60 minutes, supplemented by a detailed participant workbook and scheduled as follows: 1) intensive phase (weeks 1-12), 12 weekly calls; 2) consolidation phase (weeks 13-24), 6 bi-weekly calls; 3) maintenance phase (weeks 25-52), 1 monthly call. Coaches were hired and trained specifically for MEDEA, they are located at a centralized call center and receive support from coordinating nutrition, PA, and behavioral experts. Regular meetings with study team and investigators assure standardized delivery of the intervention and troubleshooting. Intervention goals include weight loss ≥10% of baseline weight, caloric restriction of 500-1000 Kcal/day, increased PA to 150 minutes/week in the initial phase and 225-300 minutes/week in the maintenance phase. Toolbox solutions are offered to tailor the intervention and meet the needs of specific ethnic, socioeconomic or other patient populations with difficulties in achieving intervention goals. All participants in both arms receive a health education program focusing on healthy living. Accrual: MEDEA will enroll 220 patients overall. Recruitment started in June 2020. Statistical considerations: The primary analysis of MEDEA will compare the primary endpoint of CRF scores at the 12-month post-randomization time point between arms. The study has 90.0% power at two-sided α=0.05 to detect a standardized effect size of 0.40 (sample size inflated for drop outs). For interpreting the clinical significance of effects, 0.2, 0.5 and 0.8 standard deviation effects will be considered as small, moderate, and large (Cohen, 1988). All other measures, time points and analyses will be considered secondary or exploratory. Citation Format: Antonio Di Meglio, Elise Martin, Stefan Michiels, Cecile Charles, Tracy E. Crane, Aude Barbier, Bruno Raynard, Anthony Mangin, Olivier Tredan, Paul H. Cottu, Laurence Vanlemmens, Carine Segura-Djezzar, Anne Lesur, Barbara Pistilli, Florence Joly, Thomas Ginsbourger, Bernadette Coquet, Guillemette Jacob, Aude Sirven, Julia Bonastre, Jennifer A. Ligibel, Ines Vaz-Luis. MEDEA: A randomized trial of weight loss to reduce cancer-related fatigue (CRF) among overweight and obese breast cancer (BC) patients [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr OT-38-01.

Ovarian cancer is the most common cause of gynecological cancer death in United States women. Efforts to improve progression free survival (PFS) and quality of life (QoL) after treatment for ovarian cancer are necessary. Observational studies suggest that lifestyle behaviors, including diet and physical activity, are associated with lower mortality in this population. The Lifestyle Intervention for Ovarian Cancer Enhanced Survival (LIVES) NRG 0225 study is a randomized, controlled trial designed to test the hypothesis that a 24 month lifestyle intervention will significantly increase PFS after oncological therapy for stage II-IV ovarian cancer. Women are randomized 1:1 to a high vegetable and fiber, low-fat diet with daily physical activity goals or an attention control group. Secondary outcomes to be evaluated include QoL and gastrointestinal health. Moreover an a priori lifestyle adherence score will be used to evaluate relationships between adoption of the diet and activity goals and PFS. Blood specimens are collected at baseline, 6, 12 and 24 months for analysis of dietary adherence (carotenoids) in addition to mechanistic biomarkers (lipids, insulin, telomere length). Women are enrolled at NRG clinic sites nationally and the telephone based lifestyle intervention is delivered from The University of Arizona call center by trained health coaches. A study specific multi-modal telephone, email, and SMS behavior change software platform is utilized for information delivery, coaching and data capture. When completed, LIVES will be the largest behavior-based lifestyle intervention trial conducted among ovarian cancer survivors.

6018 Background: Chronotype is defined as an individual’s propensity to sleep at a specific time in a 24-hour cycle with late chronotype associated with poorer health outcomes including cancer. Chronotype remains relatively undefined in ovarian cancer. The Lifestyle Intervention for oVarian cancer Enhanced Survival (LIVES) study is testing whether 1205 women randomized to a diet and physical activity intervention for 24-months will have longer progression-free survival versus an attention control. Here we determine the association of late and early vs mid chronotypes and patient reported outcomes (PROs), lifestyle behaviors and biomarkers of metabolic health and inflammation in ovarian cancer survivors post-treatment (≤ 6.5 months). Methods: Chronotype was determined using self-reported time to bed (early < 9 pm; mid ≥ 9 pm - ≤12 am; late > 12 am) captured through the Pittsburg Sleep Quality Index and PROs were measured using subscales of the Rand-36 questionnaire. Validated questionnaires for diet and physical activity were used and biomarkers were collected at routine clinic visits. A total subsample of 438 ovarian cancer survivors enrolled in NRG/GOG 0225- LIVES study with all available baseline measures were included in analyses. Descriptive statistics, general linear mixed models, and Pearson correlations were performed. Results: Reported pain was significantly higher in late chronotypes (P < 0.05) when compared to early and mid-chronotypes. Total sleep duration was significant between the 3 chronotypes (P < 0.05) with late chronotype experiencing less sleep (6.77 ± 1.67 hrs) than mid chronotype (7.04 ± 1.31 hrs) and early chronotype (7.56 ± 1.33 hrs). Higher reported pain was significantly correlated to poorer CRP levels (r = -0.198, P < 0.001) suggesting higher systemic inflammation and poorer blood insulin levels (r = -0.116, P < 0.05) independent of chronotype classification. All other subscales of the RAND 36 and physical activity were not associated with chronotype. Diet quality trended towards significance with a positive association observed in early and an inverse association in late chronotypes (P = 0.06). Conclusions: Late chronotypes reported higher levels of pain which was associated with poorer sleep and diet quality and higher levels of inflammation and insulin. More robust data, including actigraphy, are being analyzed and will provide additional insight of the role of circadian rhythm and phenotype on pain and key biomarkers in ovarian cancer survivors. Clinical trial information: NCT00719303.

Lifestyle-related factors influence risk of endometrial and ovarian cancers, but few studies have examined their joint associations with risk of these cancers. Using multivariable Cox regression models, we assessed the association of a healthy lifestyle index (HLI-a composite score (range, 0-20) involving diet, alcohol consumption, physical activity, body mass index, and smoking; higher scores represent healthier behavior) with risk of endometrial and ovarian cancers among 108,136 postmenopausal women who were recruited in the US Women's Health Initiative study between 1993 and 1998. After a median follow-up of 17.9 years, 1,435 endometrial cancer cases and 904 ovarian cancer cases had been ascertained. Women in the highest quintile of the HLI score had a lower risk of overall, type I, well-differentiated, moderately differentiated, poorly differentiated, and localized endometrial cancer than those in the lowest quintile (for quintile 5 vs. quintile 1, hazard ratio (HR) = 0.61 (95% CI: 0.51, 0.72), HR = 0.60 (95% CI: 0.49, 0.72), HR = 0.66 (95% CI: 0.46, 0.96), HR = 0.69 (95% CI: 0.52, 0.90), HR = 0.49 (95% CI: 0.34, 0.72), and HR = 0.61 (95% CI: 0.50, 0.74), respectively). The HLI score had a weak positive association with risk of serous ovarian cancer. Our findings underscore the potential importance of a healthy lifestyle in lowering endometrial cancer risk among postmenopausal women.

Study Objectives To evaluate the associations between sedentary time, total (total-PA), light (light-PA), moderate (MOD-PA), and vigorous (VIG-PA) physical activity with indices of sleep in postmenopausal women. Methods Baseline self-reported data from the Women’s Health Initiative Observational Study (n = 75 074) were used in this cross-sectional analysis. Total-PA, light-PA, MOD-PA, and VIG-PA were categorized by metabolic equivalents of the activity (MET-hour [hr]/week [wk]) and were estimated using validated questionnaires. Sedentary time was categorized by hr/day and was estimated via questionnaire. Logistic regression was used to examine the associations between these variables and short sleep (≤6 hr/night), long sleep (≥10 hr/night), poor sleep quality, and insomnia symptoms after adjustment for age, race, socioeconomic status, body mass index, health status, depressive symptoms, smoking status, alcohol use, hormone therapy, and comorbidities. Results Higher sedentary time (>11 hr/day) was associated with higher odds of short sleep (odds ratio [OR] = 1.80, 95% confidence interval [CI]: 1.72–1.88), poor sleep quality (OR = 1.85, 95% CI: 1.74–1.97), and insomnia symptoms (OR = 1.56, 95% CI: 1.49–1.64). Light-PA (>0 MET-hr/wk) was associated with lower odds of short sleep (OR = 0.96, 95% CI: 0.92–1.00), and higher amounts of total-PA (OR = 0.90, 95% CI: 0.84–0.97), light-PA (OR = 0.94, 95% CI: 0.89–1.00), and MOD-PA (OR = 0.91, 95% CI: 0.86–0.97) were associated with lower odds of poor sleep quality. Conclusions Our findings suggest that higher levels of light and moderate intensity physical activity are associated with better sleep quality, whereas higher amounts of sedentary time are associated with short sleep and lower quality sleep. Future studies should investigate the directionality of these associations and potential causal pathways.

Objective Accurate and efficient measurement of patient-reported outcomes is key in cancer symptom management trials. The newer Patient Reported Outcomes Measurement Information System (PROMIS) and previously developed measures of similar conceptual content (legacy) are available to measure symptoms and functioning. This report compares the performance of two sets of measures, PROMIS and legacy, in a recently completed trial of a supportive care intervention that enrolled breast cancer patients and their friend or family caregivers. Methods Patient-caregiver dyads (N = 256) were randomized to either reflexology delivered by caregivers or usual care control. Post-intervention, PROMIS and legacy measures of symptoms and functioning were analyzed in relation to trial arm, while adjusting for baseline values. Responsiveness of the two sets of measures was assessed using effect sizes and P-values for the effect of trial arm on patients' and caregivers' symptom and functioning outcomes. Results Similar conclusions about intervention effects were found using PROMIS and legacy measures for pain, fatigue, sleep, anxiety, physical, and social functioning. Different conclusions were obtained for patient and caregiver depression: legacy measures indicated the efficacy of reflexology, while PROMIS depression measure did not. Conclusion Evidence of similar responsiveness supports the use of either set of measures for symptoms and functioning in clinical and general populations. Differences between PROMIS and legacy measures of depression need to be considered when choosing instruments for use in trials of supportive care interventions and in clinical practice.

Purpose Endometrial cancer is the most commonly diagnosed gynecologic cancer, but no convincing dietary risk factors for this cancer have been identified. Among postmenopausal women, we examined how four key a priori diet quality indices—the Healthy Eating Index-2010, Alternative Healthy Eating Index-2010, alternate Mediterranean Diet, and Dietary Approaches to Stop Hypertension are related to the risk of endometrial cancer in the Women's Health Initiative Clinical Trials and Observational Study. Methods Our prospective cohort study included 84,415 postmenopausal women with a uterus who completed a food frequency questionnaire at enrollment. Cox proportional hazards models were used to estimate multivariate hazard ratios (HRs) and 95% confidence intervals (CIs) for endometrial cancer associated with increasing quintiles of diet quality index scores. Results During 13.3 years of follow-up, 1392 endometrial cancer cases occurred. After adjustment for known risk factors, having better diet quality (Q5 vs. Q1) was not associated with the risk of endometrial cancer, as evidenced using Healthy Eating Index-2010 (HR: 1.11, 95% CI: 0.93–1.33), Alternative Healthy Eating Index-2010 (HR: 0.98, 95% CI: 0.82–1.17), alternate Mediterranean Diet (HR: 0.98, 95% CI: 0.82–1.17), or Dietary Approaches to Stop Hypertension (HR: 1.00, 95% CI: 0.84–1.19). Conclusions Diet quality was not associated with endometrial cancer risk in this large cohort of postmenopausal women.

Ovarian cancer is a leading cause of gynecological cancer death. There is a need to identify modifiable dietary risk factors for this disease. To evaluate the role of diet in ovarian cancer risk, we performed a PRISMA-directed systematic review that included prospective cohort studies with >200 cases (n = 24). Higher risk for ovarian cancer was shown for total, animal, and dairy fat (five of nine studies), as well as total nitrate and possibly total vitamin C. No associations were demonstrated for red meat, fiber, vitamin A, vitamin E, β-carotene, or folate. Vegetables were associated with lower risk in one of three studies; fruit showed no association, although risk estimates were all greater than 1.0. Isoflavones and flavonoids were associated with modestly lower risk in two studies and tea intake was associated with lower risk in one of two studies. This review suggests that no specific dietary factors are consistently associated with ovarian cancer risk. Data by tumor subtypes are limited, but suggest that differential associations by tumor subtype may exist and should be evaluated. Studies of ample sample size, varied exposure, which can better control for dietary measurement error, are needed to fully define dietary recommendations for ovarian cancer prevention. Cancer Epidemiol Biomarkers Prev; 23(2); 255–73. ©2013 AACR.

The mission of the American Society of Preventive Oncology (ASPO) includes fostering the continuing professional development of its members. One major activity of ASPO is to prepare the next generation of cancer prevention and control researchers for successful careers. The process of applying for

The optimal amount of vegetable consumption required to reduce chronic disease risk is widely debated. Intervention trials evaluating biological activity of vegetables at various doses are limited. We conducted a 3-dose, crossover feeding trial to test the hypothesis that vegetable intake is associated in a dose-dependent manner with increased plasma carotenoids and subsequently reduced oxidative stress and inflammation in 49 overweight, postmenopausal women. Participants were assigned in random order to 2 (130 g), 5 (287 g), and 10 (614 g) daily servings of fresh, greenhouse-grown vegetables for 3-wk intervals with a 4-wk washout period between treatments. Plasma total carotenoids significantly increased from 1.63 to 2.07 μmol/L with a dose of 2 vegetable servings, from 1.49 to 2.84 μmol/L with a dose of 5 vegetable servings, and from 1.40 to 4.42 μmol/L with a dose of 10 vegetable servings (pre-post paired ttests, all P < 0.001). The change during each feeding period increased with each dose level (P < 0.001). Urine concentrations of 8-isoprostane F2α, hexanoyl lysine, and serum high sensitivity C-reactive protein were not affected by any administered vegetable dose. In this variable-dose vegetable study, a dose-response for plasma carotenoids was demonstrated without significant change in oxidative stress and inflammation in overweight, postmenopausal women.

141 Background: Rectal cancer survivors often experience persistent long-term effects of treatment. Functional deficits, such as bowel dysfunction, are associated with poor quality of life (QOL). There is a lack of evidence-based interventions to address bowel dysfunction symptoms in rectal cancer survivors. The purpose of this abstract is to describe the development and design of the Altering Intake, Managing Symptoms (AIMS) intervention to manage bowel dysfunction in rectal cancer survivors. Methods: Survivors with stage I-III rectosigmoid colon or rectal cancer who are 6 months post-treatment, > 21 years, and English-speaking are eligible to participate. The AIMS intervention is a ten (30-40 minute) session, 4 month, telephone-based intervention delivered by trained health coaches. Outcome measures are assessed at baseline, 4 and 6 months, and include the MSKCC Bowel Function Tool, the COH-QOL-CRC, and adherence to cancer survivorship diet guidelines. Results: Based on the Chronic Care Self-Management Model (CCM), the AIMS intervention applies social cognitive theory to improve self-efficacy and self-management of bowel symptoms by coaching survivors to modify their diets to attenuate symptoms and enhance diet quality. Motivational interviewing-based behavioral approaches are applied, such as goal setting, self-monitoring, identification of barriers, and problem-solving. Monitoring of diet health involves review of 24 hour dietary recalls in conjunction with food and symptom diaries to promote survivor-directed behavior change resulting in improved bowel health. Conclusions: The AIMS intervention is among the first and few to address diet behavior changes for symptom management in rectal cancer survivors. It has the potential to positively impact the quality of long-term rectal cancer survivorship by integrating classic behavior change theories for cancer symptom management. Findings from the study will inform the design and development of future multi-institutional Phase II and III randomized trials. Clinical trial information: NCT03063918.

Poor sleep quality and short sleep duration have been associated with elevated risk for several cancer types; however, the relationship between sleep and cancer outcomes has not been well characterized. We assessed the association between pre-diagnostic sleep attributes and subsequent cancer survival within the Women's Health Initiative (WHI).We identified WHI participants in whom a first primary invasive cancer had been diagnosed during follow-up (n = 21,230). Participants provided information on sleep characteristics at enrollment. Cox regression was used to calculate hazard ratios (HRs) and 95% confidence intervals (CIs) for associations between these pre-diagnostic sleep characteristics and cancer-specific survival for all cancers combined and separately for common cancers. Analyses were adjusted for age, study arm, cancer site, marital status, income, smoking, physical activity, and time to diagnosis.No individual pre-diagnostic sleep characteristics were found to be significantly associated with cancer survival in analyses of all cancer sites combined; however, women who reported short sleep duration (≤ 6 h sleep/night) combined with frequent snoring (≥ 5 nights/w experienced significantly poorer cancer-specific survival than those who reported 7-8 h of sleep/night and no snoring (HR = 1.32, 95% CI: 1.14-1.54). Short sleep duration (HR = 1.46, 95% CI: 1.07-1.99) and frequent snoring (HR = 1.34, 95% CI: 0.98-1.85) were each associated with poorer breast cancer survival; those reporting short sleep combined with frequent snoring combined had substantially poorer breast cancer survival than those reporting neither (HR = 2.14, 95% CI: 1.47-3.13).Short sleep duration combined with frequent snoring reported prior to cancer diagnosis may influence subsequent cancer survival, particularly breast cancer survival.

Ovarian cancer is the leading cause of gynecological cancer death in US women with an estimated 22280 new cases and 15500 deaths annually (1). Most cases are diagnosed at an advanced stage of disease, thus contributing to low survival rates (1). Efforts to identify prognostic factors for ovarian cancer are needed, and diet may provide a modifiable influence on survival (1). The role of diet in the development of ovarian cancer is not clearly understood (2), and evidence in relation to survival after diagnosis is sparse. Only two prior observational studies have specifically evaluated prediagnostic diet and its association with survival after ovarian cancer diagnosis. A case-control study by Nagle et al. demonstrated a 25% greater survival in 609 Australian women previously treated for stage I–IV invasive epithelial ovarian cancer who consumed greater amounts of vegetables (3). Additionally, prediagnosis diet was evaluated in relation to ovarian cancer survival in an Illinois cohort of 341 ovarian cancer survivors with follow-up for seven to 11 years (4). Diets higher in vegetables and fruit and lower in meat were associated with longer survival (4). Dietary quality, summarized in a score that reflects the combined effects of cancer-associated food exposures (5,6), may be best suited to evaluate the influence of overall diet on cancer survival. Similar analyses evaluating the association between diet quality and risk of breast (7–9), colorectal (10), and pancreatic (11) cancer offer compelling support for this approach. Here we present an analysis from a large sample of postmenopausal women enrolled in the Women’s Health Initiative designed to test the hypothesis that the Healthy Eating Index (HEI)–2005, a measure of overall diet quality (12,13), is inversely associated with mortality after ovarian cancer. Additionally, we sought to determine if any associations between diet quality and mortality were modified by obesity, diabetes, or physical activity, factors that are included in current recommendations targeting survival after cancer (14,15).

Evidence suggests that higher plasma carotenoid concentrations are protective in relation to breast cancer recurrence. This simple randomized carrot juice intervention study was designed to test the hypothesis that daily intake of 8 ounces of fresh BetaSweet (anthocyanin-rich) or Balero orange carrot juice would increase plasma total carotenoid concentrations to levels previously shown to be associated with reduced breast cancer recurrence. It was hypothesized that regular carrot juice intake would be associated with reductions in oxidative stress (8-iso-PGF2α) and inflammation (thromboxane B2, prostaglandin E2 metabolites, and hsC-reactive protein). Sixty-nine overweight breast cancer survivors consumed fresh carrot juice made from study-provided carrots for 3 wk. Total plasma carotenoids increased by 1.65 and 1.38 umol/L for the BetaSweet and Balero carrot juice, respectively. Rise in total plasma carotenoids for the overall sample was inversely associated with 8-iso-PGFα (OR: 0.13; 95% CI: 0.20 to 0.75; no differences were shown by carrot variety. These results suggest daily intake of fresh carrot juice is a simple and effective approach to increasing plasma total carotenoids and in turn reducing oxidative stress, but not inflammatory markers, in women previously treated for breast cancer.

e24093 Background: There are over 3.8 million breast cancer survivors in the United States, and many experience long-term side effects from chemotherapy. Factors associated with peripheral neuropathy (PN), one troubling side effect, following breast cancer among women are unknown. Methods: We included 2,420 women enrolled in the Women’s Health Initiative and diagnosed prospectively with local or regional stage breast cancer and followed in the Life and Longevity After Cancer (LILAC) study. PN was assessed by response to the baseline LILAC questionnaire regarding the presence of “nerve problems, tingling sensations” after treatment. Data were collected on initial course of therapy (surgery, radiation, and chemotherapy) through Medicare linkage or the LILAC staging and treatment form. Chi-square and Wilcoxon rank-sum tests were used for univariate comparison of socio-demographics, clinical and diagnosis characteristics associated with the presence or absence of PN. Results: The sample included 1,913 women (79%) with local and 507 women (21%) with regional stage disease. Initial course of therapy included either surgery alone (21%), surgery and radiation (53%), or surgery and chemotherapy (+/- radiation) (26%). Seventeen percent of women reported experiencing PN days (30%), months (46%) or years (24%) following treatment. Three-quarters (74%) reported ongoing symptoms at the time of the LILAC survey. PN was reported by 33% of chemotherapy recipients, compared to 12% in the surgery alone group, and 11% in the group that received surgery and radiation (p