Mixed-method approach to informing a lifestyle intervention to improve the survivorship of patients with endometrial cancer.

OBJECTIVES: To identify endometrial cancer survivors' (ECS) barriers and facilitators for participation in lifestyle interventions to improve their dietary and exercise behaviors. Our secondary objective is to determine baseline information: physical activity level, quality of life (QoL), and impact of COVID-19 on exercise, diet, and mental health. METHODS: Obese, early-stage ECS participated in 2-part mixed-methods data collection; Part 1: survey gathering sample characteristics, QoL, exercise, and basic endometrial cancer- related knowledge. Part 2: virtual focus group or individual interviews using a brainwriting premortem protocol. Statistical analysis was performed using SAS (version 8.3). Qualitative data were analyzed using deductive thematic coding guided by the RE-AIM framework. RESULTS: Twenty percent (70/358) of ECS from a survivorship database and clinic recruitment completed the survey; 16 ECS provided qualitative feedback. Common barriers to intervention participation included time and resource costs, meeting frequency, and pessimism about weight loss maintenance. Facilitators included an opportunity to connect with other survivors and a focus on health rather than weight loss. Most ECS could not identify exercise guidelines (60%) and 83% were not meeting these guidelines. Higher BMI was correlated with a lower confidence in completing in moderate physical activity (p-value = 0.0206). Post-COVID-19 pandemic, physical activity, nutritional decisions, and/or mental health worsened for 67% of ECS. CONCLUSION: ECS are a disparate population, with worsening behaviors and mental health following the pandemic. The identified ECS-specific barriers and facilitators to behavioral intervention participation are being used to simultaneously improve the reach of and adherence to a lifestyle intervention aimed at improving their health and QoL.

A phase III study of transdermal granisetron versus oral ondansetron for women with gynecologic cancers receiving pelvic chemoradiation.

PURPOSE: To compare rates of complete response (no emesis, retching, or rescue antiemetics) in the late phase (days 4-7 post-chemotherapy) of cycle 1 between transdermal granisetron and oral ondansetron in cervical, endometrial, or vaginal cancer survivors undergoing chemoradiation at The University of Texas MD Anderson Cancer Center and LBJ Hospital in Houston, TX. METHODS: In this non-blinded parallel design trial, eligible patients received a granisetron patch replaced every 7 days or 8 mg of ondansetron thrice daily continued for 72 h after chemotherapy completion. Data were collected on medication compliance, episodes of chemotherapy-induced nausea and vomiting (CINV), use of rescue antiemetics, and effects of CINV on quality of life. RESULTS: Seventy-five survivors receiving chemoradiation for cervical (n = 61), endometrial (n = 12), or vaginal (n = 2) cancer were electronically randomized to transdermal granisetron (n = 41) or oral ondansetron (n = 34). In the late phase of cycle 1, the rate of complete response was 49.8% (95% CI, 35.2-64.3%) for transdermal granisetron and 39.7% (95% CI, 24.4-56.1%) for oral ondansetron. The posterior probability that transdermal granisetron achieved a higher success rate in controlling late-onset CINV compared with oral ondansetron was 82%. During the acute phase (day 1 post-chemotherapy) of cycles 2 and 3, transdermal granisetron patients used more rescue antiemetics than oral ondansetron patients (p = 0.006 and p = 0.003, respectively). Otherwise, no between-group differences in CINV events were observed. Medication compliance and the effect of CINV on quality of life were similar between groups. CONCLUSION: Transdermal granisetron was 82% more like to control CINV than oral ondansetron in the late phase of cycle 1 and performed similarly to oral ondansetron in all other cycles. Transdermal granisetron should be considered an option as prophylactic antiemetic therapy for gynecologic cancer survivors undergoing chemoradiation.

Body mass index and attitudes towards health behaviors among women with endometrial cancer before and after treatment.

INTRODUCTION: Some experts have argued that obesity-related malignancies such as endometrial cancer are a "teachable moment" that lead to meaningful changes in health behaviors. It is unclear if endometrial cancer survivors lose weight following treatment. Our goal with this investigation was to evaluate post-treatment changes in body mass index (BMI) and attitudes towards health behaviors in endometrial cancer survivors. METHODS: Incident endometrial cancer cases undergoing surgery between 2009-2015 were identified in the Marketscan Commercial database and linked with BMI data and health behavior questionnaires from the Marketscan Health Risk Assessment database. Patients were excluded for insufficient BMI data. Standard statistical methods, including the two-sample Wilcoxon rank sum test, χ2 test, and McNemar's test, were used. RESULTS: 655 patients with a median age of 54 (IQR 49-58) were identified and analyzed. Median duration of follow-up was 595 days (IQR 360-1091). Mean pre- and post-treatment BMI was 35.5 kg/m2 (median 35.0; IQR 27.0-42.3) and 35.6 kg/m2 (median 34.3; IQR 28.0-42.0), respectively. Median BMI change in the entire cohort was 0 kg/m2 (IQR -1.0 to 2.0). Weight gain (n=302; 46.1%) or no change in weight (n=106; 16.2%) was seen in most patients. Among the 302 patients who gained weight, the mean pre-treatment BMI was 34.0 kg/m2 and mean increase was 2.8 kg/m2 (median 2.0; IQR 1.0-3.4). Among the 247 cases who lost weight, the mean pre-treatment BMI was 38.6 kg/m2 and mean decrease was 3.2 kg/m2 (median 2.0; IQR 1.0-4.0). No pre- to post-treatment differences were observed in health behavior questionnaires regarding intention to better manage their diet, exercise more, or lose weight. DISCUSSION: Most endometrial cancer survivors gain weight or maintain the same weight following treatment. No post-treatment changes in attitudes regarding weight-related behaviors were observed. The systematic delivery of evidence-based weight loss interventions should be a priority for survivors of endometrial cancer.

Clinicopathologic features and treatment in patients with early stage uterine clear cell carcinoma: A 16-year experience.

OBJECTIVE: To evaluate clinicopathologic factors and adjuvant treatment effects on recurrence free (RFS) and overall survival (OS) in early stage uterine clear cell carcinoma (UCCC). METHODS: Our retrospective review included central pathology confirmed stage I or II UCCC treated and/or followed between 2000 and 2016. Cases with pure or mixed histology with >50% UCCC were included. Data were analyzed using Kaplan-Meier method and Cox proportional hazards regressions. RESULTS: 112 women were identified. Median age was 65.5 years (range 34-94). Most patients had mixed UCCC (61%), while 39% had pure UCCC. The majority of patients had stage IA UCCC (66%) versus stage IB (15%) or stage II (18%) disease. Adjuvant treatment included chemotherapy + radiation (26%), brachytherapy (27%), whole pelvic radiation (15%), chemotherapy alone (8%), and observation (24%). Thirty-eight (34%) women had recurrent disease. Median RFS was 4.32 years (95% CI 2.77-5.78). On multivariate analysis, age ≥70 (HR 2.48, 95% 1.28-4.81) and positive LVSI (HR 2.19, 95% CI 1.15-4.18) were associated with shorter RFS. Median OS was 9.8 years (95% CI 7.46-15.93). On multivariate analyses, age ≥70 (HR 3.57, 95% CI 1.64-7.74) and positive LVSI (HR 2.46, 95% CI 1.12-5.37) were associated with shorter OS. In this retrospective descriptive uncontrolled patient series, adjuvant treatment type did not impact RFS or OS. CONCLUSIONS: OS approaches 10 years for early stage UCCC patients. Women ≥70 years have worse PFS and OS regardless of treatment modality, encouraging consideration of quality of life implications when electing for adjuvant therapy.

Endometrial cancer survivors' sleep patterns before and after a physical activity intervention: A retrospective cohort analysis.

OBJECTIVE: To identify the baseline sleep patterns of endometrial cancer survivors and examine the impact of a physical activity intervention on their sleep quality via retrospective secondary analysis. METHODS: Early-stage endometrial cancer survivors participated in a 6-month single-arm exercise intervention using printed materials, telephone-based counseling, and pedometers to encourage adherence to exercise guidelines. Participants completed questionnaires evaluating their sleep (PSQI), physical activity (CHAMPS), quality of life (SF-36), and stress (PSS) at baseline and study completion. RESULTS: Ninety-five survivors had PSQI data at both time points. Mean age was 57.1 years (range, 25-76). Mean body mass index was 34.3 kg/m2. The majority were non-Hispanic white (75%) and had stage I disease (80%). At baseline, most survivors (61%) had poor sleep quality (PSQI > 5), with 24% reporting fairly or very bad sleep. The majority (63%) slept <7 h/night. At least once during the preceding month, 83% had an episode of daytime dysfunction. A pairwise comparison showed that obese survivors had more sleep disturbances than normal weight survivors (p = 0.029). No other clinicodemographic factors were associated with sleep. In unadjusted analyses, sleep quality significantly improved in women who increased weekly total or moderate/vigorous physical activity (p = 0.004 and p < 0.050, respectively). This association persisted after adjusting for the potential covariates of age, time since diagnosis, obesity status, disease stage, and treatment (p = 0.026). CONCLUSIONS: Our data demonstrated that poor sleep is common and detrimental to endometrial cancer survivors. Increasing exercise may improve this dysfunction and should be investigated as part of a prospective study.

Prospective assessment of patient-reported outcomes in gynecologic cancer patients before and after pelvic exenteration.

OBJECTIVE: Pelvic exenteration (PE) is a surgical procedure associated with significant morbidity offered to select women with locally advanced or recurrent gynecologic cancers. This ongoing study examines an array of patient-reported outcomes and satisfaction with PE. METHODS: Since February 2009, prospectively enrolled participants completed questionnaires evaluating body image (BIS), depression (CESD), social support (DUFSS), symptoms (MDASI), sexual function (SAQ), functional status (SF-12), quality of life (The Stoma-QOL), satisfaction with decision (SWD) and an investigator-designed survey at baseline, 6, and 12months after PE. Mann-Whitney and Wilcoxon signed-rank tests were used to evaluate the data. RESULTS: Fifty-four women enrolled. Median age was 56years (31, 85). Median BMI was 30.7kg/m2 (16.8, 54.4). The majority of patients (78%) were white. Cancer diagnoses included 41% cervix, 22% uterus, 19% vagina, 17% vulva and 2% ovary. Most surgeries were total PEs (76%). Patients were satisfied with their decision to undergo PE at 6 and 12months. One year after exenteration, 79% of women stated they would have a PE again. Sexual pleasure decreased from baseline to 12months after PE (p=0.02), while sexual discomfort remained unchanged (p=0.42). Body image worsened over time (p=0.003). Physical functioning (SF-12) declined (p=0.001), while mental functioning remained stable (p=0.46). There were no significant changes in stoma-related QOL, social support, or depression scores. CONCLUSIONS: Despite a decrease in physical functioning, persistent low body image and sexual pleasure, most women were satisfied with their decision and would undergo pelvic exenteration again. This study identifies survivorship issues that should be addressed after PE.

Minimally invasive hysterectomy surgery rates for endometrial cancer performed at National Comprehensive Cancer Network (NCCN) Centers.

OBJECTIVES: Minimally invasive surgery (MIS) is a quality measure for endometrial cancer (EC) established by the Society of Gynecologic Oncology and the American College of Surgeons. Our study objective was to assess the proportion of EC cases performed by MIS at National Comprehensive Cancer Network (NCCN) centers and evaluate perioperative outcomes. METHODS: A retrospective cohort study of women who underwent surgical treatment for EC from 2013 to 2014 was conducted at four NCCN centers. Multivariable mixed logistic regression models analyzed factors associated with failure to perform MIS and perioperative complications. RESULTS: In total 1621 patients were evaluated; 86.5% underwent MIS (robotic-assisted 72.5%, laparoscopic 20.9%, vaginal 6.6%). On multivariable analysis, factors associated with failure to undergo MIS were uterine size >12cm (Odds Ratio [OR]: 0.17, 95% CI 0.03-0.9), stage III (OR: 0.16, 95% CI 0.05-0.49) and IV disease (OR: 0.07, 95% CI 0.02-0.22). For stage I/II disease, complications occurred in 5.1% of MIS and 21.7% of laparotomy cases (p<0.01). Laparotomy was associated with increases in any complication (OR: 6.0, 95% CI 3.3-10.8), gastrointestinal (OR: 7.2, 95% CI 2.6-19.5), wound (OR: 3.7, 95% CI 1.5-9.2), respiratory (OR 37.5, 95% CI 3.9-358.0), VTE (OR 10.5, 95% CI 1.3-82.8) and 30-day readmission (OR: 2.6, 95% CI 1.4-4.9) compared to MIS. CONCLUSIONS: At NCCN-designated centers, the MIS hysterectomy rate in EC is higher than the published national average, with low perioperative complications. Previously identified disparities of age, race, and BMI were not observed. A proposed MIS hysterectomy benchmark of >80% in EC care is feasible when performed at high volume centers.

Sexual health of endometrial cancer survivors before and after a physical activity intervention: A retrospective cohort analysis.

OBJECTIVE: Sexual dysfunction is common in endometrial cancer survivors (ECS). Our group previously tested a six-month exercise intervention in ECS. We performed a secondary analysis to determine intervention's impact on sexual health. METHODS: We studied 100 post-treatment Stage I-IIIa sedentary ECS who participated in a non-controlled, single-arm, home-based exercise intervention utilizing telephone counseling, printed material, and pedometers. Quality-of-life and physical activity measures were collected at baseline and six months. Sexual function (SF) and sexual interest (SI) scores were extracted from the QLACS questionnaire. RESULTS: Baseline SF and SI were lower in survivors with less than a four-year college degree (P<0.001). Baseline SI was higher in survivors who were married or living with a significant other (P=0.012). No significant differences in SF or SI were observed based on obesity status, race, time since diagnosis, or treatment type. Post-intervention, mean SF score improved (P=0.002), 51% of participants had improved SI, and 43% had improved SF. When controlled for age and time since diagnosis, a one-hour increase in weekly physical activity was associated with a 6.5% increased likelihood of improved SI (P=0.04). Increased physical activity was not associated with improved SF. CONCLUSIONS: Although causation cannot be determined in this study, the correlation between receipt of an exercise intervention and improved sexual health for ECS is a novel finding. This finding suggests a role for physical activity as a strategy to improve the sexual health of ECS, which our group is examining in a larger prospective study.

Feasibility of a lifestyle intervention for overweight/obese endometrial and breast cancer survivors using an interactive mobile application.

OBJECTIVE: The study aimed to assess a one-month lifestyle intervention delivered via a web- and mobile-based weight-loss application (app) (LoseIt!) using a healthcare-provider interface. METHODS: Early-stage overweight/obese (body mass index [BMI]≥25kg/m(2)) cancer survivors (CS) diagnosed in the past three years, and without recurrent disease were enrolled and received exercise and nutrition counseling using the LoseIt! app. Entry and exit quality of life (FACT-G) and Weight Efficacy Lifestyle Questionnaire (WEL) measuring self-efficacy were measured along with anthropometrics, daily food intake, and physical activity (PA) using the app. RESULTS: Mean participant age was 58.4±10.3years (n=50). Significant reductions (p<0.0006) in anthropometrics were noted between pre- and post-intervention weight (105.0±21.8kg versus 98.6±22.5kg); BMI (34.9±8.7kg/m(2) versus 33.9±8.4kg/m(2)); and waist circumference (108.1±14.9cm versus 103.7±15.1cm). A significant improvement in pre- and post-intervention total WEL score was noted (99.38±41.8 versus 120.19±47.1, p=0.043). No significant differences were noted in FACT-G, macronutrient consumption, and PA patterns. CONCLUSION: These results indicate that a lifestyle intervention delivered via a web- and mobile-based weight-loss app is a feasible option by which to elicit short-term reductions in weight. Though these results parallel the recent survivors of uterine cancer empowered by exercise and healthy diet (SUCCEED) trial, it is notable that they were achieved without encumbering significant cost and barrier-access issues (i.e. time, transportation, weather, parking, etc.).

Radical Trachelectomy for Early-Stage Cervical Cancer: A Survey of the Society of Gynecologic Oncology and Gynecologic Oncology Fellows-in-Training.

OBJECTIVE: The aim of this study was to survey gynecologic oncologists and fellows-in-training regarding the role of radical trachelectomy (RT) and conservative surgery in patients with early-stage cervical cancer. MATERIALS AND METHODS: From June 2012 to September 2012, the Society of Gynecologic Oncology member practitioners (n = 1353) and gynecologic oncology fellows (n = 156) were sent group-specific surveys investigating current practice, training, and the future of RT for early-stage cervical cancer management. RESULTS: Twenty-two percent of practitioners (n = 303) and 24.4% of fellows (n = 38) completed the surveys. Of the practitioners, 50% (n = 148) report performing RT, 98% (n = 269) support RT as treatment for squamous carcinoma, and 71% (n = 195) confirm the use of RT for adenocarcinoma. Most practitioners offer RT treatment for stages IA2 to IB1 smaller than 2 cm (n = 209, 76.8%) regardless of grade (77.7%) or lymph vascular space invasion (n = 211, 79.3%). Only 8% (n = 23) of practitioners feel that RT is appropriate for stage IBI larger than 2 cm. Respectively, both practitioners and fellows most frequently perform robotic-assisted (47.0%, n = 101 and 59.1%, n = 13) and abdominal (40.5%, n = 87 and 68.2%, n = 15) RT approaches. After training, fellows project the use of robotic-assisted (71%, n = 22) or abdominal methods (58.1%, n = 18). Overall, 75% (n = 227) of practitioners and 60% (n = 23) of fellows speculate that over the next 5 years, less radical procedures will be used to manage early-stage cervical cancer. CONCLUSIONS: Our findings suggest that practitioners and fellows believe RT remains an option for early-stage cervical cancer patients. However, a significant proportion of all respondents believe that less radical surgery may be a future consideration for patients with low-risk early-stage cervical cancer.

Health care and social media platforms in hospitals.

The objective of this article is to illustrate user characteristics of a hospital's social media structure using analytics and user surveys. A 1-year retrospective analysis was conducted along with an Internet survey of users of the hospital's Facebook, Twitter, and blog. Of the survey respondents (n = 163), 95.7% are female and 4.3% are male; most are ages 50-59 years (31.5%) and 40-49 years (27.8%); and 93.2% are Caucasian. However, the hospital system database revealed 55% female and 37% minority population, respectively. Of the survey respondents, 61.4% reported having a bachelor's degree or higher, whereas only 11.7% reported having a high school degree/equivalent or lower. However, within the hospital patient databases, 93% of patients have a high school degree/equivalent or lower and only 3% have a bachelor's degree or higher in our women's services population. Social media were used to seek personal health information 68.7% (n = 112), to learn about hospital programming 27.6% (n = 45), and to seek family health information 25.2% (n = 41). Respondents younger than 49 years of age were more likely to seek personal health information using social media compared to those 50 years of age and older (p = .02). Respondents with a bachelor's degree or higher education were statistically less likely to search for physician information compared to those less educated individuals (p = .04). We conclude that social media may play an important role in personal health information, especially for young female respondents; however, the survey provides strong evidence that further research is needed to ensure that social network sites provided by hospitals are reaching the full spectrum of health system patients.

A natural experiment to determine if FitEx works: Impact of a statewide walking program.

The National Cooperative Extension System offers walking programs, but impacts are underreported. One program offered in two state systems is FitEx, an 8-week, group-based behavior change intervention. The purpose of this work was to evaluate FitEx through the RE-AIM (reach, effect, adoption, implementation, maintenance) Framework, with a primary focus on reach and effectiveness (individual-level dimensions). Through a pragmatic, natural experiment, the impact of FitEx was assessed from 2015 to 2020. Reach was operationalized as the number and characteristics of eligible community members who participated. Effectiveness was operationalized as changes in physical activity levels. From 2015 to 2020, there were 1995 FitEx participants (274 ± 233 participants per year) who were 45.22 ± 14.13 years of age, predominantly female (83%) and White (78%). At the start of the program, 33% met physical activity guidelines and during the program 58% met guidelines (X2(1, 1648) = 1.6; P < .0). The reach and effectiveness of FitEx are comparable to-and in some cases, greater than-similar community-based walking programs. FitEx consistently reached middle-aged insufficiently active adults. Future work is needed to reach a more diverse population, establish objectively measured impacts, and establish a process to scale FitEx across the nation.

The National Cooperative Extension System offers walking programs, but impacts are not always reported. One program offered in two state systems is FitEx, an 8-week, group-based program to help people change their physical activity practice. The goal of this work was to evaluate FitEx through the RE-AIM (reach, effect, adoption, implementation, maintenance) Framework, with a focus on who is reached and if the program is effective. Through a real-world study, the impact of FitEx was assessed from 2015 to 2020. Reach outcomes were the number and traits of people who joined FitEx. Effectiveness outcomes were changes in participants' physical activity levels. From 2015 to 2020, 1995 people took part in FitEx (an average of 274 per year). They were on average 45.22 years of age, mostly female (83%), mostly non-Hispanic White (78%). At the start of FitEx, 33% met physical activity guidelines. During the program, 58% met guidelines. The reach and effectiveness of FitEx are equal or better than other community-based walking programs. Over the years, FitEx enrolled middle-aged, less active adults. Future work is needed to reach a more diverse population, start measuring physical activity through objective tools, and begin a process of scaling FitEx across the nation.

The Dearth of Representation in FDA Approved Drug Trials.

The generalizability of data derived from randomized controlled trials is of paramount importance given their utility in the Food & Drug Administration (FDA) drug approval process. An essential part of this process is the inclusion of reliably reported gender, race and ethnicity data in trials that lead to FDA drug approval. Despite previous mandates by the FDA and Clinicaltrials.gov, gender and race-specific data remains under reported. We reviewed 100 most recently approved FDA medications, and abstracted the clinical trial data from Clinicaltrials.gov that supported their approval. We then compared these FDA approved trials to non-FDA approved trials from the same year and of similar size. We found that 40% of the FDA trials were missing race/ethnicity information, while 24% of these trials did not include gender information. We demonstrate that there remains a significant amount of missing gender and racial/ethnic data in trials that lead to FDA-approved medications.

Identification of weight loss interventions for translation among endometrial cancer survivors: A RE-AIM analysis.

Interventions for obesity-related cancers that combine nutrition and physical activity for weight loss exist; however, their application to survivors of endometrial cancer is unknown. Furthermore, little is known about pre-implementation perceptions of existing programs from a variety of interested persons (physicians, researchers) who may be part of the implementation team. Adapting an existing intervention rather than developing a new intervention may speed the translational lag time as long as intervention characteristics and fit within the delivery system are considered during the planning phase. To describe the process of determining the core elements of obesity-related interventions for cancer survivors and determine which one might be best delivered by an urban healthcare system that predominantly serves individuals who live in rural areas of Virginia and West Virginia. A pragmatic review of the literature was conducted via PubMed and Google Scholar with broad search terms of cancer survivor AND weight loss AND health intervention. Identified interventions were scored related to the Practical, Robust Implementation and Sustainability Model-which is an extension of RE-AIM framework to guide the understanding of who, what, where, when, and how the intervention was conducted. Intervention characteristics are reported. In addition, ratings from three independent reviewers on the validated 5-point Likert scale of an intervention's acceptability, appropriateness, and feasibility in the intended delivery system were collected and summarized. Twelve interventions were identified with an average sample size of 241(±195) and a range of 48-683 participants. Target populations included survivors of colorectal, breast, and endometrial cancers as well as general cancer survivors and included both men and women or only women. Most participants (74%) identified as white/Caucasian and average age ranged from 47.1 to 65.9 years. Program duration ranged from 4 weeks to 18 months, with an average duration of 32 weeks. Intervention dosage ranged from three times a week to once a month. Intervention acceptability, appropriateness, and feasibility had average and standard deviation ratings of 3.52(±0.46), 3.41(±0.45), and 3.21(±0.46), respectively, out of 5. The four interventions with the highest combined acceptable, appropriate, and feasible scores are being considered for potential use as an obesity-related intervention for survivors of endometrial cancer. Future work is needed to determine relevant adaptations and efficacy among survivors of endometrial cancer with obesity. Our approach may be beneficial for other interventionists aiming to speed intervention development and implementation.

Weight loss improves morbidity and mortality associated with obesity-related cancer occurrence. Many interventions that target weight loss through physical activity and nutrition already exist. However, interventions specifically designed for endometrial cancer survivors with obesity are limited. Furthermore, the degree to which these programs will work in a given clinical system is unknown. This study explored existing interventions, applied a framework to analyze intervention characteristics, and used a validated tool to score the degree to which interventions would fit within the intended delivery system; in this case, a healthcare system that predominantly serves patients from rural areas.

Adaptations to a statewide walking program: Use of iterative feedback cycles between research and delivery systems improves fit for over 10 years.

FitEx is an 8-week, group-based physical activity and fruit and vegetable consumption program co-created and implemented with the Cooperative Extension System. Effectiveness and delivery personnel perceptions of the program are promising; however, ongoing adaptations are required to continuously meet shifting needs of both researchers and delivery systems. We applied the APDER iterative cycles of implementation over 15 years to understand dynamic and ongoing adaptations as well as implications for FitEx sustainability. Each year, an IRPP between delivery (FitEx deliverers) and research (FitEx developers) systems shared feedback on program core elements and strategies for adaptation through regular team meetings, emails, and evaluations. While the core elements (delivering to groups, goal setting, feedback, and self-monitoring) of FitEx remained consistent, changes were made to address logistical factors, emergent research questions, and technological advancements. For example, program deliverers suggested decreasing training time and making program content available on demand rather than through traditional in-person training. Using APDER with a long-standing IRPP allowed the delivery system to provide feedback to program developers to co-create ongoing adaptations and data-driven decisions. Future work in response to shifting needs includes Fitbit integration and technological updates to the usability of the FitEx platform. Our aim is to report the 15+ years of applying the Assess, Plan, Do, Evaluate, Report (APDER) process with an integrated research-practice partnership (IRPP) for co-creation of ongoing adaptations of FitEx and to share methods for capturing relevant data for decision-making to integrate health promotion programs in community settings.

This study focuses on the collaborative adaptations of an 8-week physical activity and fruit/vegetable consumption program called FitEx through a long-standing partnership of over 10 years between researchers developing FitEx (developers) and community-based health educators delivering FitEx (deliverers) to fit the needs of the delivery systems and the communities they serve. Developers and deliverers partnered through the following six steps: (i) collaboratively assess needs for adaptation to improve program fit, participant reach, and deliverer adoption; (ii) plan the "what, when, where, how" to adapt and implement; (iii) work together to co-create and implement these adaptations; (iv) evaluated who is adopting and whom is being reaching; (v) report on what's working and not working through a two-way communication loop between research and delivery systems; (vi) repeat. One example of a collaborative adaptation is when the developers added the option of a 1-h online training to reduce travel time for in-person training. This study reports how this partnership and cyclic method for co-adaptations helped ensure that FitEx continues to be sustained and maintained in response to shifting needs over the last 15+ years of its implementation.

Dysgerminoma Masquerading as Gestational Trophoblastic Neoplasia.

Background: Persistent elevation in beta-human chorionic gonadotropin (ß-hCG) following a pregnancy is concerning for gestational trophoblastic neoplasia (GTN). However, the differential diagnosis should remain broad during the evaluation process. Case: A 34-year-old G3P3 presented with elevated ß-hCG four months after cesarean delivery with bilateral tubal ligation. The patient was treated with methotrexate for a presumed new ectopic pregnancy. Due to persistent ß-hCG elevation, she received actinomycin-D for GTN treatment. After completing chemotherapy, her ß-hCG increased. The patient underwent a laparoscopic hysterectomy with unplanned left oophorectomy due to its nodular appearance at the time of surgery. Pathology confirmed a dysgerminoma of the ovary and benign uterus. Conclusion: Although dysgerminomas are uncommon, they should be considered when ß-hCG levels remain elevated despite therapies for more common pathologies.

Reallocating Cervical Cancer Preventive Service Spending from Low- to High-Value Clinical Scenarios.

Timely follow-up care after an abnormal cervical cancer screening test result is critical to the prevention and early diagnosis of cervical cancer. The current inadequate and inequitable delivery of these potentially life-saving services is attributed to several factors, including patient out-of-pocket costs. Waiving of consumer cost-sharing for follow-up testing (e.g., colposcopy and related cervical services) is likely to improve access and uptake, especially among underserved populations. One approach to defray the incremental costs of providing more generous coverage for follow-up testing is reducing expenditures on "low-value" cervical cancer screening services. To explore the potential fiscal implications of a policy that redirects cervical cancer screening resources from potentially low- to high-value clinical scenarios, we analyzed 2019 claims from the Virginia All-Payer Claims Database to quantify (i) total spending on low-value cervical cancer screening and (ii) out-of-pocket costs associated with colposcopy and related cervical services among commercially insured Virginians. In a cohort of 1,806,921 female patients (ages 48.1 ± 24.8 years), 295,193 claims for cervical cancer screening were reported, 100,567 (34.0%) of which were determined to be low-value ($4,394,361 total; $4,172,777 for payers and $221,584 out-of-pocket [$2/patient]). Claims for 52,369 colposcopy and related cervical services were reported ($40,994,016 total; $33,457,518 for payers and $7,536,498 out-of-pocket [$144/patient]). These findings suggest that reallocating savings incurred from unnecessary spending to fund more generous coverage of necessary follow-up care is a feasible approach to enhancing cervical cancer prevention equity and outcomes. PREVENTION RELEVANCE: Out-of-pocket fees are a barrier to follow-up care after an abnormal cervical cancer screening test. Among commercially insured Virginians, out-of-pocket costs for follow-up services averaged $144/patient; 34% of cervical cancer screenings were classified as low value. Reallocating low-value cervical cancer screening expenditures to enhance coverage for follow-up care can improve screening outcomes. See related Spotlight, p. 363.

Management and Treatment of Recurrent Epithelial Ovarian Cancer.

Most women with advanced epithelial ovarian cancer will experience many episodes of recurrent disease with progressively shorter disease-free intervals. For women whose disease continues to respond to platinum-based drugs, the disease can often be controlled for 5 years or more. Enormous progress has been made in the management of this disease, and new targeted treatments such as antiangiogenic drugs, poly(adenosine diphosphate-ribose) polymerase inhibitors, and immune checkpoint inhibitors offer potential for improved survival. A variety of combination strategies are being evaluated to leverage these agents. The role of secondary cytoreduction remains a topic of active investigation.

Defining Survivorship Trajectories Across Patients With Solid Tumors: An Evidence-Based Approach.

Importance: Survivorship involves a multidisciplinary approach to surveillance and management of comorbidities and secondary cancers, overseen by oncologists, surgeons, and primary care physicians. Optimal timing and coordination of care, however, is unclear and often based on arbitrary 5-year cutoffs. Objective: To determine high- and low-risk periods for all tumor types that could define when survivorship care might best be overseen by oncologists and when to transition to primary care physicians. Design, Setting, and Participants: In this pan-cancer, longitudinal, observational study, excess mortality hazard, calculated as an annualized mortality risk above a baseline population, was plotted over time. The time this hazard took to stabilize defined a high-risk period. The percent morality elevation above age- and sex-matched controls in the latter low-risk period was reported as a mortality gap. The US population-based Surveillance, Epidemiology, and End Results database defined the cancer population, and the US Census life tables defined controls. Incident cases of patients with cancer were separated into tumor types based on International Classification of Diseases for Oncology definitions. Exposures: Population-level data on incident cancer cases was compared with the general US population. Main Outcomes and Measures: Overall mortality and cause of death were reported on observed cancer cases. Results: A total of 2 317 185 patients (median age, 63 years; 49.8% female) with 66 primary tumor types were evaluated. High-risk surveillance period durations ranged from less than 1 year (breast, prostate, lip, ocular, and parathyroid cancers) up to 19 years (unspecified gastrointestinal cancers). The annualized mortality gap, representing the excess mortality in the stable period, ranged from a median 0.26% to 9.33% excess annual mortality (thyroid and hypopharyngeal cancer populations, respectively). Cluster analysis produced 6 risk cluster groups: group 1, with median survival of 16.2 (5th to 95th percentile range [PR], 10.7-40.2) years and median high-risk period of 2.5 (PR, 0-5.0) years; group 2, 8.3 (PR, 5.1-23.3) and 2.5 (PR, 4.0-8.0) years; group 3, 2.8 (PR, 1.4-3.7) and 7.0 (PR, 6.0-11.1) years; group 4, 1.6 (PR, 1.5-1.8) and 6.0 (PR, 5.1-11.4) years; group 5, 0.8 (PR, 0.5-1.2) and 0.8 (PR, 0.5-1.2) years; and group 6, 0.5 (PR, 0.4-0.8) and 12.0 (PR, 9.3-12.9) years, respectively. Subanalyses of selected tumor types in these groups revealed that stratifying on stage and histologic type can change the risk cluster and guidance for care. Conclusions and Relevance: These findings indicate that a standardized 5-year surveillance period is inadequate for some cancers while excessive for others. High-risk cancers require the most resources with the longest high-risk period, highest persistent baseline mortality risk, and longest period of primary cancer mortality, all arguing for longer follow-up with an oncologist in these cancers.