Evaluating the implementation and impact of navigator-supported remote symptom monitoring and management: a protocol for a hybrid type 2 clinical trial.

BACKGROUND: Symptoms in patients with advanced cancer are often inadequately captured during encounters with the healthcare team. Emerging evidence demonstrates that weekly electronic home-based patient-reported symptom monitoring with automated alerts to clinicians reduces healthcare utilization, improves health-related quality of life, and lengthens survival. However, oncology practices have lagged in adopting remote symptom monitoring into routine practice, where specific patient populations may have unique barriers. One approach to overcoming barriers is utilizing resources from value-based payment models, such as patient navigators who are ideally positioned to assume a leadership role in remote symptom monitoring implementation. This implementation approach has not been tested in standard of care, and thus optimal implementation strategies are needed for large-scale roll-out. METHODS: This hybrid type 2 study design evaluates the implementation and effectiveness of remote symptom monitoring for all patients and for diverse populations in two Southern academic medical centers from 2021 to 2026. This study will utilize a pragmatic approach, evaluating real-world data collected during routine care for quantitative implementation and patient outcomes. The Consolidated Framework for Implementation Research (CFIR) will be used to conduct a qualitative evaluation at key time points to assess barriers and facilitators, implementation strategies, fidelity to implementation strategies, and perceived utility of these strategies. We will use a mixed-methods approach for data interpretation to finalize a formal implementation blueprint. DISCUSSION: This pragmatic evaluation of real-world implementation of remote symptom monitoring will generate a blueprint for future efforts to scale interventions across health systems with diverse patient populations within value-based healthcare models. TRIAL REGISTRATION: NCT04809740 ; date of registration 3/22/2021.

Integration of Palliative Care Into Standard Oncology Care: American Society of Clinical Oncology Clinical Practice Guideline Update.

Purpose To provide evidence-based recommendations to oncology clinicians, patients, family and friend caregivers, and palliative care specialists to update the 2012 American Society of Clinical Oncology (ASCO) provisional clinical opinion (PCO) on the integration of palliative care into standard oncology care for all patients diagnosed with cancer. Methods ASCO convened an Expert Panel of members of the ASCO Ad Hoc Palliative Care Expert Panel to develop an update. The 2012 PCO was based on a review of a randomized controlled trial (RCT) by the National Cancer Institute Physicians Data Query and additional trials. The panel conducted an updated systematic review seeking randomized clinical trials, systematic reviews, and meta-analyses, as well as secondary analyses of RCTs in the 2012 PCO, published from March 2010 to January 2016. Results The guideline update reflects changes in evidence since the previous guideline. Nine RCTs, one quasiexperimental trial, and five secondary analyses from RCTs in the 2012 PCO on providing palliative care services to patients with cancer and/or their caregivers, including family caregivers, were found to inform the update. Recommendations Inpatients and outpatients with advanced cancer should receive dedicated palliative care services, early in the disease course, concurrent with active treatment. Referral of patients to interdisciplinary palliative care teams is optimal, and services may complement existing programs. Providers may refer family and friend caregivers of patients with early or advanced cancer to palliative care services.

Financial Relationships With Industry Among National Comprehensive Cancer Network Guideline Authors.

IMPORTANCE: Financial conflicts of interest (FCOIs) among authors of clinical practice guidelines have the potential to influence treatment recommendations. OBJECTIVE: To quantify FCOIs with industry among authors of the National Comprehensive Cancer Network (NCCN) guidelines. DESIGN, SETTING, AND PARTICIPANTS: We assessed FCOIs occurring during 2014 among NCCN guideline authors in the United States. All were physician members of the NCCN guideline committees for lung, breast, prostate, and colorectal cancer as of the end of 2014. The data source for FCOIs was Open Payments, which is publically reported by the Centers for Medicare and Medicaid Services. This study was cross-sectional. MAIN OUTCOMES AND MEASURES: The proportion of NCCN authors having FCOIs with industry; the average amount received from industry sources per author. RESULTS: Of 125 guideline authors, 108 (86%) had at least 1 reported FCOI. Authors received an average of $10 011 (range, $0-$106 859) in general payments (GPs), which include consulting, meals, lodging, and similar transfers of value, and $236 066 (range $0-$2 756 713) in industry research payments (RPs), including funding associated with clinical trials. Approximately 84% of authors received GPs, while 47% received RPs. Eight (6%) had FCOIs in excess of the $50 000 net and/or $20 000 single-company maximums stipulated by NCCN. CONCLUSIONS AND RELEVANCE: Among NCCN guideline authors, FCOIs involving RPs were of greater value, while those involving GPs were more prevalent. Although FCOIs may result from engaging in important scholarship, FCOIs may still influence guideline authors in counterproductive ways. Research is needed to understand how best to manage author FCOIs during guideline creation.

Statewide geographic variation in outcomes for adults with acute myeloid leukemia in North Carolina.

BACKGROUND: Population-based studies have demonstrated survival disparities related to socioeconomic factors for patients with acute myeloid leukemia (AML). The objective of the current study was to determine whether the local health care infrastructure, represented by Area Health Education Centers (AHEC) region, or treating center experience, represented by National Cancer Institute Comprehensive Cancer Center (NCICCC) designation, were associated with outcomes among patients with AML in North Carolina. METHODS: Patients who were diagnosed with AML from 2003 to 2009 were identified using the University of North Carolina Lineberger Integrated Cancer Information and Surveillance System, a database linking insurance claims to the North Carolina Cancer Registry. A Cox proportional-hazards model was used to explore survival based on AHEC region. A subset of patients who received inpatient chemotherapy was examined to evaluate the impact of treatment at an NCICCC. RESULTS: Nine hundred patients were identified in the study period, 553 of whom received inpatient chemotherapy therapy within 30 days of diagnosis. Almost one-half of these patients (n = 294) received chemotherapy at a non-NCICCC. Among the patients who received intensive inpatient therapy, residence in 3 of 9 AHEC regions was associated with a higher risk of mortality (hazard ratio: range, 1.97-4.03; P < .01) at 1 year in multivariate analysis. Treatment at a non-NCICCC was not associated with an increased risk of mortality at 1 year (hazard ratio, 1.25; 95% confidence interval, 0.95-1.65). CONCLUSIONS: Survival among patients with AML in North Carolina varies according to geographic region. Further examination of local practice and referral patterns may inform strategies to improve AML outcomes across the state. Cancer 2016;122:3041-3050. © 2016 American Cancer Society.

Clinical Benefits Associated With Medicaid Coverage Before Diagnosis of Gynecologic Cancers.

PURPOSE: Many low-income patients enroll in Medicaid at the time of cancer diagnosis, which improves survival outcomes. Medicaid enrollment before cancer diagnosis may confer additional benefits. Our objective was to compare stage at diagnosis and overall mortality between women with and without Medicaid enrollment before gynecologic cancer diagnosis. METHODS AND MATERIALS: Women younger than 65 years with a gynecologic cancer (2003 to 2008) were identified through the North Carolina Central Cancer Registry and linked to state Medicaid enrollment files. Those with and without Medicaid enrollment within 6 months before diagnosis were identified. Propensity matching was used to balance the exposure groups. Stage at diagnosis was evaluated by using logistic regression, and all-cause mortality was assessed with Cox proportional hazard models. RESULTS: Of 564 women, one half (n = 282) had prediagnosis Medicaid enrollment. Disease sites included the cervix (44%), uterus (25%), ovary (26%), and vulva/vagina (5%). More than one half (51%) of cancers were advanced stage. Women without prediagnosis Medicaid had an increased odds of advanced-stage disease (hazard ratio, 1.46; 95% CI, 1.03 to 2.05). Crude survival outcomes differed significantly between the groups; however, when adjusted for stage at diagnosis, lack of prediagnosis Medicaid coverage had a hazard ratio of 1.19 (95% CI, 0.92 to 1.53). CONCLUSION: Medicaid enrollment before gynecologic cancer diagnosis is associated with an earlier stage at presentation. Given the existence of a cervical cancer screening program in North Carolina and lack of Medicaid expansion, these data suggest that screening programs alone are not sufficient to counteract the delay in diagnosis that is common for uninsured individuals.

Evaluation of pedometry as a patient-centered outcome in patients undergoing hematopoietic cell transplant (HCT): a comparison of pedometry and patient reports of symptoms, health, and quality of life.

AIMS: We evaluated pedometry as a novel patient-centered outcome because it enables passive continuous assessment of activity and may provide information about the consequences of symptomatic toxicity complementary to self-report. METHODS: Adult patients undergoing hematopoietic cell transplant (HCT) wore pedometers and completed PRO assessments during transplant hospitalization (4 weeks) and 4 weeks post-discharge. Patient reports of symptomatic treatment toxicities (single items from PRO-CTCAE, http://healthcaredelivery.cancer.gov/pro-ctcae ) and symptoms, physical health, mental health, and quality of life (PROMIS(®) Global-10, http://nih.promis.org ), assessed weekly with 7-day recall on Likert scales, were compared individually with pedometry data, summarized as average daily steps per week, using linear mixed models. RESULTS: Thirty-two patients [mean age 55 (SD = 14), 63 % male, 84 % white, 56 % autologous, 43 % allogeneic] completed a mean 4.6 (SD = 1.5, range 1-8) evaluable assessments. Regression model coefficients (ß) indicated within-person decrements in average daily steps were associated with increases in pain (ß = -852; 852 fewer steps per unit increase in pain score, p < 0.001), fatigue (ß = -886, p < 0.001), vomiting (ß = -518, p < 0.01), shaking/chills (ß = -587, p < 0.01), diarrhea (ß = -719, p < 0.001), shortness of breath (ß = -1018, p < 0.05), reduction in carrying out social activities (ß = 705, p < 0.01) or physical activities (ß = 618, p < 0.01), and global physical health (ß = 101, p < 0.001), but not global mental health or quality of life. CONCLUSIONS: In this small sample of HCT recipients, more severe symptoms, impaired physical health, and restrictions in the performance of usual daily activities were associated with statistically significant decrements in objectively measured daily steps. Pedometry may be a valuable outcome measure and validation anchor in clinical research.

Gynecologic cancer outcomes in the elderly poor: A population-based study.

BACKGROUND: Adults aged ≥65 years who are dually enrolled in Medicare and Medicaid are an at-risk group in health care. However, to the best of the authors' knowledge, the outcomes of women with gynecologic cancers in this population are unknown. METHODS: The current study was a population-based cohort study of North Carolina state cancer registry cases of uterine, ovarian, cervical, and vulvar/vaginal cancers (2003-2009), with linked enrollment in Medicare and state Medicaid. Outcomes of all-cause mortality and stage of disease at the time of diagnosis were analyzed as a function of enrollment status using multivariate analysis and survival curves. RESULTS: Of 4522 women aged ≥65 years (3702 of whom were enrolled in Medicare [82%] and 820 of whom were dually enrolled [18%]), there were 2286 cases of uterine (51%), 1587 cases of ovarian (35%), 302 cases of cervical (7%), and 347 cases of vulvar/vaginal (8%) cancers. Dual enrollees had increased all-cause mortality overall (adjusted hazard ratio [aHR], 1.34; 95% confidence interval [95% CI], 1.19-1.49), and within each cancer site (uterine: aHR, 1.22 [95% CI, 1.02-1.47]; ovarian: aHR, 1.25 [95% CI, 1.05-1.49]; cervical: aHR, 1.34 [95% CI, 0.96-1.87]; and vulvar/vaginal: aHR, 1.93 [95% CI, 1.36-2.72]). Increased odds of advanced-stage disease at the time of diagnosis among dual enrollees was only present in patients with uterine cancer (adjusted odds ratio, 1.38; 95% CI, 1.06-1.79). Stratified survival curves demonstrated the strongest disparities among women with early-stage uterine and early-stage vulvar/vaginal cancers. CONCLUSIONS: Women aged ≥65 years who were dually enrolled in Medicare and Medicaid were found to have an overall 34% increase in all-cause mortality after diagnosis with a gynecologic cancer compared with the non-dually enrolled Medicare population. Women with early-stage uterine and vulvar/vaginal cancers appeared to have the most disparate outcomes. Because these malignancies are generally curable, they have the most potential for benefit from targeted interventions.

Harnessing technology to improve clinical trials: study of real-time informatics to collect data, toxicities, image response assessments, and patient-reported outcomes in a phase II clinical trial.

PURPOSE: In clinical trials, traditional monitoring methods, paper documentation, and outdated collection systems lead to inaccuracies of study information and inefficiencies in the process. Integrated electronic systems offer an opportunity to collect data in real time. PATIENTS AND METHODS: We created a computer software system to collect 13 patient-reported symptomatic adverse events and patient-reported Karnofsky performance status, semi-automated RECIST measurements, and laboratory data, and we made this information available to investigators in real time at the point of care during a phase II lung cancer trial. We assessed data completeness within 48 hours of each visit. Clinician satisfaction was measured. RESULTS: Forty-four patients were enrolled, for 721 total visits. At each visit, patient-reported outcomes (PROs) reflecting toxicity and disease-related symptoms were completed using a dedicated wireless laptop. All PROs were distributed in batch throughout the system within 24 hours of the visit, and abnormal laboratory data were available for review within a median of 6 hours from the time of sample collection. Manual attribution of laboratory toxicities took a median of 1 day from the time they were accessible online. Semi-automated RECIST measurements were available to clinicians online within a median of 2 days from the time of imaging. All clinicians and 88% of data managers felt there was greater accuracy using this system. CONCLUSION: Existing data management systems can be harnessed to enable real-time collection and review of clinical information during trials. This approach facilitates reporting of information closer to the time of events, and improves efficiency, and the ability to make earlier clinical decisions.

Validation study of a web-based assessment of functional recovery after radical prostatectomy.

BACKGROUND: Good clinical care of prostate cancer patients after radical prostatectomy depends on careful assessment of post-operative morbidities, yet physicians do not always judge patient symptoms accurately. Logistical problems associated with using paper questionnaire limit their use in the clinic. We have implemented a web-interface ("STAR") for patient-reported outcomes after radical prostatectomy. METHODS: We analyzed data on the first 9 months of clinical implementation to evaluate the validity of the STAR questionnaire to assess functional outcomes following radical prostatectomy. We assessed response rate, internal consistency within domains, and the association between survey responses and known predictors of sexual and urinary function, including age, time from surgery, nerve sparing status and co-morbidities. RESULTS: Of 1581 men sent an invitation to complete the instrument online, 1235 responded for a response rate of 78%. Cronbach's alpha was 0.84, 0.86 and 0.97 for bowel, urinary and sexual function respectively. All known predictors of sexual and urinary function were significantly associated with survey responses in the hypothesized direction. CONCLUSIONS: We have found that web-based assessment of functional recovery after radical prostatectomy is practical and feasible. The instrument demonstrated excellent psychometric properties, suggested that validity is maintained when questions are transferred from paper to electronic format and when patients give responses that they know will be seen by their doctor and added to their clinic record. As such, our system allows ready implementation of patient-reported outcomes into routine clinical practice.

Physician visits prior to treatment for clinically localized prostate cancer.

BACKGROUND: The 2 primary therapeutic interventions for localized prostate cancer are delivered by different types of physicians, urologists, and radiation oncologists. We evaluated how visits to specialists and primary care physicians (PCPs) by men with localized prostate cancer are related to treatment choice. METHODS: Using the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database, we identified 85 088 men with clinically localized prostate cancer diagnosed at age 65 years or older, between 1994 and 2002. Men were categorized by primary treatment received within 9 months of diagnosis: radical prostatectomy (n = 18 201 [21%]), radiotherapy (n = 35 925 [42%]), androgen deprivation (n = 14 021 [17%]), or expectant management (n = 16 941 [20%]). Visits to specialists and PCPs were analyzed by patient characteristics and primary therapies received and were identified using Medicare claims and the American Medical Association Physician Masterfile. RESULTS: Overall, 42 309 men (50%) were seen exclusively by urologists, 37 540 (44%) by urologists and radiation oncologists, 2329 (3%) by urologists and medical oncologists, and 2910 (3%) by all 3 specialists. There was a strong association between the type of specialist seen and primary therapy received. Visits to PCPs were infrequent between diagnosis and receipt of therapy (22% of patients visited any PCP and 17% visited an established PCP) and were not associated with a greater likelihood of specialist visits. Irrespective of age, comorbidity status, or specialist visits, men seen by PCPs were more likely to be treated expectantly. CONCLUSIONS: Specialist visits relate strongly to prostate cancer treatment choices. In light of these findings, prior evidence that specialists prefer the modality they themselves deliver and the lack of conclusive comparative studies demonstrating superiority of one modality over another, it is essential to ensure that men have access to balanced information before choosing a particular therapy for prostate cancer.

Department of Defense prostate cancer clinical trials consortium: a new instrument for prostate cancer clinical research.

BACKGROUND: In 2005, the US Department of Defense, through the US Army Medical Research and Materiel Command, Office of the Congressionally Directed Medical Research Programs, created a funding mechanism to form a clinical trials consortium to conduct phase I and II studies in prostate cancer. This is the first report of the Prostate Cancer Clinical Trials Consortium (PCCTC). PATIENTS AND METHODS: The Department of Defense award supports a consortium of 10 prostate cancer research centers. Memorial Sloan-Kettering Cancer Center was awarded the Coordinating Center grant for the consortium and charged with creating an infrastructure to conduct early-phase multicenter clinical trials. Each participating center was required to introduce >or=1 clinical trial per year and maintain accrual of a minimum of 35 patients per year. RESULTS: The PCCTC was launched in 2006 and now encompasses 10 leading prostate cancer research centers. Fifty-one trials have been opened, and 1386 patients have been accrued at member sites. Members share an online clinical trial management system for protocol tracking, electronic data capture, and data storage. A legal framework has been instituted, and standard operating procedures, an administrative structure, editorial support, centralized budgeting, and mechanisms for scientific review are established. CONCLUSION: The PCCTC fulfills a congressional directive to create a clinical trials instrument dedicated to early-phase prostate cancer studies. The member institutions have built an administrative, informatics, legal, financial, statistical, and scientific infrastructure to support this endeavor. Clinical trials are open and accruing in excess of federally mandated goals.

Use of information resources by patients with cancer and their companions.

BACKGROUND: Use of the Internet is common among patients with cancer and their companions. However, little is known about patterns of use of print or telephone-based resources amidst growing Internet utilization, nor is it known whether different types of information are sought from electronic compared with print media. It is not clear as to whether patients and their companions differ in their patterns of content seeking. METHODS: A survey was developed to evaluate the use of electronic and nonelectronic informational resources by patients and their companions. During a 10-week period, this questionnaire was administered to 443 outpatients and 124 paired companions attending an urban academic cancer center. RESULTS: In this cohort, 64% of patients and 76% of companions were computer owners, with home Internet access indicated by 58% and 68%, respectively. Use of the Internet to obtain cancer-related information was reported by 44% of patients and 60% of companions. Print resources were used by 79% of patients and 83% of companions, with telephone resources used by 22% and 23%, respectively. The majority of Internet users also read print content (85%), whereas one-half of print users did not access data electronically (52%). Topic areas sought via print and the Internet were similar, with the exception of nutrition-related information, which was more commonly sought in print texts. There was a high rate of concordance between patient and companion use of both electronic and nonelectronic resources. CONCLUSIONS: Despite recent publicity and scrutiny focusing on the quality of Internet health care content, print products remain the most common source of information sought by patients with cancer. Future investigation should focus on the quality of print products used by patients.