Mary S. McCabe

Models for Delivering Survivorship Care

Survivors of adult cancer face lifetime health risks that are dependent on their cancer, cancer treatment exposures, comorbid health conditions, genetic predispositions, and lifestyle behaviors. Content, intensity, and frequency of health care that addresses these risks vary from survivor to survivor. The aims of this article are to provide a rationale for survivor health care and to articulate a taxonomy of models of survivor care that is applicable to both community practices and academic institutions.

Patient Online Self-Reporting of Toxicity Symptoms During Chemotherapy

PURPOSE Tracking symptoms related to treatment toxicity is standard practice in routine care and during clinical trials. Currently, clinicians collect symptom information via complex and often inefficient mechanisms, but there is growing interest in collecting outcome information directly from patients. PATIENTS AND METHODS The National Cancer Institute Common Terminology Criteria for Adverse Events schema for seven common symptoms was adapted into a Web-based patient-reporting system, accessible from desktop computers in outpatient clinics and from home computers. Eighty patients with gynecologic malignancies beginning standard chemotherapy regimens were enrolled between April and September 2004. During an 8-week observation period, participants were encouraged to log in and report symptoms at each follow-up visit, or alternatively, to access the system from home. RESULTS All patients completed an initial log in. At each subsequent appointment, most enrollees (80% to 85%) reported symptoms using the online system, with a mean of three follow-up visits per patient during the observation period (range, one to six). Sixty of 80 patients (75%) logged in at least once from home. Use was significantly associated with prior Internet experience. Forty-two severe toxicities (grade 3 to 4) entered from home prompted seven clinician interventions. Most patients (96%) found the system useful and would recommend it to others. CONCLUSION Patients are capable of reporting symptoms experienced during chemotherapy using a Web-based interface. Assessment in the clinical trial setting and comparison of direct patient- versus clinician-based approaches for reporting symptoms and their severity are warranted.

Survivorship care planning after the Institute of Medicine recommendations: how are we faring?

IntroductionThis study evaluates the concordance of treatment summaries (TSs) and survivorship care plans (SCPs) delivered to breast cancer survivors within the LIVESTRONG™ Network of Survivorship Centers of Excellence with Institute of Medicine (IOM) recommendations and describes additional structure/process variables.MethodSeven NCI-designated comprehensive cancer centers and six community-based centers participated. TS/SCPs for 65 patients were rated against IOM recommendations using a study-derived checklist, and surveys were administered to better understand the structure and process of delivering TSs/SCPs.ResultsOn average, fewer than half of IOM content recommendations were met for TSs (M = 46%) and less than two thirds for SCPs (M = 59%). No sites achieved ≥75% overall concordance with IOM recommendations for TSs and only two of 13 met this criterion for SCPs. Content domain scores across sites varied widely, as did the number of sites addressing domain content with ≥75% concordance. Nonetheless, resources required for document preparation and delivery were substantial.DiscussionGaps in concordance with IOM recommendations exist even in dedicated survivorship centers. A substantial time burden was also noted. Further research is needed to determine which informational elements are essential, to develop and test strategies for improving efficiency and reach, and to determine if outcomes of survivorship care planning warrant the resources required in their preparation and delivery.Implications for survivorsTSs and SCPs have been recommended for all cancer survivors. Essential elements must be determined, approaches made more efficient, outcome improvements demonstrated, and cost-benefit analyses determined before survivors should expect widespread implementation of this recommendation for survivorship care.

Long-Term Toxicity Monitoring via Electronic Patient-Reported Outcomes in Patients Receiving Chemotherapy

PURPOSE In cancer treatment trials, clinicians traditionally report patient toxicity symptoms. Alternatively, patients could provide this information directly. PATIENTS AND METHODS The Common Terminology Criteria for Adverse Events (CTCAE) is the mandated instrument for tracking patient toxicity symptoms in National Cancer Institute (NCI)-sponsored cancer treatment trials. We adapted CTCAE symptom items into patient language and uploaded these to an online platform. Lung cancer outpatients receiving chemotherapy were invited to self-report selected symptoms at visits via waiting area computers or optional home access. Symptom reports were printed for nurses at visits, but no instructions were given with regard to use of this information. RESULTS From June 2005 through March 2006, 125 patients were invited to participate, and 107 chose to enroll. Mean length of participation was 42 weeks (range, 1 to 71 weeks), by which time 35% died. The average number of clinic visits was 12 (range, 1 to 40 visits). At each consecutive visit, most patients (mean, 78%) logged in without significant attrition. Reasons for failure to log in included having no reminder and having inadequate time. Although 76% of enrollees had home computers, only 15% self-reported from home. Satisfaction with the system was high (90%), but only 51% felt communication was improved. All participating nurses understood the reports and felt this information was useful for clinical decisions, documentation, and discussions. However, only one of seven nurses discussed reports with patients frequently, with insufficient time being the most common barrier to discussions. CONCLUSION Online patient self-reporting is a feasible long-term strategy for toxicity symptom monitoring during chemotherapy, even among patients with advanced cancer and high symptom burdens. However, without explicit reminders and clinician feedback, patients demonstrated limited voluntary interest in self-reporting between visits.

Evaluation of an online platform for cancer patient self-reporting of chemotherapy toxicities.

The current mechanism for monitoring toxicity symptoms in cancer trials depends on a complex paper-based process. Electronic collection of patient-reported outcomes (PROs) may be more efficient and accurate. An online PRO platform was created including a simple data entry interface, real-time report generation, and an alert system to e-mail clinicians when patients self-report serious toxicities. Feasibility assessment involving 180 chemotherapy patients demonstrated high levels of use at up to 40 follow-up clinic visits per patient over 16 months (85% of patients at any given visit), with high levels of patient and clinician acceptance and satisfaction (>95%). Alerts were used as the basis for delayed chemotherapy treatments, dose modifications, and scheduling changes. These results demonstrate that online patient-reporting is a feasible strategy for chemotherapy toxicity symptom monitoring, and may improve safety and satisfaction with care. Ongoing multi-center research will evaluate the impact of this approach on clinical and administrative outcomes.

Risk-Based Health Care, the Cancer Survivor, the Oncologist, and the Primary Care Physician

Cancer survivors face substantial risks for morbidity, reduced quality of life, and premature mortality related to the cancer itself and/or the interventions undertaken to control cancer. Risk-based care that involves a personalized systematic plan of periodic screening, surveillance, and prevention relevant to the cancer experience is recommended to address the comprehensive health needs of the growing population of cancer survivors. Risk-based care and coordination between oncology and primary care providers have been identified as important metrics of quality cancer survivorship care. Various models of survivorship care, treatment summaries, and survivorship care plans have been promoted as methods to facilitate communication among providers across care transitions and improve survivor access to quality survivorship care. However, research supporting the feasibility of implementing these practices and their effectiveness in enhancing health outcomes is limited. This article reviews key concepts underpinning clinical and research initiatives endeavoring to improve access to quality care among long-term survivors and summarizes results of intervention studies implementing these elements in transitioning survivors from oncology to primary care providers for long-term follow-up care.

The National Cancer Institute Audit of the National Surgical Adjuvant Breast and Bowel Project Protocol B-06

BACKGROUND The National Surgical Adjuvant Breast and Bowel Project (NSABP) Protocol B-06, a clinical trial sponsored by the National Cancer Institute (NCI), has provided evidence of the value of lumpectomy and breast irradiation for treating women with breast cancer in an early stage. Publicity generated by the discovery that the study included fraudulent data on patients enrolled by St. Luc Hospital in Montreal aroused concern about the overall accuracy of the data and conclusions. To address this concern, the NCI conducted an audit of other participating institutions. METHODS In 1994, data on 1554 of the 1809 randomized patients (85.9 percent) enrolled by centers other than St. Luc Hospital were audited at 37 clinical sites in North America. The audit included data on eligibility, survival, disease-free survival, the length of time to a recurrence of cancer in the ipsilateral breast, and documentation of signed informed consent. RESULTS End points were assessed for all 1554 patients, and eligibility was assessed for 1507 patients; 47 patients were excluded because their forms were not complete or not returned. A total of 1429 patients had their eligibility status verified. Of a total of 7770 data points examined with respect to the number of positive nodes at base line, treatment characteristics, first events (excluding death), recurrence of cancer in the ipsilateral breast, and survival, 7577 (97.5 percent) were verified, 123 (1.6 percent) could not be verified, and 70 (0.9 percent) were discrepant with the NSABP file. Of the 1554 patients, 1340 (86.2 percent) had all audited items (including eligibility) verified, 69 (4.4 percent) had at least one discrepant item, and 113 (7.3 percent) had at least one unverified item (as a result of missing or incomplete data); 32 (2.1 percent) were not assessed for eligibility but had no other discrepant or unverifiable items. Written informed consent was documented for 1098 patients before surgery and 210 after surgery; no date appeared on the signed form for 137. The informed-consent status was not verified for 71 patients and could not be determined for 38. The rates of verification of end-point data and documentation of written informed consent were similar among the total-mastectomy group, the lumpectomy group, and the group treated by lumpectomy and breast irradiation. CONCLUSIONS The audit confirms the adequacy of the data on which the reanalysis of Protocol B-06 and the results after 12 years of follow-up are based.

Adult cancer survivorship care: experiences from the LIVESTRONG centers of excellence network

BackgroundThe objectives of this study were to characterize survivorship models of care across eight LIVESTRONG Survivorship Center of Excellence (COE) Network sites and to identify barriers and facilitators influencing survivorship care.MethodsUsing the framework of the Chronic Care Model (CCM), quantitative and qualitative methods of inquiry were conducted with the COEs. Methods included document reviews, key informant telephone interviews with 39 participants, online Assessment of Chronic Illness Care (ACIC) surveys with 40 participants, and three site visits.ResultsSeveral overarching themes emerged in qualitative interviews and were substantiated by quantitative methods. Health system factors supporting survivorship care include organization and leadership commitment and program champions at various levels of the health care team. System barriers include reimbursement issues, lack of space, and the need for leadership commitment to support changes in clinical practices as well as having program “champions” among clinical staff. Multiple models of care include separate survivorship clinics and integrated models as well as consultative models. COEs’ scores on the ACIC survey showed overall “reasonable support” for survivorship care; however, the clinical information system domain was least developed. Although the ACIC findings indicated “reasonable support” for self-management, the qualitative analysis revealed that self-management support was largely limited to health promotion provided in clinic-based education and counseling sessions, with few COEs providing patients with self-management tools and interventions.ConclusionsThe CCM framework captured experiences and challenges of these COEs and provided insight into the current state of survivorship care in the context of National Cancer Institute-designated comprehensive cancer centers. Findings showed that cancer patients and providers could benefit from clinical information systems that would better identify candidates for survivorship care and provide timely information. In addition, a crucial area for development is self-management support outside of clinical care.Implications for cancer survivorsCancer survivors may benefit from learning about the experience and challenges faced by the eight LIVESTRONG Centers of Excellence in developing programs and models for cancer survivorship care, and these findings may inform patient and caregiver efforts to seek, evaluate, and advocate for quality survivorship programs designed to meet their needs.

Survivorship Care: Models and Programs

OBJECTIVES To review models of care for adult cancer survivors and the challenges in program development. DATA SOURCES Review of the literature. CONCLUSION As the number of cancer survivors continues to grow, so does the need to develop unique evidence-based programs and services for this population. Survivorship should become a distinct phase of care and include: surveillance for recurrence, evaluation of and treatment for medical and psychosocial consequences of treatment, recommendations for screening for new primary cancers, health promotion recommendations, and provision of a written care plan to the patient and other health professionals. IMPLICATIONS FOR NURSING PRACTICE Many challenges remain to evaluating care models and actualizing clinical services nationally, but oncology nurses are uniquely positioned to take the lead in the care of cancer survivors of all ages.

Cancer Care and Cancer Survivorship Care in the United States: Will We Be Able to Care for These Patients in the Future?

The combination of a shortfall in oncologists and primary care physicians and an increased number of patients using more health care resources raises concerns about our health care systems ability to accommodate future patients with cancer and cancer survivors.