American Cancer Society nutrition and physical activity guideline for cancer survivors.

The overall 5-year relative survival rate for all cancers combined is now 68%, and there are over 16.9 million survivors in the United States. Evidence from laboratory and observational studies suggests that factors such as diet, physical activity, and obesity may affect risk for recurrence and overall survival after a cancer diagnosis. The purpose of this American Cancer Society guideline is to provide evidence-based, cancer-specific recommendations for anthropometric parameters, physical activity, diet, and alcohol intake for reducing recurrence and cancer-specific and overall mortality. The audiences for this guideline are health care providers caring for cancer survivors as well as cancer survivors and their families. The guideline is intended to serve as a resource for informing American Cancer Society programs, health policy, and the media. Sources of evidence that form the basis of this guideline are systematic literature reviews, meta-analyses, pooled analyses of cohort studies, and large randomized clinical trials published since 2012. Recommendations for nutrition and physical activity during cancer treatment, informed by current practice, large cancer care organizations, and reviews of other expert bodies, are also presented. To provide additional context for the guidelines, the authors also include information on the relationship between health-related behaviors and comorbidities, long-term sequelae and patient-reported outcomes, and health disparities, with attention to enabling survivors' ability to adhere to recommendations. Approaches to meet survivors' needs are addressed as well as clinical care coordination and resources for nutrition and physical activity counseling after a cancer diagnosis.

American Cancer Society guideline for diet and physical activity for cancer prevention.

The American Cancer Society (ACS) publishes the Diet and Physical Activity Guideline to serve as a foundation for its communication, policy, and community strategies and, ultimately, to affect dietary and physical activity patterns among Americans. This guideline is developed by a national panel of experts in cancer research, prevention, epidemiology, public health, and policy, and reflects the most current scientific evidence related to dietary and activity patterns and cancer risk. The ACS guideline focuses on recommendations for individual choices regarding diet and physical activity patterns, but those choices occur within a community context that either facilitates or creates barriers to healthy behaviors. Therefore, this committee presents recommendations for community action to accompany the 4 recommendations for individual choices to reduce cancer risk. These recommendations for community action recognize that a supportive social and physical environment is indispensable if individuals at all levels of society are to have genuine opportunities to choose healthy behaviors. This 2020 ACS guideline is consistent with guidelines from the American Heart Association and the American Diabetes Association for the prevention of coronary heart disease and diabetes as well as for general health promotion, as defined by the 2015 to 2020 Dietary Guidelines for Americans and the 2018 Physical Activity Guidelines for Americans.

The Value of Pharmaceutical Industry-Sponsored Patient Registries in Oncology Clinical Research.

In May 2019, the US Food and Drug Administration (FDA) released the Framework for FDA's Real-World Evidence (RWE) Program, a draft guidance to evaluate the potential use of real-world data in facilitating regulatory decisions. As a result, pharmaceutical companies and medical communities see patient registries, which are large, prospective, noninterventional cohort studies, as becoming increasingly important in providing evidence of treatment effectiveness and safety in clinical practice. Patient registries are designed to collect longitudinal clinical data on a broad population to address critical medical questions over time. With their large sample sizes and broad inclusion criteria, patient registries are often used to generate RWE in the general and underrepresented patient populations that are less likely to be studied in controlled clinical trials. Here, we describe the value of industry-sponsored patient registries in oncology/hematology settings to healthcare stakeholders, in drug development, and in fostering scientific collaboration.

The impact of clean intermittent catheterization on students and families in the school environment.

INTRODUCTION: Clean intermittent catheterization (CIC) is often used for bladder emptying in children with lower urinary tract dysfunction. Until recently, the emphasis in assessing the effects of CIC has been on preserving kidney function, reducing urinary tract infection, and achieving urinary continence. Few studies have investigated the impact of CIC on students and families in a school setting. This study sought to examine what students and caregivers experienced when CIC was required during the school day and how schools adjusted to a student needing to perform it. MATERIALS AND METHODS: A phenomenological approach utilizing semistructured interviews was performed to understand the impact of CIC on students. Purposeful sampling identified eligible families. A guide was developed from expert opinion validated by a pilot sample with feedback collated into a family/provider codesigned questionnaire. Interviews emphasized the impact and challenges students faced at school. Transcripts were coded using Dedoose software with emerging themes identified and a code book was created for closed coding that led to thematic analysis. RESULTS: A total of 40 families (52 caregivers and children > 12 years) were interviewed. Emergent themes included: Caregivers and students felt (1) school personnel were not always aware of nor prepared regarding the implications of CIC; (2) school bathrooms were often less than ideal (e.g., location, size, cleanliness, privacy, and availability); and (3) student participation in extracurricular activities was challenging. CONCLUSIONS: This study identifies potential areas of intervention in meeting the needs of students who require CIC and the importance of having collaborative efforts of caregivers, health care providers, and school personnel in addressing and meeting CIC needs. Care coordination that involves consistent communication and careful planning between health care teams, school personnel, students, and caregivers can optimize a student's educational experience.

Views among Malawian women about joining HIV prevention clinical trials when pregnant.

BACKGROUND: The pressing need to expand the biomedical HIV prevention evidence base during pregnancy is now increasingly recognized. Women's views regarding participation in such trials and initiating PrEP while pregnant are critical to inform evolving policy and best practices aimed at responsibly expanding evidence-based access for this population. METHODS: We conducted 35 semi-structured interviews with reproductive-aged women in Malawi in the local language, Chichewa. Participants were HIV-negative and purposively sampled to capture a range of experience with research during pregnancy. Women's perspectives on enrolling in three hypothetical HIV prevention trial vignettes while pregnant were explored, testing: (1) oral PrEP (Truvada) (2) a vaginal ring (dapivirine), and (3) a randomized trial comparing the two. The vignettes were read aloud to participants and a simple visual was provided. Interviews were audio-recorded, transcribed, translated, and coded using NVivo 11. Thematic analysis informed the analytic approach. RESULTS: A majority of women accepted participation in all trials. Women's views on research participation varied largely based on their assessment of whether participation or nonparticipation would best protect their own health and that of their offspring. Women interested in participating described power dynamics with their partner as fueling their HIV exposure concerns and highlighted health benefits of participation-principally, HIV protection and access to testing/treatment and ancillary care, and perceived potential risks of the vignettes as low. Women who were uninterested in participating highlighted potential maternal and fetal health risks of the trial, challenges of justifying prevention use to their partner, and raised some modality-specific concerns. Women also described ways their social networks, sense of altruism and adherence requirements would influence participation decisions. CONCLUSIONS: The majority of participants conveyed strong interest in participating in biomedical HIV prevention research during pregnancy, largely motivated by a desire to protect themselves and their offspring. Our results are consistent with other studies that found high acceptance of HIV prevention products during pregnancy, and support the current direction of HIV research policies and practices that are increasingly aimed at protecting the health of pregnant women and their offspring through responsible research, rather than defaulting to their exclusion.

Lost to Care and Back Again: Patient and Navigator Perspectives on HIV Care Re-engagement.

Engagement in HIV care is critical to achieve viral suppression and ultimately improve health outcomes for people living with HIV (PLWH). However, maintaining their engagement in care is often a challenging goal. Utilizing patient navigators, trained in an adapted ARTAS intervention, to help re-engage out-of-care PLWH has proven to be a valuable resource. This qualitative study describes the encounters between PLWH (n = 11) and their care re-engagement navigators (n = 9). Participants were interviewed in-person; interviews were transcribed and analyzed using the strengths model of case management. PLWH shared how working with navigators increased their motivation to return to HIV care and assisted them to overcome barriers that were a hindrance to care engagement. Navigators described a strengths-based approach to working with their clients, thus helping facilitate PLWH care re-engagement goals and successes. Results from this study may inform the development of effective HIV navigation programs to re-engage out-of-care PLWH, often the hardest-to-engage.

Past Care Predicts Future Care in Out-of-Care People Living with HIV: Results of a Clinic-Based Retention-in-Care Intervention in North Carolina.

Poor retention in care is associated with higher viral load (VL) results and decreased rates of viral load suppression (VS) in people living with HIV (PLWH). Therefore, improving retention in HIV care is a priority of national significance. The NC-LINK Retention Project utilized a systematic approach to identify, locate, and attempt to return to care patients who did not attend a clinic appointment for 6-9 months. Clinical and surveillance data were used to evaluate associations between patient characteristics and VL outcomes. Between January 1, 2013 and December 31, 2014, 1118 patients at participating clinics were identified as out-of-care and referred to retention staff. Of these, 712 (64%) were located in North Carolina. Patients with recent prior medical care (aPR 1.43, 95% CI 1.25, 1.66) and recent VS (aPR 1.28, 95% CI 1.16, 1.41) were more likely to be located. Of located patients, 58% re-engaged in care within 90 days of retention referral. Patients who achieved VS within 180 days were more likely to be 40-49 years (aPR 1.19 95% CI 1.01-1.40; compared with 18-29 age group), had insurance at their last visit (aPR 1.19 95% CI 1.01-1.77), had a care visit in the prior year (aPR 1.37 95% CI 1.05-1.77), and had VS at the prior care visit (aPR 2.54 95% CI 1.98-3.25). Clinic-based retention efforts may be effective at helping PLWH decrease out-of-care periods, but prior patterns of care usage persist.

Caregiver role in HIV medication adherence among HIV-infected orphans in Tanzania.

Youth living with HIV in sub-Saharan Africa face numerous challenges in adhering to HIV treatment. The AIDS epidemic has left many of these youth orphaned due to AIDS-related death of one or both parents. It is imperative to understand the family context of youth living with HIV in order to develop responsive interventions to improve adherence to antiretroviral therapy. We conducted qualitative in-depth interviews with 17 HIV-infected AIDS orphans, ages 13-24 years, screened positive for mental health difficulties according to the Patient Health Questionaire-9 (PHQ-9) or UCLA PTSD Reaction Index (PTSD-RI), and receiving outpatient HIV care at an adolescent medical clinic in Moshi, Tanzania. Treatment-related support varied by orphan status. Paternal orphans cared for by their biological mothers and maternal orphans cared for by grandmothers described adherence support such as assistance taking medication and attending clinic. Double orphans did not report adherence support. Several maternal and double orphans faced direct interference from caregivers and household members when they attempted to take their medications. Caregivers play a significant role in treatment adherence and must be considered in interventions to increase medication adherence in HIV-infected orphans. Findings from this study informed caregiver participation in Sauti ya Vijana (The Voice of Youth), a mental health intervention for youth living with HIV in Tanzania.

Characterizing and prognosticating chronic lymphocytic leukemia in the elderly: prospective evaluation on 455 patients treated in the United States.

BACKGROUND: Median age at diagnosis of patients with chronic lymphocytic leukemia (CLL) is > 70 years. However, the majority of clinical trials do not reflect the demographics of CLL patients treated in the community. We examined treatment patterns, outcomes, and disease-related mortality in patients ≥ 75 years with CLL (E-CLL) in a real-world setting. METHODS: The Connect® CLL registry is a multicenter, prospective observational cohort study, which enrolled 1494 adult patients between 2010-2014, at 199 US sites. Patients with CLL were enrolled within 2 months of initiating first line of therapy (LOT1) or a subsequent LOT (LOT ≥ 2). Kaplan-Meier methods were used to evaluate overall survival. CLL- and infection-related mortality were assessed using cumulative incidence functions (CIF) and cause-specific hazards. Logistic regression was used to develop a classification model. RESULTS: A total of 455 E-CLL patients were enrolled; 259 were enrolled in LOT1 and 196 in LOT ≥ 2. E-CLL patients were more likely to receive rituximab monotherapy (19.3 vs. 8.6%; p < 0.0001) and chemotherapy-alone regimens (p < 0.0001) than younger patients. Overall and complete responses were lower in E-CLL patients than younger patients when given similar regimens. With a median follow-up of 3 years, CLL-related deaths were higher in E-CLL patients than younger patients in LOT1 (12.6 vs. 5.1% p = 0.0005) and LOT ≥ 2 (31.3 vs. 21.5%; p = 0.0277). Infection-related deaths were also higher in E-CLL patients than younger patients in LOT1 (7.4 vs. 2.7%; p = 0.0033) and in LOT ≥ 2 (16.2 vs. 11.2%; p = 0.0786). A prognostic score for E-CLL patients was developed: time from diagnosis to treatment < 3 months, enrollment therapy other than bendamustine/rituximab, and anemia, identified patients at higher risk of inferior survival. Furthermore, higher-risk patients experienced an increased risk of CLL- or infection-related death (30.6 vs 10.3%; p = 0.0006). CONCLUSION: CLL- and infection-related mortality are higher in CLL patients aged ≥ 75 years than younger patients, underscoring the urgent need for alternative treatment strategies for these understudied patients. TRIAL REGISTRATION: The Connect CLL registry was registered at clinicaltrials.gov: NCT01081015 on March 4, 2010.

HIV patient retention: the implementation of a North Carolina clinic-based protocol.

Decreased visit attendance leads to poor health outcomes, decreased viral suppression, and higher mortality rates for persons living with HIV. Retention in care is an important factor in improving health status for people living with HIV but continues to be a challenge in clinical settings. This paper details the development and implementation of the NC-LINK Retention Protocol, a clinic-based protocol to locate and reengage out-of-care patients, as part of overall clinic retention efforts. The protocol was implemented as one of four interventions of the NC-LINK Systems and Linkages Project, a multi-site initiative funded by the HIV/AIDS Bureau and the Special Projects of National Significance. Lists of out-of-care patients who had not received HIV medical care in over nine months and did not have a future appointment were created each month. Patient navigators, case managers, and other staff then followed a standardized protocol to locate and reengage these patients in care. A total of 452 patients were identified for reengagement services. Of those, 194 (43%) returned to care, 108 (24%) had another definitive outcome (incarcerated, deceased, or relocated) and 150 (33%) were referred for additional follow-up to locate and reengage in care. In summary, 67% of patients were located through the efforts of the clinic staff. The results of this intervention indicate that it is possible to successfully integrate a protocol into the existing infrastructure of a clinic and reengage a majority of out-of-care patients into medical care.

Ethical considerations in developing an evidence base for pre-exposure prophylaxis in pregnant women.

Though many women in need of access to HIV preventive regimes are pregnant, there is a dearth of data to guide these care decisions. While oral pre-exposure prophylaxis (PrEP) has been shown to prevent HIV infection in numerous high-risk populations, pregnant women have been excluded from all major prospective trials. We propose for ethical examination a theoretical trial-a prospective, observational study of PrEP for pregnant women at risk for HIV in sub-Saharan Africa-highlighting an ethical tradeoff that characterizes issues faced for advancing research in pregnancy. On the one hand, an "opportunistic" study design has certain ethical advantages: as formally construed, the research activity usually begins after decisions to use PrEP during pregnancy are made in the clinical setting. This minimizes research risks and avoids ethical problems that a randomized controlled trial (RCT) comparing PrEP to placebo would entail, particularly withholding care proven beneficial in other populations. On the other hand, observational studies yield less precise information than RCTs. This raises a broader question about the pace of research with pregnant women, as it typically takes many years after a drug's approval for use in the general population to determine safety of the medication in pregnancy. Such delays can have the effect of making it impossible to ethically conduct an RCT with pregnant women, reducing the likelihood that the research community is able to obtain robust, pregnancy-specific evidence. While an observational cohort is potentially the most ethically and scientifically justified research design to study PrEP in pregnancy, earlier involvement of pregnant women in studies of newer preventives may lead to evidence that is more timely and robust.

Real-world clinical experience in the Connect® chronic lymphocytic leukaemia registry: a prospective cohort study of 1494 patients across 199 US centres.

The clinical course of chronic lymphocytic leukaemia (CLL) is heterogeneous, and treatment options vary considerably. The Connect® CLL registry is a multicentre, prospective observational cohort study that provides a real-world perspective on the management of, and outcomes for, patients with CLL. Between 2010 and 2014, 1494 patients with CLL and that initiated therapy, were enrolled from 199 centres throughout the USA (179 community-, 17 academic-, and 3 government-based centres). Patients were grouped by line of therapy at enrolment (LOT). We describe the clinical and demographic characteristics of, and practice patterns for, patients with CLL enrolled in this treatment registry, providing patient-level observational data that represent real-world experiences in the USA. Fluorescence in situ hybridization (FISH) analyses were performed on 49·3% of patients at enrolment. The most common genetic abnormalities detected by FISH were del(13q) and trisomy 12 (45·7% and 20·8%, respectively). Differences in disease characteristics and comorbidities were observed between patients enrolled in LOT1 and combined LOT2/≥3 cohorts. Important trends observed include the infrequent use of genetic prognostic testing, and differences in patient characteristics for patients receiving chemoimmunotherapy combinations. These data represent experiences of patients with CLL in the USA, which may inform treatment decisions in everyday practice.

A Review of Recent Literature on Trauma Among Individuals Living with HIV.

Persons living with HIV (PLWH) report disproportionately high levels of exposure to traumatic events in childhood and adulthood. Traumatic experiences are associated with negative health and behavioral outcomes. Current research in this area seeks to further explicate the myriad health effects of trauma on PLWH and the pathways through which trauma operates. In this paper, we review articles published in English between January 2014 and June 2015 that examine traumatic experiences among PLWH, including intimate partner violence (IPV), domestic abuse, child abuse, and other forms of violence. A selection of studies examining trauma among PLWH and its associations with mental health, antiretroviral medication adherence, clinical outcomes, HIV disclosure, and sexual risk behaviors were included. Studies describing trauma coping strategies and interventions were also included. We conclude with recommendations for care of trauma-exposed PLWH and directions for future research.

Open surgical treatment of femoroacetabular impingement in adolescent athletes: preliminary report on improvement of physical activity level.

BACKGROUND: The surgical dislocation of the hip (SDH) approach has gained popularity in the treatment of femoroacetabular impingement (FAI) secondary to pediatric hip disorders. However, it has been suggested that SDH may preclude a return to previous levels of function in athletes. The purpose of this study was (1) to determine the level of activity and pain in young athletes before and after open hip surgery through an SDH approach for the treatment of FAI; (2) to investigate how clinical improvement correlates with physical activity; (3) to determine whether articular cartilage injury and the complexity of surgical procedures are associated with improvement in activity level and pain. METHODS: SDH was utilized in 29 young athletes treated for symptomatic FAI (20 males 9 females, age range 12.7 to 20.7 years (mean age, 17 y)). Evaluation included sport(s) played, University of California Los Angeles (UCLA) physical activity level, and clinical outcome in terms of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)-Pain scores. Intraoperative articular cartilage status and anteroposterior pelvic and lateral hip radiographs were assessed. RESULTS: All patients had regularly participated in one or more of 13 distinct sports. The median UCLA score increased with marginal significance (P=0.057) after surgery. Change in the level of pain from preoperatively to postoperatively, as measured by the WOMAC-Pain subscale, was found to be statistically significant (P=0.0024). A statistically significant correlation between changes in UCLA and WOMAC was estimated (ρ=-0.61, P≤0.001). No statistically significant correlation was found between change in UCLA and the addition of a second procedure other than femoral head-neck osteochondroplasty. Finally, no statistically significant correlation was found between severity of cartilage injury and change in UCLA or WOMAC scores. The femoral α-angle improved an average of 22.7 degrees (P<0.001) after surgery. CONCLUSIONS: Pain relief and maintenance or improvement in activity level may be achieved with open FAI surgery through an SDH approach in young athletes. Although this approach is more invasive than hip arthroscopy, it should be considered in the management of adolescents with FAI and complex hip deformities associated with pediatric disorders such as slipped capital femoral epiphysis and Perthes disease. LEVEL OF EVIDENCE: Level IV-case series; retrospective.

Association of health-related quality of life with gender in patients with B-cell chronic lymphocytic leukemia.

PURPOSE: This analysis examined associations between gender and health-related quality of life (HRQOL) in patients with B-cell chronic lymphocytic leukemia (CLL) as they initiate therapy for CLL outside the clinical trial setting. METHODS: Baseline data were collected as part of Connect® CLL Registry, a prospective observational study initiated in community, academic, and government centers. Patient demographics and clinical characteristics were provided by clinicians. Patients reported HRQOL using the Brief Fatigue Inventory (BFI), EQ-5D, and Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu). Mean scores were analyzed, with statistical significance of differences determined by ANOVA. Multivariate analysis also considered age and line of therapy. RESULTS: Baseline HRQOL data were available for 1,140 patients: 710 (62 %) men and 430 (38 %) women from 161 centers. Patients were predominantly white (89 %) with mean age 69 ± 11 years. Women reported significantly worse global fatigue (P <0.0001), fatigue severity (P <0.0001), and fatigue-related interference (P = 0.0005) versus men (BFI). Pain/discomfort (P = 0.0077), usual activities (P = 0.0015), and anxiety/depression (P = 0.0117) were significantly worse in women than in men (EQ-5D). With women reporting a better social/family score (P = 0.0238) and men reporting a better physical score (P = 0.0002), the mean FACT-G total score did not differ by gender. However, the mean FACT-Leu total score was better among men versus women (P = 0.0223), primarily because the mean leukemia subscale score was significantly better among men (P <0.0001). Multivariate analysis qualitatively confirmed these findings. CONCLUSIONS: Connect® CLL Registry results indicate that significant differences exist in certain HRQOL domains, as women reported greater levels of fatigue and worse functioning in physical domains.

Experiences Navigating the Pregnancy Care Continuum During the COVID-19 Pandemic.

INTRODUCTION: The COVID-19 pandemic led to unprecedented changes in care delivery across the pregnancy care continuum. Our primary objective with this research was to characterize the range of ways that the early months of the COVID-19 pandemic affected pregnancy, childbirth, and postpartum care experiences. METHODS: Pregnant and recently pregnant patients (n = 20) from obstetrics and gynecology clinical sites associated with Massachusetts General Hospital were interviewed about their experiences with prenatal care, childbirth, and postpartum care during the first wave of the COVID-19 pandemic. Interview transcripts were analyzed for emergent themes. RESULTS: This sample included 20 pregnant and postpartum people, including 11 individuals who tested positive for COVID-19 during pregnancy or postpartum and nine with suspected infection. The ways in which COVID-19 or suspected COVID-19 affected experiences of prenatal care, childbirth, and postpartum care were complex and varied. Three themes were identified across narratives of pregnancy, birth, and postpartum care: patient perceptions of diminished access to care, stigma due to COVID-19 infection, and limited capacity of providers to honor patient preferences. CONCLUSIONS: A better understanding of pregnant and recently pregnant people's experiences during the early months of the COVID-19 pandemic can inform infection control policies and clinical care delivery practices that are more congruent with the needs and values of pregnant, birthing, and postpartum people as institutions craft responses to future pandemics. Approaches that maximize meaningful access across the pregnancy care continuum, center patients' priorities within adapted care models, and honor patient preferences as much as possible are important aspects of an appropriate response to future waves of COVID-19 and other pandemics.

A profile of skin cancer prevention media coverage in 2009.

BACKGROUND: Little is known about the coverage of skin cancer prevention messages in news print media. OBJECTIVE: To perform a content analysis of mass-media articles from newspaper and magazines pertaining to skin cancer prevention in 4 specific months (January, May, July, and October) in 2009 and assess the extent of coverage of skin cancer prevention messages. METHODS: We conducted a content analysis of 144 articles related to skin cancer prevention extracted from strategic media scans of selected months in 2009. We sought to provide the frequency of mass-media content categorized by theme and focus related to ultraviolet radiation (UVR) protection and risk-reducing behaviors. RESULTS: The audience for the vast majority (78%) of the articles was the general public. Among the assessed articles, more were published in May (49%) and July (35%) than in the remaining other months. The two most frequent themes focused on 'protection of the skin' (32%) and on 'skin cancer prevention' (23%) via risk reduction behavioral practices. Analysis of message content regarding UVR reduction practices showed that many mentioned 'use of sunscreen' (65% of messages) with the least-often mentioned behaviors being 'seek shade' (6.3%) and 'do not burn' (1.4%). In addition, a quarter of the articles lacked any content mentioning recommended UVR reduction behaviors. LIMITATIONS: This study was limited to the narrow scope of articles published in 2009 and for selected months. CONCLUSIONS: This profile of mass-media content regarding skin cancer prevention revealed gaps in coverage of UVR reduction behaviors with possible room for improvement. Strategies for improving and comprehensiveness of coverage of recommended skin cancer prevention behaviors in the media are discussed.