Application of the CuSum technique to evaluate changes in recruitment strategies.

BACKGROUND: While lagging subject enrollment in longitudinal clinical trials is a complex problem, the best recruitment strategy has not been established. Cumulative summation (CuSum) is a statistical process control procedure often applied in quality improvement efforts to detect trend shifts in highly variable serial data. OBJECTIVES: To describe changes in efforts to increase referrals and enrollment in a longitudinal quality-of-life breast cancer study, determine effects of changes in referral strategies on enrollment using a novel application of CuSum, and discuss implications of CuSum as a tool for prospectively managing the subject recruitment process. METHOD: Ten referrals and eight enrollments per month for a total of 31 months were estimated to meet study subject accrual requirements in the clinical trial. The estimates were used as standards in performing CuSum calculations. CuSum was applied to monthly referral and enrollment data and trend graphs were generated. Alterations in recruitment tactics and strategies were evaluated as to whether changes in trend occasioned such alterations. Unplanned changes in trend were noted. RESULTS: While monthly data were highly variable, an average of 8.42 referrals and 5.92 enrollments were realized during Months 1-12. Based on these figures, projected accrual for 31 months would have enrolled only 184 subjects, 66 subjects short of target. CuSum illustrated this trend. Subsequent shifts in enrollment trends were shown with improvements in referral. DISCUSSION: Indications for use of CuSum include (a) earlier detection of enrollment trend shifts, and (b) earlier discrimination between effective and ineffective recruitment. Thus, CuSum has implications for both evaluating the effects of planned and unplanned process changes and for managing the recruitment process.

Fertility options in young breast cancer survivors: a review of the literature.

PURPOSE/OBJECTIVES: To describe the impact of treatment on fertility, discuss fertility-sparing options available for women with breast cancer, and explore pregnancy subsequent to breast cancer. DATA SOURCES: Published research, clinical articles, book chapters, and abstracts. DATA SYNTHESIS: The risk of amenorrhea associated with alkylating agents in breast cancer survivors is well known. Fertility-sparing options before, during, and after treatment are possible with the use of assistive reproductive technology. Young breast cancer survivors are concerned about stimulating recurrence with subsequent pregnancy, health during pregnancy, and family matters. CONCLUSIONS: Current data about the effects of treatment on amenorrhea, subsequent pregnancy after treatment, preservation of ovarian function during adjuvant therapy, and management of ovarian failure in young women with breast cancer are important to include in discussions and counseling. IMPLICATIONS FOR NURSING: Young women deserve a thoughtful discussion about their concerns among their multidisciplinary team, including oncology nurses, oncologists, and social workers. Effects of treatment on fertility are well known. Women with fertility concerns should be referred to a reproductive endocrinology team at the time of diagnosis rather than after treatment has ended.

Cardiac toxicity related to cancer treatment.

Cardiac toxicity is a dose-limiting toxicity that may occur during cancer treatment or several years after therapy ends. Cardiac toxicity may be caused by chemotherapy, biotherapy, and radiation therapy and may result in cardiomyopathy, congestive heart failure, dysrhythmias, and myocardial ischemia. The risk for developing cardiac toxicity varies based on type of treatment, patient age, presence of preexisting or concurrent heart disease, and concomitant treatment. Patients at high risk require careful evaluation and monitoring during and in the years following therapy to detect cardiac changes. Fortunately, cardioprotective agents and newer radiation therapy techniques decrease the risk for treatment-related cardiac toxicity. Oncology nurses can become more informed in the assessment of cardiac toxicity and can arm themselves with knowledge about early identification of symptoms as well as specific agents and treatments that increase risk for cardiac toxicity.

Early diagnosis key to epithelial ovarian cancer detection.

Ovarian cancer is the fourth leading cause of cancer death for women and the most fatal of all gynecologic malignancies. Labeled "the whispering disease," ovarian cancer has an insidious onset with vague symptoms such as gastrointestinal upset, abdominal bloating and fatigue. Early diagnosis is often delayed and patients present with advanced disease. This article provides an overview of ovarian cancer, including epidemiology, classification, risk factors, screening and early detection.

Advances in cancer research and practice.

The cure and management of patients with cancer are constantly evolving. The rapid translation of scientific findings into clinical therapeutics has resulted in a variety of efficacious cancer agents. Results from recently completed and ongoing clinical trials continue to demonstrate the efficacy and tolerability of many of these new cancer therapies. This supplement aims to provide the oncology nurse with a better understanding of the pathophysiology and management of a variety of cancers. Each article provides practical information to the nurse treating cancer in clinical practice. At the conclusion of this educational activity, the participant should be able to discuss the most recent advances in the medical management of leukemia as well as lung, breast, and ovarian cancer; to describe the role and report the results of new molecular-targeted therapies in treating malignancies; to review new therapies for managing chemotherapy-related hematologic toxicities, cognitive impairment, fatigue, and pain; and to recognize the need and discuss the measures used to improve symptom control and supportive care in the palliative setting.

The nurse's relationship-based perceptions of patient quality of life.

PURPOSE/OBJECTIVES: To explore patients' quality of life (QOL) as defined by RNs in adult and pediatric oncology settings and to examine, from the perspectives of clinical nurses, the knowledge that is needed to apply QOL research outcomes in clinical practice. DESIGN: Qualitative research design using a focus group technique to explore the research questions. SETTING: Three sites (i.e., a pediatric research center in western Tennessee and oncology nurses from a chapter of the Oncology Nursing Society [ONS] in Central Florida and another in upstate New York). SAMPLE: 24 oncology nurses working with adult or pediatric patients or both. METHODS: Oncology nurses were approached at work or through their local ONS chapters for a focus group discussion. FINDINGS: 47 unique themes were reported by all five focus groups in response to three questions. The most frequently reported themes were (a) Using the Patient's Standard, (b) Nursing Strategies, (c) Differences Decrease QOL Care, (d) Maintaining Social Interests, (e) Insightful Relations With Patient, and (f) Nurse-Patient Communication. CONCLUSIONS: Nurses' assessments of QOL primarily are based on their established relationships with their patients. From these relationships, nurses derive perceptions of patients' QOL and clinical direction for interventions to positively influence QOL. Based on these findings, the investigators developed a conceptual model of the nurses' relationship-based perceptions of patients' QOL. IMPLICATIONS FOR NURSING: The current QOL measures have minimal importance to nurse clinicians. Because nurse clinicians rely on their relationships with patients to assess QOL, available tools should be made more clinically useful. Further research should be conducted using the new conceptual model, specifically to learn more about how nurses complete a QOL assessment within the context of the nurse-patient relationship.

Existing and emerging endocrine therapies for breast cancer.

Endocrine therapy is first-line therapy for patients with estrogen receptor-positive or progesterone receptor-positive metastatic breast cancer. Commonly used endocrine therapies are tamoxifen, megestrol acetate, and aromatase inhibitors. Although tamoxifen and megestrol acetate have a favorable therapeutic profile, there are risks associated with these agents. With tamoxifen, the partial agonist property can lead to thromboembolic events. An important adverse event of megestrol acetate is weight gain and fluid retention in some patients. The aromatase inhibitors are currently used as second-line therapy after tamoxifen failure. A recent study showed that anastrozole, an aromatase inhibitor, is as effective or even superior to tamoxifen when used as a first-line therapy. However, not all patients will respond to currently available therapies. A new class of drug, the estrogen receptor downregulators, has been developed. Fulvestrant, the first agent in this new class, not only induces the degradation of the estrogen receptor but also is an estrogen antagonist; further, its lack of agonist activity provides a better safety profile. Two phase III trials have proven that fulvestrant is at least as effective as anastrozole in postmenopausal women with advanced breast cancer. Fulvestrant is an effective and safe endocrine therapy for postmenopausal women who have failed prior endocrine therapy.