A randomized, double-blind, placebo-controlled study of oral coenzyme Q10 to relieve self-reported treatment-related fatigue in newly diagnosed patients with breast cancer.

BACKGROUND: Coenzyme Q10 (CoQ10) is a common antioxidant supplement with known cardioprotective effects and potential anticancer benefits. OBJECTIVES: We performed a randomized, double-blind, placebo-controlled study of oral CoQ10 in female breast cancer patients with the primary objective of determining CoQ10's effects on self-reported fatigue, depression, and quality of life (QOL). Methods Eligible women with newly diagnosed breast cancer and planned adjuvant chemotherapy were randomized to oral supplements of 300 mg CoQ10 or placebo, each combined with 300 IU vitamin E, divided into 3 daily doses. Treatment was continued for 24 weeks. Blood tests, QOL measures, and levels of plasma CoQ10 and vitamin E were obtained at baseline and at 8, 16, and 24 weeks. Mixed-effects models were used to assess treatment differences in outcomes over time. RESULTS: Between September 2004 and March 2009, 236 women were enrolled. Treatment arms were well balanced with respect to age (range, 28-85 years), pathologic stage (stage 0, 91%; stage 1, 8%; stage II, 1%), ethnicity (white, 87%; black, 11%; Hispanic, 2%), and planned therapy. Baseline CoQ10 levels in the CoQ10 and placebo arms were 0.70 and 0.73 microg/mL, respectively; the 24-week CoQ10 levels were 1.83 and 0.79 microg/mL, respectively. There were no significant differences between the CoQ10 and placebo arms at 24 weeks for scores on the Profile of Mood States-Fatigue questionnaire (least squares means, 7.08 vs 8.24, P = .257), the Functional Assessment of Chronic Illness Therapy-Fatigue tool (37.6 vs 37.6, P = .965), the Functional Assessment of Cancer Therapy-Breast Cancer instrument (111.9 vs 110.4, P = .577), or the Center for Epidemiologic Studies-Depression scale (11.6 vs 12.3, P = .632). CONCLUSIONS: Supplementation with conventional doses of CoQ10 led to sustained increases in plasma CoQ10 levels but did not result in improved self-reported fatigue or QOL after 24 weeks of treatment.

Applying a conceptual model for examining health-related quality of life in long-term breast cancer survivors: CALGB study 79804.

OBJECTIVES: The Survivor's Health and Reaction study used a quality-of-life model adapted for cancer survivors by Dow and colleagues to identify factors related to global health-related quality of life (HRQL) and to document the prevalence of problems and health-oriented behaviors in a follow-up study of breast cancer patients who participated in CALGB 8541. METHODS: A total of 245 survivors (78% of those invited) who were 9.4-16.5 years post-diagnosis completed surveys that inquired about current HRQL, economic, spiritual, physical and psychosocial concerns, and health-oriented behaviors (e.g. smoking, exercise, and supplement use). A regression model was developed to examine factors related to global HRQL across all domains. RESULTS: The regression model revealed that decreased energy levels (odds ratio (OR)=1.05, 95% confidence interval (CI): 1.03, 1.07), having heart disease (OR=5.01, 95% CI: 1.39, 18.1), having two or more co-morbidities (OR=2.39, 95% CI: 1.10, 5.19), and lower social support (OR=1.03, 95% CI: 1.02, 1.05) were associated with lower global HRQL. Factors related to psychological, spiritual, and economic domains were not predictive of global HRQL. Regarding lifestyle changes, some women reported engaging in health-oriented behaviors since their cancer diagnosis, such as improving eating habits (54%), increasing exercise (32%), and reducing/quitting smoking (20%). The most prevalent problems reported by women at follow-up were menopausal symptoms (64%), such as hot flashes and vaginal dryness, osteoporosis (25%), and lymphedema (23%). CONCLUSION: Suggestions are provided to target interventions, such as provider-based strategies, in order to improve HRQL in long-term breast cancer survivors.

A Project Team Analysis Using Tuckman's Model of Small-Group Development.

BACKGROUND: Concerns about equitable workloads for nursing faculty have been well documented, yet a standardized system for workload management does not exist. A project team was challenged to establish an academic workload management system when two dissimilar universities were consolidated. METHOD: Tuckman's model of small-group development was used as the framework for the analysis of processes and effectiveness of a workload project team. Agendas, notes, and meeting minutes were used as the primary sources of information. RESULTS: Analysis revealed the challenges the team encountered. Utilization of a team charter was an effective tool in guiding the team to become a highly productive group. Lessons learned from the analysis are discussed. CONCLUSION: Guiding a diverse group into a highly productive team is complex. The use of Tuckman's model of small-group development provided a systematic mechanism to review and understand group processes and tasks. [J Nurs Educ. 2016;55(12):675-681.].

Cancer screening among Native Americans in eastern North Carolina.

The purpose of the study is to explore cancer screening predictors and practices among Lumbee Indians in eastern North Carolina. Interviewers from the community conducted phone interviews with 333 men and 456 women aged 40 and older randomly selected from the Lumbee Tribal roll as part of the Lumbee Diabetes and Health Survey. The survey has sections on demographic information and health conditions, family history of chronic conditions, and health behaviors. This paper reports on cancer screening behaviors. Rates of ever being screened for breast, cervical, prostate and colon cancer were relatively high compared with overall national rates. Predictors included younger age, better health, more education, and lifestyle factors such as engaging in regular physical activity and not smoking. Future research should focus on developing culturally appropriate campaigns to increase the frequency of cancer screening to conform to guidelines, and educational programs and interventions to reach Lumbee Indians most at risk for not being screened.

Reduction of 30-Day Preventable Pediatric Readmission Rates With Postdischarge Phone Calls Utilizing a Patient- and Family-Centered Care Approach.

INTRODUCTION: The purpose of this project was to evaluate the effectiveness of postdischarge phone calls on 30-day preventable readmission rates within the pediatric hospital setting. Because the unit of care identified was patients and their families, a patient- and family-centered care approach was used. METHOD: The project used an exploratory design and was conducted at a 154-bed pediatric hospital facility. A sample of 15 patients meeting project inclusion criteria was selected before and after the intervention, and medical records were reviewed to identify if a 30-day preventable readmission had occurred. RESULTS: Medical record review revealed four preintervention readmissions, providing an overall preintervention readmission rate of 26%. Only one readmission was discovered after the intervention, yielding an overall postintervention readmission rate of 6%. DISCUSSION: The sample size was not large enough to show statistical significance, but clinical significance was seen, with readmission rates for the project target population decreasing below the rates recorded in 2012.

Lymphedema: Knowledge, Treatment, and Impact Among Breast Cancer Survivors.

Lymphedema is an understudied consequence of surgery for breast cancer. It is estimated that as many as 60% of breast cancer survivors report symptoms of lymphedema. Few studies have examined the impact of lymphedema on the lives of women with breast cancer. The goal of this pilot study was to identify knowledge about, treatment received for, and the effect of lymphedema among a group of breast cancer survivors and physicians. Forty women with lymphedema and 10 physicians who treat breast cancer patients participated. Overall, women knew little to nothing about lymphedema before they developed it. After diagnosis, the primary source of information about lymphedema was a doctor or physical therapist. The majority of women received compressive garment therapy (75%), 46.9% received mechanical compressive therapy, 26% received bandaging, and 22% received physical therapy. More than half (55%) reported that clothing and appearance were affected by their condition and 48% reported that routine daily activities were impaired. Hot weather (58%) and regular arm use (40%) were reported to exacerbate the swelling. Most physicians reported that they did not routinely counsel women or provide written information on lymphedema prevention to their patients, and the extent to which women's daily living was affected by the condition was not always recognized. These findings have implications for interventions aimed at educating women and providers about lymphedema.

Increasing participation of minorities in cancer clinical trials: summary of the "Moving Beyond the Barriers" Conference in North Carolina.

A day-long seminar was held at Wake Forest University School of Medicine to address barriers among ethnic minorities in cancer clinical trials and explore ways that individuals who design and conduct clinical trials could increase minority representation. Speakers addressed implications of under-representation of minorities and identified barriers to minority participation. State-wide focus group results were presented and revealed suspicion of medical research among minorities and the need for bridging to minority communities to improve participation in cancer clinical trials. Working groups assembled and identified barriers specific to trial design, providers, and participants. Attendees were encouraged to devise strategies within their institutions to overcome barriers to minority participation.

Understanding biological safety.

A biocompatible device is one that can coexist with living tissue without causing harm. A lack of biocompatibility is usually caused by a chemical interaction between a reactive molecule in or on the device and the tissue with which it comes in contact (although tissue injury may also be caused by mechanical interaction). This article explains the causes and the effects of bioincompatibility.

Health-related quality of life in long-term breast cancer survivors: differences by adjuvant chemotherapy dose in Cancer and Leukemia Group B study 8541.

BACKGROUND: The Survivor's Health and Reaction (SHARE) study examined health-related quality of life (HRQL) in breast cancer patients who had participated in Cancer and Leukemia Group B Trial 8541 from 1985 to 1991. METHODS: In total, 245 survivors (78% of eligible patients) who were 9.4 to 16.5 years postdiagnosis (mean, 12.5 years postdiagnosis) completed HRQL surveys relating to 5 domains. Analyses examined HRQL domains according to 3 different chemotherapy dose levels that were administered in the original treatment trial: low-dose cyclophosphamide, doxorubicin, and fluorouracil (CAF) at 300 mg/m(2), 30 mg/m(2), and 300 x 2 mg/m(2), respectively, over 4 cycles; standard-dose CAF at 400 mg/m(2), 40 mg/m(2), and 400 x 2 mg/m(2), respectively, over 6 cycles; and high-dose CAF at 600 mg/m(2), 60 mg/m(2) and 600 x 2 mg/m(2), respectively, over 4 cycles. RESULTS: In univariate analyses, a statistically significant difference was observed on the Medical Outcomes Study 36-item short form Physical Role Functioning subscale by treatment group, with lower mean scores in the standard treatment arm (mean, 65.05) compared with mean scores in the low-dose arm (mean, 74.66) and the high-dose arm (mean, 84.94; P.0001). However, multivariate analysis revealed that treatment arm no longer was statistically significant, whereas the following factors were associated with decreased physical role functioning: age >or=60 years (odds ratio [OR], 3.55; P = .006), increased comorbidity interference total score (OR, 1.64; P = .005), lower vitality (OR, 1.05; P = .0002), and increased menopausal symptoms (OR, 1.04 P = .02). CONCLUSIONS: At 9.4-16.5 years after their original diagnosis, differences in physical role functioning among breast cancer survivors who had received 3 different dose levels of chemotherapy were explained by clinical and demographic variables, such as age, fatigue, menopausal symptoms, and comorbidities. Prospective studies are needed to further assess the role of these factors in explaining HRQL and physical role functioning among long-term survivors.

Economic outcomes of breast cancer survivorship: CALGB study 79804.

BACKGROUND: Over 80% of women diagnosed with breast cancer will be survivors. We sought to determine the economic consequences of surviving breast cancer. METHODS: Disease-free survivors who had received adjuvant chemotherapy for stage II breast cancer on CALGB study 8541 participated in a study of long-term outcomes. Survey responses were used to determine the types and frequency of medical resources used in follow-up, annual direct medical costs, and survivor perceptions of the personal economic impact of breast cancer. RESULTS: 245 of 314 (78%) invited breast cancer survivors (median follow-up 12.2 years, range 9.3-16.4) completed the surveys. Eighty-seven percent reported having cancer specialist follow-up in the past year. The following percentages of survivors reported having had, for breast cancer follow-up, at least once in the past year: breast examination 92%, mammogram 88%, bone scan 18%, chest radiograph 59%, tumor marker studies 37%. When follow-up care included a medical oncologist, resources were more likely to be used at least according to published follow-up guidelines, or over-used. Median annual cost of follow-up per survivor was US 630 dollars (range US 0-10,817 dollars) with higher costs associated with medical oncology follow-up, lower income, and younger age. Few women reported a negative impact of breast cancer on employment, but 16% reported being denied life insurance. CONCLUSIONS: Among long-term breast cancer survivors, patient self-report data suggest that over-use of medical resources for follow-up appears common. When follow-up care included a medical oncologist, resources were more likely to be used appropriately, or over-used. Costs of follow-up are higher with medical oncology follow-up, lower income and among younger survivors. The annual cost of follow-up varies widely and may be driven by over-use of follow-up tests.

Clinical trial enrollment of rural patients with cancer.

PURPOSE: The goal of this study was to examine the effect of a rural community clinical oncology program-based cancer-care intervention program that was launched to increase the number of rural patients with cancer enrolled in clinical trials. DESCRIPTION OF STUDY: Five rural counties in eastern North Carolina served as intervention communities, and five rural counties in South Carolina served as the comparison region. The intervention counties used a rapid tumor-reporting system, a nurse facilitator who identified and prompted oncologists to enter patients into clinical trials, a quarterly newsletter to primary-care physicians about cancer treatment and clinical trials, and a health educator who focused on community-wide education regarding cancer prevention, treatment, and clinical trial information. Outcomes included changes in knowledge and attitudes about clinical trials among the primary-care providers who were surveyed and enrollment in clinical treatment trials for breast and colorectal cancer, as analyzed by comparing practice pattern data from before and after the intervention. RESULTS: The results indicate that the intervention was not effective. The proportion of primary-care physicians who were aware of clinical trials for their patients with cancer rose slightly in comparison counties (26% to 34%) but remained constant (41% to 43%) in intervention counties. Perceived patient and actual physician barriers toward clinical trial participation were reported by the physicians. A minority of potentially eligible patients with breast or colon cancer in both North Carolina and South Carolina were enrolled in clinical trials. CLINICAL IMPLICATIONS: These data suggest that different types of interventions may be needed to improve accrual to cancer treatment trials in rural communities. In addition, the role that primary-care providers play in encouraging patients with cancer to participate in clinical treatment trials needs further exploration.