A randomized trial of the electronic Lung Cancer Symptom Scale for quality-of-life assessment in patients with advanced non-small-cell lung cancer.

Introduction: Improving health-related quality of life (hrqol) is a key goal of systemic therapy in advanced lung cancer, although routine assessment remains challenging. We analyzed the impact of a real-time electronic hrqol tool, the electronic Lung Cancer Symptom Scale (elcss-ql), on palliative care (pc) referral rates, patterns of chemotherapy treatment, and use of other supportive interventions in patients with advanced non-small-cell lung cancer (nsclc) receiving first-line chemotherapy. Methods: Patients with advanced nsclc starting first-line chemotherapy were randomized to their oncologist receiving or not receiving their elcss-ql data before each clinic visit. Patients completed the elcss-ql at baseline, before each chemotherapy cycle, and at subsequent follow-up visits until disease progression. Prospective data about the pc referral rate, hrqol, and use of other supportive interventions were collected. Results: For the 95 patients with advanced nsclc who participated, oncologists received real-time elcss-ql data for 44 (elcss-ql arm) and standard clinical assessment alone for 51 (standard arm). The primary endpoint, the pc referral rate, was numerically higher, but statistically similar, for patients in the elcss-ql and standard arms. The hrqol scores over time were not significantly different between the two study arms. Conclusions: The elcss-ql is feasible as a tool for use in routine clinical practice, although no statistically significant effect of its use was demonstrated in our study. Improving access to supportive care through the collection of patient-reported outcomes and hrqol should be an important component of care for patients with advanced lung cancer.

Factors related to decision making and substance use in adolescent survivors of childhood cancer: a presenting clinical profile.

BACKGROUND: Adolescent survivors of childhood cancer are more vulnerable to the consequences of health risk behaviors because of the late effects of their disease and its treatment. Decision making related to risk behaviors is important as they have reached an age during which initiation of substance use risk behavior is common. OBJECTIVE: Factors associated with decision making and substance use behaviors (smoking, alcohol use, and illicit drug use) were identified among adolescent survivors of childhood cancer, the role of cognitive function was examined, and their rates of substance use behaviors were compared to a sample from the general population. METHODS: A cohort of 243 adolescent survivors, ages 14-19 years, participated who were recruited from three cancer centers (St. Jude Children's Research Hospital, Hackensack University, and Long Beach Medical Center). A cross-sectional survey was used to assess cognitive and psychosocial factors for a presenting clinical profile to predict quality decision making and substance use behaviors. Validated measures using online data entry were obtained at the time of their annual visit for evaluation of late effects of treatment. Cancer and treatment factors were abstracted from the medical record. Eight factors (nine for substance use risk behavior) were examined in two regression models, quality decision making and substance use. RESULTS: In the model to predict poor-quality decision making for this cohort, gender and risk motivation (a surrogate for resiliency to social influence) were each significant predictors, with male gender and less resiliency each associated with poor decision making. Significant predictors of lifetime substance use were older presenting age, lower resiliency to social influence, poorer abstract ability (representing executive function impairment), history of current school problems, and negative substance use risk behavior modeling by household members and closest friend; CNS-associated late effects were only marginally associated. For current substance use, three factors remained significant in this cohort: older presenting age, lower resiliency, and negative risk behavior modeling. IMPLICATIONS FOR CANCER SURVIVORS: Study results characterize a presenting clinical profile for adolescent survivors with poor-quality decision making regarding substance use risk behaviors that will be helpful to health professionals counseling teen survivors about the impact of risk behaviors on disease-and treatment-related late effects.

A comparison of visual analogue and numerical rating scale formats for the Lung Cancer Symptom Scale (LCSS): does format affect patient ratings of symptoms and quality of life?

PROBLEM AND PURPOSE: The Lung Cancer Symptom Scale (LCSS), a site-specific health-related quality of life measure for patients with lung cancer, was originally developed using a Visual Analogue Scale (VAS) format. However, the VAS format is not readily compatible with data management and software programs using scanning. The primary aim of this study was to evaluate the convergence of ratings obtained with a Numerical Rating Scale (NRS), with an 11-pt response category format, to those obtained with a VAS format. The intent was to determine the degree of agreement between two formats to generalize the existing psychometric properties for the original measure to the new presentation. DESIGN/SETTING: This methodological study evaluated the feasibility, reliability, and validity of a NRS format for the LCSS. The study was conducted at two cancer centers in New York City. PATIENTS/PROCEDURES: Sixty-eight patients with non-small cell lung cancer (NSCLC) completed both versions of the LCSS along with demographic and feasibility questions on a single occasion. The VAS form was administered first, followed by the NRS form to prevent bias. The intraclass correlation coefficient (ICC), Lin's concordance correlation coefficient (CCC), and Bland-Altman plots were used to evaluate agreement and to characterize bias. RESULTS: Cronbach's alpha for the NRS format total score was 0.89 for the 68 patients with NSCLC. Agreement was excellent, with both the ICC and CCC > or = 0.90 for the two summary scores (total score and average symptom burden index) for the LCSS. Only five of the nine individual items showed this level of strict agreement. An agreement criterion of > or = 0.80 (representing excellent) was observed for seven of the nine individual items (all but appetite loss and hemoptysis). Mean differences tended to be slightly lower for the VAS format compared to the NRS format (more so for the appetite and hemoptysis items), with evidence of scale shift for the same two items. The summary measures showed good concordance as measured by the ICC and CCC, but did display mean differences (VAS - NRS) of -2.7 and -3.1, respectively. CONCLUSIONS: Overall, the NRS format for the LCSS suitable for scanning has good feasibility, reliability (internal consistency), and convergent validity. The complete set of concordance evaluation measures supports the reproducibility of VAS scores by NRS scores, particularly for the two summary scores.

The relationship of resiliency to decision making and risk behaviors of cancer-surviving adolescents.

Adolescents with a history of cancer frequently engage in risk behaviors. The purpose of this correlational study was to explore factors that affect decision making and risk behaviors (smoking, alcohol use, and illicit drug use) of cancer-surviving adolescents. A sample of 52 teen survivors participated at two cancer centers. In addition to a medical record review and IQ testing, several psychosocial measures were administered in a semistructured interview with the teen survivor. Three antecedent factors (cognitive function, resiliency, and role modeling of risk behaviors by parents and peers) were examined in a hierarchical regression model to predict decision making. These same factors, with an additional mediating variable (decision making), were examined in a hierarchical logistic regression model to predict risk behaviors in teen survivors. In the decision-making model, adjusted for demographic covariates, resiliency was a marginally significant predictor of decision making. As non-resiliency increases, quality of decision making may decrease for teen survivors. In the model to predict risk behaviors, four factors (cognitive function, resiliency, role modeling, and decision making) were added to the basic model, controlling for the same covariates. Resiliency and decision making were highly significant predictors of one or more risk behaviors. Non-resilient teen survivors with poor-quality decision making are more likely to engage in risk behaviors of substance use and need intervention that is aimed at improving decision-making skills to reduce these behaviors.

A clinical profile to predict decision making, risk behaviors, clinical status, and health-related quality of life for cancer-surviving adolescents: part 2.

This is the second part of a two-part article describing a multifactorial model of clinical factors predicting decision-making quality, risk behaviors, clinical status, and health-related quality of life for cancer-surviving adolescents. To support the conceptualization of the model, findings from the literature and from the research program of the current author are presented. In part 1, support for the antecedent predictors, both primary and secondary factors, was presented. In part 2, the mediator of decision making, the moderator of risk motivation, and the expected outcomes related to risk behaviors, clinical status, and health-related quality of life are addressed. Besides a description supporting the second part of the clinical profile and its empirical underpinnings in part 2, methodologic challenges in future research and implications for clinical trials and clinical use specific to cancer-surviving adolescents also are discussed.

A clinical profile to predict decision making, risk behaviors, clinical status, and health-related quality of life for cancer-surviving adolescents. Part 1.

The purpose of this two-part series is to describe a multifactorial model of clinical factors predicting decision-making quality, risk behaviors, clinical status, and health-related quality of life for cancer-surviving adolescents. This model was developed as a clinical profile to help health professionals in better identifying cancer-surviving adolescents at highest risk for substance use. Findings in the literature and results from the program of research by the author are presented to support the conceptualization of the model. In part 1, support for the antecedent predictors, both primary and secondary factors, is presented. Part 2 addresses decision making as a mediator, risk motivation as a moderator, and the expected outcomes related to risk behaviors, clinical status, and quality of life. In addition to describing the first part of the clinical profile in part 1, the background, theoretical basis of the model, and definitions of the model constructs also are provided.

Normative data and trends in quality of life from the Lung Cancer Symptom Scale (LCSS).

Normative data and trends for a disease- and site-specific quality of life (QL) instrument for individuals with lung cancer, the Lung Cancer Symptom Scale (LCSS), are presented to facilitate the user's interpretation of test scores. Data for patients enrolled in two large, identical, randomized trials of a new combination chemotherapy regimen for patients with stages III and IV non-small-cell lung cancer (NSCLC) were combined into one dataset (n = 673). For these patients with a Karnofsky performance status (KPS) of 60-100%, QL had been prospectively measured at baseline, day 29 and every 6 weeks thereafter. Descriptive statistics for the LCSS are presented for three time points (baseline, day 29 and day 71) and for specific demographic and disease-related characteristics (age, gender, race, performance status and stage of disease) to provide expected values and their variability during chemotherapy. Data from a small dataset of 63 NSCLC inpatients with KPS scores of 20-50% are also presented for a comparison sample of supportive care for inpatients and hospice patients. For the 673 NSCLC patients at baseline there were no significant differences in QL by age, gender, or race. Major presenting lung cancer symptoms at baseline for this combined sample were dyspnea 87%, cough 86%, pain 81%, loss of appetite 75%, and hemoptysis 41%. Of these patients, 81% had three or more presenting symptoms at baseline (2% had no symptoms; 5%, one symptom; 12%, two symptoms; 18%, three symptoms; 27%, four symptoms; and 36%, five symptoms). The mean LCSS baseline score (best = 0; worst = 100) was 26.56 (SD 16.10). The mean scores for day 29 and day 71 were 25.46 (SD 16.52) and 25.30 (SD 16.93), respectively, but follow-up assessments on progressers were not obtained. Stage III patients had a mean LCSS score of 23.7 (SD 15.1), whereas stage IV patients reported a mean LCSS score of 27.3 (SD 16.3). The mean LCSS score for the group with KPS 60-70% was 34.8 (SD 15.5), and that for the group with KPS 80-100% was 23.3 (SD 15.1). The mean LCSS score for the lower performance group, with KPS scores of 20-50% at baseline, was 46.85 (SD 17.65).

Testing the effects of a decision-making and risk-reduction program for cancer-surviving adolescents.

PURPOSE/OBJECTIVES: To test the effects of a decision-making and risk-reduction program for cancer-surviving adolescents. DESIGN: Prospective clinical trial using a quasi-experimental pretest/post-test design with repeated measures. SETTING: Two survivor follow-up clinics and a camp for children and adolescents with cancer located in upstate New York. SAMPLE: A convenience sample of 64 survivors (13-21 years of age). The intervention group consisted of 21 survivors who attended a workshop, and the comparison group consisted of 43 survivors who did not attend the workshop. METHODS: Intervention-integrated information specific to survivorship, decision-making skills, risk behaviors, and social support from peers and healthcare professionals. The educational component of the program lasted one day (five one-hour units), and the social component lasted overnight. A single, semistructured interview at the time of the previous yearly evaluation visit was used for baseline data. Testing was conducted during home visits at 1, 6, and 12 months. MAIN RESEARCH VARIABLES: Decision making, risk motivation, and risk behaviors (i.e., smoking, alcohol use, and illicit drug use). FINDINGS: The effect of the intervention for improving decision making was significant at 1-month postintervention, marginally significant at 6-months postintervention, and highly significant at 12-months postintervention. The effect of the intervention for motivation toward alcohol use was significant at 1-month postintervention and marginally significant at 6-months postintervention; however, the intervention had no effect on smoking motivation at any of the three time intervals. The effect of the intervention for improving smoking behavior was marginally significant at 6-months postintervention and was marginally significant at 12-months postintervention for alcohol use. CONCLUSIONS: The intervention had a dampening effect on the upward trajectory of substance use, a path that is well-known to increase with age for both genders in the general population. This short, five-hour program for improving decision making and affecting substance use of teen survivors shows promise; however, a larger sample is needed to enhance findings. IMPLICATIONS FOR NURSING PRACTICE: Besides tailoring risk-behavior information based on actual or potential late effects of treatment to each teen survivor during follow-up visits, oncology professionals need to provide booster programs to refine decision-making skills within meaningful decision context for teen survivors as a means of reducing risk behaviors.

Quality parental decision making and distress.

The purpose of this study was to test three hypotheses in the context of parenting an adolescent: (1) socioeconomic status (SES), parental gender, marital status, and age of parent will be predictors of quality decision-making for parents of adolescents; (2) as predispositional and situational distress increase, quality decision making among these parents will decrease; and (3) predispositional distress will be as strong a predictor for quality decision making as situational distress. The sample included 123 parents of adolescents ages 13 to 19 years. SES was the only significant predictor (11%) for parental decision making; the higher the SES, the more quality in decision making reported. Moderate negative correlations were obtained between predispositional distress and quality decision making and situational distress and quality decision making. Both predispositional distress and situational distress contributed equally as predictors of quality decision making.

Intervention booster: adding a decision-making module to risk reduction and other health care programs for adolescents.

A generic adolescent intervention booster of the decision-making module, "Choices for Tomorrow: Decision Making as a Life Tool," is described for patient education. The intent of the intervention booster is refinement of adolescent decision-making skills by teaching a life tool for making lifestyle decisions (such as smoking and alcohol use) and other health-related decisions. An overview of the module is presented. The module includes a curriculum, a 17-minute life-action videocassette, a participant's workbook, and two instruments to measure outcomes. The theoretical framework is based on the health/choice model, the Janis and Mann conflict model of decision making, and the Piagetian cognitive framework related to adolescent development. The decision-making module can be used alone or as a "booster" to supplement the content of new or existing intervention programs that are aimed at health promotion and maintenance during adolescence. Because the module was originally developed for adolescents who have survived cancer, a population that often experiences cognitive impairment from treatment, it includes cognitive remediation strategies (such as memory aids). The decision-making module can also be used in other learning situations with healthy or chronically ill adolescents and/or their parents.

Cognitive late effect factors related to decision making and risk behaviors of cancer-surviving adolescents.

The purpose of this correlational study was to examine factors related to cognitive late effects of treatment that may be predictors of decision making and risk behaviors for cancer-surviving adolescents. A convenience sample of 52 survivors (ages 14-19 years, disease-free for 5 years, no treatment for 2 years, and with all types of cancer except primary brain tumors) participated in this study at two regional survivor follow-up clinics. A medical record review, a semistructured interview with the teen, and intelligence testing on a separate day were used to collect data. A history of cancer therapy threatening cognitive function (defined as > or = 18 gy of radiotherapy, intrathecal or high-dose systemic methotrexate, or both) was a marginally significant predictor of poorer-quality decision making in the first regression model. Poorer-quality decision making was a significant predictor of one or more risk behaviors in the second model. Younger age at initial treatment and lower cognitive ability (full-scale IQ) were not significant predictors for either of the models. There were no significant differences for the Wechsler IQ subtests related to abstract and analytic ability by cognitive threat status. Post hoc analysis indicated that lack of sensitivity to change of the Wechsler IQ measure may have affected outcomes. Abstract and/or analytic ability may be important links for decision making and risk behaviors of teen survivors, thus warranting further examination within a larger sample. Intervention to improve decision making needs to be provided for teen survivors; this may be true especially when there is a history of therapy threatening cognitive function.

A dilemma in analysis: issues in the serial measurement of quality of life in patients with advanced lung cancer.

Despite the availability of several instruments to evaluate quality of life (QL) over time in patients with lung cancer, barriers in measurement remain. This methodological study used LCSS data (Lung Cancer Symptom Scale, a disease- and site-specific QL measure) to examine analysis methods to quantify QL where data needed for serial evaluation may be missing. Data from two large randomized trials, conducted at 30 centers, of a new combination chemotherapy regimen incorporating a new agent for patients (n = 673) with Stage III and IV non-small cell lung cancer were obtained for this study. QL had been prospectively measured at baseline, day 29, and every six weeks thereafter using the LCSS. For the slope analysis (SA) and area under the curve (AUC) analyses, an adjustment score of zero was used to indicate QL on the day of death (mortality adjustment) and each subsequent day until the end of the assessment period. Significant differences in QL, symptom scores and known prognostic factors at baseline were found in the attrition group. SA and AUC analysis allowed inclusion of 581 patients, giving an adequacy rate of 86%. By using a mortality adjustment, an additional 45 patients were included, increasing the inclusion rate to 93%. With the use of the mortality adjustment, QL was shown to decline over the interval, as opposed to rise if the adjustment had not been performed. The conclusions of the study were: (1) analysis for serial data using SA and AUC provides useful, but differing information; (2) when attrition (caused by death) is a factor, a mortality adjustment presented a more accurate assessment of QL as an endpoint; (3) more frequent evaluations of QL will capture rapid changes in patient status and reduce the attrition bias; (4) all patients should be followed until they die; and (5) QL should be given full consideration as a primary endpoint separate from survival.

Decision making and risk behaviors of cancer-surviving adolescents and their peers.

The specific aims of this descriptive, comparative study were (1) to compare the decision-making quality and prevalence of risk behaviors (smoking, alcohol consumption, and illicit drug use) between 52 cancer-surviving adolescents and their peers; (2) to compare the relationship of decision-making quality and risk behavior prevalence in a subset of survivors who had a history of therapy with cognitive threat due to late effects of treatment to those without cognitive threat; and (3) to test the hypothesis that the higher the number of quality decision criteria adhered to, the fewer the risk behaviors exhibited by cancer-surviving adolescents. Findings indicated that the majority of teen survivors reported practicing poor-quality decision making for five of the seven criteria (peers, four of seven). There were no significant differences in decision making between teen survivors and their peers nor between survivors with cognitive threat and those without. Peers were significantly more likely to engage in one or more risk behaviors than teen survivors, but comparisons with two normative samples (state and national) revealed that cigarette smoking and alcohol use of the teen survivors were comparable with the general population. There was no significant difference in risk behaviors between survivors with a history of therapy with cognitive threat and those without. Survivors who reported higher adherence to quality decision criteria were less likely to report exhibiting risk behaviors than those with poorer decision making. Using the context of late effects due to cancer treatment, oncology nurses need to provide guidance in quality decision making as well as in risk behavior education.

Comparison of instruments for measuring quality of life in patients with lung cancer.

This review compares the key features and psychometric properties of three site-specific quality of life measures that are currently being used in clinical trials for new therapeutic agents for lung cancer. These measures include the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) and its lung cancer module (EORTC-QLQ-LC13), the Functional Assessment of Cancer Therapy--Lung Cancer Quality of Life Instrument (FACT-L), and the Lung Cancer Symptom Scale (LCSS). Differences are found among the three instruments. However, these differences allow choice of detail concerning specific aspects of quality of life, depending on the purpose of the assessment. All three instruments have acceptable feasibility. The FACT-L and LCSS are also reliable measures for lung cancer patients, but the EORTC lung cancer module needs refinement of its pain subscale and further testing of reliability. Additionally, all three instruments have support for validity, with the LCSS and EORTC lung cancer modules having had more extensive testing, and having been tested with larger samples than the FACT-L. The EORTC and FACT are still under development; thus, each will need further testing. The LCSS has fewer questionable psychometric properties than the other two measures, and the development of items is complete. For repeated measures with patients with the progressive disease of lung cancer, the LCSS provides less patient and staff burden with its nine-item patient and six-item observer scales. Both the EORTC lung cancer module and FACT-L are measures that expect the core measure to be administered, requiring 40+ items each. Alternatively, the EORTC and the FACT, including their site-specific modules, provide a more comprehensive assessment than the LCSS, if that is the intent of the quality of life assessment.

Establishing comprehensive specialty follow-up clinics for long-term survivors of cancer. Providing systematic physiological and psychosocial support.

Late effects of multi-modality treatments may result in organ compromise or new primary cancers for a growing population of long-term survivors of cancer. It is estimated that there will be 180,000-220,000 childhood cancer survivors living in the United States in the year 2000. This number of survivors warrants program planning specific to their needs. Add to this the number of patients diagnosed with cancer as adults who have reached 5-year survival status, and the total population of long-term survivors of cancer justifies special programs to deal with the issues of survivorship. This paper addresses several questions: (a) What are the needs of cancer survivors? (b) Can these needs be met through specialty survivor clinics? (c) What are the benefits of survivor follow-up clinics? (d) Should survivor clinics for children and adults become standard care? The clinic structure and objectives, and daily procedures for a follow-up clinic in New York State are presented as one model of care. Benefits for a free-standing clinic also are discussed as well as financial considerations and directions for research.

Quality of life during clinical trials: conceptual model for the Lung Cancer Symptom Scale (LCSS).

To appreciate the full benefits of treatment for lung cancer, especially in trials that fail to show improvements in survival, data recording the quality of life must be captured and refined to produce meaningful information. A conceptual model for quality of life for lung cancer patients was tested to obtain information about the dimensions of the quality-of-life construct for ongoing development and testing of a subjective measure for clinical trials. Using a longitudinal study design, the stability of predictive factors of the physical and functional dimensions of quality of life were examined using regression analysis. A patient-rated quality-of-life measure, the Lung Cancer Symptom Scale (LCSS), was administered to 144 non-small-cell lung cancer patients at baseline, day 29, and day 71 of a chemotherapy trial. The range of explained variance for all three components of the lung cancer model over three assessment points was as follows: symptomatic distress 41%-53%, activity status 48%-52%, and overall quality of life 35%-53%. The three dimensions fluctuated slightly during intervention, but were relatively stable factors across all three times of evaluation. The LCSS model explained nearly half of the variance for quality of life experienced by lung cancer patients during therapy with a new chemotherapeutic agent. These findings provide support that the physical and functional dimensions are important predictors of quality of life for individuals with lung cancer. Meaningful subjective quality-of-life data can be obtained to evaluate an intervention by using a disease- and site-specific quality-of-life measure for individuals with lung cancer, based on a reproducible conceptual model such as the LCSS, which is suitable for serial measurement for the progressive disease of lung cancer.

Psychometric properties of two instruments to measure quality decision making.

The results of testing two instruments for consequential decision making are reported: a screening instrument, the Decision Making Quality Scale (DMQS), which assesses the degree to which a person adheres to seven quality criteria of decision making; and a diagnostic measure, the Decision Making Quality Inventory (DMQI), which assesses an individual's dominant decision-making style through six sequential stages of the process. The instruments are conceptually linked through the same theoretical framework, the Janis and Mann (1977) conflict model of decision making, as well as operationally linked as counterpart instruments. Feasibility of the instruments was demonstrated with low readability indexes, reasonable administration times, and respondent acceptability by six samples (N = 766). Content validity was supported by panels of experts in decision theory. Reliability coefficients were consistently high ( > .70) for all samples. Support for construct validity was obtained using the contrasted groups approach and relationship testing. The instruments are ready for research and clinical use with healthy adolescents and their parents, as well as with adolescents and young adults who have experienced a chronic illness such as cancer and with their parents.