Pilot study of a Spanish language measure of financial toxicity in underserved Hispanic cancer patients with low English proficiency.

Background: Financial toxicity (FT) reflects multi-dimensional personal economic hardships borne by cancer patients. It is unknown whether measures of FT-to date derived largely from English-speakers-adequately capture economic experiences and financial hardships of medically underserved low English proficiency US Hispanic cancer patients. We piloted a Spanish language FT instrument in this population. Methods: We piloted a Spanish version of the Economic Strain and Resilience in Cancer (ENRICh) FT measure using qualitative cognitive interviews and surveys in un-/under-insured or medically underserved, low English proficiency, Spanish-speaking Hispanics (UN-Spanish, n = 23) receiving ambulatory oncology care at a public healthcare safety net hospital in the Houston metropolitan area. Exploratory analyses compared ENRICh FT scores amongst the UN-Spanish group to: (1) un-/under-insured English-speaking Hispanics (UN-English, n = 23) from the same public facility and (2) insured English-speaking Hispanics (INS-English, n = 31) from an academic comprehensive cancer center. Multivariable logistic models compared the outcome of severe FT (score > 6). Results: UN-Spanish Hispanic participants reported high acceptability of the instrument (only 0% responded that the instrument was "very difficult to answer" and 4% that it was "very difficult to understand the questions"; 8% responded that it was "very difficult to remember resources used" and 8% that it was "very difficult to remember the burdens experienced"; and 4% responded that it was "very uncomfortable to respond"). Internal consistency of the FT measure was high (Cronbach's α = 0.906). In qualitative responses, UN-Spanish Hispanics frequently identified a total lack of credit, savings, or income and food insecurity as aspects contributing to FT. UN-Spanish and UN-English Hispanic patients were younger, had lower education and income, resided in socioeconomically deprived neighborhoods and had more advanced cancer vs. INS-English Hispanics. There was a higher likelihood of severe FT in UN-Spanish (OR = 2.73, 95% CI 0.77-9.70; p = 0.12) and UN-English (OR = 4.13, 95% CI 1.13-15.12; p = 0.03) vs. INS-English Hispanics. A higher likelihood of severely depleted FT coping resources occurred in UN-Spanish (OR = 4.00, 95% CI 1.07-14.92; p = 0.04) and UN-English (OR = 5.73, 95% CI 1.49-22.1; p = 0.01) vs. INS-English. The likelihood of FT did not differ between UN-Spanish and UN-English in both models (p = 0.59 and p = 0.62 respectively). Conclusion: In medically underserved, uninsured Hispanic patients with cancer, comprehensive Spanish-language FT assessment in low English proficiency participants was feasible, acceptable, and internally consistent. Future studies employing tailored FT assessment and intervention should encompass the key privations and hardships in this population.

Short-form adaptive measure of financial toxicity from the Economic Strain and Resilience in Cancer (ENRICh) study: Derivation using modern psychometric techniques.

OBJECTIVES: This study sought to evaluate advanced psychometric properties of the 15-item Economic Strain and Resilience in Cancer (ENRICh) measure of financial toxicity for cancer patients. METHODS: We surveyed 515 cancer patients in the greater Houston metropolitan area using ENRICh from March 2019 to March 2020. We conducted a series of factor analyses alongside parametric and non-parametric item response theory (IRT) assessments using Mokken analysis and the graded response model (GRM). We utilized parameters derived from the GRM to run a simulated computerized adaptive test (CAT) assessment. RESULTS: Among participants, mean age was 58.49 years and 278 (54%) were female. The initial round factor analysis results suggested a one-factor scale structure. Negligible levels of differential item functioning (DIF) were evident between eight items. Three items were removed due to local interdependence (Q3>+0.4). The original 11-point numerical rating scale did not function well, and a new 3-point scoring system was implemented. The final 12-item ENRICh had acceptable fit to the GRM (p<0.001; TLI = 0.94; CFI = 0.95; RMSEA = 0.09; RMSR = 0.06) as well as good scalability and dimensionality. We observed high correlation between CAT version scores and the 12-item measure (r = 0.98). During CAT, items 2 (money you owe) and 4 (stress level about finances) were most frequently administered, followed by items 1 (money in savings) and 5 (ability to pay bills). Scores from these four items alone were strongly correlated with that of the 12-item ENRICh (r = 0.96). CONCLUSION: These CAT and 4-item versions provide options for quick screening in clinical practice and low-burden assessment in research.

Effects of patient-reported outcome assessment order.

BACKGROUND: In clinical trials and clinical practice, patient-reported outcomes are almost always assessed using multiple patient-reported outcome measures at the same time. This raises concerns about whether patient responses are affected by the order in which the patient-reported outcome measures are administered. METHODS: This questionnaire-based study of order effects included adult cancer patients from five cancer centers. Patients were randomly assigned to complete questionnaires via paper booklets, interactive voice response system, or tablet web survey. Linear Analogue Self-Assessment, Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events, and Patient-Reported Outcomes Measurement Information System assessment tools were each used to measure general health, physical function, social function, emotional distress/anxiety, emotional distress/depression, fatigue, sleep, and pain. The order in which the three tools, and domains within tools, were presented to patients was randomized. Rates of missing data, scale scores, and Cronbach's alpha coefficients were compared by the order in which they were assessed. Analyses included Cochran-Armitage trend tests and mixed models adjusted for performance score, age, sex, cancer type, and curative intent. RESULTS: A total of 1830 patients provided baseline patient-reported outcome assessments. There were no significant trends in rates of missing values by whether a scale was assessed earlier or later. The largest order effect for scale scores was due to a large mean score at one assessment time point. The largest difference in Cronbach's alpha between the versions for the Patient-Reported Outcomes Measurement Information System scales was 0.106. CONCLUSION: The well-being of a cancer patient has many different aspects such as pain, fatigue, depression, and anxiety. These are assessed using a variety of surveys often collected at the same time. This study shows that the order in which the different aspects are collected from the patient is not important.

Financial Hardship in Survivorship Care Delivery.

Cancer-related financial hardship is highly prevalent and affects individuals in the setting of cancer care delivery across the survivorship trajectory. Mitigating financial hardship requires multi-level solutions at the policy, payer, health-care system, provider, and individual patient levels. At the highest level, strategies for intervention include enacting policies to improve price transparency and expand insurance coverage. Also needed are implementing systematic screening and financial navigation in cancer care delivery; improving cost communication by provider care teams; developing patient-reported measures that incorporate the multiple, complex dimensions of financial hardship, as reflected in the Economic Strain and Resilience in Cancer tool; and advancing electronic medical record infrastructure to manage data on patient financial hardship. For individual patients, activating their social networks, community resources, and employers provides patient-level support resources to enhance coping. The proposed multi-level approach is needed to overcome financial hardship in the setting of high-quality, high-value cancer care delivery.

The Treatment-induced Neuropathy Assessment Scale (TNAS): a psychometric update following qualitative enrichment.

BACKGROUND: The validation of the Treatment-induced Neuropathy Assessment Scale (TNAS v2.0), a patient-reported outcome measure of symptoms associated with cancer treatment-induced peripheral neuropathy (TIPN), was previously reported. Further patient input (qualitative interviewing, cognitive debriefing) suggested that the measure should be modified to better reflect the TIPN experience. We report the performance of a revised version (TNAS v3.0) for assessing TIPN across cancer treatments. This TNAS version incorporates extensive patient input, in accordance with FDA guidance on the development of patient-reported outcomes measures. Patients with multiple myeloma, colorectal cancer, or gynecological cancer treated with bortezomib, oxaliplatin, or taxane-platinum combination therapy, respectively, completed the TNAS v3.0, European Organization for Research and Treatment of Cancer Chemotherapy-Induced Peripheral Neuropathy (EORTC-CIPN20), and a cognitive debriefing survey during a scheduled clinic visit. Patients also participated in in-depth qualitative interviews about their TIPN symptoms. The psychometric properties of the TNAS v3.0 were evaluated. RESULTS: Cognitive debriefing survey results were summarized and showed that most patients found the items easy to complete, comprehensible, acceptable, and not redundant. A notable change from TNAS v2.0 was the separation of "numbness" from "tingling," although these 2 items remained the most severe, followed by a new "pain" item. The Cronbach coefficient alphas for the 9-item TNAS were 0.88 and 0.90 at the first and second administrations, respectively, indicating good reliability. The test-retest reliability of the TNAS was 0.97. The correlation coefficients for the 9-item TNAS and the EORTC-CIPN20 were 0.69 for the sensory subscale, 0.70 for the motor subscale, and 0.32 for the autonomic subscale, indicating good validity. CONCLUSION: This psychometric evaluation showed that the TNAS v3.0 is valid and reliable. Further research is needed to determine clinically meaningful differences in TNAS v3.0 scores and demonstrate its responsiveness over time.

Assessment of baseline symptom burden in treatment-naïve patients with lung cancer: an observational study.

BACKGROUND: Patients with newly diagnosed lung cancer who have not yet begun treatment may already be experiencing major symptoms produced by their disease. Understanding the symptomatic effects of cancer treatment requires knowledge of pretreatment symptoms (both severity and interference with daily activities). We assessed pretreatment symptom severity, interference, and quality of life (QOL) in treatment-naïve patients with lung cancer and report factors that correlated with symptom severity. METHODS: This was a retrospective analysis of data collected at initial intake. Symptoms/interference were rated on the MD Anderson Symptom Inventory (MDASI) between 30 days prediagnosis and 45 days postdiagnosis. We examined symptom severity by disease stage and differences in severity by histology. Linear regression analyses identified significant predictors of severe pain and dyspnea. RESULTS: Of 460 eligible patients, 256 (62%) had adenocarcinoma, 30 (7%) had small cell carcinoma, and 100 (24%) had squamous cell carcinoma; > 30% reported moderate-to-severe (rated ≥ 5, 0-10 scale) pretreatment symptoms. The most-severe were fatigue, disturbed sleep, distress, pain, dyspnea, sadness, and drowsiness. Symptoms affected work, enjoyment of life, and general activity (interference) and physical well-being (QOL) the most. Patients with advanced disease (n = 289, 63%) had more-severe symptoms. Cancer stage was associated with pain severity; both histology and cancer stage were associated with severe dyspnea. CONCLUSION: One third of lung cancer patients were symptomatic at initial presentation. Quantification of pretreatment symptom burden can inform patient-specific palliative therapy and differentiate disease-related symptoms from treatment-related toxicities. Poorly controlled symptoms could negatively affect treatment adherence and therapeutic outcomes.

Concept domain validation and item generation for the Treatment-Induced Neuropathy Assessment Scale (TNAS).

PURPOSE: Treatment-induced peripheral neuropathy (TIPN) is a difficult problem experienced by patients with cancer that can interfere with their ability to receive optimal therapy. The Treatment-Induced Peripheral Neuropathy Scale (TNAS) is a patient-reported outcome (PRO) measure developed to assess TIPN symptom burden. However, PRO validation is an ongoing process. The aim of this qualitative study was to define the conceptual model, establish content domain validity, and refine items for the TNAS based on patient input. METHODS: Patients who received bortezomib, oxaliplatin, or platinum-taxane combination therapy reported their experience of TIPN in single qualitative audiotaped interviews. Themes of the TIPN experience were identified by descriptive analysis of the transcribed interviews. RESULTS: Three groups of 10 patients each who had received bortezomib, oxaliplatin, or platinum-taxane combination therapy, for a total of 30 patients, reported their experiences. Two themes reported by patients were TIPN sensations and functional interference. Five sensations (numbness, tingling, pain, heat or burning, and coldness) and five functional impacts (using hands, walking, maintaining balance or falling, wearing shoes, and sleeping) were reported by at least 20% of patients and were selected for inclusion in the TNAS v3.0 for additional psychometric testing. CONCLUSIONS: The assessment of TIPN must be convenient, reliable, and practical for patients, who are the most reliable source of information about symptoms. The TNAS, developed with direct patient input, provides an easily administered and conceptually valid method of patient report of TIPN burden for use in research and practice.

Correction to: Long-term patient reported outcomes following radiation therapy for oropharyngeal cancer: cross-sectional assessment of a prospective symptom survey in patients ≥65 years old.

In the original publication [1] the name of author Jeremy M. Aymard was spelled wrong. The original article was updated to rectify this error.

Long-term patient reported outcomes following radiation therapy for oropharyngeal cancer: cross-sectional assessment of a prospective symptom survey in patients ≥65 years old.

BACKGROUND: Given the potential for older patients to experience exaggerated toxicity and symptoms, this study was performed to characterize patient reported outcomes in older patients following definitive radiation therapy (RT) for oropharyngeal cancer (OPC). METHODS: Cancer-free head and neck cancer survivors (>6 months since treatment completion) were eligible for participation in a questionnaire-based study. Participants completed the MD Anderson Symptom Inventory-Head and Neck module (MDASI-HN). Those patients ≥65 years old at treatment for OPC with definitive RT were included. Individual and overall symptom severity and clinical variables were analyzed. RESULTS: Of the 79 participants analyzed, 82% were male, 95% white, 41% T3/4 disease, 39% RT alone, 27% induction chemotherapy, 52% concurrent, and 18% both, and 96% IMRT. Median age at RT was 71 yrs. (range: 65-85); median time from RT to MDASI-HN was 46 mos. (2/3 > 24 mos.). The top 5 MDASI-HN items rated most severe in terms of mean (±SD) ratings (0-10 scale) were dry mouth (3.48 ± 2.95), taste (2.81 ± 3.29), swallowing (2.59 ± 2.96), mucus in mouth/throat (2.04 ± 2.68), and choking (1.30 ± 2.38) reported at moderate-severe levels (≥5) by 35, 29, 29, 18, and 13%, respectively. Thirty-nine % reported none (0) or no more than mild (1-4) symptoms across all 22 MDASI-HN symptoms items, and 38% had at least one item rated as severe (≥7). Hierarchical cluster analysis resulted in 3 patient groups: 1) ~65% with ranging from none to moderate symptom burden, 2) ~35% with moderate-severe ratings for a subset of classically RT-related symptoms (e.g. dry mouth, mucus, swallowing) and 3) 2 pts. with severe ratings of most items. CONCLUSIONS: The overall long-term symptom burden seen in this older OPC cohort treated with modern standard therapy was largely favorable, yet a higher symptom group (~35%) with a distinct pattern of mostly local and classically RT-related symptoms was identified.

Clinical outcome assessment in malignant glioma trials: measuring signs, symptoms, and functional limitations.

The shared goal of all parties developing therapeutics against malignant gliomas is to positively impact the lives of people affected by these cancers. Clinical outcome assessment (COA) tools, including measures of patient-reported outcome, performance outcome, clinician-reported outcome, and observer-reported outcome, allow patient-focused assessments to complement traditional efficacy measures such as overall survival and radiographic endpoints. This review examines the properties of various COA measures used in malignant glioma clinical trials to date and cross references their content to the priority signs, symptoms, and functional limitations defined through a community survey conducted by the National Brain Tumor Society. The overarching goal of this initiative is to identify COA measures that are feasible and have appropriate psychometric properties for use in this patient population as well as highlight where further development is needed.

Favorable patient reported outcomes following IMRT for early carcinomas of the tonsillar fossa: Results from a symptom assessment study.

BACKGROUND: A questionnaire-based study was conducted to assess long-term patient reported outcomes (PROs) following definitive IMRT-based treatment for early stage carcinomas of the tonsillar fossa. METHODS: Participants had received IMRT with or without systemic therapy for squamous carcinoma of the tonsillar fossa (T1-2 and N0-2b) with a minimum follow-up of 2years. Patients completed a validated head and neck cancer-specific PRO instrument, the MD Anderson Symptom Inventory-Head and Neck module (MDASI-HN). Symptoms were compared between treatment groups of interest and overall symptom burden was evaluated. RESULTS: Of 139 participants analyzed, 51% had received ipsilateral neck IMRT, and 62% single modality IMRT alone (no systemic therapy). There were no differences in mean severity ratings for the top-ranked individual symptoms or symptom interference for those treated with bilateral versus ipsilateral neck IMRT alone. However, 40% of those treated with bilateral versus 25% of those treated with ipsilateral neck RT alone reported moderate-to-severe levels of dry mouth (p=0.03). Fatigue, numbness/tingling, and constipation were rated more severe for those who had received systemic therapy (p<0.05 for each), but absolute differences were small. Overall, 51% had no more than mild symptom ratings across all 22 symptoms assessed. CONCLUSIONS: The long-term patient reported symptom profile in this cohort of tonsil cancer survivors treated with definitive IMRT-based treatment showed a majority of patients with no more than mild symptoms, low symptom interference, and provides an opportunity for future comparison studies with other treatment approaches.

Measuring Therapy-Induced Peripheral Neuropathy: Preliminary Development and Validation of the Treatment-Induced Neuropathy Assessment Scale.

UNLABELLED: Various sensory and motor effects are associated with cancer treatment-induced peripheral neuropathy. The current method for capturing the multifaceted nature of neuropathy includes a combination of objective tests, clinician evaluation, and subjective patient report, an approach that is often not logistically feasible, especially for multisite trials. We report the performance of a brief yet comprehensive, easily administered measure, the Treatment-Induced Neuropathy Assessment Scale (TNAS), for assessing the severity and course of neuropathy across various cancer treatments. Data were derived from 4 longitudinal or cross-sectional patient cohorts (N = 573). Patients with multiple myeloma treated primarily with bortezomib and patients with colorectal cancer receiving oxaliplatin evaluated candidate items. Cognitive debriefing showed that all items were easy to understand, and this preliminary TNAS demonstrated reliability, validity, and sensitivity. Numbness/tingling was the most severe item, regardless of therapeutic agent. Although numbness and general pain were moderately correlated, patients perceived them as distinct. Most TNAS items were more severe at follow-up, demonstrating the sensitivity of the instrument to accumulating dose. The TNAS will be refined with further patient input, with final psychometric evaluation conducted in a new patient sample receiving treatments known to be associated with peripheral neuropathy. The nonpainful component of neuropathy may be more disabling than the pain component. PERSPECTIVE: Our data suggest that the nonpainful components of neuropathy may be more disabling than the pain component during cancer treatment. Here we report data on sensory and motor symptoms reported by patients receiving neurotoxic cancer therapy, and we detail the development of a neuropathy assessment scale that follows regulatory guidance for patient-reported outcomes.

Symptoms and socio-economic impact of ependymoma on adult patients: results of the Adult Ependymoma Outcomes Project 2.

Ependymoma is a rare central nervous system tumor of adults. Reports of patient symptoms, interference patterns and costs encountered by patients and families are limited. Adult ependymoma patients completed the online Ependymoma Outcomes Questionnaire II. The survey assesses disease and functional status as well as socio-economic factors. Descriptive statistics were used to report disease characteristics as well as economic and social impact. Independent samples t test was used to test if differences exist between high- and low-income groups in terms of symptom severity. Correlations were calculated between symptoms and cost estimates. 86 international patients participated (male = 50 %). The economic analysis focused on 78 respondents from the US. 48 % were employed and 55 % earned ≥$60,000. Tumors were located in the brain (44 %), spine (44 %) or both (12 %). Spine patients compared to brain patients reported significantly worse pain (4.4 versus 2.2, p < .003), numbness (5.3 versus 2.2, p < .001), fatigue (5.1 versus 3.6, p < .03), changes in bowel patterns (3.8 versus 1.4, p < .003) and weakness (4.2 versus 2.1, p < .006). Brain patients compared with spine patients had increased lack of appetite (.4 versus 2, p < .014). Patients with lower income (≤$59,999) had more problems concentrating (p < .024) and worse cognitive module severity scores (p < .024). Estimated average monthly out-of-pocket spending was $168 for medical co-pays and $59 for prescription medication. Patients with ependymoma are highly affected by their symptoms. Spinal patients report higher severity of symptoms. Patients in the lower income group report significantly higher severity of cognitive symptoms independent of disease site.

Patterns of symptom burden during radiotherapy or concurrent chemoradiotherapy for head and neck cancer: a prospective analysis using the University of Texas MD Anderson Cancer Center Symptom Inventory-Head and Neck Module.

BACKGROUND: A prospective longitudinal study to profile patient-reported symptoms during radiotherapy (RT) or concurrent chemoradiotherapy (CCRT) for head and neck cancer was performed. The goals were to understand the onset and trajectory of specific symptoms and their severity, identify clusters, and facilitate symptom interventions and clinical trial design. METHODS: Participants in this questionnaire-based study received RT or CCRT. They completed the University of Texas MD Anderson Cancer Center Symptom Inventory-Head and Neck Module before and weekly during treatment. Symptom scores were compared between treatment groups, and hierarchical cluster analysis was used to depict clustering of symptoms at treatment end. Variables believed to predict symptom severity were assessed using a multivariate mixed model. RESULTS: Among the 149 patients studied, the majority (47%) had oropharyngeal tumors, and nearly one-half received CCRT. Overall symptom severity (P < .001) and symptom interference (P < .0001) became progressively more severe and were more severe for those receiving CCRT. On multivariate analysis, baseline Eastern Cooperative Oncology Group performance status (P < .001) and receipt of CCRT (P < .04) correlated with higher symptom severity. Fatigue, drowsiness, lack of appetite, problem with mouth/throat mucus, and problem tasting food were more severe for those receiving CCRT. Both local and systemic symptom clusters were identified. CONCLUSIONS: The findings from this prospective longitudinal study identified a pattern of local and systemic symptoms, symptom clusters, and symptom interference that was temporally distinct and marked by increased magnitude and a shift in individual symptom rank order during the treatment course. These inform clinicians about symptom intervention needs, and are a benchmark for future symptom intervention clinical trials.

The symptom burden of cancer: Evidence for a core set of cancer-related and treatment-related symptoms from the Eastern Cooperative Oncology Group Symptom Outcomes and Practice Patterns study.

BACKGROUND: A set of common cancer-related and treatment-related symptoms has been proposed for quality of care assessment and clinical research. Using data from a large, multicenter, prospective study, the authors assessed the effects of disease site and stage on the percentages of patients rating these proposed symptoms as moderate to severe. METHODS: The severity of 13 symptoms proposed to represent "core" oncology symptoms was rated by 3106 ambulatory patients with cancer of the breast, prostate, colon/rectum, or lung, regardless of disease stage or phase of care; 2801 patients (90%) repeated the assessment 4 to 5 weeks later. RESULTS: At the time of the initial assessment, approximately 33% of the patients reported ≥ 3 symptoms in the moderate-to-severe range; 11 of the 13 symptoms were rated as moderate to severe by at least 10% of all patients and 6 were rated as moderate to severe by at least 20% of those receiving active treatment. Fatigue/tiredness was the most severe symptom, followed by disturbed sleep, pain, dry mouth, and numbness/tingling. More patients with lung cancer and patients receiving active treatment reported moderate to severe symptoms. Percentages of symptomatic patients increased by disease stage, less adequate response to therapy, and declining Eastern Cooperative Oncology Group performance status. The percentages of patients reporting moderate to severe symptoms were stable across both assessments. CONCLUSIONS: The results of the current study support a core set of moderate to severe symptoms that are common across outpatients with solid tumors, that can guide consideration of progression-free survival as a trial outcome, and that should be considered in clinical care and in assessments of quality of care and treatment benefit.

Measuring the symptom burden associated with the treatment of chronic myeloid leukemia.

We developed a module of the MD Anderson Symptom Inventory (MDASI) for patients with chronic myeloid leukemia (CML). To develop the MDASI-CML, we identified CML-specific symptoms from qualitative interviews with 35 patients. A list of candidate symptoms was reduced by a panel of patients, caregivers, and clinicians to the 13 core MDASI symptom items and 6 CML-specific items; these items were subsequently administered to 30 patients. Cognitive debriefing confirmed that the items were clear, relevant, and easy to use. One additional CML-specific symptom item was added, for a total of 7. The refined MDASI-CML was administered to 152 patients once every 2 weeks for 1 year. The content, concurrent, known-group, and construct validity of the MDASI-CML were evaluated. The internal consistency and test-retest reliabilities of the module were adequate. Longitudinal analysis showed relatively stable symptom severity scores over time. The most severe symptoms were fatigue, drowsiness, disturbed sleep, muscle soreness and cramping, and trouble remembering things. Approximately one-third of the patients who completed the MDASI-CML reported persistent moderate-to-severe symptoms. The MDASI-CML is a valid and reliable symptom assessment instrument that can be used in clinical studies of symptom status in patients with CML.

Using group-based trajectory modeling to examine heterogeneity of symptom burden in patients with head and neck cancer undergoing aggressive non-surgical therapy.

PURPOSE: Treatment-related symptom burden varies significantly among patients undergoing radiotherapy or chemoradiotherapy, yet such variation is typically not reflected in the results from single-group studies. We applied group-based trajectory modeling (GBTM) to describe the heterogeneity of symptom burden among patients with head and neck cancer and to identify subgroups with distinct symptom-development trajectories. METHODS: Patients (n = 130) were recruited pretherapy and rated multiple symptoms weekly for 10 weeks via the M. D. Anderson Symptom Inventory. With the mean of five most severe symptoms over time as an outcome measure, GBTM was used to identify patient subgroups with distinct symptom trajectories. Linear mixed-effects modeling (LMM) was applied to compare with GBTM's ability to describe the longitudinal symptom data. RESULTS: The five most severe symptoms were problems with taste, difficulty swallowing or chewing, problems with mucus, fatigue, and dry mouth. A two-group GBTM model identified 68 % of patients as having high symptom burden, associated with older age, worse baseline performance status, and chemoradiotherapy treatment. A four-group GBTM model generated one stable group (4 % of patients) and three groups varying in symptom severity with both linear and quadratic functions over time. LMM revealed symptom-change patterns similar to that produced by GBTM but was inferior in identifying risk factors for high symptom burden. CONCLUSIONS: For cancer patients undergoing aggressive therapy, GBTM is capable of identifying various symptom-burden trajectories and provides severity groupings that will aid research and may be of clinical utility. These results may be generalizable to other cancer types and treatments.

Prognostic value of patient-reported symptom interference in patients with late-stage lung cancer.

PURPOSE: Patient-reported outcomes (PROs) have been found to be significant predictors of clinical outcomes such as overall survival (OS), but the effect of demographic and clinical factors on the prognostic ability of PROs is less understood. Several PROs derived from the 12-item Short-Form Health Survey (SF-12) and M. D. Anderson Symptom Inventory (MDASI) were investigated for association with OS, with adjustments for other factors, including performance status. METHODS: A retrospective analysis was performed on data from 90 patients with stage IV non-small cell lung cancer. Several baseline PROs were added to a base Cox proportional hazards model to examine the marginal significance and improvement in model fit attributable to the PRO: mean MDASI symptom interference level; mean MDASI symptom severity level for five selected symptoms; SF-12 physical and mental component summaries; and the SF-12 general health item. Bootstrap resampling was used to assess the robustness of the findings. RESULTS: The MDASI mean interference level had a significant effect on OS (p = 0.007) when the model was not adjusted for interactions with other prognostic factors. Further exploration suggested the significance was due to an interaction with performance status (p = 0.001). The MDASI mean symptom severity level and the SF-12 physical component summary, mental component summary, and general health item did not have a significant effect on OS. CONCLUSIONS: Symptom interference adds prognostic information for OS in advanced lung cancer patients with poor performance status, even when demographic and clinical prognostic factors are accounted for.

Levels of symptom burden during chemotherapy for advanced lung cancer: differences between public hospitals and a tertiary cancer center.

PURPOSE: We compared risk factors for high disease- and treatment-related symptom burden over 15 weeks of therapy in medically underserved patients with advanced non-small-cell lung cancer and in patients treated at a tertiary cancer center. PATIENTS AND METHODS: We monitored symptom severity weekly during chemotherapy. Patients were recruited from a tertiary cancer center (n=101) and three public hospitals treating the medically underserved (n=80). We used a composite symptom-severity score and group-based trajectory analysis to form two groups: one with consistently more severe symptoms and another with less severe symptoms. We examined predictors of group membership. RESULTS: Seventy percent of the sample (n=126) reported low symptom-severity levels that decreased during therapy; 30% (n=55) had consistently severe symptoms throughout the study. In multivariate analysis, patients with good performance status being treated in public hospitals were significantly more likely than patients treated at the tertiary cancer center to be in the high-symptom group (odds ratio, 5.6; 95% CI, 2.1 to 14.6; P = .001) and to report significantly higher symptom interference (P = .001). Other univariate predictors of high-symptom group membership included variables associated with being medically underserved (eg, having less education, being single, and being nonwhite). No group differences by ethnicity were observed in the public hospitals. Medically underserved patients were less likely to receive adequate pain management. CONCLUSION: Patients with advanced lung cancer and good performance status treated at public hospitals were more likely than those treated at a tertiary cancer center to experience substantial symptoms during chemotherapy.