Time to deterioration of symptoms or function using patient-reported outcomes in cancer trials.

Time-to-event endpoints for patient-reported outcomes, such as time to deterioration of symptoms or function, are frequently used in cancer clinical trials. Although time-to-deterioration endpoints might seem familiar to cancer researchers for being similar to survival or disease-progression endpoints, there are unique considerations associated with their use. The complexity of time-to-deterioration endpoints should be weighed against the information that they add to the tumour, survival, and safety data used to inform the risks and benefits of an investigational drug. Here we use the estimand framework to show how analytical decisions answer different clinical questions of interest, some of which might be uninformative. Challenges including the consideration of intercurrent events, the difficulty in maintaining adequate completion rates, and considerable patient and trial burden from long-term, serial, patient-reported outcome measurements render time to deterioration a problematic approach for widespread use. For trials in which a comparative benefit in symptoms or function is an objective, an analysis at pre-specified relevant timepoints could be a better approach.

The use of proxies and proxy-reported measures: a report of the international society for quality of life research (ISOQOL) proxy task force.

AIMS: Proxy reports are often used when patients are unable to self-report. It is unclear how proxy measures are currently in use in adult health care and research settings. We aimed to describe how proxy reports are used in these settings, including the use of measures developed specifically for proxy reporting in adult health populations. METHODS: We systematically searched Medline, PsycINFO, PsycTESTS, CINAHL and EMBASE from database inception to February 2018. Search terms included a combination of terms for quality of life and health outcomes, proxy-reporters, and health condition terms. The data extracted included clinical context, the name of the proxy measure(s) used and other descriptive data. We determined whether the measures were developed specifically for proxy use or were existing measures adapted for proxy use. RESULTS: The database search identified 17,677 possible articles, from which 14,098 abstracts were reviewed. Of these, 11,763 were excluded and 2335 articles were reviewed in full, with 880 included for data extraction. The most common clinical settings were dementia (30%), geriatrics (15%) and cancer (13%). A majority of articles (51%) were paired studies with proxy and patient responses for the same person on the same measure. Most paired studies (77%) were concordance studies comparing patient and proxy responses on these measures. DISCUSSION: Most published research using proxies has focused on proxy-patient concordance. Relatively few measures used in research with proxies were specifically developed for proxy use. Future work is needed to examine the performance of measures specifically developed for proxies. SYSTEMATIC REVIEW REGISTRATION: PROSPERO No. CRD42018103179.

Association of Patient-Reported Physician Awareness of Complementary Medicine, Medical Care Experience and Care Quality.

The aim was to examine the association of patient-reported physician awareness of biological CAM use and patient perceptions of care experience and quality with a population-based study of patients with incident lung and colorectal cancer. This was a secondary data analysis using regression models. Outcomes of interest were patient reports of medical care experience and quality ratings. Among 716 patients who reported biological CAM use, 69% reported their physicians were aware of this. Patients who reported physician awareness of biological CAM use had higher adjusted scores for medical care experience ( + 5.4, 95%CI:2.3,8.6) and care quality ( + 3.6, 95%CI:-0.3, + 7.5). These associations suggest that physicians should be encouraged to inquire about biological CAM use.

Does Knowledge of Treatment Assignment Affect Patient Report of Symptoms, Function, and Health Status? An Evaluation Using Multiple Myeloma Trials.

OBJECTIVES: Unblinded trials are common in oncology, but patient knowledge of treatment assignment may bias response to questionnaires. We sought to ascertain the extent of possible bias arising from patient knowledge of treatment assignment. METHODS: This is a retrospective analysis of data from 2 randomized trials in multiple myeloma, 1 double-blind and 1 open label. We compared changes in patient reports of symptoms, function, and health status from prerandomization (screening) to baseline (pretreatment but postrandomization) across control and investigational arms in the 2 trials. Changes from prerandomization scores at ~2 and 6 months on treatment were evaluated only across control arms to avoid comparisons between 2 different experimental drugs. All scores were on 0- to 100-point scales. Inverse probability weighting, entropy balancing, and multiple imputation using propensity score splines were used to compare score changes across similar groups of patients. RESULTS: Minimal changes from screening were seen at baseline in all arms. In the control arm, mean changes of <7 points were seen for all domains at 2 and 6 months. The effect of unblinding at 6 months in social function was a decline of less than 6 points (weighting: -3.09; 95% confidence interval -8.41 to 2.23; balancing: -4.55; 95% confidence interval -9.86 to 0.76; imputation: -5.34; 95% confidence interval -10.64 to -0.04). CONCLUSION: In this analysis, we did not find evidence to suggest that there was a meaningful differential effect on how patients reported their symptoms, function or health status after knowing their treatment assignment.

Patient and proxy reports regarding the experience of treatment decision-making in cancer care.

OBJECTIVE: Shared decision-making, including the elicitation of patient preferences regarding treatment decisions, is considered part of high-quality cancer care. However, patients may not be able to self-report due to illness, and therefore proxy reports may be used. We sought to determine the difference between proxy and patient reports about patient decisions and preferences among patients who received or were scheduled for chemotherapy using data from a large, population-based survey of patients with incident lung or colorectal cancer. METHODS: Of 3573 patients who received or were scheduled for chemotherapy, 3108 self-reported and 465 had proxies reporting on their behalf about preferred and actual decision roles regarding this treatment. Preferred and actual decision roles were assessed using the Control Preferences Scale, and categorized as shared, patient-controlled, or doctor-controlled. Multivariable logistic regression models were used to assess the association between patient and proxy responses and whether preferences were met. The models adjusted for sociodemographic and clinical variables and patient/proxy-reported health status. RESULTS: Sixty-three percent of all respondents reported actual roles in decisions that matched their preferred roles (role attainment). Proxies and patients were similarly likely to report role attainment (65% vs 63%). In adjusted analyses, proxies were more likely report role attainment (OR = 1.27, 95%CI = 1.02-1.59), but this difference was smaller if health variables were excluded from the model (OR = 1.14, 95%CI = 0.92-1.41). CONCLUSION: Most patients' preferences for treatment participation were met. Surveys from proxies appear to yield small differences on the reports of attainment of preferred treatment decision-making roles in cancer care vs surveys from patients.

Exploration of baseline patient-reported side effect bother from cancer therapy.

BACKGROUND: Patient reports of expected treatment side effects are increasingly collected as part of the assessment of patient experience in clinical trials. A global side effect item that is patient-reported has the potential to inform overall tolerability. Therefore, the aim of this study was to examine the completion and distribution of such a global single-item measure of side effect burden in five cancer clinical trials. METHODS: Data from five trials from internal Food and Drug Administration databases that included the Functional Assessment of Cancer Therapy-General single-item measure of overall side effect burden (i.e. impact on degree of bother) were analyzed. Completion rates for the side effect bother item, items adjacent to this item, and two non-adjacent items on the Functional Assessment of Cancer Therapy-General that are related to health-related quality of life were calculated at the baseline assessment and at the 3-month assessment. To evaluate the distribution, the percentage of patients reporting high levels (quite a bit or very much bother) of side effect bother at baseline and 3 months was assessed. RESULTS: Completion rates for all items were at least 80% regardless of time point or trial population. However, in three of the five trials, completion rates for the side effect bother item were lower at baseline compared to adjacent and non-adjacent items. This difference was not observed at 3 months. Up to 9.4% of patients reported high levels of side effect bother at baseline. CONCLUSION: Patients may enter trials already reporting some bother from side effects. This can make interpretation of results with respect to the investigational agent under study challenging. Patients may skip an item evaluating side effect bother at baseline, suggesting some difficulty with interpretation of what is being asked. Further study of the wording and utility of a baseline side effect bother assessment is warranted.

US Food and Drug Administration review of statistical analysis of patient-reported outcomes in lung cancer clinical trials approved between January, 2008, and December, 2017.

With the advent of patient-focused drug development, the US Food and Drug Administration (FDA) has redoubled its efforts to review patient-reported outcome (PRO) data in cancer trials submitted as part of a drug's marketing application. This Review aims to characterise the statistical analysis of PRO data from pivotal lung cancer trials submitted to support FDA drug approval between January, 2008, and December, 2017. For each trial and PRO instrument identified, we evaluated prespecified PRO concepts, statistical analysis, missing data and sensitivity analysis, instrument completion, and clinical relevance. Of the 37 pivotal lung cancer trials used to support FDA drug approval, 25 (68%) trials included PRO measures. The most common prespecified PRO concepts were cough, dyspnoea, and chest pain. At the trial level, the most common statistical analyses were descriptive (24 trials [96%]), followed by time-to-event analyses (19 trials [76%]), longitudinal analyses (12 trials [48%]), and basic inferential tests or general linear models (10 trials [40%]). Our findings indicate a wide variation in the analytic techniques and data presentation methods used, with very few trials reporting clear PRO research objectives and sensitivity analyses for PRO results. Our work further supports the need for focused research objectives to justify and to guide the analytic strategy of PROs to facilitate the interpretation of patient experience.

Global Variation in Opioid Use in Prostate Cancer Trials.

IMPORTANCE: Regional variation in opioid use may be attenuated when pharmaceutical-sponsored trials include care that is often standardized by protocols. Understanding such variation is important for global trials that sometimes include time to opioid use as an end point. OBJECTIVE: To identify whether regional and country-level variation in opioid use exists among prostate cancer clinical trials across the world. DESIGN, SETTING, AND PARTICIPANTS: International phase 3 randomized clinical trials with patients with metastatic prostate cancer and initiation from January 1, 2008, or later were identified through internal databases of the US Food and Drug Administration. Data of patients in the intention-to-treat population from each trial were pooled. Descriptive and regression analyses of the collected data were conducted from September 2018 to February 2019. EXPOSURES: Cancer therapy. MAIN OUTCOMES AND MEASURES: Opioid use data were from concomitant medications reported in the database for each trial. Logistic regression models, descriptive statistics, and χ2 tests were used to compare opioid use across world regions while adjusting for patient age, presence of visceral disease, bony disease, and baseline Eastern Cooperative Oncology Group Performance Status score and pain score. RESULTS: In total, 9670 patients (mean [SD] age of 69.2 [8.3] years) from 8 prostate cancer clinical trials in 46 countries were included. Patients in Eastern Europe (adjusted odds ratio [AOR], 0.19; 95% CI, 0.16-0.22) and Asia (AOR, 0.31; 95% CI, 0.25-0.38) were less likely to use opioids compared with patients in North America. These findings held even when the analysis was restricted to patients who reported moderate to high pain levels at baseline (Eastern Europe: AOR, 0.16 [95% CI, 0.12-0.22]; Asia: AOR, 0.47 [95% CI, 0.29-0.79]). Within North America, rates of opioid use were similar between the United States and Canada (AOR, 1.13; 95% CI, 0.93-1.37). CONCLUSIONS AND RELEVANCE: This study found that, despite the clinical trial setting, opioid use appeared to vary by world regions, suggesting that this variability should be considered in international clinical trials.

Analyzing patient-reported outcome data when completion differs between arms in open-label trials: an application of principal stratification.

PURPOSE: Cancer trials are often open-label and include patient-reported outcomes (PROs). Previous work has demonstrated that patients may complete PRO assessments less frequently in the control arm compared with the experimental arm in open-label trials. Such differential completion may affect PRO results. This paper sought to explore principal stratification methodology to address potential bias caused by the posttreatment intermediate variable of questionnaire completion. METHODS: We evaluated six randomized trials (five open-label and one double-blind) of anticancer therapies with varying levels of PRO completion submitted to the Food and Drug Administration (FDA). We applied complete case analysis (CCA), multiple imputation (MI), and principal stratification to evaluate PRO results for quality of life (QOL) and the domains of physical, role, and emotional function (PF, RF, and EF). Assignment to potential principal strata was by the expectation maximization algorithm using patient baseline characteristics. RESULTS: Completion rates in the experimental arm ranged from 66% to 94% and 51% to 95% in the control arm. Four trials had negligible completion differences between arms (1%-2%), and two had large differences favoring the experimental arm (15%-17%). For trials with negligible completion differences, principal stratification results were similar to CCA and MI results for all domains. Notable differences in point estimates may be observed in trials with large differences in completion rates. However, in the examined trials, the confidence intervals for the principal stratification estimates overlapped with the ones obtained using CCA. CONCLUSIONS: The principal stratification estimand may be a useful additional analysis, especially if PRO completion differs between arms.

Patient reported outcomes in anti-PD-1/PD-L1 inhibitor immunotherapy registration trials: FDA analysis of data submitted and future directions.

BACKGROUND: Patient-reported outcome measures can be used to capture the patient's experience with disease and treatment. Immunotherapy agents including the anti-programmed death receptor-1/programmed death-ligand-1 inhibitor therapies have unique symptomatic side effects and patient-reported outcome data can help to characterize the benefits and burdens associated with therapy. METHODS: We reviewed registration trials in the Food and Drug Administration database for five anti-programmed death receptor-1/programmed death-ligand-1 inhibitor therapies to characterize trial design and patient-reported outcome assessment strategy (cutoff 31 December 2017). We evaluated the patient-reported outcome measurement coverage of eight key symptoms related to adverse events reported in immunotherapy agent product labels (fatigue, diarrhea, cough, shortness of breath, musculoskeletal pain, rash, pruritus, and fever). RESULTS: There were a total of 28 trials across seven disease types and one tumor agnostic indication reviewed, of which 17 were randomized and 25 were open label. Of the 28 trials, 21 contained patient-reported outcome measures and all 21 used >1 instrument. The most common instruments were the EuroQol five dimension (N = 19), and the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (N = 17). Disease-specific patient-reported outcome tools were included in nine trials (six lung, one head and neck, one melanoma and one renal cell). No trial used a patient-reported outcome strategy assessing all eight selected adverse events. CONCLUSION: Collection of patient-reported outcome data in anti-programmed death receptor-1/programmed death-ligand-1 inhibitor trials were variable and did not consistently assess important symptomatic adverse events. Use of a patient-reported outcome instrument with well-defined functional scales supplemented by item libraries to incorporate relevant symptomatic adverse events may allow for improved understanding of the patient experience while receiving therapy. These data, along with other clinical data such as hospitalizations and supportive care medication use can help inform the benefit-risk assessment for regulatory purposes.

Blinding and Patient-Reported Outcome Completion Rates in US Food and Drug Administration Cancer Trial Submissions, 2007-2017.

BACKGROUND: Patient-reported outcomes (PROs) are commonly included in submissions to the United States Food and Drug Administration (FDA). Open-label designs are frequent in cancer trials. Between-arm differences in PRO missingness may affect results. We sought to compare PRO completion rates between study arms in randomized open-label and double-blind cancer trials. METHODS: Randomized, controlled trials for oncology and malignant hematology products submitted to the FDA in fiscal years 2007-2017 were identified using internal FDA databases. Applicant study reports were reviewed to assess PRO use and reporting of completion rates. Completion rates were collected for each PRO and compared between arms. Results were summarized using descriptive statistics. RESULTS: Ninety-six trials for anticancer products from 2007 to 2017 contained PROs. Fifty-one (53.1%) were randomized, controlled trials with useable information on PRO completion. The median completion rate for investigational arms was 89.7% (range = 33.7-100.0%) and 88.2% (range = 11.0-100.0%) for control arms. At six months, seven double-blind trials had gaps of at least 10% in at least one PRO between arms; in four trials, these gaps favored the control arm (median difference = 11.5%, range = 10.0-17.0%). For open-label trials, four trials had such gaps, all of which favored the investigational arm (median difference = 28.5%, range = 10.0-69.0%). CONCLUSIONS: Among trials that provided interpretable PRO completion information, completion rates were high. Most trials had comparable completion rates between arms. However, when large between-arm completion rate differences existed, differences favoring the experimental arm were more common in open-label trials compared with double-blind trials. Procedures must be put in place to improve reporting of PRO completion and reduce missingness, particularly in open-label trials.

The Association of Proxy Care Engagement with Proxy Reports of Patient Experience and Quality of Life.

OBJECTIVE: To assess the association of proxy-specific covariates with proxy-reported patient cancer care experience, quality rating, and quality of life. DATA SOURCES/STUDY SETTING: Secondary analysis of data from the Cancer Care Outcomes Research and Surveillance (CanCORS) study. STUDY DESIGN: Cross-sectional observational study. The respondents were proxies for patients with incident colorectal or lung cancer. DATA COLLECTION/EXTRACTION METHODS: Analyses used linear regression models and adjusted for patient sociodemographic and clinical characteristics. Outcomes included patients' experiences with medical care, nursing care, and care coordination, overall quality ratings, and physical and mental health, all scored on 0-100 scales (0 = worst, 100 = best). Independent variables included the proxy's relationship with the patient and engagement in patient care. PRINCIPAL FINDINGS: Of 1,011 proxies, most were the patient's spouse (50 percent) or child (36 percent). Although most proxies (66 percent) always attended medical visits, 3 percent reported never attending. After adjustment, on average children reported worse experiences and poorer quality care than spouses (4-9 points lower across outcomes). Proxies who never attended medical visits reported significantly worse medical care (-11 points, 95 percent CI = -18 to -3) and care coordination (-13 points, 95 percent CI = -20 to -6). CONCLUSIONS: Collecting data on proxy engagement in care is warranted if proxy responses are used.

Proxy and patient reports of health-related quality of life in a national cancer survey.

BACKGROUND: Proxy respondents are frequently used in surveys, including those assessing health-related quality of life (HRQOL). In cancer, most research involving proxies has been undertaken with paired proxy-patient populations, where proxy responses are compared to patient responses for the same individual. In these populations, proxy-patient differences are small and suggest proxy underestimation of patient HRQOL. In practice, however, proxy responses will only be used when patient responses are not available. The difference between proxy and patient reports of patient HRQOL where patients are not able to report for themselves in cancer is not known. The objective of this study was to evaluate the difference between patient and proxy reports of patient HRQOL in a large national cancer survey, and determine if this difference could be mitigated by adjusting for clinical and sociodemographic information about patients. METHODS: Data were from the Cancer Care Outcomes Research and Surveillance (CanCORS) study. Patients or their proxies were recruited within 3-6 months of diagnosis with lung or colorectal cancer. HRQOL was measured using the SF-12 mental and physical composite scales. Differences of ½ SD (=5 points) were considered clinically significant. The primary independent variable was proxy status. Linear regression models were used to adjust for patient sociodemographic and clinical covariates, including cancer stage, patient age and education, and patient co-morbidities. RESULTS: Of 6471 respondents, 1011 (16%) were proxies. Before adjustment, average proxy-reported scores were lower for both physical (-6.7 points, 95% CI -7.4 to -5.9) and mental (-6 points, 95% CI -6.7 to -5.2) health. Proxy-reported scores remained lower after adjustment (physical: -5.8 points, -6.6 to -5; mental: -5.8 points, -6.6 to 5). Proxy-patient score differences remained clinically and statistically significant, even after adjustment for sociodemographic and clinical variables. CONCLUSIONS: Proxy-reported outcome scores for both physical and mental health were clinically and significantly lower than patient-reported scores for these outcomes. The size of the proxy-patient score differences was not affected by the health domain, and adjustment for sociodemographic and clinical variables had minimal impact.

Differences between Proxy and Patient Assessments of Cancer Care Experiences and Quality Ratings.

OBJECTIVE: To assess the impact of proxy survey responses on cancer care experience reports and quality ratings. DATA SOURCES/STUDY SETTING: Secondary analysis of data from Cancer Care Outcomes Research and Surveillance (CanCORS). Recruitment occurred from 2003 to 2005. STUDY DESIGN: The study was a cross-sectional observational study. The respondents were patients with incident colorectal or lung cancer or their proxies. DATA COLLECTION/EXTRACTION METHODS: Analyses used linear regression models with an independent variable for proxy versus patient responses as well as study site and clinical covariates. The outcomes were experiences with medical care, nursing care, care coordination, and care quality rating. Multiple imputation was used for missing data. PRINCIPAL FINDINGS: Among 6,471 respondents, 1,011 (16 percent) were proxies. The proportion of proxy respondents varied from 6 percent to 28 percent across study sites. Adjusted proxy scores were modestly higher for medical care experiences (+1.28 points [95 percent CI:+ 0.05 to +2.51]), but lower for nursing care (-2.81 [95 percent CI: -4.11 to -1.50]) and care coordination experiences (-2.98 [95 percent CI: -4.15 to -1.81]). There were no significant differences between adjusted patient and proxy ratings of quality. CONCLUSIONS: Proxy responses have small but statistically significant differences from patient responses. However, if ratings of care are used for financial incentives, such differences could be exaggerated across practices or areas if proxy use varies.

The Effect of a "Class Smoke Free Pledge" on Breath Carbon Monoxide in Arabic Male Adolescents.

Introduction: Arabic male adolescents have a high smoking prevalence. Introduction of "Class smoke-free" pledges have been successful amongst European adolescents but have not been evaluated using objective valid measures. We tested the impact of adding a smoke free pledge strategy to a proven peer-led asthma and smoking prevention program on breath carbon monoxide level (BCO) in male high-school students in Jordan. Methods: We enrolled male students from four high-schools in Irbid, Jordan. Schools were randomly assigned to receive either TAJ (Triple A in Jordan, n = 218) or TAJ-Plus (with added class smoke-free pledge, n = 215). We hypothesized that students receiving TAJ-Plus would have greater reduction in BCO levels than those only receiving the TAJ intervention. Asthma and smoking status were assessed by self-administered questionnaires. Smoking outcomes were collected using a BCO Monitor. Results: Both groups had significant reductions in BCO levels post-intervention (p < .0001), however, decreases were greater in TAJ-Plus group (3.9 ± 0.2 vs. 4.8 ± 0.2, p < .0001). Intervention effects on BCO over time did not vary by smoking status (p = .085), asthma status (p = .602), or a combination of the two (p = .702). Conclusions: An added smoke-free pledge strategy to a proven peer-led asthma education program appears to be a promising approach to motivate adolescents to abstain from smoking in Jordan. Future research is required to determine if these results can be extended to Jordanian adolescent females. Implications: A commitment by students via a "class smoke-free" pledge can be an added incentive to motivate adolescents in Arabic-speaking countries to abstain from smoking. Social influence approaches in schools can be useful in countering the aggressive tobacco marketing campaigns targeting Jordanian and other Arabic-speaking youth. The combination of "class smoke-free" pledges and an evidence-based peer-led asthma and smoking education can be implemented in schools to influence adolescents with asthma to abstain from smoking.

Systematic review of caregiver responses for patient health-related quality of life in adult cancer care.

PURPOSE: In surveys and in research, proxies such as family members may be used to assess patient health-related quality of life. The aim of this research is to help cancer researchers select a validated health-related quality of life tool if they anticipate using proxy-reported data. METHODS: Systematic review and methodological appraisal of studies examining the concordance of paired adult cancer patient and proxy responses for multidimensional, validated HRQOL tools. We searched PubMed, CINAHL, PsycINFO and perused bibliographies of reviewed papers. We reviewed concordance assessment methods, results, and associated factors for each validated tool. RESULTS: A total of 32 papers reporting on 29 study populations were included. Most papers were cross-sectional (N = 20) and used disease-specific tools (N = 19), primarily the FACT and EORTC. Patient and proxy mean scores were similar on average for tools and scales, with most mean differences <10 points but large standard deviations. Average ICCs for the FACT and EORTC ranged from 0.35 to 0.62, depending on the scale. Few papers (N = 15) evaluated factors associated with concordance, and results and measurement approaches were inconsistent. The EORTC was the most commonly evaluated disease-specific tool (N = 5 papers). For generic tools, both concordance and associated factor information was most commonly available for the COOP/WONCA (N = 3 papers). The MQOL was the most frequently evaluated end-of-life tool (N = 3 papers). CONCLUSIONS: Proxy and patient scores are similar on average, but there is large, clinically important residual variability. The evidence base is strongest for the EORTC (disease-specific tools), COOP/WONCA (generic tools), and MQOL (end-of-life-specific tools).

Does Resilience Mediate Carer Distress After Head and Neck Cancer?

BACKGROUND: Caring for patients with head and neck cancer (HNC) can have significant negative psychological and practical impact; however, some carers seem able to cope effectively. Little research has investigated this resilience among carers. OBJECTIVE: The objective of this study was to investigate the resilience levels among carers of patients with HNC. METHODS: Carers (n = 51) from 2 cancer services in New South Wales completed the Resilience Scale (RS), the Head and Neck Information Needs Questionnaire, and the Hospital Anxiety and Depression Scale. Hospital Anxiety and Depression Scale cutoff scores (>8) were used to classify carers with clinically significant levels of anxiety or depression. RESULTS: The majority of carers (67% [34/51]) reported moderately high to high resilience. Rates of anxiety and depression among carers were 27.4% and 9.8%, respectively. Higher resilience scores were significantly correlated with lower anxiety and depression scores, as well as increasing age. Resilience Scale scores were independent of the severity of the HNC. There were no significant correlations between RS scores and Head and Neck Information Needs Questionnaire scores. Finally, increasing RS scores were associated with a decreasing probability of possible anxiety or depression. CONCLUSIONS: These results indicate that higher resilience in carers of HNC patients was associated with lower levels of psychological distress. Further investigation into the relationship between resilience and carer psychological wellbeing is warranted. IMPLICATIONS FOR PRACTICE: If further evidence supports the findings of this study, then investigating ways to build resilience will be an important clinical option for reducing carer morbidity associated with anxiety and depression. The RS could be used to assess resilience levels among carers of HNC patients.

The effect of cancer stage and treatment modality on quality of life in oropharyngeal cancer.

OBJECTIVES/HYPOTHESIS: To examine changes in health-related quality of life among oropharyngeal cancer patients by stages and across treatment types among advanced cancer patients. STUDY DESIGN: Individual prospective cohort study. METHODS: All newly diagnosed patients with oropharyngeal cancer treated with curative intent were routinely assessed. The European Organization for Research and Treatment of Cancer (EORTC) both the Main Module quality-of-life questionnaire (QLQ-C30) and the Head and Neck Cancer (HNC) Module (QLQ-H&N35) were administered at diagnosis and 3, 6, and 12 months thereafter. Complete case analysis was used following assessment of missing data. The proportion of patients with clinically significant deterioration (changes of ≥ 10 points) from baseline were calculated for each follow-up time point and compared by stage (I/II vs. III/IV) and then treatment type (chemotherapy and radiotherapy [CRT] vs. surgery and postoperative radiotherapy [S&PORT]). RESULTS: Deterioration in most domains was most frequent for stage III/IV patients at 3 months (both modules), whereas stage I/II patients experienced this at 6 months (QLQ-C30) and 12 months (H&N35). Among stage III/IV patients, this happened at all time points for S&PORT patients (QLQ-C30) versus 12 months for CRT patients (H&N35). The number of patients reporting deterioration was lower for most domains at 12 months compared to earlier periods, although dry mouth remained a problem for most patients (60%-85% across treatment/stage groups). CONCLUSIONS: Our preliminary findings suggest that general and disease-specific deterioration is of most concern for stage I/II patients at 6 and 12 months and at 3 months for advanced cancer patients. For stage III/IV patients receiving S&PORT, general deterioration remains a problem after diagnosis, whereas for CRT patients, disease-specific deterioration is of most concern at 12 months.

Nurse-led supportive care management: a 6-month review of the role of a nurse practitioner in a chemotherapy unit.

OBJECTIVES: This case study evaluates the oncology nurse practitioner (NP) role in a chemotherapy unit. BACKGROUND: The NP works in the cancer centre of a major metropolitan public hospital. The NP role was established in the chemotherapy unit in 2007. The NP reviews all patients that have an unscheduled presentation to the unit, with symptoms relating either to their disease or treatment. METHODS: All unscheduled occasions of service provided by the NP in the chemotherapy unit over 6 months were recorded. Data were collected on patient demographic characteristics, medical problems and reason for presentation. Data on duration of care, interventions and outcomes administered by the NP were captured. RESULTS: There were 87 occasions of service (72 patients) during the study period. Nausea, vomiting or dehydration were the most common presenting problems and most presenting problems were moderate or severe (n = 73, 84%). The median time to review for the NP was 5 min and nearly all consultations (n = 83, 96%) took 30 min or less. Following NP consultation, most occasions of service did not require subsequent hospital admission (n = 52, 60%), medical advice (n = 61, 70%) or medical review (n = 75, 86%). CONCLUSIONS: The NP is a valuable asset to a busy department, increasing access to timely and appropriate healthcare for patients on chemotherapy.