[show abstract][hide abstract] ABSTRACT: Contemporary tumor-directed therapies for metastatic castration-resistant prostate cancer (mCRPC) are approved to prolong life, but their effects on symptoms such as pain are less well understood as a result of the lack of analytically valid assessments of pain prevalence and severity, clinically meaningful definitions of therapeutic benefit, and methodologic standards of trial conduct. This study establishes pain characteristics in the mCRPC population using a PRO measure.
Patients with prostate cancer participated in an anonymous survey at five US comprehensive cancer centers in the Prostate Cancer Clinical Trials Consortium that incorporated the Brief Pain Inventory (BPI), analgesic use, and interference with daily activities. Prevalence and severity of cancer-related pain and analgesic use were tabulated according to castration-resistant status and exposure to docetaxel chemotherapy.
Four hundred sixty-one patients with prostate cancer participated, of whom 147 had mCRPC involving bone (61% [89 of 147] docetaxel exposed, 39% [58 of 147] docetaxel naive). Pain of any level was more common among docetaxel-exposed versus docetaxel-naive patients with mCRPC (70% [62 of 89] v 38% [22 of 58], respectively; P < .001). BPI score ≥ 4 was reported by 38% (34 of 89) of docetaxel-pretreated and 24% (14 of 58) of docetaxel-naive patients with mCRPC; 40% of these patients with pain intensity ≥ 4 reported no current narcotic analgesic.
Pain prevalence and severity were higher in patients with prior docetaxel exposure. Analgesics were underutilized. These results provide a method for estimating accruals along the disease continuum, and for enabling design of trials appropriately powered to assess pain.
[show abstract][hide abstract] ABSTRACT: PURPOSEPatient-reported outcomes are increasingly used in routine outpatient cancer care to guide clinical decisions and enhance communication. Prior evidence suggests good patient compliance with reporting at scheduled clinic visits, but there is limited evidence about compliance with long-term longitudinal reporting between visits. PATIENTS AND METHODS
Patients receiving chemotherapy for lung, gynecologic, genitourinary, or breast cancer at a tertiary cancer center, with access to a home computer and prior e-mail experience, were asked to self-report seven symptomatic toxicities via the Web between visits. E-mail reminders were sent to participants weekly; patient-reported high-grade toxicities triggered e-mail alerts to nurses; printed reports were provided to oncologists at visits. A priori threshold criteria were set to determine if this data collection approach merited further development based on monthly (≥ 75% participants reporting at least once per month on average) and weekly compliance rates (60% at least once per week).ResultsBetween September 2006 and November 2010, 286 patients were enrolled (64% were women; 88% were white; median age, 58 years). Mean follow-up was 34 weeks (range, 2 to 214). On average, monthly compliance was 83%, and weekly compliance was 62%, without attrition until the month before death. Greater compliance was associated with older age and higher education but not with performance status. Compliance was greatest during the initial 12 weeks. Symptomatic illness and technical problems were rarely barriers to compliance. CONCLUSION
Monthly compliance with home Web reporting was high, but weekly compliance was lower, warranting strategies to enhance compliance in routine care settings.
Journal of Clinical Oncology 06/2013; · 18.04 Impact Factor
[show abstract][hide abstract] ABSTRACT: OBJECTIVE: The Brief Pain Inventory (BPI) was designed to yield separate scores for pain intensity and interference. It has been proposed that the pain interference factor can be further broken down into unique factors of affective (e.g., mood) and activity (e.g., work) interference. The purpose of this analysis was to confirm this affective/activity interference dichotomy. PATIENTS AND METHODS: A retrospective confirmatory factor analysis was completed for a sample of 184 individuals diagnosed with castrate-resistant prostate cancer (age 40-86, mean = 65.46, 77% White non-Hispanic) who had been administered the BPI as part of Cancer and Leukemia Group B trial 9480. A one-factor model was compared against two-factor and three-factor models that were developed based on the design of the instrument. RESULTS: Root mean squared error of approximation (0.075), comparative fit index (0.971), and change in chi-square, given the corresponding change in degrees of freedom (13.33, P < 0.05) values for the three-factor model (i.e., pain intensity, activity interference, and affective interference), were statistically superior in comparison with the one- and two-factor models. This three-factor structure was found to be invariant across age, mean prostate-specific antigen, and hemoglobin levels. CONCLUSIONS: These results confirm that the BPI can be used to quantify the degree to which pain separately interferes with affective and activity aspects of a patient's everyday life. These findings will provide clinical trialists, pharmaceutical sponsors, and regulators with confidence in the flexibility of the BPI as they consider the use of this instrument to assist with understanding the patient experience as it relates to treatment.
[show abstract][hide abstract] ABSTRACT: We used the Female Sexual Function Index (FSFI) to investigate the prevalence of sexual dysfunction (SD) and factors associated with diminished sexual functioning in early stage endometrial cancer (EC) patients treated with simple hysterectomy and adjuvant brachytherapy.
A cohort of 104 patients followed in a radiation oncology clinic completed questionnaires to quantify current levels of sexual functioning. The time interval between hysterectomy and questionnaire completion ranged from <6 months to >5 years. Multivariate regression was performed using the FSFI as a continuous variable (score range, 1.2-35.4). SD was defined as an FSFI score of <26, based on the published validation study.
SD was reported by 81% of respondents. The mean (± standard deviation) domain scores in order of highest-to-lowest functioning were: satisfaction, 2.9 (± 2.0); orgasm, 2.5 (± 2.4); desire, 2.4 (± 1.3); arousal, 2.2 (± 2.0); dryness, 2.1 (± 2.1); and pain, 1.9 (± 2.3). Compared to the index population in which the FSFI cut-score was validated (healthy women ages 18-74), all scores were low. Compared to published scores of a postmenopausal population, scores were not statistically different. Multivariate analysis isolated factors associated with lower FSFI scores, including having laparotomy as opposed to minimally invasive surgery (effect size, -7.1 points; 95% CI, -11.2 to -3.1; P<.001), lack of vaginal lubricant use (effect size, -4.4 points; 95% CI, -8.7 to -0.2, P=.040), and short time interval (<6 months) from hysterectomy to questionnaire completion (effect size, -4.6 points; 95% CI, -9.3-0.2; P=.059).
The rate of SD, as defined by an FSFI score <26, was prevalent. The postmenopausal status of EC patients alone is a known risk factor for SD. Additional factors associated with poor sexual functioning following treatment for EC included receipt of laparotomy and lack of vaginal lubricant use.
International journal of radiation oncology, biology, physics 05/2012; 84(2):e187-93. · 4.59 Impact Factor
[show abstract][hide abstract] ABSTRACT: Patient reporting of symptoms in a questionnaire with a 7-day recall period was expected to differ from symptom reporting in a 7-day symptom diary on the basis of cognitive theory of memory processes and several studies of symptoms and health behaviors.
A total of 101 adults with chronic obstructive pulmonary disease (COPD) completed a daily diary of items measuring symptoms and impacts of COPD for 7 days, and on the seventh day they completed a questionnaire of the same items with a 7-day recall period. The analysis examined concordance of 7-day recall with summary descriptors of the daily responses, examined the magnitude and covariates (patient characteristics and response patterns) of the difference between 7-day recall and mean of daily responses, and compared the discriminant ability and ability to detect change of 7-day recall and mean of daily responses.
A 7-day recall was moderately concordant with the mean and maximum of daily responses and was 0.34 to 0.50 SDs higher than the mean of daily responses. Only the weekly report itself was a covariate of the difference. The discriminant ability and ability to detect change were equivalent.
In measuring the weeklong experience of COPD symptoms and impacts on groups of patients, the 7-day recall scores were higher than the daily diary scores, but equivalent in detecting change over time.
Value in Health 05/2012; 15(3):466-74. · 2.19 Impact Factor
[show abstract][hide abstract] ABSTRACT: Adverse symptom event reporting is vital as part of clinical trials and drug labeling to ensure patient safety and inform risk-benefit decision making. The purpose of this study was to assess the reliability of adverse event reporting of different clinicians for the same patient for the same visit.
A retrospective reliability analysis was completed for a sample of 393 cancer patients (42.8% men; age 26-91, M = 62.39) from lung (n = 134), prostate (n = 113), and Ob/Gyn (n = 146) clinics. These patients were each seen by two clinicians who independently rated seven Common Terminology Criteria for Adverse Events (CTCAE) symptoms. Twenty-three percent of patients were enrolled in therapeutic clinical trials.
The average time between rater evaluations was 68 min. Intraclass correlation coefficients were moderate for constipation (0.50), diarrhea (0.58), dyspnea (0.69), fatigue (0.50), nausea (0.52), neuropathy (0.71), and vomiting (0.46). These values demonstrated stability over follow-up visits. Two-point differences, which would likely affect treatment decisions, were most frequently seen among symptomatic patients for constipation (18%), vomiting (15%), and nausea (8%).
Agreement between different clinicians when reporting adverse symptom events is moderate at best. Modification of approaches to adverse symptom reporting, such as patient self-reporting, should be considered.
Quality of Life Research 10/2011; 21(7):1159-64. · 2.41 Impact Factor
[show abstract][hide abstract] ABSTRACT: Patient reporting of symptoms in a questionnaire with a 7-day recall period is expected to differ from reporting in daily symptom diaries.
38 patients with cystic fibrosis (CF) completed 77 week-long symptom diaries. Each diary day comprised 13 symptom items with 5-point response scales. Days 1-6 of the diary had a 24-hour recall period. Day 7 had a 7-day recall period. Concordance of 7-day recall with summary descriptors of daily reports (e.g. mean, maximum) was examined and ability of 7-day recall and mean of daily reports to discriminate between well and ill periods of health compared.
The average difference in scores was less than 0.25 response scale points. 7-day recall was most concordant with the mean of daily reports. Discriminant ability was comparable.
In this study sample, a questionnaire with 7-day recall provided information similar to a daily diary about the week-long experience of CF symptoms.
Journal of cystic fibrosis: official journal of the European Cystic Fibrosis Society 12/2010; 9(6):419-24. · 3.19 Impact Factor
[show abstract][hide abstract] ABSTRACT: This study aimed to evaluate the relevance and importance of two SF-36 subscales, Vitality (VT) and Physical Function (PF), to assess concepts of energy and physical function in patients with type 2 diabetes mellitus (DM) and non-dialysis CKD-related anemia.
Patients with clinical history of DM and non-dialysis CKD-related anemia (n = 68) were identified as follows: 40 participated in concept elicitation (CE) interviews; 20 in cognitive interviews (CI), and 8 in pilot interviews. Relevance and importance ratings for SF-36 VT and PF items were obtained. Interviews were recorded, transcribed, and patient expressions of concepts coded. Inter-rater agreement was used to evaluate coding consistency. Concepts elicited were mapped to SF-36 VT and PF items.
Patients (n = 64) were 65.6% women, 42.2% Caucasian, with mean age of 66.1 ± 11.6 years. Of 830 coded concepts, 388 (47%) were "Energy" expressions and 287 (35%) were "PF limitations" expressions. Low energy was reported by 85% patients and rated as an important limitation by 88%. Limitations in PF were reported by 56-82% patients and rated important by 44-96%. CE and CI quotes correspond well to SF-36 VT and PF items.
SF-36 VT and PF contents were suitable for assessing energy and physical function limitations, respectively, in this patient population.
Quality of Life Research 12/2010; 20(6):889-901. · 2.41 Impact Factor
[show abstract][hide abstract] ABSTRACT: Patient reporting of type 2 diabetes symptoms in a questionnaire with a 7-day recall period was expected to be different from symptom reports using a 7-day diary with repeated 24-h recall based on cognitive theory of memory processes and prior literature. This study compared these two types of recall in patients diagnosed with type 2 diabetes (T2D).
One hundred and forty adults with T2D completed a daily diary for 7 days containing 9 T2D-related symptom and impact items. On day 7, patients completed the same items with a 7-day recall period. We examined the concordance of 7-day recall with summary descriptors of the daily reports and compared the scores and the discriminant ability of 7-day recall and mean of daily reports.
Seven-day recall was most concordant with the mean of daily reports. The average difference in scores was small (range 0.22-0.77 on 11-point scale) and less than 0.5 standard deviations. For some items, the difference was positively associated with the variation in daily reports. The discriminant ability was comparable.
In this study population, a questionnaire with 7-day recall provided information consistent with a daily diary measure of the average week-long experience of T2D symptoms and impacts.
Quality of Life Research 11/2010; 20(5):769-77. · 2.41 Impact Factor
[show abstract][hide abstract] ABSTRACT: Previous analyses report the impact of erythropoiesis-stimulating agents (ESAs) on health-related quality of life across various populations. In this analysis, we review published studies and quantify the effect of ESA therapy on energy/fatigue and physical function in nondialysis patients with chronic kidney disease (CKD) related anemia.
Systematic literature search to identify articles (1980-2008) that evaluated effects of ESAs on patient-reported energy and physical function.
Nondialysis CKD patients with anemia enrolled in prospective trials.
Prospective studies measuring energy or physical function with both baseline and follow-up measurement.
Improvements in energy and physical function assessed using effect size, a measure of treatment responsiveness.
14 studies were identified: 11 measured energy and 14 measured physical function. The 36-Item Short-Form Health Survey (SF-36) was the most common instrument used to report energy and physical function. Of 11 studies measuring energy, 2 were double-blind randomized placebo-controlled trials (RCTs), 5 were open-label RCTs, and 4 were single-arm open-label studies. Eight of 11 studies reported statistically significant improvements in energy. Effect size for energy ranged from small (0.24) to large (1.90) in ESA-treated groups and was moderate in each arm of the low- versus high-hemoglobin target RCTs. Of 14 studies measuring physical function, 2 were double-blind RCTs, 6 were open-label RCTs, and 6 were single-arm open-label studies. Ten of 14 studies reported statistically significant improvements in physical function. Effect size for physical function ranged from small (0.37) to large (2.38) in ESA-treated groups and was negligible to moderate in each arm of low- versus high-hemoglobin target studies.
Findings and conclusions were limited by the available evidence.
RCTs and single-arm studies indicate that treatment of anemia with ESAs improves energy and physical function in nondialysis CKD patients.
American Journal of Kidney Diseases 03/2010; 55(3):519-34. · 5.29 Impact Factor
[show abstract][hide abstract] ABSTRACT: Purpose
The National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a library of question items that enables patient reporting of adverse events (AEs) in clinical trials. This study contributes content validity evidence of the PRO-CTCAE by incorporating cancer patient input of the relevance and comprehensiveness of the item library.
Cognitive interviews were conducted among patients undergoing chemotherapy or radiation therapy at multiple sites to evaluate comprehension, memory retrieval, judgment, and response mapping related to AE terms (e.g., nausea), attribute terms (regarding frequency, severity, or interference), response options, and recall period. Three interview rounds were conducted with ≥20 patients completing each item per round. Items were modified and retested if ≥3 patients exhibited cognitive difficulties or if experienced by ≤25 % patients.
One hundred and twenty-seven patients participated (35 % ≤high school, 28 % non-white, and 59 % female). Most AE terms (63/80) generated no cognitive difficulties. The remaining 17 were modified without further difficulties by Round 3. Terms were comprehended regardless of education level. Attribute terms and response options required no modifications. Patient adherence to recall period (7 days) was improved when the reference period was incorporated.
This study provides evidence confirming comprehension of the US English language versions of items in the PRO-CTCAE library for measuring symptomatic AEs from the patient perspective within the context of cancer treatment. Several minor changes were made to the items to improve item clarity, comprehension, and ease of response judgment. This study helps to establish the content validity of PRO-CTCAE items for patient reporting of AEs during cancer treatment.