Development and validation of a symptom index for advanced hepatobiliary and pancreatic cancers: the National Comprehensive Cancer Network Functional Assessment of Cancer Therapy (NCCN-FACT) Hepatobiliary-Pancreatic Symptom Index (NFHSI).

BACKGROUND: The 45-item Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire assesses health-related quality of life in patients with liver, bile duct, and pancreatic cancers. Although the FACT-Hep was initially derived from patient input, this study's researchers sought to verify adequate coverage of items by soliciting open-ended input from patients with advanced disease. METHODS: As part of a larger study in collaboration with the National Comprehensive Cancer Network (NCCN), 50 people (60% male, 80% caucasian, average age 60.4 years) with stage 3 or 4 hepatobiliary or pancreatic cancer were recruited. Participants generated and ranked up to 10 important symptoms and concerns that physicians should monitor when assessing the value of chemotherapy. Patients were also able to provide open-ended, qualitative information that was evaluated systematically. Ten expert physicians also provided input on priority symptoms. RESULTS: The resulting 18-item NCCN-FACT Hepatobiliary-Pancreatic Symptom Index (NFHSI-18) demonstrated high internal consistency (α = .89) and moderate to strong correlations with measures of physical well-being (ρ = .76), emotional well-being (ρ = 0.52), and functional well-being (ρ = 0.57). Scores on the NFHSI-18 were also highly correlated with the original hepatobiliary scale of the FACT-Hep (ρ = .82; all P < .001). Compared with patients with better performance status, patients with poor performance status had worse NFHSI-18 symptom scores, F(3,47) = 9.74; P = .0003. CONCLUSIONS: The NFHSI-18 assesses symptoms of importance to patients with hepatobiliary and pancreatic cancers and demonstrates promising measurement properties. The scale is a good candidate for brief symptom assessment in clinical trials.

Priority symptoms in advanced breast cancer: development and initial validation of the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy-Breast Cancer Symptom Index (NFBSI-16).

OBJECTIVES: By using methods consistent with recent regulatory guidance on patient-reported outcomes as endpoints in clinical trials, we created a new version of the Functional Assessment of Cancer Therapy-Breast Cancer Symptom Index (FBSI), with emphasis on patient input during the development process. METHODS: We obtained input on the most important symptoms to monitor during treatment for stage III or IV breast cancer from 52 patients recruited from National Comprehensive Cancer Network institutions as well as support service organizations. Participating patients shared their top-priority symptoms/concerns through open-ended interviews and symptom checklists. To ensure adequate content coverage, we evaluated results alongside the original version of the FBSI, which was created on the basis of a survey of oncology clinicians at National Comprehensive Cancer Network institutions and items in the Functional Assessment of Chronic Illness Therapy measurement system. We also obtained input from 10 National Comprehensive Cancer Network oncologists regarding whether symptoms were primarily related to disease or treatment. RESULTS: We selected breast cancer-related symptoms and concerns endorsed as high priority by both oncology patients and clinicians for inclusion in the new National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy-Breast Cancer Symptom Index-16 (NFBSI-16), which includes all eight items from the original FBSI and eight additional items from Functional Assessment of Chronic Illness Therapy measures. The NFBSI-16 is formatted by subscale: Disease-Related Symptom, Treatment Side-Effect, and General Function and Well-Being. Results provide preliminary support for NFBSI-16's internal consistency reliability (α = 0.87) and validity as evidenced by moderate-to-strong relationships with expected criteria. CONCLUSIONS: Reflecting the priority symptoms of breast cancer patients and clinicians, the NFBSI-16 can be used to help evaluate the effectiveness of treatments for advanced breast cancer in clinical practice and research.

Development and validation of 11 symptom indexes to evaluate response to chemotherapy for advanced cancer.

Recent guidance from the FDA discusses patient-reported outcomes as end points in clinical trials. Using methods consistent with this guidance, the authors developed symptom indexes for patients with advanced cancer. Input on the most important symptoms was obtained from 533 patients recruited from NCCN Member Institutions and 4 nonprofit social service organizations. Diagnoses included bladder, brain, breast, colorectal, head and neck, hepatobiliary/pancreatic, kidney, lung, ovarian, and prostate cancers and lymphoma. Physician experts in each of these diseases were also surveyed to differentiate symptoms that were predominantly disease-based from those that were predominantly treatment-induced. Results are evaluated alongside previously published indexes for 9 of these 11 advanced cancers that were created based on expert provider surveys, also implemented at NCCN Member Institutions. Final results are 11 symptom indexes that reflect the highest priorities of people affected by these 11 advanced cancers and the experienced perspective of the people who provide their medical treatment. Beyond the clinical value of such indexes, they may also contribute significantly to satisfying regulatory requirements for a standardized tool to evaluate drug efficacy with respect to symptomatology.

A new index of priority symptoms in advanced ovarian cancer.

OBJECTIVE: This study sought to develop and examine preliminary validity of the NCCN-FACT Ovarian Symptom Index-18 (NFOSI-18), a new ovarian cancer-specific symptom index comprised of symptoms rated as highest priority by both oncology clinical experts and women with advanced ovarian cancer. METHODS: Fifty-one women with advanced ovarian cancer rated the importance of 30 symptoms associated with advanced ovarian cancer. Ten gynecologic oncologists then rated symptoms according to whether they were predominantly disease- or treatment-related. Patient priorities were then reconciled with previously-published clinician priorities for symptom measurement in ovarian cancer. This produced the NFOSI-18. Participants also completed measures of quality of life and performance status to examine preliminary validity of the NFOSI-18. RESULTS: An 18-item symptom index for advanced ovarian cancer was developed, including three subscales: disease-related symptoms, treatment-related symptoms, and general function/well-being. Lower NFOSI-18 scores indicate greater high-priority symptom burden. Preliminary reliability suggests good internal consistency (α=0.80). The NFOSI-18 and its subscales were significantly positively associated with quality of life validity criteria. Scores on the NFOSI-18 differed significantly by performance status, with poor performance status associated with lower NFOSI-18 scores. CONCLUSIONS: The NFOSI-18 shows preliminary evidence for reliability and validity as a brief assessment of the most important symptoms associated with treatment for advanced ovarian cancer.

Efficient assessment of the most important symptoms in advanced prostate cancer: the NCCN/FACT-P Symptom Index.

BACKGROUND: Owing to the spectrum of symptoms, side effects, and concerns in clinically advanced prostate cancer (PC), effective symptom assessment is imperative. In line with recent regulatory guidance on the development of patient-reported outcomes, we undertook a multistep/multistudy approach to develop and test a new symptom index (NCCN FACT-Prostate Symptom Index-17 that can be used to examine the effectiveness of noncurative treatments in advanced PC. METHODS: This included significant input from two waves of expert medical providers (n=66 and 11, respectively) and two waves of patient engagement and testing (n=50 and 24, respectively). The resulting 17-item symptom index for advanced PC was then divided into sets or categories based on whether the symptoms are predominantly disease or treatment related. RESULTS: Preliminary reliability estimates suggest good internal consistency (α=0.86) and relationships with expected outside validity criteria are moderate to strong. CONCLUSIONS: This new tool may help clinicians and researchers quickly target and measure important symptoms and concerns in advanced PC, leading to increased knowledge of treatment effectiveness of noncurative therapies and improvements in the quality of patient care. Copyright © 2010 John Wiley & Sons, Ltd.

Age-associated differences in fatigue among patients with cancer.

CONTEXT: There has been some suggestion that the fatigue experienced by older cancer patients is more severe than that of younger cohorts; however, there is little empirical evidence to support this claim. OBJECTIVES: The goal of the present study was to determine the differential impact of age and cancer diagnosis on ratings of fatigue using a validated self-report instrument. METHODS: The Functional Assessment of Chronic Illness Therapy-Fatigue subscale consists of 13 items measuring fatigue experience and its impact on daily life, with scores ranging from 0 (severe fatigue) to 52 (no fatigue). Fatigue data were available from the U.S. general population (n=1075; 51.3% female, 45.9+/-16.5 years) and a sample of mixed-diagnosis cancer patients (n=738; 64.3% female, 58.7+/-13.6 years). General population participants were recruited using an Internet-based survey panel; patients with cancer were recruited from Chicago-area oncology clinics. RESULTS: On average, the cancer patient group reported more severe fatigue than the general population group (36.9 vs. 46.6; F[1,1797]=271.95, P<0.001). There was evidence for increased fatigue with age (F[6,719]=2.56, P<0.02) among patients with cancer, but not in the general population (P=0.06). Furthermore, the group x age interaction was not significant (P=0.44). Hemoglobin (Hgb) was treated as a covariate for 430 patients with available data; there was no main effect for age in this analysis. CONCLUSION: Older adults, whether they had a cancer diagnosis, reported more fatigue than younger adults. These differences may be explained, in part, by Hgb level. Future research would be helpful to explore longitudinal changes in fatigue in the general population and guide fatigue management for the older cancer patient.

Fatigue is the most important symptom for advanced cancer patients who have had chemotherapy.

Cancer fatigue has been defined and described as an important problem. However, few studies have assessed the relative importance of fatigue compared with other patient symptoms and concerns. To explore this issue, the authors surveyed 534 patients and 91 physician experts from 5 NCCN member institutions and community support agencies. Specifically, they asked patients with advanced bladder, brain, breast, colorectal, head and neck, hepatobiliary/pancreatic, kidney, lung, ovarian, or prostate cancer or lymphoma about their "most important symptoms or concerns to monitor." Across the entire sample, and individually for patients with 9 cancer types, fatigue emerged as the top-ranked symptom. Fatigue was also ranked most important among patients with 10 of 11 cancer types when asked to rank lists of common concerns. Patient fatigue ratings were most strongly associated with malaise (r = 0.50) and difficulties with activities of daily living, pain, and quality of life. Expert ratings of how much fatigue is attributable to disease versus treatment mostly suggested that both play an important role, with disease-related factors predominant in hepatobiliary and lung cancer, and treatment-related factors playing a stronger role in head and neck cancer.

Assessment is not enough: a randomized controlled trial of the effects of HRQL assessment on quality of life and satisfaction in oncology clinical practice.

The potential benefits of health-related quality of life (HRQL) assessment in oncology clinical practice include better detection of problems, enhanced disease and treatment monitoring and improved care. However, few empirical studies have investigated the effects of incorporating such assessments into routine clinical care. Recent randomized studies have reported improved detection of and communication about patients' concerns, but few have found effects on patient HRQL or satisfaction. This study examined whether offering interpretive assistance of HRQL results would improve these patient outcomes. Two hundred and thirteen participants with metastatic breast, lung or colorectal cancer were randomly assigned to one of three conditions: usual care; HRQL assessment or HRQL assessment followed by a structured interview and discussion. Interviews about patients' assessment responses were conducted by a research nurse, who then presented HRQL information to the treating nurse. HRQL and treatment satisfaction outcomes were assessed at 3 and 6 months. No significant differences were found between study conditions in HRQL or satisfaction. Results suggest that routine HRQL assessment, even with description of results, is insufficient to improve patient HRQL and satisfaction. It is suggested that positive effects may require supplementing assessment results with specific suggestions for clinical management changes.