Enhancing patient-provider communication with the electronic self-report assessment for cancer: a randomized trial.

PURPOSE: Although patient-reported cancer symptoms and quality-of-life issues (SQLIs) have been promoted as essential to a comprehensive assessment, efficient and efficacious methods have not been widely tested in clinical settings. The purpose of this trial was to determine the effect of the Electronic Self-Report Assessment-Cancer (ESRA-C) on the likelihood of SQLIs discussed between clinicians and patients with cancer in ambulatory clinic visits. Secondary objectives included comparison of visit duration between groups and usefulness of the ESRA-C as reported by clinicians. PATIENTS AND METHODS: This randomized controlled trial was conducted in 660 patients with various cancer diagnoses and stages at two institutions of a comprehensive cancer center. Patient-reported SQLIs were automatically displayed on a graphical summary and provided to the clinical team before an on-treatment visit (n = 327); in the control group, no summary was provided (n = 333). SQLIs were scored for level of severity or distress. One on-treatment clinic visit was audio recorded for each participant and then scored for discussion of each SQLI. We hypothesized that problematic SQLIs would be discussed more often when the intervention was delivered to the clinicians. RESULTS: The likelihood of SQLIs being discussed differed by randomized group and depended on whether an SQLI was first reported as problematic (P = .032). Clinic visits were similar with regard to duration between groups, and clinicians reported the summary as useful. CONCLUSION: The ESRA-C is the first electronic self-report application to increase discussion of SQLIs in a US randomized clinical trial.

Depression screening using the Patient Health Questionnaire-9 administered on a touch screen computer.

OBJECTIVE: To (1) evaluate the feasibility of touch screen depression screening in cancer patients using the Patient Health Questionnaire-9 (PHQ-9), (2) evaluate the construct validity of the PHQ-9 using the touch screen modality, and (3) examine the prevalence and severity of depression using this screening modality. METHODS: The PHQ-9 was placed in a web-based survey within a study of the clinical impact of computerized symptom and quality of life screening. Patients in medical oncology, radiation oncology, and hematopoietic stem cell transplantation (HSCT) clinics used the program on a touch screen computer in waiting rooms prior to therapy (T1) and during therapy (T2). Responses of depressed mood or anhedonia (PHQ-2 cardinal depression symptoms) triggered additional items. PHQ-9 scores were provided to the oncology team in real time. RESULTS: Among 342 patients enrolled, 33 (9.6%) at T1 and 69 (20.2%) at T2 triggered the full PHQ-9 by endorsing at least one cardinal symptom. Feasibility was high, with at least 97% completing the PHQ-2 and at least 96% completing the PHQ-9 when triggered and a mean completion time of about 2 min. The PHQ-9 had good construct validity. Medical oncology patients had the highest percent of positive screens (12.9%) at T1, while HSCT patients had the highest percent (30.5%) at T2. Using this method, 21 (6.1%) at T1 and 54 (15.8%) at T2 of the total sample had moderate to severe depression. CONCLUSIONS: The PHQ-9 administered on a touch screen computer is feasible and provides valid depression data in a diverse cancer population.

Acceptability of an Electronic Self-Report Assessment Program for patients with cancer.

Eliciting symptom and quality of life information from patients is an important component of medical and nursing care processes. Traditionally, this information has been collected with paper and pencil. However, this approach presents several barriers, including delays in receiving information, difficulty in integrating responses with electronic records, and the time required to manually score questionnaires for measurement purposes. One solution that addresses many of these barriers is the adoption of computerized screening for symptom and quality-of-life information. This research explored the acceptability of asking symptom and quality-of-life questions using the Electronic Self Report Assessment-Cancer program on wireless laptops equipped with touch-screen format. Acceptability data were explored with respect to whether any differences may be attributed to demographics and symptom and quality-of-life levels, such as depression and cognitive and emotional functioning. This evaluation used descriptive and univariate statistics to examine data from 342 participants from the ongoing ESRA-C randomized clinical trial. Research participants for the ESRA-C study were recruited from the Seattle Cancer Care Alliance, a consortium among the University of Washington Medical Center, Fred Hutchinson Cancer Research Center, and Children's Hospital and Regional Medical Center in Seattle, WA. The sample consisted of 342 adult participants who completed both baseline and follow-up survey sessions. Medical oncology represented the largest recruitment group (45.3%), followed by stem cell transplant (34.5%) and radiation oncology (20.2%). The primary finding was that patients were generally able to use ESRA-C quickly and without difficulty in a real-world clinical setting and that they were overall quite satisfied with the ESRA-C program. Significant differences were found in several acceptability areas with respect to demographics and quality of life measures such as age, sex, and severe distress. This analysis confirms that the ESRA-C application for collecting symptom and quality of life information is easy for patients to use and acceptable across a range of user characteristics. We intend to build on our work by using the survey platform in other modalities while ensuring that the patient's preferences are considered at all times.

Axillary lymph node dose with tangential breast irradiation.

PURPOSE: The advent of sentinel lymph node mapping and biopsy in the staging of breast cancer has resulted in a significant decrease in the extent of axillary nodal surgery. As the extent of axillary surgery decreases, the radiation dose and distribution within the axilla becomes increasingly important for current therapy planning and future analysis of results. This analysis examined the radiation dose distribution delivered to the anatomically defined axillary level I and II lymph node volume and surgically placed axillary clips with conventional tangential breast fields and CT-based three-dimensional (3D) planning. METHODS AND MATERIALS: Fifty consecutive patients with early-stage breast cancer undergoing breast conservation therapy were evaluated. All patients underwent 3D CT-based planning with conventional breast tangential fields designed to encompass the entire breast parenchyma. Using CT-based 3D planning, the dose distribution of the standard tangential breast irradiation fields was examined in relationship to the axillary level I and II lymph node volumes. Axillary level I and II lymph node anatomic volumes were defined by CT and surgical clips placed during complete level I-II lymph node dissection. Axillary level I-II lymph node volume doses were examined on the basis of the prescribed breast radiation dose and 3D dose distribution. RESULTS: All defined breast volumes received > or =95% of the prescribed dose. By contrast, the 95% isodose line encompassed only an average of 55% (range, 23-87%) of the axillary level I-II lymph node anatomic volume. No patient had complete coverage of the axillary level I-II lymph node region by the 95% isodose line. The mean anatomic axillary level I-II volume was 146.3 cm(3) (range, 83.1-313.0 cm(3)). The mean anatomic axillary level I-II volume encompassed by the 95% isodose line was 84.9 cm(3) (range, 25.1-219.0 cm(3)). The mean 95% isodose coverage of the surgical clip volume was 80%, and the median value was 81% (range, 58-98%). The mean volume deficit between the axillary level I-II volume and the surgical clip volume was 41.7 cm(3) (median, 30.0 cc). CONCLUSION: In this study, standard tangential breast radiation fields failed to deliver a therapeutic dose adequately to the axillary level I-II lymph node anatomic volume. No patient received complete coverage of the axillary level I-II lymph node volume. Surgically placed axillary clips also failed to delineate the level I-II axilla adequately. Definitive irradiation of the level I and II axillary lymph node region requires significant modification of standard tangential fields, best accomplished with 3D treatment planning, with specific targeting of anatomically defined axillary lymph node volumes as described, in addition to the breast parenchymal volumes.

Radiation therapy does not impact local complication rates after free flap reconstruction for head and neck cancer.

OBJECTIVE: To determine whether external beam radiation therapy (XRT), administered either before or after surgery, increases the rate and/or severity of local postoperative complications in patients with head and neck cancer who undergo microvascular free flap reconstruction. DESIGN: Retrospective cohort study. SETTING: University of Washington Medical Center, Seattle, a tertiary care hospital. PATIENTS: A total of 100 consecutive patients underwent fibular free flap reconstruction of the mandible. The study cohort was divided according to radiation treatment status: (1) no XRT (28 patients), (2) preoperative XRT (37 patients), and (3) postoperative XRT (35 patients). The median follow-up after surgery was 11 months (range, 1-89 months). MAIN OUTCOME MEASURES: Rate and severity of local postoperative complications. RESULTS: Fifty-four patients (54%) had at least 1 postoperative complication. There were no differences among the 3 XRT subgroups in the overall proportion of patients with complications of any severity (15 [54%] of 28 patients in the no XRT group, 24 [65%] of 37 patients in the preoperative XRT group, and 16 [46%] of 35 patients in the postoperative XRT group; P = .26, chi(2) analysis). There were also no differences seen when mild and severe complication rates were specifically examined (P = .58 and P = .10, respectively). No case of complete flap loss was observed. We noted no significant correlations between the rate of postoperative complications and the following covariates: total radiation dose, size of radiation field, disease stage, exposure to chemotherapy, presence of serious medical comorbidities, patient age, or history of tobacco use. CONCLUSIONS: Our experience suggests that XRT can be safely administered before or after surgery to patients undergoing head and neck free flap reconstruction at an experienced surgical referral center. Postoperative complication rates were not significantly affected by administration, timing, dose, or extent of XRT.

Computerized symptom and quality-of-life assessment for patients with cancer part I: development and pilot testing.

PURPOSE/OBJECTIVES: To develop and test an innovative computerized symptom and quality-of-life (QOL) assessment for patients with cancer who are evaluated for and treated with radiation therapy. DESIGN: Descriptive, longitudinal prototype development and cross-sectional clinical data. SETTING: Department of radiation oncology in an urban, academic medical center. SAMPLE: 101 outpatients who were evaluated for radiation therapy, able to communicate in English (or through one of many interpreters available at the University of Washington), and competent to understand the study information and give informed consent. Six clinicians caring for the patients in the sample were enrolled. METHODS: Iterative prototype development was conducted using a standing focus group of clinicians. The software was developed based on survey markup language and implemented in a wireless, Web-based format. Patient participants completed the computerized assessment prior to consultation with the radiation physician. Graphical output pages with flagged areas of symptom distress or troublesome QOL issues were made available to consulting physicians and nurses. MAIN RESEARCH VARIABLES: Pain intensity, symptoms, QOL, and demographics. INSTRUMENTS: Computerized versions of a 0 to 10 Pain Intensity Numerical Scale (PINS), Symptom Distress Scale, and Short Form-8. FINDINGS: Focus group recommendations included clinician priorities of brevity, flexibility, and simplicity for both input interface and output and that the assessment output contain color graphic display. Patient participants included 45 women and 56 men with a mean age of 52.7 years (SD = 13.8). Fewer than half of the participants (40%) reported using a computer on a regular basis (weekly or daily). Completion time averaged 7.8 minutes (SD = 3.7). Moderate to high levels of distress were reported more often for fatigue, pain, and emotional issues than for other symptoms or concerns. CONCLUSIONS: Computerized assessment of cancer symptoms and QOL is technically possible and feasible in an ambulatory cancer clinic. A wireless, Web-based system facilitates access to results and data entry and retrieval. The symptom and QOL profiles of these patients new to radiation therapy were comparable to other samples of outpatients with cancer. IMPLICATIONS FOR NURSING: The ability to capture an easily interpreted illustration of a patients symptom and QOL experience in less than 10 minutes is a potentially useful adjunct to traditional face-to-face interviewing. Ultimately, electronic patient-generated data could produce automated red flags directed to the most appropriate clinicians (e.g., nurse, pain specialist, social worker, nutritionist) for further evaluation. Such system enhancement could greatly facilitate oncology nurses coordination role in caring for complex patients with cancer.

Impact of FDG PET on defining the extent of disease and on the treatment of patients with recurrent or metastatic breast cancer.

OBJECTIVE: Our aim was to evaluate the impact of FDG PET on defining the extent of disease and on the treatment of patients with advanced breast cancer. MATERIALS AND METHODS: The medical records of 125 consecutive patients with recurrent or metastatic breast cancer referred for FDG PET from January 1998 through May 2002 were retrospectively reviewed. The rationale for FDG PET referral and the impact of FDG PET on subsequent treatment decisions for patients were determined by chart review. The impact of FDG PET on defining the extent of disease was determined by comparing the FDG PET interpretation at the time of the examination with findings from conventional imaging (CI) performed before FDG PET. FDG PET results were confirmed in nearly half (n = 61) of the patients by histopathology (n = 23) or follow-up imaging (n = 38; mean follow-up interval, 21.3 months). RESULTS: Patients were referred for FDG PET for the following reasons: evaluation of disease response or viability after therapy (n = 43 [35%]), local recurrence, with intent of aggressive local treatment (n = 39 [31%]), equivocal findings on CI (n = 25 [20%]), evaluation of disease extent in patients with known metastases (n = 13 [10%]), and elevated tumor markers with unknown disease site (n = 5 [4%]). Compared with CI findings, the extent of disease increased in 54 (43%), did not change in 41 (33%), and decreased in 30 (24%) of 125 patients using FDG PET. Results of FDG PET altered the therapeutic plan in 40 (32%), directly helped to support the therapeutic plan in 34 (27%), and did not change the plan devised before FDG PET in 51 (41%) of 125 patients. FDG PET altered therapy most frequently in the patients suspected of having locoregional recurrence and in those being evaluated for treatment response versus other referral categories (p = 0.04). For patients with confirmation of FDG PET findings, the sensitivity, specificity, and accuracy of FDG PET were 94%, 91%, and 92%, respectively. CONCLUSION: FDG PET contributes significantly to defining the extent of disease and deciding on treatment of patients with advanced breast cancer.

Postradiotherapy surveillance practice for head and neck squamous cell carcinoma--too much for too little?

INTRODUCTION: Limited information is available regarding surveillance patterns after head and neck cancer radiotherapy. We cataloged follow-up for a specified patient cohort treated at three neighboring university, community, and Veterans Administration institutions. METHODS: One hundred fifteen patients were treated with curative intent between 1994-1998 with definitive or postoperative radiotherapy for newly diagnosed squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx. One hundred patients had continuous follow-up at their treating institution and were included for analysis. Median follow-up until disease recurrence or censorship was 28.5 months. RESULTS: Median follow-up frequency was 5.7 visits/year and was highly variable. Although visit frequency correlated with disease stage and the presence of high-risk disease features, this association was lost when patients with early recurrences were removed from analysis. Procedure and test utilization closely mirrored visit frequency, resulting in a wide range of estimated yearly charges (0-15,668 dollars/year; median, 1,772 dollars/year). Actuarial 3-year overall survival for the study group was 71%. Eighty-six percent (19 of 22) of potentially salvageable locoregional failures were discovered secondary to symptomatic complaint rather than by test results. Disease failure, whether detected by symptom or testing, predicted for poor survival (22% at 24 months after recurrence). CONCLUSIONS: Postradiotherapy surveillance for head and neck cancer is inconsistently pursued. A proven correlation between intensive follow-up and improved patient survival is lacking. Surveillance directed by patient symptoms should be investigated as an alternative approach.

Treatment of salivary gland neoplasms with fast neutron radiotherapy.

OBJECTIVE: To evaluate the efficacy of fast neutron radiotherapy for the treatment of salivary gland neoplasms. DESIGN: Retrospective analysis. SETTING: University of Washington Cancer Center, Neutron Facility, Seattle. PATIENTS: The medical records of 279 patients treated with curative intent using fast neutron radiotherapy at the University of Washington Cancer Center were reviewed. Of the 279 patients, 263 had evidence of gross residual disease at the time of treatment (16 had no evidence of gross residual disease), 141 had tumors of a major salivary gland, and 138 had tumors of minor salivary glands. The median follow-up period was 36 months (range, 1-142 months). MAIN OUTCOME MEASURES: Local-regional control, cause-specific survival, and freedom from metastasis. RESULTS: The 6-year actuarial cause-specific survival rate was 67%. Multivariate analysis revealed that low group stage (I-II) disease, minor salivary sites, lack of skull base invasion, and primary disease were associated with a statistically significant improvement in cause-specific survival. The 6-year actuarial local-regional control rate was 59%. Multivariate analysis revealed size 4 cm or smaller, lack of base of skull invasion, prior surgical resection, and no previous radiotherapy to have a statistically significant improved local-regional control. Sixteen patients without evidence of gross residual disease had a 100% 6-year actuarial local-regional control. The 6-year actuarial freedom from metastasis rate was 64%. Factors associated with decreased development of systemic metastases included negative lymph nodes at the time of treatment and lack of base of skull involvement. The 6-year actuarial rate of development of grade 3 or 4 long-term toxicity (using the Radiation Therapy Oncology Group and European Organization for Research on the Treatment of Cancer criteria) was 10%. No patient experienced grade 5 toxic effects. CONCLUSIONS: Neuron radiotherapy is an effective treatment for patients with salivary gland neoplasms who have gross residual disease and achieves excellent local-regional control in patients without evidence of gross disease.

Head and neck lymph node region delineation with 3-D CT image registration.

The success of radiation therapy depends critically on accurately delineating the target volume, which is the region of known or suspected disease in a patient. Methods that can compute a contour set defining a target volume on a set of patient images will contribute greatly to the success of radiation therapy and dramatically reduce the workload of radiation oncologists, who currently draw the target by hand on the images using simple computer drawing tools. The most challenging part of this process is to estimate where there is microscopic spread of disease. We are developing methods for automatically selecting and adapting standardized regions of tumor spread based on the location of lymph nodes in a standard or reference case, together with image registration techniques. The best available image registration techniques (deformable transformations computed using "mutual information" optimization) appear promising but will need to be supplemented by anatomic knowledge-based methods to achieve a clinically acceptable match.

Detection of locoregional and distant recurrences in breast cancer patients by using FDG PET.

Cases of recurrence of breast cancer can pose considerable diagnostic and therapeutic challenges for the oncologic team. The prognosis and management decisions are based on knowledge of the true extent of disease. Conventional staging methods, including physical examination, assessment of levels of tumor markers, cross-sectional imaging, and bone scintigraphy, may not reliably demonstrate the extent of disease in all cases. Physical examination and cross-sectional imaging (computed tomography [CT] or magnetic resonance imaging) can be problematic because (a) the sequelae of previous surgery and radiation therapy can be difficult to distinguish from recurrent neoplasms and (b) early metastatic disease (small lesions) can be difficult to distinguish from benign lesions that are too small to characterize. Positron emission tomography (PET) with 2-[fluorine-18]fluoro-2-deoxy-D-glucose (FDG) can help clarify inconclusive findings from physical examination and cross-sectional imaging. FDG PET is more sensitive than CT in detection of lymphatic spread of disease to locoregional and mediastinal nodes. Metastases at distant sites including the lung, bone, and the liver are also readily detected at FDG PET. FDG PET has been proved accurate in restaging cases of recurrent breast cancer and will likely aid in directing therapy in these cases.