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International Journal of Radiation Oncology Biology Physics | 1997

DEVELOPMENT OF A HEAD AND NECK COMPANION MODULE FOR THE QUALITY OF LIFE-RADIATION THERAPY INSTRUMENT (QOL-RTI)

Andy Trotti; Darlene Johnson; Clement K. Gwede; Linda Casey; Bonnie Sauder; Alan Cantor; James Pearlman

PURPOSE/OBJECTIVE A review of available head and neck quality of life (QOL) instruments reveals them to inadequately address important radiation related side effects, or to be too cumbersome for routine use. The purpose of this study was to develop a head and neck disease specific module as a companion to the previously developed quality of life - radiation therapy instrument (QOL-RTI). The goal was to create a more complete, yet concise, head and neck site-specific module geared toward patients receiving radiation therapy for head and neck cancer. METHODS AND MATERIALS This exploratory study included 34 consecutive patients undergoing definitive radiotherapy over a 6-7 week course (60-79.8 Gy). We developed and administered a 14-item questionnaire to all eligible patients treated with radiotherapy for head and neck cancer who were not already registered in another research study assessing quality of life (e.g., RTOG). During the treatment period, the QOL-RTI general tool and the head and neck (H&N) module were administered as follows: at baseline, at week four (for test-retest), and at the end of the treatment period. For validation purposes the QOL-RTI/H&N was compared to the functional assessment cancer tool head and neck (FACT-H&N) questionnaire. The FACT-H&N was administered one time at week 4, on the same day as the QOL-RTI/H&N. This report includes the treatment phase of the study (during the course of radiation). RESULTS Mean age was 62 years (range 40-75). Internal consistency of the module was satisfactory (Chronbachs alpha = 0.85). Test-retest yielded a correlation coefficient of 0.90 (p < 0.001). Concurrent validity, established by comparing the module to the FACT/H&N , yielded a correlation coefficient of 0.85. Significant changes in quality of life scores during a course of radiation was noted for both general quality of life tool and the site specific module. For the head and neck module, the difference in the mean baseline (7.17) and end of treatment scores (4.20) was 2.94, or 42% change (p < 0.0001). A smaller, yet still significant, difference in scores was seen in the general QOL tool (22 % change, p = 0.001). Item analysis of the module revealed statistically significant (p < 0.05) worsening in quality of life scores in the following areas: pain in throat, swallowing difficulty (meat/bread and liquids), changes in mucous and saliva, changes in taste, difficulty chewing, trouble with coughing, and speech difficulties. Items that were not significant were pain in the mouth, and appearance. CONCLUSION These initial results suggest that the H&N companion module to the QOL-RTI is a valid and reliable tool that is responsive to changes in QOL during a course of H&N radiation therapy. This tool differs from existing H&N tools by including specific assessments of mucous, saliva, taste, cough, and local pain in a concise format. Significant changes in QOL scores were noted in all of these items. Evaluation of the tool in the post-treatment period (follow-up) is ongoing.


Oncology Nursing Forum | 2005

Burnout in clinical research coordinators in the United States

Clement K. Gwede; Darlene Johnson; Cleora Roberts; Alan Cantor

PURPOSE/OBJECTIVES To assess burnout among clinical research coordinators (CRCs) and to determine which personal and job-related factors are associated with burnout. DESIGN Random, stratified, cross-sectional mail survey. SETTING CRCs from membership lists of clinical research organizations. SAMPLE 252 CRCs in the United States. To be included in the study, participants must have been in their current position longer than six months and involved in clinical trial coordination or data management. Of 2,770 records, 900 CRCs were mailed questionnaires; 35% (316) responded, and 252 of those were eligible for analysis. Eligible respondents were Caucasian (86%), female (94%), and employed full-time (92%) in an oncology setting (71%). METHODS Respondents completed mailed self-administered questionnaires measuring burnout, job satisfaction, personality characteristics, perceived work overload, and selected personal- and employment-related data. Data analyses included descriptive, univariate, and multivariate statistics. MAIN RESEARCH VARIABLE Burnout. FINDINGS About 70% of respondents were satisfied with their job, and 74% would still choose the clinical research profession. Approximately 44% reported high emotional exhaustion, a component of burnout. Factors independently associated with high emotional exhaustion burnout were low satisfaction with job (p 0.0001), high perceived daily workload (p 0.0001), and low endurance personality (p = 0.002). CONCLUSIONS Burnout is prevalent in CRCs. Job dissatisfaction, perceived daily work overload, low endurance, and nurturance personality traits were associated with high burnout. IMPLICATIONS FOR NURSING Nurses are involved significantly in clinical trial coordination. High burnout rates have potentially negative implications for data quality and productivity in clinical trial data management-important values for nursing and the clinical research profession.


Strahlentherapie Und Onkologie | 2002

Measurement of quality of life in head and neck cancer patients utilizing the quality of life radiation therapy questionnaire

Monika Janda; Darlene Johnson; Hedwig Woelfl; Michael Trimmel; Tim Bressmann; Heidi Schröckmayr; Joachim Widder; Andy Trotti

Background: Quality of life (QOL) measures give patients the possibility to express subjective changes in wellbeing. We aimed to translate the radiation specific quality of life questionnaire (QOL-RTI) and the companion head and neck module (H&N) questionnaire into German and to test its reliability, validity and sensitivity. Patients and Methods: After translation and final revisions based on qualitative interviews with ten patients, 97 head and neck cancer patients were screened for eligibility. Patients answered the 38 items questionnaire at baseline and twice in week 4 of radiotherapy for test-retest reliability. Internal consistency was calculated using Chronbachs alpha. Patients also completed the functional assessment of cancer tool plus head and neck (FACT-G plus H&N) for concurrent validity. Item analyses were performed to test the sensitivity. Results: Chronbachs alpha yielded α=0.85 for the QOL-RTI and α=0.80 for the H&N module, test-retest reliability scores were r=0.87 and r=8.83, respectively. The correlation of the QOL-RTI plus H&N and the FACT plus H&N was r=0.79. Questionnaire sensitivity was supported by significant changes in the mean score of 45.8% of the QOL-RTI items and 78.6% of the H&N items between baseline and week 4 of radiotherapy. Conclusions: The German version of the QOL-RTI was shown to be a reliable, valid and sensitive tool to assess the quality of life of patients undergoing radiotherapy. The H&N module is useful for patients undergoing treatment for head and neck cancer.Hintergrund: Die Erfassung der subjektiven Lebensqualität von Patienten mit Tumorerkrankungen dient der Einschätzung der Auswirkungen der Behandlung auf das subjektive Wohlbefinden der Patienten. Wir übersetzten daher den für die Strahlentherapie spezifischen Fragebogen zur Lebensqualität (QOL-RTI) und das Modul für Patienten mit Kopf-Hals-Tumoren (H&N) ins Deutsche und testeten die Reliabilität, Validität und Sensitivität der deutschen Version. Patienten und Methoden: Der aus 38 Fragen bestehende Fragebogen wurde übersetzt und die Güte der Übersetzung durch qualitative Interviews mit zehn Patienten überprüft. Danach wurden 97 Patienten mit dem Fragebogen vor Beginn und zweimal in der Woche 4 der Bestrahlung (zur Berechnung der Reliabilität) befragt. In der Woche 4 beantworteten die Patienten einen zusätzlichen Fragebogen zur Überprüfung der Validität. Weiter wurden die Sensitivität der einzelnen Fragebogenitems berechnet. Ergebnisse: Die interne Konsistenz des Fragebogens mittels Chronbachs alpha ergab α=0,85 für den QOL-RTI und α=0,80 für das H&N Modul. Die Test-Retest-Reliabilität ergab r=0,87 für den QOL-RTI und r=0,83 für das H&N-Modul. Die Sensitivität des Fragebogens war hoch, 45,8% der Fragen des QOL-RTI und 78,6% des H&N-Moduls veränderten ihren Mittelwert von vor Beginn der Bestrahlung zur Woche 4 der Bestrahlung. Schlussfolgerungen: Die deutsche Übersetzung des QOL-RTI kann als zuverlässiges, valides und sensitives Messinstrument zur Erfassung der Lebensqualität für Patienten, die eine strahlentherapeutische Behandlung erhalten, bezeichnet werden. Das H&N-Modul kann sinnvoll bei Patienten mit Tumoren im Kopf-Hals-Bereich im deutschen Sprachraum Anwendung finden.


International Journal of Radiation Oncology Biology Physics | 2001

Assessment of quality of life and oral function of patients participating in a phase II study of radioprotection of oral and pharyngeal mucosa by the prostaglandin E1 analoge misoprostol (Rtog 96-07)

Darlene Johnson; Charles Scott; James E. Marks; Thomas E. Seay; James N. Atkins; Lawrence Berk; Raul T Meoz; James A. Wheeler

PURPOSE The oral complications associated with radiotherapy to the head and neck are a significant dose-limiting factor. The goals of this study were to determine whether oropharyngeal rinsing and ingestion of misoprostol protect mucous membranes from the acute effects of irradiation, and to evaluate the quality-of-life (QOL) outcomes of patients receiving misoprostol. We report the results of the QOL outcomes of patients in this study. METHODS AND MATERIALS A total of 33 patients with resected or intact cancer of the oral cavity, oropharynx, supraglottic larynx, or hypopharynx were registered to receive postoperative radiotherapy plus misoprostol or primary radiotherapy plus misoprostol. All patients were scheduled to receive 60-70 Gy at 2 Gy/d within 6-7 weeks. QOL and function were evaluated. RESULTS A decrease in the QOL and function occurred in all areas covered by the questionnaire at the 6-week interval. This decrease was significant for eating, saliva, taste, and mucous. Of these significant factors, taste, saliva, and mucous consistency had not resolved by 12 weeks. CONCLUSION Increased understanding of the impact of treatment on QOL and symptoms will formulate the rational design of toxicity interventions and enhance the multidisciplinary care of head-and-neck patients.


International Journal of Radiation Oncology Biology Physics | 1999

Can costs be measured and predicted by modeling within a cooperative clinical trials group? Economic methodologic pilot studies of the radiation therapy oncology group (RTOG) studies 90-03 and 91-04

Jean B. Owen; Perry W. Grigsby; Thomas M Caldwell; Andre Konski; Darlene Johnson; W. Demas; Benjamin Movsas; Christopher U. Jones; Todd H. Wasserman

PURPOSE To (1) measure radiation therapy costs for patients in randomized controlled clinical trials, (2) compare measured costs to modeling predictions, (3) examine cost distributions, and (4) assess feasibility of collecting economic data within a cooperative group. METHODS The Radiation Therapy Oncology Group conducted economic pilot studies for two Phase III studies that compared fractionation patterns. Expected quantities of Current Procedural Terminology (CPT) codes and relative value units (RVU) were modeled. Institutions retrospectively provided procedure codes, quantities, and components, which were converted to RVUs used for Medicare payments. Cases were included if the radiation therapy quality control review judged them to have been treated per protocol or with minor variation. Cases were excluded if economic quality review found incomplete economic data. RESULTS The median and mean RVUs were within the range predicted by the model for all arms of one study and above the predicted range for the other study. CONCLUSION The model predicted resource use well for patients who completed treatment per protocol. Actual economic data can be collected for critical cost items. Some institutions experienced difficulty collecting retrospective data, and prospective collection of data is likely to allow wider participation in future Radiation Therapy Oncology Group economic studies.


Hematology-oncology Clinics of North America | 2000

Cancer and Aging

Lodovico Balducci; Darlene Johnson; Claudia Beghe

Cancer will become the leading cause of morbidity and death as the global population ages. While health and health care disparities have been well documented in culturally and linguistically diverse patients with cancer, aging involves unique biological, medical, and social considerations that must be further explored as it also influences cancer prevention and cancer treatment in these populations. Further, even though aging is common to all cultures and latitudes, the cultural context in which the experience occurs varies even within the Western context. As such, cancer specialists must learn to not only account for the functional but also for the cultural diversity of the older population in medical decisions related to cancer prevention and cancer treatment. In addition, use of screening instruments such the CGA also represent a milestone in the management of older individuals. It is also currently being modified to become more cost effective and to provide more precise information related to life expectancy and tolerance of cancer treatment. The increase in cultural diversity in the oncology setting also influences cancer treatment. A clinician must be able to act within the boundaries of cultural competence when ministering to older cancer patients. Cultural specific instruments to assess older individuals are particularly desirable in a multicultural society, but also strive to effectively communicate with these individuals in these populations, their families and significant others. With proper patient selection and information, older individuals may obtain the same degree of benefits from cancer prevention and cancer treatment as younger individuals, and age should never be a criteria for health care discrimination.


Drug Information Journal | 2001

Organization of Clinical Research Services at Investigative Sites: Implications for Workload Measurement

Clement K. Gwede; Stephanie Daniels; Darlene Johnson

The impact of the structure and organization of clinical research services (data management model) on the workload of clinical research coordinators (CRCs) at investigative sites is undocumented. This paper describes three types of data management models and their potential influence on the workload of CRCs. A 20-item survey, covering information about accrual to clinical trials, staffing levels, use of workload measurement tools, and the data management model, was e-mailed to nine CRCs working at selected cancer centers in the United States. Six CRCs representing four university-based institutions and two community hospitals responded. Staffing levels and number of patients placed on clinical trials varied by institution and data management model. One out of six centers used a workload formula based upon the time it takes to complete a task. The centralized clinical data management model and the modified/mixed models were common. Our findings suggest that it is important to understand the structure of the clinical data management model, among other factors, in evaluating the workload of CRCs.


International Journal of Radiation Oncology Biology Physics | 1996

1050 Validation of the quality of life-radiation therapy instrument (QOL-RTI) in patients receiving definitive radiation therapy for locally advanced prostate cancer

Clement K. Gwede; Jay L. Friedland; Darlene Johnson; Linda Casey; Alan Cantor; Bonnie Saudder; Kathleen L. Beres

Purpoealobjectfve: Ths incidence of prostate cancer has tripled over the last 10 years, co&led over the last four years and continues to increase. A common method of treating prostate cancer is with external bsam radiotherapy with or without hormones. Accurate and comprehensive documentation through prospective studies with long term follow-up is necessary to reduce the negative impact of treatment on a patient% quality of life. While it is increasingly recognized that radiation therapy tmatment for prostate cancer may result in permanent alteration of the patient’s quality of life, the extent and timing of this change in quality of life has not been adequately investigated in a comprehensive and prospective manner. Furthermore, there are limited instruments developed for use with patients undergoing definitive radiotherapy. The purpose of this paper is to report on the validation of the Quality of Lie Radiation Therapy Instrument (QOL-RTI), a 24-item visual analogue general quality of life tool developed for use with patients receiving radiotherapy. Materials & Methods: Health related quality of life was assessed in a prospective study of 62 patients treated with either combined hormonal therapy (HT) plus external beam radiotherapy (EBRT) or EBRT alone for locally advanced prostate cancer. Quality life was measured prospectively before, during, and after radiation therapy. Results: The estimeted reliability of the subscales was assessed with coefficient alpha which ranged from 0.57 to 0.66. Internal consistency was calwlated using initial questionnaires for tha entire sample, yielding a Cronbach’s alpha of 0.82. Test-retest produced a correlation coeffitient of 0.75 (p<O.OOOl) [n=60). Construct validity was assessed by a repeated measures design to look for time effect, group effect, group and time interaction effect. We examined quality of life total scores, subscale total scores and performance status scores for patients who were treated with HT+ EBRT and patients who received EBRT alone, at various time frames before, during and after treatment. Analysis of Variance showed evidence of time effect in two subscales of the instrument: functional health (p<O.O002) and emotional/psychological functioning (p~O.007). Kamofsky Performance Status (KPS) scores were also significant for the time effect. These findings suggest that the QOL-RTI is capable of detecting changes in certain domains of quality of life in this population. There was no evidence of treatment group effect or time/group (treatment) interaction effect for all the above variables. Conclusion: These findings suggest that the QOL-RTI is a reliable and valid instrument for use with prostate cancer patients. The data also suggests that the salience of different domains of quality of life varies in this patient population and it also appears to suggest the need for a disease specific module for use with the QOL-RTI in prostate cancer patients. Additionally, several methodological issues related to administration and data management for the visual analogue tool are discussed. The experience in this study and in a previous pilot study have inspired new directions in the further development of the QOL-RTI for other sites.


International Journal of Radiation Oncology Biology Physics | 2007

The impact of concurrent granulocyte macrophage-colony stimulating factor on radiation-induced mucositis in head and neck cancer patients: A double-blind placebo-controlled prospective Phase III study by Radiation Therapy Oncology Group 9901

Janice K. Ryu; S. Swann; Francis G. LeVeque; Charles W. Scarantino; Darlene Johnson; A. Chen; André Fortin; Jon David Pollock; Harold Kim; K.K. Ang


Oncology Nursing Forum | 2001

Music as a therapeutic intervention for anxiety in patients receiving radiation therapy.

Smith M; Casey L; Darlene Johnson; Clement K. Gwede; Riggin Oz

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Clement K. Gwede

University of South Florida

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Andy Trotti

University of South Florida

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Charles Scott

Radiation Therapy Oncology Group

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James E. Marks

Missouri Baptist Medical Center

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Lawrence Berk

University of South Florida

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Linda Casey

University of South Florida

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Raul T Meoz

National Foundation for Cancer Research

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