Quality Of Life Tools Research Articles

P0478 QUALITY OF LIFE IN CHILDHOOD CONSTIPATION: A CASE CONTROL STUDY

Introduction: The aim of this study was to determine the effect of chronic constipation on quality of life (QoL) in children and adolescents. Methods: From 10/ 2002 to 11/ 2003, 224 children, (140 male, aged 10.6 +/− 2.9 yrs) and 224 parents were administered a health related QoL tool (PedsQL) in pediatric gastroenterology and general pediatric practices at time of initial evaluation. The PedsQL consists of 4 measures (physical, emotional, social, school) and are scored on a 0 (poor) to100 (best) scale. Children and their families with constipation (CONS, n=80) were compared to control patients: inflammatory bowel disease (IBD, n=42), gastroesophageal reflux disease (GERD, n=56), and healthy children (HC, n=46). Children with constipation had associated abdominal pain (89%) and fecal soiling (29%). Scores were also compared between children and parents to assess differences in perception. Results: CONS children had overall lower quality of life self-reported scores compared to controls: IBD (70 vs. 84, p<0.05); GERD (70 vs. 80, p <0.05); HC (70 vs. 88, p<0.05). There was no difference in QoL between CONS children with or without fecal soiling (70 vs. 74, p=ns). CONS children reported lower physical scores: IBD (75 vs. 85, p<0.02); GERD (75 vs. 85, p<0.05); HC (75 vs. 87, p<0.05). Parents of CONS children reported overall lower quality of life scores compared to their own children’s self reported scores: (61 vs. 70, p<0.05). CONS children presented with longer duration of symptoms versus controls (43.8 months vs. 14.2 months, p<0.001). Duration of symptoms for CONS was associated with lower parent reported scores (p<0.002). Families of CONS children reported a positive family history of constipation and/or irritable bowel syndrome more than controls (40.2% vs. 8.9%, p<0.05). Conclusion: At time of initial evaluation, children with chronic constipation have a lower QoL as compared to those who have IBD and GERD. Self-reported lower QoL scores maybe a reflection of associated abdominal pain and painful defecation leading to impaired physical ability. Parents perceptions of low QoL in their children likely represent concerns with duration of symptoms and family members that have similar complaints. Increased recognition by practioners on the lowered QoL and high level of parental concern in pediatric chronic constipation may lead to more prompt and aggressive management as is seen in children with IBD and GERD. Disease specific health related QOL tools need to be created for better evaluation and assessment of therapeutic intervention.

Developing a self-assessment quality of life tool

The specialist nurse is in a prime position to provide holistic care and this care can be optimised by adequately addressing areas of a patient’s quality of life that are deficient. This article describes the development of a simple,quality of life assessment tool that allows treatment decisions to be based around patient selfassessment,in addition to the assessment made by the specialist nurse.

Living with a terminal illness: patients' priorities.

Our understanding of terminal illness and its consequences has been predominantly based on models derived from expert definition, rather than the patient's perspective. More recently, quality of life tools have been developed to enable patient choice in responses. However, an even broader approach may be needed to help identify goals for care for patients who are terminally ill. The aim of this paper is to report on an exploratory, qualitative study exploring what people living with terminal illness considered were the areas of priority in their lives. Ten people living with terminal cancer were interviewed. Analysis of the interviews incorporated principles of narrative analysis and grounded theory. Over 30 categories were identified and collated into five inter-related themes (personal/intrinsic factors, external/extrinsic factors, future issues, perceptions of normality and taking charge) encompassing the issues of importance to all participants. Each theme focused on 'life and living' in relation to life as it was or would be without illness. Practical issues of daily living and the opportunity to address philosophical issues around the meaning of life emerged as important areas. The central theme, 'taking charge', concerned with people's levels of life engagement, was integrally connected to all other themes. The findings suggest that the way in which health professionals manage patients' involvement in matters such as symptom relief can impact on existential areas of concern. Understanding patients' perspectives in relation to each theme may assist health professionals to develop management strategies appropriate to their needs. The findings challenge some aspects of traditional 'expert-defined' outcome measures. As this was an exploratory study, further work is needed to test and develop the model presented.

Phase III quality-of-life study results: impact on patients’ quality of life to reducing xerostomia after radiotherapy for head-and-neck cancer—RTOG 97-09

Purpose To determine whether prevention of hyposalivation after curative radiotherapy (RT) to the head and neck improves patients’ quality of life (QOL). Methods and materials Patients were to receive at least 50 Gy to 50% of the volume of the major salivary glands, provide unstimulated and stimulated saliva samples, and complete the University of Washington head-and-neck QOL tool before RT and 3 and 6 months after RT. Patients were randomized to receive pilocarpine 5 mg or placebo q.i.d. Results A total of 249 patients was randomized between March 1998 and January 2000. Of these, 214 were eligible for QOL analysis. Patients were evenly distributed between arms by race, gender, tobacco use, tumor site, T stage (50% T2-T3), and salivary function. A Karnofsky performance status of 90% was more common in the pilocarpine arm. Twenty percent of the patients on the pilocarpine arm and 29% of the patients on the placebo arm were taking nutritional supplements. The placebo arm patients had greater mouth pain and chewing difficulties. Compliance for the QOL tool at 3 and 6 months was 65% and 50%, respectively. Despite statistically significant ( p = 0.047 and p = 0.049, respectively) preservation of salivary function in the pilocarpine arm, patients on the pilocarpine arm reported difficulties with swallowing (75%), activity (80%), hyposalivation (64%), and taste (81%). No difference was noted between arms at 3 months in mucositis scores, with both arms demonstrating increased requirement for oral nutrients. Conclusion Objective prevention of hyposalivation did not affect patients’ assessment of salivary function or QOL because of the greater impact mucositis plays in QOL after RT.

P2329 Quality of life tools predict symptom severity in survivors of a myocardial infarction

P2329 Quality of life tools predict symptom severity in survivors of a myocardial infarction

Family caregivers and indicators of cancer-related distress

Increases in the cost of medical care coupled with shorter hospital stays and an aging population are but a few of the reasons why home care for patients has become so important. This study examines variables that contribute to distress among lay-caregivers who provide home care to cancer survivors. Participants consisted of 135 survivor-caregiver dyads in which the caregiver was a member of the survivor's family or a close friend. Measures of caregiver distress were selected from the Ferrell et al. (1995) quality of life tool; predictor variables included cancer survivor and caregiver demographics, physical and emotional health status and behavioural characteristics. Hierarchical regression analysis indicated that, jointly, the three sets of indicators accounted for 35% of caregiver distress. Standardized regression coefficients indicated that relational deprivation (feelings of loss of togetherness, planned activities and contact with other individuals) was the most important predictor of caregiver distress (p<0.01). Female sex, less practice of healthy behaviours, greater number of patient care needs and pessimistic expectations (all ps<0.05) also were significant predictors in the final trimmed model. Results suggest that cancer support services that address the needs of the care receiver with the protection of the family caregiver in mind should be considered.

Validation of two global and generic quality of life questionnaires for population screening: SCREENQOL and SEQOL.

Population screening may harm quality of life (QoL), and traditional health-related QoL tools could be inadequate to evaluate this risk. Two global and generic QoL instruments were developed for studying the QoL consequences of screening (SCREENQOL), and QoL variation in a normal population (SEQOL). SCREENQOL and SEQOL (Self-Evaluation of Quality of Life Questionnaire) are self-administered questionnaires with items rated on 5-point Likert scales. SCREENQOL consists of 21 items measuring QoL across 6 different dimensions based upon validated QoL questionnaires. SEQOL consists of 317 items measuring QoL across 8 different dimensions, based on an integrative theory of QoL, a theoretical framework from a Danish QoL survey involving 7,222 persons 31 to 33 years old. For further validation, SEQOL and SCREENQOL were sent to 2,460 persons 18 to 88 years old randomly selected from the Danish Central Person Register together with Nottingham Health Profile (NHP) and Sickness Impact Profile (SIP). For SCREENQOL and SEQOL, test-retest reliability correlation was both >0.8, Cronbach's alpha was 0.65 and 0.75, correlation (r) to NHP was 0.67 and 0.49, to SIP 0.46 and 0.27, respectively (p

Quality of life instruments for caregivers of patients with cancer: a review of their psychometric properties.

The quality of life of caregivers of patients with cancer is an important construct given the substantial impact of caring on the physical, psychological, social, and financial well-being of caregivers. Moreover, caring for patients with cancer also affects family functioning and places burdens on caregivers. The reliability and validity of instruments used to assess the quality of life of caregivers of patients with cancer were reviewed to aid in the selection of the most appropriate measures for research and practice. (1980-2000) and (1982-2000) searches located relevant quality of life instruments using the keywords "cancer and quality of life" and "caregiver or spouse or partner." The search identified the following instruments: the Caregiver Quality of Life Index-Cancer Scale, the Caregiver Quality of Life Index, the Quality of Life Tool, and the Quality of Life Index-Cancer Version. Quality of life instruments developed specifically to measure the quality of life of caregivers of patients with cancer had the best psychometric properties. The Caregiver Quality of Life Index-Cancer Scale, in particular, met or exceeded minimum psychometric criteria for reliability and validity. The development of reliable and valid caregiver quality of life measures is an important factor in developing interventions to enhance quality of life of caregivers of patients with cancer.

Migraine: the doctor-patient link. results of a needs assessment.

To do a needs assessment directed to neurologists attending a workshop on communication skills emphasizing relationships between physician and patient, assessment of disability and quality of life of migraine patients, and communication of therapies for migraine. A structured questionnaire was sent to all participants related to the issues indicated in the objective. This was prepared by the faculty and the results were collated by the author and presented at the beginning of the workshop. This paper overviews the use and results of a needs assessment to highlight learning needs of the participants and to focus the issues, interest and interactions of neurologists in a workshop. The workshop focused primarily on communication skills and on the understanding of disability and quality of life issues in migraine patients. In general the responses revealed that the attendees were neurologists in practice for more than 15 years, that over 50% had prior knowledge of communication skills and used them in various ways, and 74% were involved in teaching family physicians. Some knew and used disability and quality of life tools but up to one third of participants did not assess disability in their patients. Most wanted to learn more about communication skills and other objectives noted and 19% of respondents wanted to learn more about prophylactic antimigraine treatments and how to differentiate/contrast the triptans. Using a needs assessment tool allowed organizers of an educational workshop to determine the current knowledge and perceived and unperceived needs of the participants with respect to communication skills, assessing disability and quality of life issues, and communication of treatments to migraine patients.

A Comparison of the Objective and Subjective Outcomes of Colposuspension for Stress Incontinence in Women

Objectives To investigate the impact of colposuspension for stress incontinence on the symptoms and quality of life of women undergoing both primary and repeat surgery for genuine stress incontinence and in addition to assess the use of a condition specific quality of life questionnaire as an outcome measure following surgery. Design Prospective case series: videocystourethrography performed before and between six and twelve months after surgery. Validated condition specific quality of life (QoL) questionnaires completed by women before and six to twelve months after surgery. Setting A tertiary referral Urogynaecology Unit in a teaching hospital. Participants A consecutive series of 83 women undergoing colposuspension between March 1995 and December 1997. Pre-operative assessment and surgery was performed by, or was under the direct supervision of, the unit director. Intervention Modified Burch colposuspension. Main outcome measures Objective results of surgery assessed with videocystourethrography. Subjective results evaluated using a condition specific QoL tool, the Kings Health Questionnaire (KHQ). Symptom severity was evaluated as a component of the condition specific QoL questionnaire. Results Objective cure was demonstrated in 92% of women undergoing primary surgery with an 8% incidence of de-novo detrusor instability and a 10% incidence of voiding difficulties. In the group of women having repeat surgery the objective cure rate was 81% with no de-novo detrusor instability and a 6% incidence of post-operative voiding difficulties. QoL scores improved in 95% of women. Improvements of over 25% were seen in 70% of women and of over 50% in 28%. However, 2.4% of women recorded a deterioration in QoL scores. Conclusions Colposuspension performed in this setting, assessed using both objective and standardised subjective measures, completed by women themselves, appears to produce good objective and subjective results and leads to enhanced quality of life in the great majority of women.

Evaluation of 3 quality of life measurement tools in patients with chronic heart failure

Objective: The objectives of this study are to (1) Address issues related to selecting a quality of life (QOL) measuring tool; and (2) Present data from a pilot test comparing 3 QOL tools (Medical Outcomes Study Short Form-36 [SF-36], the Minnesota Living with Heart Failure Questionnaire [LHFQ], and a visual analogue scale). Design: Descriptive comparative. Setting: A Southern university-affiliated tertiary medical center outpatient heart failure clinic. Patients: Thirty adults, randomly selected from those treated in a multidisciplinary, nurse practitioner–managed heart failure clinic. Results: Significant correlations were found among the global or broader measures of QOL (visual analog scale and LHFQ Total score) and the component scores (LHFQ Emotional, LHFQ Physical, SF-36 Mental [MCS], and SF-36 Physical [PCS]), with the only exception being that of the LHFQ Total and the SF-36 PCS. Mental and physical components of QOL were not related within the SF-36 or between the SF-36 PCS and the LHFQ Emotional score. However, the emotional and physical scores were highly and significantly related within the LHFQ and between the SF-36 MCS and the LHFQ Physical score. Conclusions: The SF-36 was better able to differentiate physical and emotional aspects of QOL in this sample. The LHFQ subscales may be less useful in QOL assessment than the total score. (Heart Lung® 2001;30:332-40.)

PGI17: COMPARISON OF GENERIC VERSUS DISEASE SPECIFIC TOOLS FOR THE MEASUREMENT OF HEALTH-RELATED QUALITY OF LIFE IN CROHN'S DISEASE

Health-related quality of life (HRQoL) research suggests that, due to unique characteristics of a disease state, disease specific tools are better discriminators of health status than generic tools. OBJECTIVE: To compare generic (SF-12) versus disease specific (SIBDQ) quality of life tools in a cohort of patients receiving treatment for Crohn's Disease (CD). METHODS: Structural Equation Modeling techniques were used to evaluate the effectiveness of the SF-12 and the SIBDQ for evaluating health status patients with CD. A cohort of 151 patients with CD receiving drug therapy was administered both instruments via telephone survey. RESULTS: The variance explained by the SIBDQ in this population was 11.6% while the SF-12 explained 55.7%. Adapted models of both the SIBDQ and SF-12 resulted in explained variance of 54.8% and 84.1%, respectively. CONCLUSIONS: Given these results, the generic HRQoL tool was significantly better than the disease specific tool at measuring and accounting for health status in this population. Patients with moderate or severe CD have previously been shown to have differing clinical response to therapy based upon disease severity, whereby patients with more severe disease have better response. Due to these possible unique clinical outcomes of newer medications such as infliximab, the effectiveness of disease specific tools may be compromised since improving therapies may affect HRQoL in a different manner than therapies previously available. Other innovative therapies, such as biologic response modifiers for rheumatoid arthritis, may have similar findings related to HRQoL measurement. This potential problem with HRQoL measurement is likely to increase as biopharmaceutical and pharmacogenomic research increases the number and rate of new product approvals. These findings have important implications related to measurement of HRQoL in clinical trials and pharmacoeconomic evaluation of medications. This suggests a need for careful reevaluation of disease specific tools given the clinical effects of newer therapies.

Quality of life in breast cancer patients: a cluster analytic approach

Quality of life (QOL) questionnaires are integrated into clinical trials in order to evaluate different treatments, and rarely used in a diagnostic sense. The aim of this study was to identify clinically meaningful subgroups by means of established QOL tools. Since January 1995, a field study funded by the German Ministry of Health was conducted to evaluate quality of care of breast cancer patients in eastern Thuringia. During the follow-up period, the European Organization of Research and Treatment of Cancer (EORTC), Quality of Life C30 and the breast specific module BR23 were mailed. One-hundred-fifty-eight women answered both questionnaires. A cluster analysis was performed to distinguish subgroups on the basis of QOL-BR23 scores. According to the QOL outcomes, four subgroups could be described. There was a strong relation to operative treatment (p < 0.05), while no association with the adjuvant treatment strategy was observed. The subsets identified on the basis of BR23 scores were significantly related to all C30 domains. It was possible to demonstrate the clinical validity in terms of clinical and sociodemographic data. No association was found with the marital status or the highest level of education, while a worsening of the financial situation was associated. It could be shown that a distinction of patient subgroups based on clinically meaningful BR23 data is possible. Subgroups with specific profiles could be identified. In the future, the characterisation of subgroups could provide a possibility to generate indications for specific supportive interventions.

Quality of Life endpoints in prostate chemoprevention trials

Although the ultimate goal of any chemoprevention study is to extend life by preventing cancer, it is also important that in doing so, the quality of life is not reduced. Hence, quality of life (QOL) endpoints are secondary only in importance to survival as an endpoint for prostate chemoprevention trials. One can conceptualize QOL endpoints as just another surrogate endpoint biomarker. QOL can be administered and collected in a valid and reliable fashion from cancer patients as demonstrated by numerous clinical trials. To date more than 25 prostate cancer QOL tools have been developed with over 700 different items. However, patients may be asymptomatic, leaving the sensitivity and specificity of the QOL instrumentation in question. Judicious use of a global QOL measure supplemented by protocol-specific or disease-specific instruments is an efficient approach for prostate chemoprevention trials. Clinical significance and missing data considerations need to be elucidated a priori in definitive terms so that results are directly interpretable from the data obtained. The effect of chemopreventive agents on QOL needs to be sufficiently modest to be practical to justify administration in a healthy population. As such, great care needs to be given to a priori determination of the QOL constructs that are most likely to change.

A comparison of the objective and subjective outcomes of colposuspension for stress incontinence in women

Objectives To investigate the impact of colposuspension for stress incontinence on the symptoms and quality of life of women undergoing both primary and repeat surgery for genuine stress incontinence and in addition to assess the use of a condition specific quality of life questionnaire as an outcome measure following surgery. Design Prospective case series: videocystourethrography performed before and between six and twelve months after surgery. Validated condition specific quality of life (QoL) questionnaires completed by women before and six to twelve months after surgery. Setting A tertiary referral Urogynaecology Unit in a teaching hospital. Participants A consecutive series of 83 women undergoing colposuspension between March 1995 and December 1997. Pre-operative assessment and surgery was performed by, or was under the direct supervision of, the unit director. Intervention Modified Burch colposuspension. Main outcome measures Objective results of surgery assessed with videocystourethrography. Subjective results evaluated using a condition specific QoL tool, the Kings Health Questionnaire (KHQ). Symptom severity was evaluated as a component of the condition specific QoL questionnaire. Results Objective cure was demonstrated in 92% of women undergoing primary surgery with an 8% incidence of de-novo detrusor instability and a 10% incidence of voiding difficulties. In the group of women having repeat surgery the objective cure rate was 81% with no de-novo detrusor instability and a 6% incidence of post-operative voiding difficulties. QoL scores improved in 95% of women. Improvements of over 25% were seen in 70% of women and of over 50% in 28%. However, 2.4% of women recorded a deterioration in QoL scores. Conclusions Colposuspension performed in this setting, assessed using both objective and standardised subjective measures, completed by women themselves, appears to produce good objective and subjective results and leads to enhanced quality of life in the great majority of women.

Validation of the United States' version of the World Health Organization Quality of Life (WHOQOL) instrument

In 1991, the World Health Organization initiated a project to simultaneously develop a quality of life (QOL) instrument in 15 countries: The World Health Organization Quality of Life (WHOQOL) instrument. This was intended as a generic QOL tool for use with patients across varying disease types, severities of illness, and cultural subgroups. The objective of the current study was to evaluate the WHOQOL-100 in the U.S., one of the original 15 participating countries. The WHOQOL is a 100-item self-report instrument consisting of 24 subscales within six domains: Physical, Psychological, Independence, Social, Environment, and Spiritual. Four additional items pertain to overall QOL/health. We tested the WHOQOL-100 (U.S. version) in a sample of 443 adults ( n = 251 chronically ill, n = 128 healthy, and n = 64 childbearing) in the U.S. to test its reliability (internal consistency, test–retest), construct validity (convergent, discriminant), responsiveness, and factor structure. The WHOQOL-100 (U.S. version) has acceptable internal consistency (alpha range: 0.82–0.95 across domains) and reproducibility (ICC range: 0.83–0.96 at 2-week retest interval). It is responsive to change in clinical conditions, as evidenced by predicted score change (effect size) in women after childbirth. Construct validity was demonstrated by (1) its correlation with the Short Form-36 and Subjective Quality of Life Profile, and (2) its ability to discriminate between the diverse samples in this study. The conceptual structure was confirmed exactly with the exception of four facets that did not correlate most highly with the domains to which they were originally assigned, but these differences were minor. The WHOQOL measurement system is suitable for evaluating the QOL of adults in the U.S. The psychometric properties will be continually evaluated as more data become available in the U.S.

The development of a quality of life tool for use in palliative cancer care

The development of a quality of life tool for use in palliative cancer care

Development of a head and neck companion module for the quality of life–radiation therapy instrument (QOL-RTI)

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 (Chronbach’s α = 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.

Quality-of-life changes in patients with thyroid cancer after withdrawal of thyroid hormone therapy.

Quality of life (QOL) is an important consideration as patients survive longer with cancer and is an area of increasing interest in patients with thyroid cancer who undergo long-term cancer surveillance. However, there are few disease-specific QOL tools available to evaluate QOL in patients with thyroid cancer. The purposes of this longitudinal, repeated-measures study were to: (1) test a new instrument, the QOL-Thyroid Scale, during thyroid hormone withdrawal; and (2) to evaluate the impact of thyroid hormone withdrawal on patients' perceived changes in quality of life. The sample included 34 subjects (mean age 40 years) undergoing thyroid hormone withdrawal in preparation for scanning procedures. Subjects completed three instruments (demographic data tool, the QOL-Thyroid, and the FACT-G) at four specific time points in relationship to scanning. The results demonstrated that the QOL-Thyroid tool is a reliable and valid measure of QOL. Cronbach's alpha coefficient of r = .78 between QOL-Thyroid and FACT-G indicated good concurrent validity. Second, the impact of thyroid hormone withdrawal on QOL showed significant changes in physical, psychological, and social well-being across the four testing points. The greatest changes occurred between peak hormone withdrawal and thyroxine (T4) therapy. While it is generally known that patients suffer troublesome physical symptoms relating to thyroid hormone withdrawal, the negative psychological, family, and work sequelae are less apparent. In conclusion, the QOL-Thyroid is a reliable and valid measure for use in evaluating patients undergoing scanning procedures and may be used to identify and target teaching and support for high-risk areas in patients lives that are negatively affected by hormone withdrawal.

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

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.