Adaptation of Remote Symptom Monitoring Using Electronic Patient-Reported Outcomes for Implementation in Real-World Settings.

PURPOSE: Despite evidence of clinical benefits, widespread implementation of remote symptom monitoring has been limited. We describe a process of adapting a remote symptom monitoring intervention developed in a research setting to a real-world clinical setting at two cancer centers. METHODS: This formative evaluation assessed core components and adaptations to improve acceptability and fit of remote symptom monitoring using Stirman's Framework for Modifications and Adaptations. Implementation outcomes were evaluated in pilot studies at the two cancer centers testing technology (phase I) and workflow (phase II and III) using electronic health data; qualitative evaluation with semistructured interviews of clinical team members; and capture of field notes from clinical teams and administrators regarding barriers and recommended adaptations for future implementation. RESULTS: Core components of remote symptom monitoring included electronic delivery of surveys with actionable symptoms, patient education on the intervention, a system to monitor survey compliance in real time, the capacity to generate alerts, training nurses to manage alerts, and identification of personnel responsible for managing symptoms. In the pilot studies, while most patients completed > 50% of expected surveys, adaptations were identified to address barriers related to workflow challenges, patient and clinician access to technology, digital health literacy, survey fatigue, alert fatigue, and data visibility. CONCLUSION: Using an implementation science approach, we facilitated adaptation of remote symptom monitoring interventions from the research setting to clinical practice and identified key areas to promote effective uptake and sustainability.

Not immune to inequity: minority under-representation in immunotherapy trials for breast and gynecologic cancers.

OBJECTIVE: To describe the participation of minority women in clinical trials using immunologic agents for breast and gynecologic cancers. METHODS: A retrospective review of completed clinical trials involving immunotherapy for breast and gynecologic cancers was performed. Completed trials were examined for data on race, tumor type, and start year. Minority enrollment was stratified by tumor site. Based on Center for Disease Control and Prevention age-adjusted incidence for race, expected and observed ratios of racial participation were calculated and compared using Χ2 testing, p≤0.05. RESULTS: A total of 53 completed immunotherapy clinical trials involving 8820 patients were reviewed. Breast cancer trials were most common (n=24) and involved the most patients (n=6248, 71%). Racial breakdown was provided in 41 studies (77%) for a total of 7201 patients. Race reporting was lowest in uterine (n=4, 67%) and cervical cancer trials (n=6, 67%), and highest in ovarian cancer trials (n=12, 86%). White patients comprised 70% (n=5022) of all the patients included. Only 5% of patients involved were black (n=339), and 83% of these patients (n=282) were enrolled in breast cancer trials. Observed enrollment of black women was 32-fold lower for ovarian, 19-fold lower for cervical, 15-fold lower for uterine, and 11-fold lower for breast cancer than expected. While all trials reported race between 2013 and 2015, no consistent trend was seen towards increasing race reporting or in enrollment of black patients over time. CONCLUSION: Racial disparities exist in clinical trials evaluating immunologic agents for breast and gynecologic cancers. Recruitment of black women is particularly low. In order to address inequity in outcomes for these cancers, it is crucial that significant attention be directed towards minority representation in immuno-oncologic clinical trials.

Factors associated with HPV vaccination initiation among United States college students.

Human papillomavirus (HPV) remains the most common sexually transmitted infection (STI) in the U.S. despite widespread availability of a safe, effective vaccine. Although young adults are at greatest risk of HPV infection, extensive vaccine promotion and intervention efforts has been directed toward 11-12-year-olds. College students represent an ideal audience for HPV vaccine "catch-up;" however, research indicates inconsistent HPV vaccination rates within this demographic. An online survey assessing HPV and HPV vaccine knowledge and behaviors was distributed to all undergraduate college students at a large, public university in the Deep South region of the U.S. The primary outcome was receipt of HPV vaccination (binary response options of Yes/No). Logistic regression analyses were performed to determine predictors of HPV vaccination. Of the 1,725 who completed the survey, 47.0% reported having received at least one dose of HPV vaccine; overall series completion (series = 3 doses for this population) was 17.4%. The primary outcome was HPV initiation among college students, defined as having received at least one dose of the HPV vaccine. Results indicated substantial gaps in participants' knowledge of their vaccination status. Provider and parental recommendations as well as social influences were shown to significantly impact student vaccination status, emphasizing the importance of incorporating these elements in future interventions, potentially as multi-level strategies. Future college interventions should address HPV and vaccination knowledge and the importance of provider and parental recommendations.

Health care-related time costs in patients with metastatic breast cancer.

BACKGROUND: Burdens related to time spent receiving cancer care may be substantial for patients with incurable, life-limiting cancers such as metastatic breast cancer (MBC). Estimates of time spent on health care are needed to inform treatment-related decision-making. METHODS: Estimates of time spent receiving cancer-related health care in the initial 3 months of treatment for patients with MBC were calculated using the following data sources: (a) direct observations from a time-in-motion quality improvement evaluation (process mapping); (b) cross-sectional patient surveys; and (c) administrative claims. Average ambulatory, inpatient, and total health care time were calculated for specific treatments which differed by antineoplastic type and administration method, including fulvestrant (injection, hormonal), letrozole (oral, hormonal), capecitabine (oral, chemotherapy), and paclitaxel (infusion, chemotherapy). RESULTS: Average total time spent on health care ranged from 7% to 10% of all days included within the initial 3 months of treatment, depending on treatment. The greatest time contributions were time spent traveling for care and on inpatient services. Time with providers contributed modestly to total care time. Patients receiving infusion/injection treatments, compared with those receiving oral therapy, spent more time in ambulatory care. Health care time was higher for patients receiving chemotherapeutic agents compared to those receiving hormonal agents. CONCLUSION: Time spent traveling and receiving inpatient care represented a substantial burden to patients with MBC, with variation in time by treatment type and administration method.

HPV Vaccination Communication Messages, Messengers, and Messaging Strategies.

Human papillomavirus (HPV) causes over 39,000 cancers annually in the US. The HPV vaccine is safe and effective but underutilized to prevent cancer. In the US, only 37% of adolescents ages 13-17 have received the full vaccine series. Ineffective messages and misinformation about the vaccine have negatively impacted its uptake in the US. It was initially only approved for girls and early marketing focused on cervical cancer prevention and prevention of HPV as a sexually transmitted infection. Understanding effective messages and methods of dissemination is critical to address suboptimal vaccine uptake. Qualitative interviews were conducted with 34 participants to identify best practices for HPV vaccination messaging in SC. Participants included state leaders representing public health, medical associations, K-12 public schools, universities, insurers, and cancer advocacy organizations. Recommended HPV vaccine messages included focusing on cancer prevention rather than sexual transmission, routinizing the vaccine, and highlighting risks/costs of HPV. Targeting messages to specific demographics and utilizing multiple media platforms to disseminate consistent, scientifically accurate messages were recommended. Strategies such as appealing to parents' moral responsibility to protect their children against cancer and addressing the ubiquity of HPV and sharing growing evidence that HPV may be transmitted independent of sexual activity were also recommended. Suggested HPV vaccine messengers included trusted peers, medical professionals, and health associations. Culture-centered narratives to raise the voices of cancer survivors and parents were also recommended. This study provides an array of HPV vaccination messages and dissemination strategies for optimizing HPV vaccination rates.

Barriers, facilitators, and potential strategies for increasing HPV vaccination: A statewide assessment to inform action.

OBJECTIVE: The objective was to investigate how state level strategies in South Carolina could maximize HPV vaccine uptake. DESIGN: An environmental scan identified barriers, facilitators, and strategies for improving HPV vaccination in South Carolina. Interviews were conducted with state leaders from relevant organizations such as public health agencies, medical associations, K-12 schools, universities, insurers, and cancer advocacy organizations. A thematic content analysis design was used. Digital interview files were transcribed, a data dictionary was created and data were coded using the data dictionary. RESULTS: Thirty four interviews were conducted with state leaders. Barriers to HPV vaccination included lack of HPV awareness, lack of provider recommendation, HPV vaccine concerns, lack of access and practice-level barriers. Facilitators included momentum for improving HPV vaccination, school-entry Tdap requirement, pharmacy-based HPV vaccination, state immunization registry, HEDIS measures and HPV vaccine funding. Strategies for improving HPV vaccination fell into three categories: 1) addressing lack of awareness about the importance of HPV vaccination among the public and providers; 2) advocating for policy changes around HPV vaccine coverage, vaccine education, and pharmacy-based vaccination; and 3) coordination of efforts. DISCUSSION: A statewide environmental scan generated a blueprint for action to be used to improve HPV vaccination in the state.

CD8, FoxP3, and CD45RO+ Lymphocytic Infiltrates in Type I and Type II Endometrial Cancers in African American and European American Females.

African American (AA) females with endometrial carcinoma have a significantly worse prognosis with regard to disease-free survival and overall survival than their European American (EA) counterparts and this finding is true across all stages and grades. The presence of tumor-infiltrating lymphocytes (TILs) has been demonstrated to be of prognostic significance in a variety of malignancies, including endometrial cancers. This study aims to determine whether clinically significant differences in levels of CD8+ cytotoxic T lymphocytes, FoxP3+ regulatory T lymphocytes, and CD45RO+ memory T lymphocytes exist between races and to document the clinical impact of TILs. One hundred ten patients with endometrial adenocarcinoma, treated with hysterectomy from 2003 to 2011 were studied. Patients were selected to provide equal representation across type and grade for both EAs and AAs. Immunohistochemical stains were used to highlight CD8-positive, FoxP3-positive, and CD45RO-positive TILs at the endometrial-myometrial interface on slides from paraffin-embedded tissue. Patients with "high" or "low" levels of TILs were compared with respect to the race, tumor type, and survival. High levels of CD45RO+ TILs were associated with improved overall survival in EA women (hazard ratio, 0.32; 95% confidence interval, 0.11-0.92; P=0.034). Comparatively, AA women with high levels of CD45RO+ TILs received no survival benefit (hazard ratio, 0.96; 95% confidence interval, 0.35-2.64; P=0.94). High levels of CD8-positive or FoxP3-positive TILs, alone, had no impact on survival. EA patients with TILs containing high levels of CD45RO cells but low levels of CD8+ cells lost the survival benefit; however, limited numbers preclude significant conclusions from this observation. Neither tumor type nor race were predictive of the levels of TILs of any type. Further study with a larger sample size is required to determine the impact of TIL subtype combinations on survival.

An association between Trichomonas vaginalis and high-risk human papillomavirus in rural Tanzanian women undergoing cervical cancer screening.

OBJECTIVE: The goal of this study was to determine the prevalence of vaginitis and its association with high-risk human papillomavirus (HR HPV) in women undergoing cervical cancer screening in rural Tanzania. METHODS: For the purpose of cervical cancer screening, cytology and HR HPV polymerase chain reaction data were collected from 324 women aged between 30 and 60 years. Microscopy and gram stains were used to detect yeast and bacterial vaginosis. Cervical nucleic acid amplification test specimens were collected for the detection of Trichomonas vaginalis (TV), Chlamydia trachomatis, and Neisseria gonorrhoeae. RESULTS: The majority of women were married (320 of 324) and reported having a single sexual partner (270 of 324); the median age of participants was 41 years. HR HPV was detected in 42 participants. Forty-seven percent of women had vaginitis. Bacterial vaginosis was the most common infection (32.4%), followed by TV (10.4%), and yeast (6.8%). In multivariable logistic regression analysis, TV was associated with an increased risk of HR HPV (odds ratio, 4.2 [95% CI, 1.7-10.3]). Patients with TV were 6.5 times more likely to have HPV type 16 than patients negative for TV (50% vs 13.3%) (odds ratio, 6.5 [95% CI, 1.1-37]). CONCLUSIONS: Among rural Tanzanian women who presented for cervical cancer screening, Trichomonas vaginitis was significantly associated with HR HPV infection (specifically type 16).