A retrospective study of quality of life in a community sample of patients with early stage breast cancer.

Few studies have examined the pattern of change in quality of life (QoL) over time among patients with breast cancer, or the impact of disease recurrence on QoL. This retrospective study examined QoL among patients with stage I-IIIB breast cancer. Individual, disease and treatment characteristics were abstracted from the medical record, and linked with QoL data collected as a routine part of patient care. The sample included patients with nonrecurrent (N = 100) and recurrent (N = 19) disease, who completed 1,449 QoL assessments. Linear mixed model analysis showed that disease recurrence significantly and adversely affected QoL across all domains. QoL did not appear to deteriorate before recurrence. The pattern of adjustment after recurrence varied across QoL domains in theoretically consistent ways. Study findings suggest that patients show improvement in some areas after recurrence, but generally do not recover previous levels of QoL.

The AIM Higher Initiative: new procedures implemented for assessment, information, and management of chemotherapy toxicities in community oncology clinics.

Chemotherapy-related toxicities are common and often undertreated in routine cancer care. Initiatives to improve toxicity management in practices may not always be effective. Quality improvement programs must engage multiple disciplines of the healthcare team and sustain efforts to institute and maintain procedures that address practice needs. The Assessment, Information, and Management (AIM) Higher Initiative, a quality improvement program undertaken at 15 community oncology practices, was initiated to improve the AIM of chemotherapy-related toxicities in patients with cancer. AIM Higher focuses on improving five chemotherapy-related toxicities: neutropenia, anemia, depression and anxiety, diarrhea and constipation, and nausea and vomiting. Led by a nurse champion at each of the clinics, a variety of new procedures, processes, and tools were implemented to improve quality of care. Nurses and practice administrators can use the quality improvement processes to generate changes in procedures and practices.

A prospective investigation of chemotherapy-induced neutropenia and quality of life.

This prospective study of chemotherapy-induced neutropenia (CIN) explored the association between the relative grade of neutropenia and symptom burden and quality of life (QOL). Eighty-four adult cancer patients from nine community oncology centers receiving 1 of 13 myelosuppressive chemotherapies were evaluated at days 0, 4, 7, 9, 11, 14, and 21 of their respective first cycle. Neutropenia grade (grade 3/4 vs grades 0 to 2) was determined by serial absolute neutrophil count (ANC) measures. Measures of patient-reported outcomes included the Rotterdam Symptom Checklist (RSCL), Hospital Anxiety and Depression Scale (HADS), Cancer Care Monitor-Medical Isolation Scale (CCM-MIS), and SF-36. Changes in outcomes from baseline to highest grade of neutropenia were evaluated using mixed model-repeated measures for each of 15 outcomes. Compared with grades 0-2, grade 3/4 neutropenia was associated with greater symptom burden and worse QOL for six measures (P < 0.05). The pattern of differences suggested that measures of symptom distress and social functioning were sensitive to patient changes associated with grade 3/4 neutropenia. Worsening of symptom burden and QOL appears to be associated with severe afebrile neutropenia. A causal relationship between neutropenia and worse symptoms and QOL remains difficult to establish due to the confounding of the effects of neutropenia with other adverse effects of chemotherapy.

Experiencing neutropenia: quality of life interviews with adult cancer patients.

BACKGROUND: Neutropenia is a common toxicity in chemotherapy but detailed information about how neutropenia is associated with changes in patients' quality of life is not readily available. This prospective study interviewed patients with grade 4 neutropenia to provide qualitative information on patients' experience of developing and coping with grade 4 neutropenia during a cycle of chemotherapy. METHODS: A sample of 34 patients who developed grade 4 neutropenia during the first cycle of chemotherapy completed a total of 100 structured clinical interviews. Interviews were transcribed, and 2 raters inductively developed 5 broad categories comprising 80 specific complaint domains nominated by patients. Thirty-five patient-nominated problems were mentioned in 5% or more of the interviews. RESULTS: Fatigue was the most common physical symptom. Interference in daily routine, negative self-evaluation, negative emotion, and social isolation were other common complaints associated with neutropenia. CONCLUSION: Neutropenia is associated with a number of negative experiences among cancer patients undergoing chemotherapy, and these negative experiences have an adverse effect on the patient's quality of life. Oncology nurses can play a key role in helping patients manage adverse effects to maintain their quality of life.

Medical visits for chemotherapy and chemotherapy-induced neutropenia: a survey of the impact on patient time and activities.

BACKGROUND: Patients with cancer must make frequent visits to the clinic not only for chemotherapy but also for the management of treatment-related adverse effects. Neutropenia, the most common dose-limiting toxicity of myelosuppressive chemotherapy, has substantial clinical and economic consequences. Colony-stimulating factors such as filgrastim and pegfilgrastim can reduce the incidence of neutropenia, but the clinic visits for these treatments can disrupt patients' routines and activities. METHODS: We surveyed patients to assess how clinic visits for treatment with chemotherapy and the management of neutropenia affect their time and activities. RESULTS: The mean amounts of time affected by these visits ranged from approximately 109 hours (hospitalization for neutropenia) and 8 hours (physician and chemotherapy) to less than 3 hours (laboratory and treatment with filgrastim or pegfilgrastim). The visits for filgrastim or pegfilgrastim were comparable in length, but treatment with filgrastim requires several visits per chemotherapy cycle and treatment with pegfilgrastim requires only 1 visit. CONCLUSIONS: This study provides useful information for future modelling of additional factors such as disease status and chemotherapy schedule and provides information that should be considered in managing chemotherapy-induced neutropenia.

A survey of pain-related hospitalizations, emergency department visits, and physician office visits reported by cancer patients with and without history of breakthrough pain.

Pain is a common problem for cancer patients and can result in substantial medical costs, but little is known about the characteristics of pain that may predict these costs. This study applied telephone survey methodology to investigate the relationship between breakthrough pain (BTP) and the use of medical resources in a cancer population with pain. A nonrandom sample of 1,000 cancer patients was contacted by using standard telephone survey techniques. Eligible patients were questioned about the occurrence of BTP and pain-related hospitalizations, emergency department visits, and physician office visits. Patients who indicated that they had experienced BTP were compared with similar patients who had not experienced BTP by using cost estimations derived from patient reports of health care use. The analysis indicated that BTP patients were more likely to have experienced pain-related hospitalizations and physician office visits. When statistical control was made for patient ratings of the effectiveness of scheduled analgesics, BTP had higher costs associated with pain-related hospitalizations and physician office visits. The total cost of pain-related hospitalizations, emergency visits, and physician office visits was 12,000 US dollars/yr per BTP patient and 2,400 US dollars/yr per non-BTP patient. Cancer patients with BTP may sustain higher direct medical costs than patients without BTP. Implications and limitations of the study are discussed, and studies that will further clarify the relationship between BTP and medical costs are encouraged.

Sleep and quality of life in breast cancer patients.

This study described sleep in a heterogeneous sample of breast cancer patients using the Pittsburgh Sleep Quality Index (PSQI) and examined the relation between sleep disturbance and health-related quality of life as measured by the Rand 36-Item Health Survey. Chemotherapy and radiation therapy were explored as predictors of sleep disturbance in breast cancer patients, and the sleep characteristics of breast cancer patients were compared to the sleep characteristics of a sample of medical patients with general medical conditions. Results showed that 61% of breast cancer patients had significant sleep problems. Sleep was characterized by reduced total sleep time with sleep frequently being disturbed by pain, nocturia, feeling too hot, and coughing or snoring loudly. Despite the frequency of significant sleep disturbance, pharmacological and cognitive-behavioral treatments of sleep problems were observed to be inadequate. Limited evidence was found for the role of chemotherapy and radiation therapy in the sleep disturbance of breast cancer patients, and the general pattern of sleep disturbance in breast cancer patients was not significantly different than that observed in medical patients with general medical conditions. Breast cancer patients having significant sleep problems had greater deficits in many areas of health-related quality of life. The implications of the findings and study limitations are discussed.

Description and predictors of direct and indirect costs of pain reported by cancer patients.

The purpose of this study was to describe direct and indirect costs associated with pain in cancer patients and to examine potential predictors of these costs. The study surveyed cancer outpatients about direct costs resulting from pain-related hospitalizations, emergency department visits, physician office visits, and use of analgesic medications and indirect costs related to money spent on pain-related transportation, complementary methods to improve pain management, educational materials, over-the counter medication, domestic support, and childcare. Furthermore, the study examined age, marital status, race, income level, pain severity, pain interference, and presence of breakthrough pain as predictors of direct and indirect costs. Three hundred and seventy-three cancer outpatients were sampled. One hundred and forty-four cancer patients (39%) reported experiencing cancer-related pain and completed the study questionnaires. Seventy-six percent (76%) of the patients had experienced at least one pain-related cost, resulting in an average monthly direct cost of US$ 891/month per patient. Sixty-nine percent (69%) of patients had experienced some type of direct medical cost due to pain, resulting in an average total direct pain-related cost of US$ 825/month per patient. Fifty-seven percent (57%) of patients reported incurring at least one indirect pain-related expense for an average indirect cost of US$ 61/month per patient. Higher pain intensity, greater pain interference, and presence of breakthrough pain predicted higher direct and indirect medical expenses. Younger age and lower income level also predicted higher direct medical expenses.

The Zero Acceptance of Pain (ZAP) Quality Improvement Project: evaluation of pain severity, pain interference, global quality of life, and pain-related costs.

The Zero Acceptance of Pain (ZAP) Quality Improvement Project was a multi-site effort to improve the lives of outpatients with cancer pain by enhancing the clinical practice of pain assessment and management. Independent samples of patients completed self-report measures of severity of pain, pain interference, global quality of life, pain treatment satisfaction, general medical treatment satisfaction, pain attitudes, and pain-related medical costs before and after the implementation of ZAP. Results suggested that ZAP decreased the severity of recent pain, decreased interference of pain on daily functioning, and improved satisfaction with pain treatment and attitudes about addiction to opioid medication. Direct medical costs consisting of pain-related hospitalizations, emergency department visits, and physician office visits were greatly reduced. In summary, the findings of this study support the idea that clinic-based efforts to improve the practice of pain management are effective in improving the lives of cancer patients who are experiencing pain.

Implications of IV monoclonal antibody infusion reaction for the patient, caregiver, and practice: results of a multicenter study.

GOALS OF WORK: Targeted monoclonal antibodies (MoAbs) have become a promising treatment option for patients with cancer. However, there is a risk of developing infusion reactions (IRs) with MoAbs. This study was conducted to evaluate the impact of IRs on staff time and costs among patients receiving an initial infusion of cetuximab (Erbitux) and rituximab (Rituxan). PATIENTS AND METHODS: A prospective multicenter study involving time and motion and activity sampling methods was conducted among patients with cancer receiving their first outpatient infusion of cetuximab or rituximab. Patients were observed from initiation of MoAb infusion to the end of the clinic visit. IRs were classified as absent, mild/moderate, and severe/life threatening. Staff time and costs were estimated for preparation and administration of MoAb, other chemotherapy agents, and for management of IRs. Resource costs were compared across IR groups within each MoAb. MAIN RESULTS: Among 161 patients enrolled, 32% of 71 patients on cetuximab and 39% of 90 patients on rituximab experienced IRs. Treatment of patients who experienced IRs required more staff time (31-80% more time) and resulted in higher human resource costs (increase of 17-65 US dollars) than patients who did not experience IRs. CONCLUSIONS: IRs following cetuximab and rituximab administration are common and are associated with measurably increased costs of care. The frequency of IRs suggests the importance of identifying clinical guidelines for intervention and management.

A health economic model of breakthrough pain.

Although the literature adequately addresses the biologic basis, epidemiology, and management of breakthrough pain (BTP), it does not yet describe the full impact of this troubling, widespread phenomenon. The risks of a scanty understanding of BTP impact are failure to take preventive measures, underdiagnosis, undertreatment, and inappropriate management. Studies to date of the impact of BTP have followed pharmacoeconomic approaches. Building on prior efforts, this paper develops a more comprehensive health economic model that encompasses the full spectrum of costs, outcomes, risks and benefits associated with BTP and its management. The authors provide a rubric within which stakeholders--including providers, institutional leaders, administrators, and policymakers--can systematically balance the myriad potential effects of different treatment scenarios to guide decision-making. The paper then extends this model to the population level, providing a template for health economic analysis of alternate strategies for managing BTP, and delineating steps for accomplishing the analysis.

Retrospective chart review of severe infusion reactions with rituximab, cetuximab, and bevacizumab in community oncology practices: assessment of clinical consequences.

GOALS OF WORK: Monoclonal antibody (MoAb) treatments can result in severe infusion reactions. Managing infusion reactions in the outpatient setting introduces clinical and resource challenges for patients and providers, but there is little information regarding prevention, management, or outcomes of severe infusion reactions. This study represents one of the first attempts to describe the clinical consequences of severe infusion reactions associated with MoAb treatment. MATERIALS AND METHODS: Clinic staff identified adults treated with rituximab, cetuximab, or bevacizumab who experienced a grade 3 or higher (severe) infusion reaction. Chart reviews from 19 oncology practice sites across the USA captured patient demographics, infusion reaction management procedures, and clinical outcomes. MAIN RESULTS: With an average age of 62 years, the sample comprised of 76 patients who experienced a severe infusion reaction while receiving rituximab (n = 47), cetuximab (n = 24), and bevacizumab (n = 5). The most common pretreatment medications were acetaminophen and antihistamine in the rituximab group and corticosteroids (42%) in the cetuximab group. All cetuximab and the majority of rituximab severe infusion reactions occurred during the first cycle of therapy. Postinfusion reaction management typically included corticosteroids, oxygen, and intravenous fluids. Overall, 22% were hospitalized for a mean of 4 days (range = 2.0 to 6.0 days). Permanent discontinuation of MoAb therapy occurred after the majority of cetuximab (79 to 100%) related severe infusion reactions. CONCLUSIONS: Severe infusion reactions are intensive events that present a serious challenge to patients and oncology practices. Efforts to prevent or reduce such reactions could be of great benefit.

Symptom Burden for Patients with Metastatic Colorectal Cancer Treated with First-Line FOLFOX or FOLFIRI with and Without Bevacizumab in the Community Setting.

BACKGROUND: FOLFOX (oxaliplatin/leucovorin/5-fluorouracil) and FOLFIRI (irinotecan/leucovorin/5-fluorouracil) with or without bevacizumab have become standard-of-care regimens in first-line treatment of metastatic colorectal cancer. However, there is a paucity of symptom burden information regarding these regimens from the patient perspective in community oncology. PATIENTS AND METHODS: This retrospective chart review and telephone interview study examined patients with first-line metastatic colorectal cancer from 5 community oncology centers treated with FOLFOX or FOLFIRI with and without bevacizumab. Patientreported outcomes were taken from the Patient Care Monitor 1.0 Revised, a validated tablet computer-based questionnaire that measures symptom burden and several scales of functioning and quality of life. A subset of patients completed structured telephone interviews about the impact of treatment on practical activities and income. RESULTS: Eighty-eight patients with an average age of 62 years were included. Patients completed a median of 8 cycles of treatment. The most common moderate to severe symptom complaint was fatigue. Gastrointestinal symptoms were common but did not cluster in one regimen versus another. Neuropathyrelated symptoms were also common across all regimens except FOLFIRI without bevacizumab. Nausea and neutropenia were common indications for concomitant medications. One third reported work and other activity interference, and care produced outof- pocket expenditures in excess of $1000. CONCLUSION: Although sample size was small in the FOLFIRI-based regimens, patient reports and chart records suggested that there was not a systematic difference between FOLFOX and FOLFIRI regimens in type of symptom. The addition of bevacizumab did not appear to increase symptom burden.

Greater physical and psychological symptom burden in patients with grade 3/4 chemotherapy-induced neutropenia.

BACKGROUND: Neutropenia is a common toxicity caused by chemotherapy that can lead to febrile neutropenia, infection, and dose reductions or delays that can diminish the efficacy of treatment. The relationship between chemotherapy-induced neutropenia and symptom burden is less well known. Recent data show a trend toward a greater incidence, duration, and severity of other toxicities of chemotherapy in patients with grade 4 neutropenia. PATIENTS AND METHODS: This retrospective study examined the relationship between symptom burden and neutropenia in the first cycle of chemotherapy, using the Cancer Care Monitor (CCM) to evaluate symptom burden in 5 domains: Physical Symptoms, Side Effects, Distress, Despair, and Neutropenia Index. Data were collected from the medical records of 51 adult patients with cancer who had been treated with standard 21-day regimens without granulocyte colony-stimulating factor support. Patients had been assessed before treatment and at midcycle (days 6-14) for complete blood cell count and symptom burden. RESULTS: The symptom burden in all 5 CCM domains was greater in patients with grade 3 (n = 8) or grade 4 (n = 16) neutropenia at midcycle than in patients with grade 0-2 neutropenia. Age, chemotherapy regimen or dose, and day of midcycle assessment were not significantly correlated with the severity of symptoms. CONCLUSION: Understanding the relationship between symptom burden and chemotherapy-induced neutropenia can lead to more appropriate use of supportive care in patients treated with chemotherapy.

Patient and caregiver time burden associated with anaemia treatment in different patient populations.

GOALS: Cancer patients treated with chemotherapy often develop anaemia. This cross-sectional analysis examined the effect of anaemia treatment on patient and caregiver time and activities. MATERIALS AND METHODS: The analysis included 9,920 patients from 646 US outpatient oncology centres. Patients completed a survey that contained questions about travel time, total time for the visit and other impacts. RESULTS: The mean time taken for a single clinic visit to receive anaemia treatment was 2.2 h. On average, patients receiving epoetin alfa required 17.6 h more than patients receiving darbepoetin alfa to complete a course of anaemia treatment. All patients in the study reported that they had to adjust at least one activity as a result of clinic visits. Older patients, women and patients from low-income areas were more likely to be accompanied during clinic visits. CONCLUSIONS: Reducing the number of clinic visits needed for anaemia treatment by using darbepoetin alfa may benefit patients.

Sex differences in patients who have cancer with mild anemia: symptom burden and quality of life.

The same criterion for mild anemia (10 < hemoglobin [Hgb]<12 g/dL) has been used for male and female patients. Mild anemia is associated with greater symptom burden and reduced quality of life (QOL). We compared male and female patients who have mild anemia with each other and with their respective normal groups. Patients (N = 3553) from a community oncology database were sorted by sex and Hgb level into 3 anemic and 2 normal groups: men with 10 /= 14 g/dL, and women with Hgb >/= 12 g/dL. Patients receiving chemotherapy (< 30 days) and/or growth factor (< 60 days) were excluded. Each case provided same-day scores on the Cancer Care Monitor, a validated measure of symptom burden, functioning, and health-related QOL comprising 7 scales. Compared with respective normal groups, male and female patients with mild anemia showed greater symptom burden, lower functioning, and worse QOL (P <0.05). Compared with normal men and women, patients with mild anemia showed clinically significant differences in terms of effect size (Cohen's d, 0.11- 0.91). Men with 10

Impact of chemotherapy-induced neutropenia on quality of life: a prospective pilot investigation.

PURPOSE: In this exploratory, prospective study evaluated quality of life (QoL) changes in patients with diverse cancers during the first cycle of myelosuppressive chemotherapy. PATIENTS AND METHODS: Of 80 patients enrolled, 71 were observed during one of five chemotherapy regimens: docetaxel; CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone); carboplatin-paclitaxel; carboplatin-docetaxel; and carboplatin-gemcitabine. Complete blood counts were taken weekly. QoL and symptom burden measures were administered at baseline and throughout the cycle, and included SF-36, Cancer Care Monitor (CCM), Hospital Anxiety and Depression Scale (HADS), and Psychosocial Adjustment to Illness Scale (PAIS). Using generalized estimating equations, we modeled the change in each measure from baseline to the end of each week using the following covariates: baseline QoL measure, baseline SF-36 Physical and Mental Health Summary scores, sex, age, cycle week, grade 4 neutropenia any time in the past 7 days (yes/no), and the interaction of the latter two covariates. RESULTS: Of the 71 patients observed, 33 developed grade 4 neutropenia during the first 2 weeks. Changes from baseline in SF-36 Bodily Pain, HADS Anxiety, and PAIS Social Environment scores were significantly less favorable (P<0.05) when patients experienced grade 4 neutropenia any time in the past 7 days compared to when they did not (grade 0-3). A similar, but non-significant, trend was also observed for 12 other QoL measures. CONCLUSION: QoL may be adversely affected up to 7 days after patients experience grade 4 (versus grade 0-3) neutropenia. Such findings need to be examined further in studies with adequate statistical power to test a priori hypotheses regarding specific QoL measures.