Baseline characteristics and recruitment for SWOG S1820: altering intake, managing bowel symptoms in survivors of rectal cancer (AIMS-RC).

PURPOSE: Many survivors of rectal cancer experience persistent bowel dysfunction. There are few evidence-based symptom management interventions to improve bowel control. The purpose of this study is to describe recruitment and pre-randomization baseline sociodemographic, health status, and clinical characteristics for SWOG S1820, a trial of the Altering Intake, Managing Symptoms in Rectal Cancer (AIMS-RC) intervention. METHODS: SWOG S1820 aimed to determine the preliminary efficacy, feasibility, and acceptability of AIMS-RC, a symptom management intervention for bowel health, comparing intervention to attention control. Survivors with a history of cancers of the rectosigmoid colon or rectum, within 6-24 months of primary treatment completion, with a post-surgical permanent ostomy or anastomosis, and over 18 years of age were enrolled. Outcomes included total bowel function, low anterior resection syndrome, quality of life, motivation for managing bowel health, self-efficacy for managing symptoms, positive and negative affect, and study feasibility and acceptability. RESULTS: The trial completed accrual over a 29-month period and enrolled 117 participants from 34 institutions across 17 states and one US Pacific territory. At baseline, most enrolled participants reported self-imposed diet adjustments after surgery, persistent dietary intolerances, and bowel discomfort post-treatment, with high levels of constipation and diarrhea (grades 1-4). CONCLUSIONS: SWOG S1820 was able to recruit, in a timely manner, a study cohort that is demographically representative of US survivors of rectal cancer. Baseline characteristics illustrate the connection between diet/eating and bowel symptoms post-treatment, with many participants reporting diet adjustments and persistent inability to be comfortable with dietary intake. GOV REGISTRATION DATE: 12/19/2019. GOV IDENTIFIER: NCT#04205955.

The Women's Health Initiative Randomized Trials and Clinical Practice: A Review.

Importance: Approximately 55 million people in the US and approximately 1.1 billion people worldwide are postmenopausal women. To inform clinical practice about the health effects of menopausal hormone therapy, calcium plus vitamin D supplementation, and a low-fat dietary pattern, the Women's Health Initiative (WHI) enrolled 161 808 postmenopausal US women (N = 68 132 in the clinical trials) aged 50 to 79 years at baseline from 1993 to 1998, and followed them up for up to 20 years. Observations: The WHI clinical trial results do not support hormone therapy with oral conjugated equine estrogens plus medroxyprogesterone acetate for postmenopausal women or conjugated equine estrogens alone for those with prior hysterectomy to prevent cardiovascular disease, dementia, or other chronic diseases. However, hormone therapy is effective for treating moderate to severe vasomotor and other menopausal symptoms. These benefits of hormone therapy in early menopause, combined with lower rates of adverse effects of hormone therapy in early compared with later menopause, support initiation of hormone therapy before age 60 years for women without contraindications to hormone therapy who have bothersome menopausal symptoms. The WHI results do not support routinely recommending calcium plus vitamin D supplementation for fracture prevention in all postmenopausal women. However, calcium and vitamin D are appropriate for women who do not meet national guidelines for recommended intakes of these nutrients through diet. A low-fat dietary pattern with increased fruit, vegetable, and grain consumption did not prevent the primary outcomes of breast or colorectal cancer but was associated with lower rates of the secondary outcome of breast cancer mortality during long-term follow-up. Conclusions and Relevance: For postmenopausal women, the WHI randomized clinical trials do not support menopausal hormone therapy to prevent cardiovascular disease or other chronic diseases. Menopausal hormone therapy is appropriate to treat bothersome vasomotor symptoms among women in early menopause, without contraindications, who are interested in taking hormone therapy. The WHI evidence does not support routine supplementation with calcium plus vitamin D for menopausal women to prevent fractures or a low-fat diet with increased fruits, vegetables, and grains to prevent breast or colorectal cancer. A potential role of a low-fat dietary pattern in reducing breast cancer mortality, a secondary outcome, warrants further study.

Long-Term Effect of Randomization to Calcium and Vitamin D Supplementation on Health in Older Women : Postintervention Follow-up of a Randomized Clinical Trial.

BACKGROUND: Although calcium and vitamin D (CaD) supplementation may affect chronic disease in older women, evidence of long-term effects on health outcomes is limited. OBJECTIVE: To evaluate long-term health outcomes among postmenopausal women in the Women's Health Initiative CaD trial. DESIGN: Post hoc analysis of long-term postintervention follow-up of the 7-year randomized intervention trial of CaD. (ClinicalTrials.gov: NCT00000611). SETTING: A multicenter (n = 40) trial across the United States. PARTICIPANTS: 36 282 postmenopausal women with no history of breast or colorectal cancer. INTERVENTION: Random 1:1 assignment to 1000 mg of calcium carbonate (400 mg of elemental calcium) with 400 IU of vitamin D3 daily or placebo. MEASUREMENTS: Incidence of colorectal, invasive breast, and total cancer; disease-specific and all-cause mortality; total cardiovascular disease (CVD); and hip fracture by randomization assignment (through December 2020). Analyses were stratified on personal supplement use. RESULTS: For women randomly assigned to CaD versus placebo, a 7% reduction in cancer mortality was observed after a median cumulative follow-up of 22.3 years (1817 vs. 1943 deaths; hazard ratio [HR], 0.93 [95% CI, 0.87 to 0.99]), along with a 6% increase in CVD mortality (2621 vs. 2420 deaths; HR, 1.06 [CI, 1.01 to 1.12]). There was no overall effect on other measures, including all-cause mortality (7834 vs. 7748 deaths; HR, 1.00 [CI, 0.97 to 1.03]). Estimates for cancer incidence varied widely when stratified by whether participants reported supplement use before randomization, whereas estimates on mortality did not vary, except for CVD mortality. LIMITATION: Hip fracture and CVD outcomes were available on only a subset of participants, and effects of calcium versus vitamin D versus joint supplementation could not be disentangled. CONCLUSION: Calcium and vitamin D supplements seemed to reduce cancer mortality and increase CVD mortality after more than 20 years of follow-up among postmenopausal women, with no effect on all-cause mortality. PRIMARY FUNDING SOURCE: National Heart, Lung, and Blood Institute of the National Institutes of Health.

Health Behavior Change Intervention Preferences Expressed by American Indian Cancer Survivors From a Southwest Tribal Community: Semistructured Interview Study.

BACKGROUND: While many factors, including social determinants of health, affect cancer mortality, one modifiable risk factor that may contribute to cancer disparities is obesity. The prevalence of obesity in the American Indian/Alaska Native population is 48.1% per the Centers for Disease Control and Prevention. The overall cancer mortality for the American Indian/Alaska Native population is 18% higher than the White population as reported by the American Cancer Society. Interventions tailored to American Indian/Alaska Native communities that promote healthy lifestyle behaviors after cancer diagnosis and prior to cancer surgery (prehab) might improve cancer outcomes for this population. OBJECTIVE: The aim of the study is to characterize the lifestyle behaviors of San Carlos Apache cancer survivors and identify preferences for the adaption of a prehab intervention. METHODS: Semistructured interviews and validated questionnaires were completed with San Carlos Apache cancer survivors (N=4), exploring their viewpoints on healthy lifestyle and cancer risk and preferences for program development. A thematic content analysis was conducted. RESULTS: Participants had an average BMI of 31 kg/m2 and walked 53 minutes daily. The majority of participants reported a high willingness to change eating habits (n=3, 75%). All 4 reported willingness to participate in a diet and exercise program. Important themes and subthemes were identified: (1) cancer is perceived as a serious health condition in the community (N=4, 100%); (2) environmental exposures are perceived as cancer-causing threats (n=3, 75%); (3) healthy diet, exercise, and avoiding harmful substances are perceived as mitigating cancer risk (n=3, 75%); (4) barriers to healthy habits include distance to affordable groceries (n=3, 75%) and lack of transportation (n=2, 50%); (5) there is high interest in a prehab program geared toward patients with cancer (N=4, 100%); and (6) standard monitoring practiced in published prehab programs showed early acceptability with participants (N=4, 100%). CONCLUSIONS: Collaboration with tribal partners provided important insight that can help inform the adaptation of a culturally appropriate prehab program for San Carlos Apache patients diagnosed with cancer.

Infertility and risk of postmenopausal breast cancer in the women's health initiative.

PURPOSE: Although infertility (i.e., failure to conceive after ≥ 12 months of trying) is strongly correlated with established breast cancer risk factors (e.g., nulliparity, number of pregnancies, and age at first pregnancy), its association with breast cancer incidence is not fully understood. Previous studies were primarily small clinic-based or registry studies with short follow-up and predominantly focused on premenopausal breast cancer. The objective of this study was to assess the relationship between infertility and postmenopausal breast cancer risk among participants in the Women's Health Initiative (analytic sample = 131,784; > 25 years of follow-up). METHODS: At study entry, participants were asked about their pregnancy history, infertility history, and diagnosed reasons for infertility. Incident breast cancers were self-reported with adjudication by trained physicians reviewing medical records. Cox proportional hazards models were used to estimate risk of incident postmenopausal breast cancer for women with infertility (overall and specific infertility diagnoses) compared to parous women with no history of infertility. We examined mediation of these associations by parity, age at first term pregnancy, postmenopausal hormone therapy use at baseline, age at menopause, breastfeeding, and oophorectomy. RESULTS: We observed a modest association between infertility (n = 23,406) and risk of postmenopausal breast cancer (HR = 1.07; 95% CI 1.02-1.13). The association was largely mediated by age at first term pregnancy (natural indirect effect: 46.4% mediated, CI 12.2-84.3%). CONCLUSION: These findings suggest that infertility may be modestly associated with future risk of postmenopausal breast cancer due to age at first pregnancy and highlight the importance of incorporating reproductive history across the life course into breast cancer analyses.

#4Corners4Health Social Media Cancer Prevention Campaign for Emerging Adults: Protocol for a Randomized Stepped-Wedge Trial.

BACKGROUND: Many emerging adults (EAs) are prone to making unhealthy choices, which increase their risk of premature cancer morbidity and mortality. In the era of social media, rigorous research on interventions to promote health behaviors for cancer risk reduction among EAs delivered over social media is limited. Cancer prevention information and recommendations may reach EAs more effectively over social media than in settings such as health care, schools, and workplaces, particularly for EAs residing in rural areas. OBJECTIVE: This pragmatic randomized trial aims to evaluate a multirisk factor intervention using a social media campaign designed with community advisers aimed at decreasing cancer risk factors among EAs. The trial will target EAs from diverse backgrounds living in rural counties in the Four Corners states of Arizona, Colorado, New Mexico, and Utah. METHODS: We will recruit a sample of EAs (n=1000) aged 18 to 26 years residing in rural counties (Rural-Urban Continuum Codes 4 to 9) in the Four Corners states from the Qualtrics' research panel and enroll them in a randomized stepped-wedge, quasi-experimental design. The inclusion criteria include English proficiency and regular social media engagement. A social media intervention will promote guideline-related goals for increased physical activity, healthy eating, and human papillomavirus vaccination and reduced nicotine product use, alcohol intake, and solar UV radiation exposure. Campaign posts will cover digital and media literacy skills, responses to misinformation, communication with family and friends, and referral to community resources. The intervention will be delivered over 12 months in Facebook private groups and will be guided by advisory groups of community stakeholders and EAs and focus groups with EAs. The EAs will complete assessments at baseline and at 12, 26, 39, 52, and 104 weeks after randomization. Assessments will measure 6 cancer risk behaviors, theoretical mediators, and participants' engagement with the social media campaign. RESULTS: The trial is in its start-up phase. It is being led by a steering committee. Team members are working in 3 subcommittees to optimize community engagement, the social media intervention, and the measures to be used. The Stakeholder Organization Advisory Board and Emerging Adult Advisory Board were formed and provided initial input on the priority of cancer risk factors to target, social media use by EAs, and community resources available. A framework for the social media campaign with topics, format, and theoretical mediators has been created, along with protocols for campaign management. CONCLUSIONS: Social media can be used as a platform to counter misinformation and improve reliable health information to promote health behaviors that reduce cancer risks among EAs. Because of the popularity of web-based information sources among EAs, an innovative, multirisk factor intervention using a social media campaign has the potential to reduce their cancer risk behaviors. TRIAL REGISTRATION: ClinicalTrials.gov NCT05618158; https://classic.clinicaltrials.gov/ct2/show/NCT05618158. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/50392.

SWOG S1820: A pilot randomized trial of the Altering Intake, Managing Bowel Symptoms Intervention in Survivors of Rectal Cancer.

BACKGROUND: Survivors of rectal cancer experience persistent bowel dysfunction after treatments. Dietary interventions may be an effective approach for symptom management and posttreatment diet quality. SWOG S1820 was a pilot randomized trial of the Altering Intake, Managing Symptoms in Rectal Cancer (AIMS-RC) intervention for bowel dysfunction in survivors of rectal cancer. METHODS: Ninety-three posttreatment survivors were randomized to the AIMS-RC group (N = 47) or the Healthy Living Education attention control group (N = 46) after informed consent and completion of a prerandomization run-in. Outcome measures were completed at baseline and at 18 and 26 weeks postrandomization. The primary end point was total bowel function score, and exploratory end points included low anterior resection syndrome (LARS) score, quality of life, dietary quality, motivation, self-efficacy, and positive/negative affect. RESULTS: Most participants were White and college educated, with a mean age of 55.2 years and median time since surgery of 13.1 months. There were no statistically significant differences in total bowel function score by group, with the AIMS-RC group demonstrating statistically significant improvements in the exploratory end points of LARS (p = .01) and the frequency subscale of the bowel function index (p = .03). The AIMS-RC group reported significantly higher acceptability of the study. CONCLUSIONS: SWOG S1820 did not provide evidence of benefit from the AIMS-RC intervention relative to the attention control. Select secondary end points did demonstrate improvements. The study was highly feasible and acceptable for participants in the National Cancer Institute Community Oncology Research Program. Findings provide strong support for further refinement and effectiveness testing of the AIMS-RC intervention.

Effects of sleep on breakfast behaviors in recently unemployed adults.

OBJECTIVES: Skipping meals is linked to negative cardiometabolic health outcomes. Few studies have examined the effects of breakfast skipping after disruptive life events, like job loss. The present analyses examine whether sleep timing, duration, and continuity are associated with breakfast eating among 186 adults who recently (past 90 days) experienced involuntary unemployment from the Assessing Daily Activity Patterns Through Occupational Transitions (ADAPT) study. METHODS: We conducted both cross-sectional and 18-month longitudinal analyses to assess the relationship between actigraphic sleep after job loss and breakfast eating. RESULTS: Later sleep timing was associated with a lower percentage of days breakfast was eaten at baseline (B = -0.09, SE = 0.02, P < .001) and longitudinally over 18 months (estimate = -0.04; SE = 0.02; P < .05). No other sleep indices were associated with breakfast consumption cross-sectionally or prospectively. CONCLUSIONS: Unemployed adults with a delay in sleep timing are more likely to skip breakfast than adults with an advancement in sleep timing. Future studies are necessary to test chronobiological mechanisms by which sleep timing might impact breakfast eating. With the understanding that sleep timing is linked to breakfast eating, the advancement of sleep timing may provide a pathway for the promotion of breakfast eating, ultimately preventing cardiometabolic disease.

Loneliness, Spirituality, and Health-Related Quality of Life in Hispanic English-Speaking Cancer Caregivers: A Qualitative Approach.

Hispanic caregivers experiencing higher caregiving burden than their non-Hispanic cohorts, due in part to contextual factors, such as barriers to accessing health care, challenging employment environments, low education and income, immigration issues, and minority stress. Spirituality may serve as a coping strategy for Hispanic caregivers that influences health-related quality of life (HRQoL), possibly by modifying loneliness associated with caregiving. We explored these concepts using semi-structured interviews (N = 10 Hispanic caregivers). Participants shared perceptions of loneliness, spirituality, and how these factors related to HRQoL. Five themes emerged: caregiver experience, coping strategies, loneliness, religion and spirituality to gain strength. Findings suggested that spirituality and religion improved HRQoL partially by reducing loneliness. Future programs to improve HRQoL in Hispanic English-speaking cancer caregivers should address spirituality.

Adherence to a Traditional Mexican Diet Is Associated with Lower Hepatic Steatosis in US-Born Hispanics of Mexican Descent with Overweight or Obesity.

Hispanics of Mexican descent have disproportionate rates of non-alcoholic fatty liver disease (NAFLD). The purpose of this work is to investigate the association between the traditional Mexican diet score (tMexS) and hepatic steatosis and fibrosis, two NAFLD-related clinical endpoints, in Hispanic adults of Mexican descent. Data from 280 Hispanic adults of Mexican descent (n = 102 men, 178 women) with overweight or obesity enrolled in a cross-sectional observational study were analyzed. The tMexS was calculated from 24 h dietary recalls. Hepatic steatosis and fibrosis measurements were assessed using transient elastography (Fibroscan®). Linear regression models testing the association between tMexS and hepatic steatosis and fibrosis were run individually and through the stratification of significant modifiers. Mean tMexS were 5.9 ± 2.1, hepatic steatosis scores were 288.9 ± 48.9 dB/m, and fibrosis scores were 5.6 ± 2.2 kPa. Among the US-born group, with every point increase in the tMexS, there was a statistically significant 5.7 lower hepatic steatosis point (95% CI: -10.9, -0.6, p-value = 0.07). Higher adherence to a traditional Mexican diet was associated with lower hepatic steatosis in US-born Hispanics of Mexican descent. Findings from the current work may serve to inform future culturally relevant interventions for NAFLD prevention and management in individuals of Mexican descent.

Examining provider perceptions and practices for comprehensive geriatric assessment among cancer survivors: a qualitative study with an implementation science focus.

Introduction: Cancer rates increase with age, and older cancer survivors have unique medical care needs, making assessment of health status and identification of appropriate supportive resources key to delivery of optimal cancer care. Comprehensive geriatric assessments (CGAs) help determine an older person's functional capabilities as cancer care providers plan treatment and follow-up care. Despite its proven utility, research on implementation of CGA is lacking. Methods: Guided by a qualitative description approach and through interviews with primary care providers and oncologists, our goal was to better understand barriers and facilitators of CGA use and identify training and support needs for implementation. Participants were identified through Cancer Prevention and Control Research Network partner listservs and a national cancer and aging organization. Potential interviewees, contacted via email, were provided with a description of the study purpose. Eight semi-structured interviews were conducted via Zoom, recorded, and transcribed verbatim by a professional transcription service. The interview guide explored providers' knowledge and use of CGAs. For codebook development, three representative transcripts were independently reviewed and coded by four team members. The interpretive process involved reflecting, transcribing, coding, and searching for and identifying themes. Results: Providers shared that, while it would be ideal to administer CGAs with all new patients, they were not always able to do this. Instead, they used brief screening tools or portions of CGAs, or both. There was variability in how CGA domains were assessed; however, all considered CGAs useful and they communicated with patients about their benefits. Identified facilitators of implementation included having clinic champions, an interdisciplinary care team to assist with implementation and referrals for intervention, and institutional resources and buy-in. Barriers noted included limited staff capacity and competing demands on time, provider inexperience, and misaligned institutional priorities. Discussion: Findings can guide solutions for improving the broader and more systematic use of CGAs in the care of older cancer patients. Uptake of processes like CGA to better identify those at risk of poor outcomes and intervening early to modify treatments are critical to maximize the health of the growing population of older cancer survivors living through and beyond their disease.

Re-visiting the call for translation of cancer survivorship research: collaborative multidisciplinary approaches to improve translation and dissemination.

BACKGROUND: The number of cancer survivors in the US is dramatically increasing and survivors are living longer, making the ongoing care and quality of life in this growing population an important public health issue. Although there has been significant progress in cancer survivorship research, gaps in translating this research to real-world settings to benefit survivors remain. METHODS: The number and type of cancer survivorship research activities in past and current projects were gathered in reports and work plans from the Cancer Prevention and Control Research Network (CPCRN). Additionally, current cross-center projects were aligned with common constructs in dissemination and implementation science to provide a narrative review of progress on translational research. RESULTS: A review of historical activities in the CPCRN indicates that there has been consistent engagement in survivorship from multiple institutions over the last decade, generating 84 grants, 168 papers and 162 presentations. The current membership of the Survivorship Workgroup includes multiple disciplines and all 8 participating institutions. Together these Workgroup members have developed 6 projects, all of which address multiple domains in translational research such as feasibility, practicality, and organizational and cultural factors that affect implementation. CONCLUSIONS: This review of past and ongoing activities in the CPCRN suggests that survivorship has been a consistent priority including the translation of evidence-based approaches into practice. Specific gaps in the translational research agenda that could be the focus of future investigations by Workgroup members and others include the practical and logistic aspects of interventions such as cost and policy.

Recruitment and Retention Strategies Used in Dietary Randomized Controlled Interventions with Cancer Survivors: A Systematic Review.

BACKGROUND: The purpose of this review was to systematically evaluate the quality of reporting of recruitment and retention methods in diet-related intervention trials among cancer survivors. METHODS: A systematic search of five databases in Spring 2023 identified dietary intervention randomized controlled trials with a minimum of 50 cancer survivors, an intervention of at least eight weeks, and at least six months of study duration. Outcomes investigated include methodologic description and reporting of recruitment and retention rates. RESULTS: Seventeen trials met inclusion criteria. Recruitment methods included cancer registry and clinician referral, hospital records, flyers, and media campaigns, and were reported in 88.2% of studies. Eleven of 17 studies (64.7%) met a priori recruitment goals. Eleven studies identified an a priori retention goal and seven met the goal. Retention goals were met more often for studies of less than one year (71.4%) versus greater than one year (50%), and for studies with remote or hybrid delivery (66.7%) versus only in-person delivery (50%). CONCLUSIONS: Recruitment goals and methods are frequently reported; reporting of retention methods and goals is limited. Efforts are needed to improve reporting of retention methods and rates to inform best practices and enhance the rigor of future dietary intervention trials.

Characterization and efficacy of lifestyle behavior change interventions among adult rural cancer survivors: a systematic review.

PURPOSE: Little is known about the intersection between age and rurality as characteristics that impact lifestyle behavior change for cancer survivors. This review aims to summarize the current literature on lifestyle behavior change interventions conducted among rural survivors of cancer, with an emphasis on older survivors. METHODS: A systematic search of five databases identified randomized controlled trials and controlled clinical trials that targeted diet, physical activity, alcohol consumption, or tobacco use change in adult cancer survivors living in rural areas of the world. RESULTS: Eight studies met the inclusion criteria. Most studies were conducted in either Australia or the USA, included survivors at least 6 weeks post-treatment, and half included only breast cancer survivors, while the other four included a mix of cancer types. All but one had a physical activity component. No articles addressed changes in alcohol or tobacco behavior. Seven (87.5%) had a fully remote or hybrid delivery model. Most of the physical activity interventions showed significant changes in physical activity outcomes, while the dietary interventions showed changes of clinical but not statistical significance. CONCLUSIONS: Few studies have been conducted to implement and evaluate the effectiveness of lifestyle behavior change interventions among older rural survivors of cancer. Future research should evaluate the acceptability and relevancy of adapted, evidence-based intervention with this population. IMPLICATIONS FOR CANCER SURVIVORS: Effective diet and physical activity interventions exist, albeit limited in terms of effective lifestyle behavior change intervention tailored to older, rural survivors of cancer, particularly in relation to alcohol and tobacco behaviors.

Surgical versus non-surgical management for patients with malignant bowel obstruction (S1316): a pragmatic comparative effectiveness trial.

BACKGROUND: Malignant small bowel obstruction has a poor prognosis and is associated with multiple related symptoms. The optimal treatment approach is often unclear. We aimed to compare surgical versus non-surgical management with the aim to determine the optimal approach for managing malignant bowel obstruction. METHODS: S1316 was a pragmatic comparative effectiveness trial done within the National Cancer Trials Network at 30 hospital and cancer research centres in the USA, Mexico, Peru, and Colombia. Participants had an intra-abdominal or retroperitoneal primary cancer confirmed via pathological report and malignant bowel disease; were aged 18 years or older with a Zubrod performance status 0-2 within 1 week before admission; had a surgical indication; and treatment equipoise. Participants were randomly assigned (1:1) to surgical or non-surgical treatment using a dynamic balancing algorithm, balancing on primary tumour type. Patients who declined consent for random assignment were offered a prospective observational patient choice pathway. The primary outcome was the number of days alive and out of the hospital (good days) at 91 days. Analyses were based on intention-to-treat linear, logistic, and Cox regression models combining data from both pathways and adjusting for potential confounders. Treatment complications were assessed in all analysed patients in the study. This completed study is registered with ClinicalTrials.gov, NCT02270450. FINDINGS: From May 11, 2015, to April 27, 2020, 221 patients were enrolled (143 [65%] were female and 78 [35%] were male). There were 199 evaluable participants: 49 in the randomised pathway (24 surgery and 25 non-surgery) and 150 in the patient choice pathway (58 surgery and 92 non-surgery). No difference was seen between surgery and non-surgery for the primary outcome of good days: mean 42·6 days (SD 32·2) in the randomised surgery group, 43·9 days (29·5) in the randomised non-surgery group, 54·8 days (27·0) in the patient choice surgery group, and 52·7 days (30·7) in the patient choice non-surgery group (adjusted mean difference 2·9 additional good days in surgical versus non-surgical treatment [95% CI -5·5 to 11·3]; p=0·50). During their initial hospital stay, six participants died, five due to cancer progression (four patients from the randomised pathway, two in each treatment group, and one from the patient choice pathway, in the surgery group) and one due to malignant bowel obstruction treatment complications (patient choice pathway, non-surgery). The most common grade 3-4 malignant bowel obstruction treatment complication was anaemia (three [6%] patients in the randomised pathway, all in the surgical group, and five [3%] patients in the patient choice pathway, four in the surgical group and one in the non-surgical group). INTERPRETATION: In our study, whether patients received a surgical or non-surgical treatment approach did not influence good days during the first 91 days after registration. These findings should inform treatment decisions for patients hospitalised with malignant bowel obstruction. FUNDING: Agency for Healthcare Research and Quality and the National Cancer Institute. TRANSLATION: For the Spanish translation of the abstract see Supplementary Materials section.

New-Onset Diabetes after an Obesity-Related Cancer Diagnosis and Survival Outcomes in the Women's Health Initiative.

BACKGROUND: Individuals diagnosed with an obesity-related cancer (ORC survivors) are at an elevated risk of incident diabetes compared with cancer-free individuals, but whether this confers survival disadvantage is unknown. METHODS: We assessed the rate of incident diabetes in ORC survivors and evaluated the association of incident diabetes with all-cause and cancer-specific mortality among females with ORC in the Women's Health Initiative cohort (N = 14,651). Cox proportional hazards regression models stratified by exposure-risk periods (0-1, >1-3, >3-5, >5-7, and >7-10 years) from ORC diagnosis and time-varying exposure (diabetes) analyses were performed. RESULTS: Among the ORC survivors, a total of 1.3% developed diabetes within ≤1 year of follow-up and 2.5%, 2.3%, 2.3%, and 3.6% at 1-3, 3-5, 5-7, and 7-10 years of follow-up, respectively, after an ORC diagnosis. The median survival for those diagnosed with diabetes within 1-year of cancer diagnosis and those with no diabetes diagnosis in that time frame was 8.8 [95% confidence interval (CI), 7.0-14.5) years and 16.6 (95% CI, 16.1-17.0) years, respectively. New-onset compared with no diabetes as a time-varying exposure was associated with higher risk of all-cause (HR, 1.27; 95% CI, 1.16-1.40) and cancer-specific (HR, 1.17; 95% CI, 0.99-1.38) mortality. When stratified by exposure-risk periods, incident diabetes in ≤1 year of follow-up was associated with higher all-cause (HR, 1.76; 95% CI, 1.40-2.20) and cancer-specific (HR0-1, 1.82; 95% CI, 1.28-2.57) mortality, compared with no diabetes diagnosis. CONCLUSIONS: Incident diabetes was associated with worse cancer-specific and all-cause survival, particularly in the year after cancer diagnosis. IMPACT: These findings draw attention to the importance of diabetes prevention efforts among cancer survivors to improve survival outcomes.

Pre-diagnosis lipid levels and mortality after obesity-related cancer diagnosis in the Women's Health Initiative cardiovascular disease biomarker cohort.

BACKGROUND: Published studies have demonstrated inconclusive relationships between serum lipid levels and mortality after cancer. METHODS: The primary objective was to evaluate the relationship between fasting lipid levels and mortality after cancer. Data were obtained on baseline lipids and outcomes after cancer from 1263 postmenopausal women diagnosed with 13 obesity-related cancers who were part of the Women's Health Initiative (WHI) lipid biomarkers cohort. Obesity-related cancers included incident invasive cancers of the breast, colorectum, endometrium, esophagus (adenocarcinoma), kidney, liver, gallbladder, pancreas, ovaries, small intestine, thyroid, stomach, as well as multiple myeloma. Baseline lipid measurements included high-density lipoprotein (HDL)-cholesterol, low-density lipoprotein (LDL)-cholesterol, and non-HDL-cholesterol. Outcomes were all cause, cancer-specific, and CVD mortality. Multivariable Cox proportional hazards models were used to measure associations between lipid levels and mortality (all cause, cancer, and CVD) after a cancer diagnosis, with lipids analyzed as continuous variables. RESULTS: Among women with obesity-related cancer, there were 707 deaths, of which 379 (54%) were due to cancer and 113 (16%) were due to CVD. Mean time from blood draw to cancer diagnosis was 5.1 years (range: 0.05-10 years). LDL-C values above the 95th percentile were associated with higher risk of all-cause mortality (p < 0.001), and cancer-specific mortality (p < 0.001), but not mortality due to CVD. Non-HDL-C values above the 65th percentile were associated with higher risk of all-cause mortality (p = 0.01) and mortality due to CVD (p = 0.003), but not cancer-specific mortality (p = 0.37). HDL-C values above the 95th percentile were associated with lower all-cause mortality (p = 0.002), and above the 65th percentile with lower cancer-specific mortality (p = 0.003), but no significant relationship with mortality due to CVD was observed. CONCLUSIONS: The relationship between pre-diagnosis fasting lipid levels and mortality after cancer diagnosis is complex. These results suggest that improved lipid control through lifestyle and anti-lipid medications could have a meaningful impact on outcomes after cancer.

Quantifying structural racism in cohort studies to advance prospective evidence.

Calls-to-action in health research have described a need to improve research on race, ethnicity, and structural racism. Well-established cohort studies typically lack access to novel structural and social determinants of health (SSDOH) or precise race and ethnicity categorization, contributing to a loss of rigor to conduct informative analyses and a gap in prospective evidence on the role of structural racism in health outcomes. We propose and implement methods that prospective cohort studies can use to begin to rectify this, using the Women's Health Initiative (WHI) cohort as a case study. To do so, we evaluated the quality, precision, and representativeness of race, ethnicity, and SSDOH data compared with the target US population and operationalized methods to quantify structural determinants in cohort studies. Harmonizing racial and ethnic categorization to the current standards set by the Office of Management and Budget improved measurement precision, aligned with published recommendations, disaggregated groups, decreased missing data, and decreased participants reporting "some other race". Disaggregation revealed sub-group disparities in SSDOH, including a greater proportion of Black-Latina (35.2%) and AIAN-Latina (33.3%) WHI participants with income below the US median compared with White-Latina (42.5%) participants. We found similarities in the racial and ethnic patterning of SSDOH disparities between WHI and US women but less disparity overall in WHI. Despite higher individual-level advantage in WHI, racial disparities in neighborhood resources were similar to the US, reflecting structural racism. Median neighborhood income was comparable between Black WHI ($39,000) and US ($34,700) women. WHI SSDOH-associated outcomes may be generalizable on the basis of comparing across race and ethnicity but may quantitatively (but not qualitatively) underestimate US effect sizes. This paper takes steps towards data justice by implementing methods to make visible hidden health disparity groups and operationalizing structural-level determinants in prospective cohort studies, a first step to establishing causality in health disparities research.

Mixed methods evaluation of the inaugural year of the Cancer Prevention and Control Research Network's (CPCRN) scholars program.

PURPOSE: A diverse workforce trained in dissemination & implementation (D&I) science is critical for improving cancer outcomes and reducing cancer-related health disparities. This study aims to describe and evaluate impact of the Cancer Prevention and Control Research Network (CPCRN) Scholars Program in preparing scholars for collaborative careers in cancer control and implementation research and practice, and offers evaluation-driven recommendations for program improvements. METHODS: The CPCRN Scholars Workgroup conducted a sequential, mixed methods evaluation. We collected baseline and follow-up surveys and invited all 20 scholars and ten mentors to participate in an exit interview. We assessed the experience with the Scholar's program, ratings of D&I competences, progress on their project, feedback about the curriculum, and understanding of implementation science. RESULTS: Over 86% partially or fully completed their project within 9 months; 78% of scholars engaged with a CPCRN workgroup. Scholars rated the following program components as valuable: the Putting Public Health Evidence in Action (PPHEIA) training (88.9%), D&I training modules (83.3%), and webinars (kickoff webinar-88.9% and selecting theories/models-88.9%). There was an increase in D&I competencies from baseline to posttest, with the greatest in community engagement topics. About 78% reported that they were satisfied with format of the activities and increased confidence in ability to discuss D&I concepts. From the qualitative interviews, the benefit of the program was becoming more knowledgeable about D&I research and networking. CONCLUSION: The inaugural year of the program yielded positive results, particularly related to increasing knowledge about D&I science and cancer control. This program builds the capacity of students, researchers and practitioners in D&I science.

Characterizing Dietary Advanced Glycation End-Product (dAGE) Exposure and the Relationship to Colorectal Adenoma Recurrence: A Secondary Analysis.

Limited studies have evaluated the association between dietary advanced glycation end-product AGE (dAGEs) intake and cancer risk; however, no studies have addressed adenoma risk or recurrence. The objective of this study was to determine an association between dietary AGEs and adenoma recurrence. A secondary analysis was conducted using an existing dataset from a pooled sample of participants in two adenoma prevention trials. Participants completed a baseline Arizona Food Frequency Questionnaire (AFFQ) to estimate AGE exposure. NƐ- carboxymethyl-lysine (CML)-AGE values were assigned to quantify foods in the AFFQ using a published AGE database, and participants' exposure was evaluated as a CML-AGE (kU/1000 kcal) intake. Regression models were run to determine the relationship between CML-AGE intake and adenoma recurrence. The sample included 1976 adults with a mean age of 67.2 y ± 7.34. The average CML-AGE intake was 5251.1 ± 1633.1 (kU/1000 kcal), ranging between 4960 and 17032.4 (kU/1000 kcal). A higher intake of CML-AGE had no significant association with the odds of adenoma recurrence [OR(95% CI) = 1.02 (0.71,1.48)] compared to participants with a lower intake. In this sample, CML-AGE intake was not associated with adenoma recurrence. Future research is needed and should be expanded to examine the intake of different types of dAGEs with consideration for the direct measurement of AGE.