Linda Sarna

Quality of Life of Long-Term Survivors of Non–Small-Cell Lung Cancer

PURPOSE To describe the quality of life (QOL) among survivors of non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS One hundred forty-two 5-year minimum self-reported disease-free survivors of NSCLC completed QOL instruments (QOL-Survivor and Medical Outcomes Study 36-Item Short Form [SF-36]) and assessments of emotional distress (Center for Epidemiologic Studies Depression Scale [CES-D]), comorbid disease, and tobacco use. Pulmonary function was assessed with a hand-held spirometer. Multivariate regression methods were used on total QOL-Survivor scores and physical (PC) and mental (MC) component scores of the SF-36. RESULTS The majority (71%) of survivors described themselves as hopeful, and 50% viewed the cancer experience as contributing to positive life changes (QOL-Survivor). Comorbidity was common (60% >or= one condition); 22% had distressed mood (CES-D >or= 16). Most were former smokers (76%); 13% continued to smoke. Half had moderate/severe pulmonary distress (forced expired volume in 1 second [FEV1] < 70% of predicted). Regression models including the set of variables (age, sex, living alone, education, smoking status, pulmonary function category, distressed mood, time since diagnosis, and comorbidity) accounted for 37%, 48%, and 29% in the QOL-total, MC, and PC scores, respectively. Primary predictors of lower QOL scores were white ethnicity and distressed mood (CES-D >or= 16) (34% of the variance explained). The primary predictor of lower MC scores was distressed mood (R(2) = 0.45). Lower PC scores were associated with older age, living alone, FEV1 less than 70% of predicted, distressed mood, time since diagnosis, and more comorbid diseases (R(2) = 0.28). CONCLUSION These findings provide the first description of the QOL of long-term survivors of lung cancer. Risk factors for poorer QOL are strongly linked to distressed mood, which is a potential target for intervention.

Randomized trial of amifostine in locally advanced non-small-cell lung cancer patients receiving chemotherapy and hyperfractionated radiation: Radiation Therapy Oncology Group trial 98-01

PURPOSE To test the ability of the cytoprotectant, amifostine, to reduce chemoradiotherapy-induced esophagitis and evaluate its influence on quality of life (QOL) and swallowing symptoms. PATIENTS AND METHODS A total of 243 patients with stage II to IIIA/B non-small-cell lung cancer received induction paclitaxel 225 mg/m(2) intravenously (IV) days 1 and 22 and carboplatin area under the curve (AUC) days 1 and 22, followed by concurrent weekly paclitaxel (50 mg/m(2) IV) and carboplatin (AUC 2), and hyperfractionated radiation therapy (69.6 Gy at 1.2 Gy bid). Patients were randomly assigned at registration to amifostine (AM) 500 mg IV four times per week or no AM during chemoradiotherapy. Beyond standard toxicity end points, physician dysphagia logs (PDLs), daily patient swallowing diaries, and QOL (EORTC QLQ-C30/LC-13) were also collected. Swallowing AUC analyses were calculated from patient diaries and PDLs. RESULTS A total of 120 patients were randomly assigned to receive AM, and 122, to receive no AM (one patient was ineligible); 72% received AM per protocol or with a minor deviation. AM was associated with higher rates of acute nausea (P = .03), vomiting (P = .007), cardiovascular toxicity (P = .0001), and infection or febrile neutropenia (P = .03). The rate of >/= grade 3 esophagitis was 30% with AM versus 34% without AM (P = .9). Patient diaries demonstrated lower swallowing dysfunction AUC with amifostine (z test P = .025). QOL was not significantly different between the two arms, except for pain, which showed more clinically meaningful improvement and less deterioration at 6 weeks follow-up (v pretreatment) in the AM arm (P = .003). The median survival rates for both arms were comparable (AM, 17.3 v no AM, 17.9 months; P = .87). CONCLUSION AM did not significantly reduce esophagitis >/= grade 3 in patients receiving hyperfractionated radiation and chemotherapy. However, patient self-assessments suggested a possible advantage to AM that is being explored with modified dosing route strategies.

Smoking, the missing drug interaction in clinical trials: Ignoring the obvious

Tobacco use is universally recognized as the foremost preventable cause of cancer in the United States and globally and is responsible for 30% of all cancer-related deaths in the United States. Tobacco use, including exposure to secondhand smoke has been implicated as a causal or contributory agent in an ever-expanding list of cancers, including lung, oral cavity and pharynx, pancreas, liver, kidney, ureter, urinary bladder, uterine cervix, and myeloid leukemia. In addition to and independent of the etiologic effects of tobacco carcinogens in numerous cancers, there is a growing literature on the direct and indirect effects of smoking on treatment efficacy (short-term and long-term outcomes), toxicity and morbidity, quality of life (QOL), recurrence, second primary tumors (SPT), and survival time as summarized below. Oncology health professionals have called for increased advocacy for tobacco control. Despite the critical relevance of smoking to cancer outcomes, most oncology clinical trials do not collect data on smoking history and status unless the malignancy is widely acknowledged as smoking related (e.g., lung or head and neck cancer). Usually, these data are collected only at trial registration. Changes in smoking status during treatment or follow-up are monitored in very few trials and are infrequently reported in sample descriptions or included in analysis plans as a potential moderator of outcomes. Based on mounting evidence that tobacco use affects cancer treatment outcomes and survival, we recommend that smoking history and status be systematically collected as core data in all oncology clinical trials: at diagnosis, at trial registration, and throughout treatment and follow-up to long-term survival or death. We feel that the inclusion and analysis of such data in clinical trials will add important information to the interpretation of outcomes and the development of scientific knowledge in this area. Smoking status has been called another “vital sign” because of its relevance to a patients immediate medical condition. We explain the critical value of knowing the smoking status of every patient with cancer at every visit by providing a brief overview of the following research findings: (a) the effects of tobacco use on cancer treatment and outcome; (b) recent findings on the role of nicotine in malignant processes; (c) some unexpected results concerning tobacco status, treatment, and disease outcome; and (d) identifying key questions that remain to be addressed. We provide a suggested set of items for inclusion in clinical trial data sets that also are useful in clinical practice.

Dimensions of symptom distress in women with advanced lung cancer: A factor analysis

OBJECTIVE To explore the structure of symptom distress in women with advanced lung cancer. DESIGN Descriptive. SETTING Oncology clinics and private offices. SUBJECTS Sixty women with advanced lung cancer (71% non-small-cell); the majority received palliative treatment (88%). OUTCOME MEASURES Symptom Distress Scale and Karnofsky Performance Status Scale. METHOD Factor analytic techniques (principal components, varimax rotation) to investigate combinations of all symptoms in the Symptom Distress Scale and combinations of serious symptoms. RESULTS Fatigue, disruptions in outlook, frequent pain, and difficulties in sleeping were rated the most distressing and were the most prevalent serious disruptions. A four-factor solution for the symptom distress ratings explained 63.3% of the variance and revealed groups of items representing emotional and physical suffering, gastrointestinal distress, respiratory distress, and malaise. Symptoms with a rating of serious distress were represented by five factors with emotional and physical suffering as separate factors. Symptoms were significantly related to Karnofsky Performance Status. CONCLUSIONS Multiple symptoms formed distinct congregations of distress. Symptom control requires consideration as a multivariate approach.

Quality of Life Supersedes the Classic Prognosticators for Long-Term Survival in Locally Advanced Non–Small-Cell Lung Cancer: An Analysis of RTOG 9801

PURPOSE To determine the added value of quality of life (QOL) as a prognostic factor for overall survival (OS) in patients with locally advanced non-small-cell lung cancer (NSCLC) treated on Radiation Therapy Oncology Group RTOG-9801. PATIENTS AND METHODS Two hundred forty-three patients with stage II/IIIAB NSCLC received induction paclitaxel and carboplatin (PC) and then concurrent weekly PC and hyperfractionated radiation (to 69.6 Gy). Patients were randomly assigned to amifostine (AM) or no AM during chemoradiotherapy. The following pretreatment factors were analyzed as prognostic factors for OS: Karnofsky performance status, stage, sex, age, race, marital status, histology, tumor location, hemoglobin, tobacco use, treatment arm (AM v no AM) and QOL scores (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 [QLQ-C30] and Lung Cancer 13 [LC-13]). A multivariate (MVA) Cox proportional hazards model was performed using a backwards selection process. RESULTS Of the 239 analyzable patients, 91% had a baseline global QOL score. Median follow-up time was 59 months for patients still alive and 17 months for all patients. Median baseline QLQ-C30 global QOL score was 66.7 on both treatment arms. Whether the global QOL score was treated as a dichotomized variable (based on the median score) or a continuous variable, all other variables fell out of the MVA for OS. Patients with a global QOL score less than 66.7 had an approximately 70% higher rate of death than patients with scores > or = 66.7 (P = .004). A 10-point higher baseline global QOL score corresponded to a decrease in the hazard of death by approximately 10% (P = .004). The other independent QOL predictors for OS were the QLQ-C30 physical functioning (P = .011) and LC-13 dyspnea scores (P = .012). CONCLUSION In this analysis, baseline global QOL score replaced known prognostic factors as the sole predictor of long-term OS for patients with locally advanced NSCLC.

Quality of life and meaning of illness of women with lung cancer.

PURPOSE/OBJECTIVES To describe the quality of life (QOL) of women with non-small cell lung cancer (NSCLC) and examine relationships of demographic, clinical, health status, and meaning of illness (MOI) characteristics to QOL. DESIGN Descriptive, cross-sectional survey. SETTING In-person interviews in homes or research offices. SAMPLE 217 women with NSCLC (greater than 6 months and less than 5 years since diagnosis, mean = 2 years); 19% of the women had advanced disease. The mean age was 65 years. METHODS Assessments of QOL with cancer-specific (QOL Scale-Patient Version) and generic (Short Form-36) self-reports, health status (i.e., number and type of comorbid conditions, presence of depressed mood using the Center for Epidemiologic Studies Depression Scale, smoking status), and MOI (positive and negative perceptions). MAIN RESEARCH VARIABLES QOL, health status, MOI, and demographic and clinical characteristics. FINDINGS Serious disruptions in psychological and social aspects of QOL were common. Depressed mood, negative conceptualizations of MOI, and younger age explained 37% of the variance of global QOL and were correlated with poorer physical, psychological, and social dimensions of QOL. Thirty-six percent reported negative ascriptions of MOI; 35% experienced depressed mood; more than 75% reported distress with their diagnosis, family distress, and impact of sexual function as lowering their QOL; and 67% reported comorbid conditions, the most common being chronic obstructive pulmonary disease (31%). CONCLUSIONS Women with lung cancer experience a range of disruptions in QOL, and more than a third associate lung cancer with negative meaning. Younger age, depressed mood, and number of comorbid diseases are risk factors for negative QOL. IMPLICATIONS FOR NURSING These findings support the importance of assessing the QOL, MOI, and health status of women with lung cancer even after treatment is completed. Younger women may be at higher risk for disruptions.

Tobacco interventions by oncology nurses in clinical practice

Tobacco use is an important risk factor in cancer, cancer recurrence, and increased treatment morbidity, but limited information is available about interventions for tobacco cessation used in oncology clinical practice. In 1996, the Agency for Health Care Policy Research (AHCPR) published the first evidence‐based smoking cessation guideline for use by health professionals. Using the AHCPR guideline as a framework, the authors describe the frequency of tobacco interventions provided by oncology nurses.

Challenges of Recruitment and Retention in Multisite Clinical Research

This article reviews recruitment and retention issues in a multisite, multistate (California, New York, Connecticut, Georgia, Alabama) 6-month prospective cross-sectional study focused on quality of life among 230 women with lung cancer. Recruitment of women into clinical trials and their retention are important, yet understudied. To date, few articles have described the challenges associated with recruiting women with lung cancer to participate in clinical research. Data from this trial were used to investigate the most effective strategies for recruitment across sites, to identify the most common reasons for refusal and attrition, and to identify challenges and potential solutions to recruitment and retention issues associated with multisite clinical research studies. Strategies for recruitment included letters from physicians, posters, announcements in community support groups, and newspaper and radio advertisements. Three sites allowed the researchers to contact potential participants directly, whereas 2 sites required the potential participants to contact the researchers for further information. Enrollment included 63% of the women eligible for the study (n = 230). The most common reasons for refusal were health limitations (n = 60), lack of interest (n = 46), and inconvenience (n = 16). The most common reasons for attrition (24% of the sample) were death (n = 21) and severity of illness (n = 13). Challenges related to recruitment and retention varied by geographic location.

Women with lung cancer: impact on quality of life

The purpose of this study was to describe disruptions in quality of life (QOL) in women suffering from lung cancer, the leading cause of cancer-related death in the United States. QOL was measured with the CARES-SF. Symptom distress was measured with the modified Symptom Distress Scale, and functional status was measured with the Karnofsky Performance Status Scale. Sixty-nine women with lung cancer participated in a one-time data collection. The typical subject was under 65 years of age, married, has had primary or recurrent non-small cell lung cancer for over 12 months, had limited disease, and was not currently receiving treatment. Subjects had greater disruptions in global QOL and its dimensions compared to a normative heterogeneous female cancer sample. The most prevalent serious disruptions were fatigue, difficulty with household chores, worry about ability to care for self, and worry about cancer progression. The global CARES-SF score was moderately correlated to functional status (r=0.69,p=<0.001), and to symptom distress (r=0.72,p=<0.001). Symptom distress was associated strongly with the physical subscale of QOL (r=0.80,p=0.001) and significantly but less strongly with all other dimensions of QOL. Significantly greater differences in disruptions of quality of life occurred in women younger than 65 years (p=0.04), women with recurrent disease (p=0.003), and women with low income (p=0.008). In stepwise regression, symptom distress predicted 53% of the variance followed by functional status (59%) and recurrence (63%) when QOL was the outcome variable.

Smoking cessation is challenging even for patients recovering from lung cancer surgery with curative intent

BACKGROUND Although it is recommended that smokers undergoing surgery for lung cancer quit smoking to reduce post-operative complications, few studies have examined patterns of smoking in the peri-operative period. The goals of this study were to determine: (1) patterns of smoking during post-operative recovery, (2) types of cessation strategies used to quit smoking, and (3) factors related to smoking after lung cancer surgery. METHODS Data were collected from 94 patients through chart review, tobacco, health status, and symptom questionnaires at 1, 2, and 4 months after surgery. Smoking status was assessed through self-report and urinary cotinine measurement. RESULTS Eighty-four patients (89%) were ever-smokers and 35 (37%) reported smoking at diagnosis. Thirty-nine (46%) ever-smokers remained abstinent, 13 (16%) continued smoking at all time-points, and 32 (38%) relapsed. Ten (46%) of those who relapsed were former-smokers and had not smoked for at least 1 year. Sixteen (46%) of those who were smoking at diagnosis received cessation assistance with pharmacotherapy being the most common strategy. Factors associated with smoking during recovery were younger age and quitting smoking < or =6 months before the diagnosis of lung cancer. Factors that were marginally significant were lower educational level, male gender, lower number of comorbidities, and the presence of pain. CONCLUSION Only half of those who were smoking received assistance to quit prior to surgery. Some patients were unable to quit and relapse rates post-surgery were high even among those who quit more than 1 year prior. Innovative programs incorporating symptom management and relapse prevention may enhance smoking abstinence during post-operative care.