Physical Well-being Scores Research Articles

Long-Term Outcomes in Patients with Intermediate-Risk Hodgkin′s Disease Treated with ≤3 Cycles of Chemotherapy followed by Subtotal Nodal Irradiation

Purpose/Objective: To assess long-term outcomes including disease control, late treatment effects, and quality of life in a cohort of patients treated with ≤3 cycles of chemotherapy (CT) followed by subtotal nodal irradiation (STNI). Materials/Methods: Among a consecutive series of 415 Hodgkin′s patients, 37 who were identified with “intermediate risk Hodgkin′s disease” (large mediastinal masses with MMT >0.33 (74%), B symptoms (19%), and/or >4 involved nodal regions) were treated with ≤3 cycles of CT followed by STNI. Disease stages were I (3), II (24), and III (10). Alkylating agent-based chemotherapy was employed in 36 of 37 patients. STNI consisted of mantle, para-aortic, and splenic or splenic pedicle fields. Minimum potential follow-up was 5 years and observed follow-up ranged from 3.3 to 32 years (median of 13.6 y). Absolute (AS), cause-specific (CS) and event-free survival (EFS), and freedom from relapse (FFR) rates were calculated using the Kaplan-Meier product limit method. Quality of life was assessed in all living patients using the Functional Assessment of Cancer Therapy (FACT) questionnaire. Results: The 15 and 20 rates of FFR were 97% and 97%; AS, 89% and 77%; CSS, 94% and 94%; and EFS, 74% and 58%. Hypothyroidism developed in 46%, herpes zoster in 24%, infertility in 11%, and transient radiation pneumonitis in 8%. One patient died from Hodgkin′s, one from treatment related leukemia, and three from intercurrent disease. Three developed second malignancies at 9 to 15 years and two developed benign tumors at 18 years. None have had any evidence of disease after treatment. All living patients completed FACT surveys and self-reported excellent quality of life with median overall physical well-being scores of 0 (on a scale of 0 to 4, with 0 being complete physical well-being) and median functional well-being scores of 4 (on a scale of 4 to 0, with 4 being complete functional well-being). Conclusions: High disease control rates can be achieved in Hodgkin′s patients with a variety of approaches, but increasing importance in treatment selection is ascribed to long-term outcomes including not only disease control but also treatment-related toxicity. This report documents excellent long-term outcomes achieved in intermediate risk Hodgkin′s disease with ≤3 cycles of chemotherapy followed by subtotal nodal irradiation, including not only disease control, toxicity profiles, cause specific and event free survival, but also self-reported physical and functional well-being.

Comparison of 2 Quality-of-Life Questionnaires in Women Treated for Breast Cancer: The RAND 36-Item Health Survey and the Functional Living Index–Cancer

A variety of health status questionnaires have been used in physical rehabilitation studies involving women with breast cancer, but the usefulness of these questionnaires as measures of physical, mental, and social well-being has not been firmly established in this population. This study was conducted to assess the convergent and discriminative properties of the RAND 36-Item Health Survey and the Functional Living Index-Cancer (FLIC). Both questionnaires were administered concurrently to 110 outpatients treated surgically for breast cancer at a National Cancer Institute-designated Comprehensive Cancer Center. Bivariate correlations and a multi-trait-multi-method matrix were used to evaluate convergent validity between summary and subscale scores from both questionnaires. Discriminative validity was assessed by testing for expected differences between women who were treated for breast cancer with and without secondary lymphedema. Correlations between overall quality-of-life scores produced by both questionnaires were modest, indicating that the instruments focus on somewhat different aspects of health-related quality of life. Global quality-of-life and physical well-being scores were lower among women with lymphedema secondary to breast cancer. The FLIC demonstrated greater sensitivity to group differences in emotional well-being. The results suggest that neither questionnaire can be replaced by the other in studies of women treated for breast cancer. Both questionnaires were able to distinguish physical functioning deficits in women with lymphedema secondary to breast cancer, but symptom- or treatment-specific measures may be required to assess more subtle difficulties related to the emotional aspects of health and functioning in this population.

Longitudinal study of quality of life in patients with localized prostate cancer undergoing radiotherapy

This study prospectively evaluated quality of life (QOL) in localized prostate cancer patients undergoing radiotherapy, and it examined the relationships between QOL, depression, fatigue, and sleep disturbance. Instruments that were used are Functional Assessment of Cancer Therapy for Prostate (FACT-P), Beck Depression Inventory (BDI), Piper Fatigue Scale (PFS), and Epworth Sleepiness Scale (ESS). We evaluated patients at preradiotherapy (PRT), midway radiotherapy (MRT), completion of radiotherapy (CRT), follow-up radiotherapy (4 to 8 wk) (FRT), and long-term follow-up radiotherapy (FRT2) (12 mo or more). Forty participants with a mean age of 67.8 yr were studied. Duration of radiotherapy was 7-8 wk. Mean long-term follow-up period post-CRT was 16.2 mo (range 12- 24 mo). All patients had clinical T1c to T2b prostate cancer. Prostate Cancer Specific (PCS) and Physical Well-Being (PWB) subscales of FACT-P, scores at MRT and CRT were significantly lower than at PRT. At FRT2, PWB scores declined further, while PCS scores increased. PFS median scores were significantly higher at CRT and at FRT2 as compared with PRT. Patients scoring higher on PFS were more likely to report a poorer QOL and PWB as measured with FACT-P questionnaire. No significant changes were noted in the BDI and ESS scores during the study periods. The PWB declined during and at CRT and worsened at FRT2. Decline in PCS subscale scores during and at CRT reflects worsening of urinary symptoms and appearance of bowel problems. The scores improved at long-term follow-up. A relationship was found to exist between physical well-being and fatigue.

French version of FACT-G: validation and comparison with other cancer-specific instruments

The aim of this study was to assess the validity of the French version of the Functional Assessment of Cancer Therapy – General (FACT-G), and to compare its psychometric properties with those of two other cancer-specific quality of life questionnaires, European Organisation for Research and Treatment of Cancer Quality of Life – Core 30 (EORTC QLQ-C30) and Functional Living Index – Cancer (FLIC). Two hundred and twenty three patients with breast or colorectal cancer completed the FACT-G questionnaire in French followed by (in random order) the QLQ-C30 and FLIC. An additional 87 patients with head and neck (H&N) cancer completed the FACT-H&N followed by the QLQ-C30 and H&N-Besançon. The French version of FACT-G was internally consistent, and its reproducibility was excellent. FACT-G Physical Well-Being and global scores correlated with all QLQ-C30 subscales. There was evidence of discriminant validity. Compared with the other tools, FACT-G included a statistically significantly higher proportion of items patients considered to be confusing or upsetting. Patients with breast or colorectal cancer expressed a preference for QLQ-C30. Use of the specific H&N additional items increased the responsiveness to change of FACT-G. The French version of FACT-G is valid and has psychometric properties similar to those of FLIC and QLQ-C30.

Prospective quality-of-life assessment in patients receiving concurrent gemcitabine and radiotherapy as a bladder preservation strategy

Objectives To assess, in a Phase I study, whether bladder preservation with concurrent gemcitabine and radiotherapy (RT) influenced patient-reported quality of life (QOL) as determined by the Functional Assessment of Cancer Therapy-Bladder (FACT-BL). Methods Between January 1998 and March 2002, 24 patients with urothelial carcinoma of the bladder were enrolled, and 23 patients underwent transuretheral resection of bladder tumor, followed by twice-weekly gemcitabine with concurrent RT. The initial dose was 10 mg/m 2 given twice weekly and increased as tolerated. To assess treatment-related QOL, patients completed the FACT-BL questionnaire. Results Of the 24 patients enrolled, 23 (96%) were assessed for toxicity and response. The FACT-generic (G) QOL assessment was obtained from 22 (92%) of 23 patients. No statistically significant difference was found in the FACT-G or FACT-BL or the combination before, during, or after treatment. The FACT-BL values were lower in patients who received higher doses of gemcitabine (greater than 20 mg/m 2 versus 20 mg/m 2 or less). At least one dose-limiting toxicity (DLT) was experienced by 5 (23%) of 22 patients. The FACT-G values were lower for those patients who experienced DLT (difference of −13.1, P = 0.07). The physical well-being scores for patients who experienced DLT were lower after treatment (difference of −5.2, P = 0.03) compared with those without DLT. Conclusions Concurrent RT and gemcitabine failed to statistically influence patient-reported QOL, although patients who received higher doses reported lower FACT-BL scores. The results of this study suggest that concurrent gemcitabine with conformal RT is a tolerable treatment regimen for bladder preservation, as demonstrated by the excellent treatment compliance and similar FACT measurements.

Health-related quality of life (HRQoL) in patients with cancer and other concurrent illnesses

This study analyzed the impact of eight common chronic medical conditions on cancer patients' health-related quality of life (HRQoL) as measured by the functional living index-cancer (FLIC). The FLIC was administered to a population of 405 people in 14 communities in the North Central US within 4-8 weeks of diagnosis with breast or colorectal cancer. At that time, patients also self-reported any other health conditions for which they had been receiving medical treatment. The impact of the selected chronic conditions on the FLIC scores was analyzed using Student's t-tests and linear multiple regression. In the bivariate analysis, patients with heart/circulation problems had lower FLIC total scores (p < 0.05), physical well-being subscale scores (p < 0.05), and nausea subscale scores (p < 0.01). Patients with diabetes had lower nausea subscale scores (p < 0.05). The social well-being subscale score was higher with the report of arthritis/joint problems (p = 0.001). In multivariate analysis adjusted for age, arthritis/joint problems were predictive of the social well-being (p < 0.01) and hardship due to cancer (p < 0.05) subscale scores; heart/circulation problems (p < 0.001) and diabetes were predictive of the nausea subscale scores. ECOG performance status was significant predictor for the FLIC total and all of the subscale scores. HRQoL as measured with the FLIC scores in patients with cancer is impacted by the presence of other concurrent health conditions; this finding has implications for HRQoL theory and application.

Prediction of Survival for Advanced Cancer Patients by Recursive Partitioning Analysis: Role of Karnofsky Performance Status, Quality of Life, and Symptom Distress

We performed an exploratory recursive partitioning analysis (RPA) in 429 metastatic cancer patients who had completed a Functional Assessment of Cancer Therapy–General (FACT-G) and a Memorial Symptom Assessment Scale–Short Form (MSAS-SF) to define survival prognostic groups. The Cox model analysis also was performed. Both RPA and Cox models included Karnofsky performance status (KPS), age, FACT-G subscales, and MSAS-SF subscales as survival predictors. Of 429 patients, 348 patients (81.1%) had expired at time of analysis. The median age was 67 years (27–89), with median length of survival of 147 days. The RPA identified four distinct survival groups (p < .0001) with three variables: KPS, physical well-being, and physical symptom distress. The most significant split was KPS of 50%, followed by physical well-being score of 25 and physical symptom distress score of 0.6. The median survival time was 29 days for patients with KPS < 50%; 146 days for patients with KPS ≥ 50% and physical well-being < 25; 292 days for patients with KPS > 50%, physical well-being ≥ 25, and physical symptom distress score > 0.6; and 610 days for patients with KPS ≥ 50%, physical well-being ≥ 25, and physical symptom distress score ≤ 0.6. The Cox model found, in addition to KPS (p < .0001) and physical well-being (p = .08), different predictors: psychological symptom distress (p = .0007), global distress index (p = .02), and age (p < .0001). We concluded that the KPS, quality of life, and symptom distress scores can be combined to define prognostic groups. Such models may be helpful for clinical decision making.

Psychological assessments for cardiac rehabilitation patients

Psychological and quality of life measures are important in the assessment of cardiac rehabilitation (CR) patients and the outcome of treatment. This study aimed to assess the utility and sensitivity to change of three simple questionnaires in a CR setting. A total of 1403 patients who entered CR over 51 months were studied. Patients completed questionnaires before and after their phase 3 CR program—Hospital Anxiety and Depression (HAD) scale, WONCA/COOP charts and an analogue score of wellbeing. The three instruments took about 5.5 min in total to complete and 30 s to interpret. There were highly significant reductions in mean anxiety score—from 6.04 to 4.67 ( P<0.001, 95% CI −1.52 to −1.16) and depression from 4.00 to 2.52 ( P<0.001, 95% CI −1.62 to −1.29) The mean analogue of wellbeing score improved from 7.09 to 8.19 ( P<0.001, 95% CI 0.97–1.22 ) There were highly significant improvements in five of the six WONCA domains. There were significant correlations between improvements in scores from all instruments. The sensitivity indices were in the ‘good’ range for changes in WONCA physical fitness domain and subjective well-being score and in the (moderate) range for changes in depression, well-being and WONCA overall health. Initial physical fitness was significantly correlated with the initial levels of all psychometric scores except anxiety and WONCA feelings, but improvements in fitness were not correlated with any changes in psychometric scores. The instruments described were quick to administer and to interpret and showed sensitivities to change superior to those which have been reported for other questionnaires. We believe them to be practical tools for use in CR units.

Rabeprazole improves and maintains overall well being in gastroesophageal reflux disease (GERD) over 5 years

Purpose: To compare the impact on overall physical well being of rabepmzole 20 rag, rabeprazole 10 mg, and placebo over 5 years of mainter~ance therapy in GERD patients. Methods: 497 patients, previously diagnosed with erosive/ulcerative GERD healed in an acute efficacy trial, entered a multicenter, double-blind, placebo-controlled, parallel-arm, 1year maintenance study. All patients completing 1 year without GERD relapse were eligible to participate for 4 more years in an extension phase. Efficacy variables of the combined 5 years (260 weeks) of study included: overall physical well-being score (scale, 0 = very good; 4 = very poor), relapse of seventy/frequency of daytime and nighttime heartburn, and antacid use. Results: At endpoint (260 weeks), both rabeprazole groups had significantly higher ratings in overall well being versus placebo (p 2; p-<0.008). Rabeprazole 20 mg also produced a significantly lower relapse rate than rabeprazole 10 mg for weeks 4-65 (p~0.038). These results in overall well being corresponded with significantly lower relapse rates with rabeprazole versus placebo in heartburn frequency and severity seen over 5 years (p-<0.02). Mean daily antacid dose consumed by the rabeprazole 20 mg group (0.17) was less than in the rabeprazole 10 mg (0.24) or placebo groups (0.24) at endpoint. For weeks 4-104 and week 143, there were significant differences in change in daily antacid use from baseline favoring both rabeprazole groups versus the placebo group (p-<0.05). Conclusions: 5-year maintenance therapy with rabeprazole improves overall well being compared with placebo. Research supported by Eisai Inc., Teaneck, NJ and Janssen Pharmaceutica Inc., Titusville, NJ.

Standard vs. Radical Pancreaticoduodenectomy for Periampullary Adenocarcinoma: A Prospective, Randomized Trial Evaluating Quality of Life in Pancreaticoduodenectomy Survivors

This study was designed to assess the health-related quality of life (QOL) of patients who had been randomly assigned to either standard or radical pancreaticoduodenectomy for periampullary adenocarcinoma. Pancreaticoduodenectomy has been performed in increasing numbers for periampullary adenocarcinoma. The appropriate extent of resection (standard vs. radical [extended]) remains controversial, particularly as concerns survival benefit. Past reports comparing standard vs. radical resection have suggested that the more extensive resection is attended by negative functional outcomes (diarrhea and weight loss) and poorer QOL, diminishing the impact of any possible survival advantage of the radical resection. A prospective, randomized single-institution trial comparing standard pancreaticoduodenectomy (pylorus preservation preferred) to radical pancreaticoduodenectomy (including distal gastrectomy and retroperitoneal lymphadenectomy) evaluated 299 patients with periampullary adenocarcinoma between April 1996 and June 2001. A standard Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) QOL survey designed for hepatobiliary cancer was sent to 150 of these patients surviving pancreaticoduodenectomy. QOL and functional status were assessed via a series of subscale scores for physical, social, emotional, and functional well-being. A total of 105 QOL surveys (70%) were returned and analyzed, with 55 of the patients having been randomized to the standard group and 50 to the radical group. The patients were evaluated at a mean of 2.2 years after pancreaticoduodenectomy. The two groups were statistically similar with regard to multiple parameters including age at operation (64.6 years), race, intraoperative blood transfusions, pathologic diagnosis and staging, and perioperative complications. The radical group had a significantly higher percentage of men (66% vs. 44%; P = 0.02), a longer operative time (369 minutes vs. 327 minutes; P < 0.001), and a longer postoperative length of hospital stay (13.6 days vs. 10.1 days; P < 0.01). The FACT-Hep total QOL scores were similar between the standard and radical groups: 143.5 vs. 147.3, respectively. Additionally, the individual FACT-G subscale scores evaluating physical (22.1 vs. 23.3), social (24.5 vs. 24.4), emotional (19.2 vs. 19.6), and functional well-being (20.6 vs. 22.4) were comparable between the standard and radical groups. Subgroup analyses based on pathologic diagnosis (pancreatic, ampullary, distal bile duct, etc.) failed to reveal any differences in QOL assessment between the standard and radical pancreaticoduodenectomy groups. Finally, QOL measures were similar when comparing time since operation (<2 years' follow-up vs. >2 years' follow-up) and age (≤65 years vs. >65 years). This is the largest report comparing QOL assessment in survivors of pancreaticoduodenectomy randomized between standard and radical resection. These data demonstrate no differences in long-term QOL between standard and radical resection. These results imply that no negative long-term QOL measures are associated with radical pancreaticoduodenectomy (as performed in this study) for periampullary adenocarcinoma. ( J Gastrointest Surg 2003;7:1–11.)

A study on the menopausal symptoms and quality of life in middle aged women

The purpose of this study is to investigate the differences Quality of Life(QOL) according to menopausal symptoms in middle aged women. The subjects consisted of 578 women(45-60 years old) residing in urban area by convenience sampling from March 15 to May 30, 2002. The data were collected by structured questionnaire that included general characteristics, menopausal symptoms and QOL scale. the collected data were analyzed by the SPSS 11.0 program that included descriptive statistics, t-test and ANOVA. The averaged age of menopause of subjects was 48.29+/-4.66 years and 74.8% in the subjects complained menopausal symptoms. As for the orders of complained menopausal symptom, it was fatigue, hot flashes, benumbed hands and feet, and irritability. The mean score of the QOL scale was showing above average level of quality of life. Religion was significantly different to the score for activity of QOL, monthly income was different to the score for activity and physical well-being of QOL. Menopausal status was significantly different to the QOL. This study suggests that a replicate study is needed. The results are also useful in developing various programs for health promotion of middle aged women.

Health-Related Quality of Life and Postoperative Length of Stay for Patients with Colorectal Cancer

Background. Length of stay (LOS) after surgery is a major determinant of resource utilization for colorectal cancer (CRC). The purpose of this study was to examine the association between pretreatment health-related quality of life (HRQL) scores and postoperative hospital LOS in a cohort of patients undergoing surgery for CRC. Methods. Seventy patients with biopsy-proven CRC were enrolled in an IRB-approved, prospective study. Information was collected concerning standard perioperative variables. Prior to surgery, all patients also completed the CRC-specific module of the Functional Assessment of Cancer Therapy (FACT-C). Perioperative variables and FACT-C scores were compared with LOS in both univariate and multivariate analysis. LOS for those patients scoring in the lowest quartile on FACT-C was compared with LOS for patients scoring in the remaining quartiles. Results. Median length of stay for the entire group was 6 (range 3–25) days. In univariate analysis, surgical complications (10.6 vs 6.6 days; P = 0.001) and with poorer FACT-C individual scale scores for Physical Well-Being (9.1 vs 7.3 days; P = 0.04), Functional Well-Being (9.6 vs 7.1 days; P = 0.006), and Colorectal Cancer Concerns (9.5 vs 7.1 days; P = 0.01) were all significantly associated with increased length of stay. In multivariate analysis, surgical morbidity (OR = 5.6; 95% CI 1.5–21.4), age >72 (OR = 6.0; 95% CI 1.6–23.5), and low FACT-C total score (OR = 4.2; 95% CI 1.1–15.6) were independently associated with increased LOS. Conclusions. Pretreatment HRQL scores as measured by FACT-C may be of benefit in the prediction of LOS. Such information may be an important and currently neglected means of risk-adjusting populations undergoing surgery for colorectal cancer for this outcome.

Meta-analysis of results from eight randomized, placebo-controlled trials on the effect of cilostazol on patients with intermittent claudication

We examined the effect of cilostazol, a type III phosphodiesterase inhibitor, on pain-free and maximal walking distance and quality of life measures. The present study examined adverse effects in 2,702 patients with stable, moderate to severe claudication enrolled in 8 randomized, double-blind, placebo-controlled trials. Treatment duration ranged from 12 to 24 weeks. Cilostazol therapy increased maximal and pain-free walking distances by 50% and 67%, respectively. In subgroup analysis, cilostazol increased pain-free and maximal walking distance similarly in men and women, in older (≥65 years) and younger patients, and in patients with and without diabetes. Quality-of-life assessments revealed enhanced scores for physical well-being. Cilostazol-treated patients reported a higher incidence of headache, bowel complaints, and palpitations than patients given placebos. Cilostazol decreased triglycerides by 15.8% and increased high-density lipoprotein cholesterol by 12.8%, but there were no deleterious effects on any hematologic or serum markers. We conclude that cilostazol significantly increases walking distance and quality-of-life measures in patients with claudication without major adverse effects.

The relationship between physical activity and self-image and problem behaviour among adolescents.

Although there are a vast array of studies which have demonstrated the psychological and physical health benefits of regular aerobic exercise for adults, few studies have focussed on children and adolescents. The current study examined associations between the extent of participation in endurance sport, and self-report data on self-image, physical and psychological health and overall lifestyle in a large representative sample of German high-school students. Almost 1000 German adolescents (aged 14-18 years) were administered a comprehensive series of questionnaires aimed at assessing anxiety-depression, trait addiction, smoking and drinking behaviour, physical ill-health reports, and self-perception of self-image, parental acceptance and educational attainment. Regular practice of endurance exercise was related to a more favourable self-image. There was a strong association between participation in sports and the type of personality that tends to be resistant to drug and alcohol addiction. Physical exercise was further significantly related to scores for physical and psychological well-being. Adolescents who engaged regularly in physical activity were characterised by lower anxiety-depression scores, and displayed much less social behavioural inhibition than their less active counterparts. It is likely that discussion of recreational or exercise involvement may provide a useful point of entry for facilitating dialogue among adolescents about concerns relating to body image and self-esteem. In terms of psychotherapeutic applications, physical activity has many additional rewards for adolescents. It is probable that by promoting physical fitness, increased physical performance, lessening body mass and promoting a more favourable body shape and structure, exercise will provide more positive social feedback and recognition from peer groups, and this will subsequently lead to improvement in an individual's self-image.

Quality of life assessment in advanced non-small-cell lung cancer patients undergoing an accelerated radiotherapy regimen: report of ECOG study 4593

Purpose: To prospectively evaluate the quality of life (QOL) before, at completion, and after therapy for patients receiving an accelerated fractionation schedule of radiotherapy for advanced, unresectable non-small-cell lung cancer in a Phase II multi-institutional trial. Methods and Materials: The Functional Assessment of Cancer Therapy-Lung (FACT-L) patient questionnaire was used to score the QOL in patients enrolled in the Eastern Cooperative Oncology Group Phase II trial (ECOG 4593) of hyperfractionated accelerated radiotherapy in non-small-cell lung cancer. Radiotherapy (total dose 57.6 Gy in 36 fractions) was delivered during 15 days, with three radiation fractions given each treatment day. The protocol was activated in 1993, and 30 patients had accrued by November 1995. The FACT-L questionnaire was administered at study entry (baseline), on the last day of radiotherapy (assessment 2), and 4 weeks after therapy (assessment 3). The FACT-L includes scores for physical, functional, emotional, and social well-being (33 items), and a subscale of lung cancer symptoms (10 additional items). The summation of the physical, functional, and lung cancer symptom subscales (21 items) constitutes the Trial Outcome Index (TOI), considered the most clinically relevant outcome measure in lung cancer treatment trials. Results: The FACT-L completion rates at the designated study time points were as follows: baseline, 30 of 30 (100%); assessment 2, 29 (97%) of 30; and assessment 3, 24 (80%) of 30. At treatment completion, statistically significant declines in QOL scores were noted, compared with baseline for physical and functional well-being. Emotional well-being scores improved at both assessment 2 and assessment 3. The physical and functional scores returned approximately to baseline values at assessment 3. The change in TOI score was evaluated as a function of the clinical response to treatment, toxicity grade, and survival; no clear association was noted. A trend for the largest decrease in QOL was noted for patient groups with shorter survival times. The mean change in the TOI score from baseline to assessment 3 was −8.96 for patients surviving < 52 weeks vs. −0.95 for those surviving > 52 weeks. Conclusions: The FACT-L questionnaire can be successfully administered to non-small-cell lung cancer patients enrolled in a prospective Phase II trial of accelerated radiation fractionation. The decrement in physical and functional QOL during treatment returned to baseline level at 4 weeks after treatment. Emotional well-being improved at all time points. A trend was noted for shorter survival times in patients with the largest negative change in TOI score. These data suggest that the clinical use of hyperfractionated accelerated radiotherapy did not cause a significant, long-term decrease in the QOL of the treated patients, and that it is feasible to perform a QOL study of patients enrolled in such a trial.

Quality of life after intraperitoneal hyperthermic chemotherapy (IPHC) for peritoneal carcinomatosis

Aims: This study assessed the functional status and quality of life (QOL) of patients with disseminated peritoneal cancer (DPC) before and after cytoreductive surgery plus intraperitoneal hyperthermic chemotherapy (IPHC).Methods: Patients with confirmed or suspected diagnosis of gastro-intestinal cancer including stomach, pancreas, hepatobiliary and colorectal cancer with peritoneal implants were enrolled in the study. Sixty-four patients completed the Functional Assessment of Cancer Therapy-Colon (FACT-C) scale and several other instruments at baseline. Forty-eight, 40, 39 and 31 patients were assessed at approximately 2 weeks post-surgery, and 3, 6 and 12 months respectively. Results: There was a significant overall effect on the physical (P=0.0025), emotional (P<0.0001) and functional well-being (P=0.0044) subscales and the FACT-C (P=0.0076). Physical and functional well-being scores decreased at post-surgery follow-up and increased relative to baseline at 3, 6 and 12 months. Nineteen per cent, 46%, 59% and 74% of patients resumed greater than 50% of their normal activities post-operatively at 3, 6 and 12 months respectively. A percentage of patients reported depressive symptoms: baseline (28%), post-operatively (33%), 3 months (23%), 6 months (21%) and 12 months (29%). Conclusions: Cytoreductive surgery followed by IPHC was well tolerated. Most patients returned to baseline or better levels of functioning within 3 months post-treatment.

Patterns over time in quality of life, coping and psychological adjustment in late stage melanoma patients: an application of multilevel models.

Quality of life (QOL) assessment is an important component within cancer research. There is often variability in QOL scores both between patients and across time. Understanding this variability in terms of personal characteristics and psychosocial factors would be useful but is often obstructed by the types of analyses that are applied to longitudinal data sets. Improved understanding can be gained with the application of multi-level or hierarchical models that allow for greater flexibility for modelling individual patterns of change over time. Questionnaires were sent to a cohort of stage IV melanoma patients seen at the Sydney Melanoma Unit between 1991 and 1996, approximately every 3 months for up to 2 years. The data reported here are from a sub-sample of 44 patients who each completed between 3 and 8 questionnaires. Three aspects of QOL were measured (effort to cope, mood and physical well-being), each with a single LASA line. Multilevel techniques were used to model the patterns of QOL over time. Covariates were added to explain variation between patients in their average QOL and change in QOL over time. The scores of each of the three QOL measures showed marked fluctuations over time. However, there was little systematic change during the study in either effort to cope (p = 0.32) or mood (p = 0.06). In contrast, the physical well-being scores of some patients improved while others deteriorated (p < 0.001). On average, physical well-being deteriorated (p < 0.001). Variability between patients accounted for 60% (effort to cope), 45% (mood) and 44% (physical well-being) of the total variance of each scale. A range of psycho-social factors including active and avoidant coping styles and psychological adjustment accounted for significant amounts of the variability between patients in each QOL measure. Individual coping and psychological adjustment are related to individual changes in QOL and to differences among patients' QOL. The study illustrates the use of multi-level techniques to further our understanding of differences between patients in their QOL and how it changes over time.

Non-ignorable missing covariates in generalized linear models

We propose a likelihood method for estimating parameters in generalized linear models with missing covariates and a non-ignorable missing data mechanism. In this paper, we focus on one missing covariate. We use a logistic model for the probability that the covariate is missing, and allow this probability to depend on the incomplete covariate. We allow the covariates, including the incomplete covariate, to be either categorical or continuous. We propose an EM algorithm in this case. For a missing categorical covariate, we derive a closed form expression for the E- and M-steps of the EM algorithm for obtaining the maximum likelihood estimates (MLEs). For a missing continuous covariate, we use a Monte Carlo version of the EM algorithm to obtain the MLEs via the Gibbs sampler. The methodology is illustrated using an example from a breast cancer clinical trial in which time to disease progression is the outcome, and the incomplete covariate is a quality of life physical well-being score taken after the start of therapy. This score may be missing because the patients are sicker, so this covariate could be non-ignorably missing.

The effect of prolonged cycles of chemotherapy on quality of life in gynaecologic cancer patients.

The aim of this study was to determine if the prescription of prolonged cycles of chemotherapy to patients with a variety of gynaecologic cancers has an adverse effect on quality of life (QOL). Patients attending a single gynaecologic oncology clinic who received greater than 6 cycles of chemotherapy were identified. Prior to each chemotherapy cycle, patients were asked to complete a modified Functional Assessment Cancer Therapy-General (FACT-G) quality of life form. QOL scores were compared to their baseline or pretreatment score (cycle 1 score), as well as to their score representing the completion of primary therapy (cycle 6 score). Seventeen patients were identified as having received greater than 6 cycles of systemic cytotoxic chemotherapy. The total number of chemotherapy cycles analyzed was 95. Comparing QOL scores for cycle 1 and 6 to cycles 7-16, we found no significant alteration (improvement or deterioration) in the following subscale scores: physical well being (PWB), social well being (SWB), and functional well being (FWB). Similarly, overall QOL as represented by the summed individual scores was also not affected by the prescription of up to 16 cycles of chemotherapy. Analysis of the emotional well being (EWB) subscale scores revealed a significant downward trend after the 12th cycle of therapy as compared to the 6th cycle (p = 0.04), however this trend was not significant when compared to the pretreatment or cycle 1 scores (p = 0.16). There was however a statistically significant progressive deterioration in the subscale score of the relationship with the doctor (RWD). This was most marked after the 10th cycle of therapy (p < 0.0001). When split by disease status, we again found no statistically significant alteration in PWB, SWB, RWD, EWB, FWB and overall QOL for cycle 1 and 6 as compared to cycles 7-17. However, those patients who were able to attain a complete clinical response (CCR) disease status, achieved a higher SWB (p = 0.003), RWD (p = 0.02), EWB (p = 0.03), and overall QOL scores (p = 0.04) while their PWB scores were not statistically different from patients with stable (p = 0.7) or progressive disease (p = 0.6). In conclusion, the prescription of prolonged cycles of chemotherapy to patients with gynaecologic cancers does not result in an overall deterioration of QOL. Further more an improvement in subscale and overall QOL was demonstrated in those patients able to attain a complete clinical response (CCR).

Quality of Life Assessment in Gynaecological Cancer Patients

The feasibility of quality of life (QOL) assessment in a heterogeneous group of gynaecological cancer patients undergoing chemotherapy was determined. All new patients being prescribed cytotoxic chemotherapy were asked to complete a modified QOL assessment tool. The elected assessment tool is the Functional Assessment Cancer Therapy-General (FACT-G) tool, comprising 33 questions under 5 broad categories: physical well-being, social well-being, relationship with doctor, emotional well-being and functional well-being. Raw scores were calculated and then transformed to a 0-100 scale. Twenty eight patients received a total of 75 treatment cycles of chemotherapy. Four patients were not offered the assessment due to language difficulties. All patients offered the test satisfactorily completed the test to allow statistical analysis. The average number of chemotherapy courses received was 2.5 (range: 1-6). Of a total possible 2,475 study items (33 items x 75 cycles), 240 items were not answered (10%). Of these 240 unanswered items, 2 items (#14 and #15) comprised 38%. The mean transformed score for physical well-being was 32 (SE 2.5), for social well-being the mean transformed score was 50 (SE 1.7), relationship with doctor 86 (SE 2.4), emotional well-being 41 (SE 2) and functional well-being was 54 (SE 2.6). The assessment of QOL indices in gynaecological cancer patients undergoing chemotherapy is feasible. Further research needs to determine the optimal QOL tool for this patient population.