Significant Changes In Quality Of Life Research Articles

Physical activity to maintain quality of life in breast cancer survivors in the Dutch Tamoxifen Exemestane Adjuvant Multicentre (TEAM) trial.

Abstract Abstract #4089 Background: Lifestyle habits such as physical activity frequently change after a breast cancer diagnosis and may unfavorably affect quality of life (QoL) as well as breast cancer outcome.
 Patients and Methods: In the Lifestyle side study of the TEAM trial, lifestyle and QoL questionnaires were filled out at approximately one year after starting hormonal therapy (T1) and again one year later (T2). The T1 questionnaire also included a retrospective assessment of pre-diagnosis lifestyle. Level of recreational physical activity was assessed as time engaged in walking, bicycling, gardening, and sports. Intensity values (METs) were assigned to each activity. The overall level of recreational physical activity was calculated by summing the MET-hours/week of all activities. QoL was assessed using the EORTC C30 and BR23 questionnaires, supplemented with FACT-ES questions covering endocrine symptoms.
 Results: A total of 543 breast cancer patients returned the first questionnaire (response 73%), of whom 454 patients also returned the second questionnaire. Relatively high levels of pre-diagnosis recreational physical activity were observed (mean±SD: 10.4±8.0 hours/week), with approximately one hour per day spent on walking or cycling. The level of recreational physical activity decreased to 8.6±7.2 hrs/wk at T1 and was partly restored at T2 (mean±SD; 9.7±7.4 hrs/wk; p<0.01 for pre-diagnosis vs T1 and T1 vs T2).
 Individuals in the lowest quartile of physical activity at T1 had a significantly worse QoL at T1 with respect to the domains of physical functioning, role functioning and sexual functioning, as compared to individuals in highest quartile of physical activity (difference of 9-15 points on a 0-100 scale; p<0.01). Similarly, individuals with a decrease of ≥15 MET-hrs/wk (equivalent to 1 hr/day of moderate-intensity activities on 5 days of the week) from pre-diagnosis to T1 also had a significantly worse QoL at T1 with respect to physical and role functioning, as compared to individuals with stable levels of physical activity (difference of 12-15 points; p<0.01). The least active group and the individuals with a strong decrease in physical activity also scored worse on fatigue (difference of 15 points on a 0-100 scale; p<0.01).
 Overall, no clinically significant changes in QoL were observed from T1 to T2. However, individuals who increased their level of physical activity from T1 to T2 more frequently experienced improved physical functioning (p=0.03) and a decrease in fatigue (p=0.12).
 Conclusions: In this population of relatively active postmenopausal breast cancer patients, being physically active is associated with better QoL. The temporal sequence of changes in both physical activity and QoL needs to be further studied, since physical activity may affect QoL and vice versa. Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 4089.

Measuring the impact of increased exercise on quality of life in older adults: the UQQoL, a new instrument.

The University of Queensland Quality of Life instrument (UQQoL) was developed to provide a quantitative measure sensitive to the impact of increased exercise on the quality of life (QoL) of older individuals. This paper describes the development and testing of the UQQoL including an exploratory study of focus group interviews with 18 participants aged 65 and over, item development and selection, and instrument piloting with groups of older adults undergoing high-intensity training. The SF-36, another established QoL tool, was also administered at the same time points for comparative purposes. The UQQoL displayed good convergent validity with selected SF-36 domains. A significant change in QoL following training was found, complementing functional improvements. This change was not detected by the SF-36. While broader testing is required, the UQQoL appears to be a reliable instrument sensitive to the change in QoL experienced by healthy community-dwelling older adults following resistance exercise.

Clinically Meaningful Differences in Patient-Reported Outcomes With Amifostine in Combination With Chemoradiation for Locally Advanced Non–Small-Cell Lung Cancer: An Analysis of RTOG 9801

The purpose of this study is to analyze changes in quality of life (QOL) and symptoms from pretreatment to 6 weeks posttreatment in a Phase III randomized study (Radiation Therapy Oncology Group 9801) of amifostine (AM) vs. no AM in patients with Stages II-III non-small-cell lung cancer receiving paclitaxel and carboplatin as induction and then concurrently with hyperfractionated radiation therapy (RT). One hundred thirty-eight patients with baseline and 6-week posttreatment QOL data were analyzed. There were no significant differences in baseline demographics between those who did and did not have QOL data. The QOL and symptoms were assessed by using the European Organization for Research and Treatment of Cancer (EORTC) Global QOL and Pain subscales and the EORTC-Lung Cancer-13 symptom tool. Clinically relevant changes in QOL were characterized by 10-point differences in individual scores pre/post treatment. A daily diary of patient-rated difficulty swallowing and a weekly physician-rated dysphagia log (using National Cancer Institute Common Toxicity Criteria) were completed during treatment. Weight loss was monitored. Differences in outcomes were examined according to smoking status, alcohol use, and sex. Patients receiving AM reported significantly greater pain reduction after chemoradiation (34% vs. no AM, 21%), less difficulty swallowing during chemoradiation, and less weight loss than patients not receiving AM. However, physician-rated assessments of dysphagia were not significantly different by treatment arm. There were no other significant changes in QOL or symptoms according to treatment arm, smoking status, alcohol use, or sex. Patient evaluations of difficulty swallowing and pain suggest benefits from AM use that are distinct from clinician-rated assessments.

Quality of life (QOL) changes in breast cancer patients participating in an anastrozole secondary prevention trial

1515 Background: Adjuvant aromatase inhibitor (AI) trials have reported a decreased incidence of contralateral breast (CLB) cancer. AIs may be associated with specific changes in QOL parameters but little is known about the mechanism. We hypothesized that 12 months (mos) of adjuvant anastrozole would worsen QOL and that changes in QOL would correlate with changes in circulating estrogens and inflammatory markers. Methods: We collected QOL data at baseline, 3, 6, and 12 mos from a prospective, single-arm study designed to determine the effect of adjuvant anastrozole on CLB density in postmenopausal women with hormone receptor-positive stage 0-III breast cancer who had completed local therapy. QOL was measured by the revised National Surgical Adjuvant Breast and Bowel Project (NSABP) menopausal symptoms questionnaire, Mayo Clinic hot flash diaries, Center for Epidemiological Studies Depression Scale (CES-D), Hospital Anxiety and Depression Scale (HADS), Medical Outcomes Study (MOS) sleep scale, MOS sexual function scale, and EuroQOL survey. Estrogens and inflammatory markers (interleukins 6 and 8 and tumor necrosis factor-alpha) concentrations were measured at 0, 6, and 12 mos. Results: From 3/04 to 9/06, 54 predominantly Caucasian women (mean age: 62.9 yrs, range: 47–79) were enrolled in the study. Musculoskeletal symptoms were greater at all treatment time points compared to baseline. Overall, there was no statistically significant change in QOL from baseline to any of the time points or when stratified by age. Although women with BMI ≥ 30 had greater decreases in estrone, estradiol, and estrone sulfate levels over time compared to women with BMI < 30 (p interactions < 0.001), menopausal symptoms increased over time only for women with BMI < 30 (p interaction < 0.03). Analysis of inflammatory markers is underway and the data will be available at the meeting. Conclusions: No significant change in overall QOL from baseline was detected during 12 months of adjuvant anastrozole. Obese women were less likely to develop menopausal symptoms despite a larger decrease in estrogen levels, suggesting an alternate etiology. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Novartis, Pfizer Oncology

A pooled analysis of quality of life measures and adverse events data in north central cancer treatment group lung cancer clinical trials

In this pooled analysis, the authors examined correlations between single-item and multiple-item quality of life (QOL) measures and assessed the agreement between clinically significant changes in QOL and patient-reported adverse events (AE). Data from 6 lung cancer clinical trials that involved 358 patients were pooled. All trials incorporated the Uniscale and 1 of 3 multiple-item assessments: the Functional Assessment for Cancer Therapy-Lung, the Lung Cancer Symptom Scale, or the Symptom Distress Scale. Spearman rank correlations and a Bland-Altman approach were used to assess agreement. Time-to-event analysis was performed using the Kaplan-Meier method. Correlations between the Uniscale and multiple-item assessments were substantial (correlation coefficient = 0.49-0.66). At least 1 10-point decline was reported in the Uniscale and multiple-item assessments by 58% of patients and 39% of patients, respectively. At least 1 severe AE (grade >or=3) was reported in 35% of patients postbaseline. The percent agreement between experiencing a severe AE and a decline in QOL was 48% and 59% for the Uniscale and multiple-item assessments, respectively. The median time to the first 10-point decline in QOL for the Uniscale and multiple-item assessments was 67 days and 142 days, respectively, and the median time to the first occurrence of a severe AE was 304 days. Information gleaned from the single-item Uniscale assessment was comparable to that gleaned from multiple-item global measures. There was moderate agreement between QOL and AE. A 10-point decline in QOL occurred earlier than Common Toxicity Criteria AE reporting. This suggests the need for inclusion of a QOL instrument in lung cancer clinical trials.

Effect of device-guided breathing exercises on blood pressure in hypertensive patients with type 2 diabetes mellitus: a randomized controlled trial

In patients with type 2 diabetes mellitus (DM2), it is hard to reach treatment objectives for blood pressure (BP) with classical treatment options. Recently, reducing breathing frequency has been advocated as a method to reduce BP. We examined if an electronic device such as Resperate, by reducing breathing frequency, would lead to BP reduction in a population of patients with DM2 and hypertension. Our secondary objective was to study the effect of this device on quality of life (QOL). A randomized, single-blind, controlled trial was conducted over a period of 8 weeks to evaluate the effect of this therapy on BP and QOL. The control group listened to music and used no other therapeutic device. BP and QOL changes were studied in 30 patients with DM2 and hypertension. There was no significant difference in change in BP between groups; -7.5 [95% confidence interval (CI) -12.7, -2.3]/-1.0 (95% CI -5.5, 3.6) mmHg in the intervention group and -12.2 (95% CI -17.4, -7.0)/-5.5 (95% CI -9.7, -1.4) mmHg in the control group. Whether or not the target breathing frequency of 10 breaths/min was reached did not affect BP. There were no significant changes in QOL. The effects of Resperate on BP and QOL were not significantly different from those found in the control group. Furthermore, 40% of patients did not reach the target breathing frequency, making this device less suitable for clinical practice in patients with DM2.

Outcomes of electrically stimulated gracilis neosphincter surgery

To examine patient quality of life (QoL) and long-term costs of electrically stimulated gracilis neosphincter surgery (ESGNS). Independently conducted prospective case-comparison study of patients at the Royal London Hospital (RLH), plus a cross-sectional study of outcomes of ESGNS performed at three other UK centres. Cases were patients who underwent ESGNS at the participating hospitals during a 5-year period from 1977. Comparisons were made with two groups of people with similar bowel disorders who did not undergo ESGNS. ESGNS is a procedure designed to improve bowel function for people living with severe faecal incontinence or stomas. It involves transposition of the gracilis muscle to form a neo-anal sphincter. The transposed muscle is electrically stimulated via an electronic pulse generator implanted beneath the skin of the abdomen. Clinical success and symptomatic outcomes of surgery. Generic, domain and condition specific measures of QoL. Comparative costs to the NHS of ESGNS and conventional alternatives. At 3 years after surgery approximately three-quarters of patients still had functioning neosphincters. At this stage, bowel-related QoL and continence improved by more than 20% for nearly two-thirds of RLH patients. However, ongoing bowel evacuation difficulties occurred in half of those with good continence outcomes. QoL improvements were maintained in the smaller group of RLH patients who had reached 4 and 5 years of follow-up, although at this stage the proportion with failed neosphincters had increased. The RLH findings were supported by those from the three other UK centres. No significant changes in QoL were observed in the comparison groups during the follow-up period. The mean cost of patient care at RLH, was 23,253 pounds. In the other three centres, the estimated mean cost of the intervention per patient was 11,731 pounds, reflecting fewer planned operations and repeat admissions. Costs of patient care for those with stomas who did not undergo ESGNS were estimated at 2125 pounds per patient-year and for those who remained with severe faecal incontinence, 442 pounds per patient-year. For patients with prior faecal incontinence, a decision to refer to ESGNS resulted in a cost-effectiveness ratio, estimated over 25 years of follow-up, of between 30,000 pounds and 40,000 pounds per quality-adjusted life-year (QALY) gained, depending on centre. The choice of stoma for these patients resulted in a slightly higher cost than ESGNS. For those with prior stoma, referral to ESGNS resulted in a cost-effectiveness ratio of between 5000 pounds and 15,000 pounds per QALY gained, depending on the centre. Cost-effectiveness ratios of around 30,000 pounds per QALY gained are generally regarded to be reasonably attractive in the UK NHS context. Although ESGNS is a major procedure associated with a high rate of long-term failure and bowel evacuation difficulty, it could be considered as an option at the extreme end of the treatment spectrum for refractory faecal incontinence. A strategy to refer patients for ESGNS would be regarded as cost-effective for patients already with stoma, whilst on the margin of cost-effectiveness for patients initially being managed conservatively.

Sheehan’s syndrome: baseline characteristics and effect of 2 years of growth hormone replacement therapy in 91 patients in KIMS – Pfizer International Metabolic Database

Sheehan's syndrome occurs as a result of ischaemic pituitary necrosis due to severe postpartum haemorrhage. It is one of the most important causes of hypopituitarism, and hence growth hormone deficiency (GHD), in developing countries. However, little is known about the effects of growth hormone (GH) replacement therapy in patients with Sheehan's syndrome. The demographic background characteristics of 91 GH-deficient patients with Sheehan's syndrome (mean age +/- s.d., 46.3 +/- 9.4 years) were compared with those of a group of 156 GH-deficient women (mean age +/- s.d., 51.5 +/- 13.1 years) with a non-functional pituitary adenoma (NFPA). The baseline characteristics and the effects of 2 years of GH replacement therapy were also studied in the 91 patients with Sheehan's syndrome and an age-matched group of 100 women with NFPA (mean age +/- s.d. 44.5 +/- 10.2 years). All patients were enrolled in KIMS (Pfizer International Metabolic Database). Patients with Sheehan's syndrome were significantly younger at pituitary disorder onset, diagnosis of GHD and at entry into KIMS than patients with NFPA (P < 0.01), and had significantly lower insulin-like growth factor I levels (P < 0.001). At baseline, quality of life (QoL) was significantly (P < 0.05) reduced in patients with Sheehan's syndrome compared with those with NFPA (P < 0.001). With regard to treatment effects, lean body mass increased significantly (P < 0.05), QoL improved significantly (P < 0.05) and total and low-density lipoprotein-cholesterol decreased significantly (P < 0.05) in patients with Sheehan's syndrome after 1 year of GH replacement therapy. Similar significant changes in QoL and lipid profiles occurred in patients with NFPA after 2 years of GH replacement. Blood pressure remained unchanged in patients with Sheehan's syndrome, but decreased significantly (P < 0.01) in the group with NFPA after 1 year, before returning to pretreatment levels at 2 years. In conclusion, patients with Sheehan's syndrome have more severe GHD compared with individuals with NFPA. GH replacement therapy in patients with Sheehan's syndrome may have beneficial effects on QoL, body composition and lipid profile.

Exercise Dose Required to Enhance Quality of Life in Cancer Survivors

0705 The treatment of certain cancers is often accompanied by serious psychological and physiological side effects that can greatly reduce the quality of life (QOL) in cancer survivors. These include: decreased aerobic capacity, muscular atrophy, decreased strength and flexibility, adverse body composition changes, depression, anxiety and fatigue. Previous studies have shown exercise to be effective in reducing or alleviating many of these side effects, leading to an improvement in overall QOL. However, most studies have utilized a pretest-posttest design that is sufficiently insensitive to recognize the exercise dose needed to generate significant change in QOL. PURPOSE: The purpose of this study was to investigate the exercise dose required to significantly improve QOL in cancer survivors. METHODS: Twenty cancer survivors (15 female, 5 male, 43–79 years of age) served as subjects. Subjects participated in a ten-week low to moderate intensity (25–40% heart rate reserve) exercise program for 14–20 minutes, three times a week. QOL was assessed weekly with the Quality of Life Index for Patients with Cancer. This scale is composed of 14 items evaluating physical condition, normal activities, and personal attitudes on general quality of life. RESULTS: ANOVA results revealed a significant increase in QOL over the ten weeks (p = .0001). Followup analysis (Scheffe post-hoc test) revealed a significant improvement in overall QOL by week 6 (p < .05). Of the 14 sub-scale components that compose the overall QOL score, the subjects improved most on their perceived strength, ability to sleep and their ability to perform daily tasks. CONCLUSIONS: These results indicate that low to moderate intensity aerobic exercise is beneficial in improving QOL and at least six weeks of aerobic activity are needed to see a significant improvement in QOL. This relatively low dose-response relationship should be beneficial in optimizing cancer survivor adherence to an exercise program.

Exercise Dose Required to Enhance Quality of Life in Cancer Survivors

0705 The treatment of certain cancers is often accompanied by serious psychological and physiological side effects that can greatly reduce the quality of life (QOL) in cancer survivors. These include: decreased aerobic capacity, muscular atrophy, decreased strength and flexibility, adverse body composition changes, depression, anxiety and fatigue. Previous studies have shown exercise to be effective in reducing or alleviating many of these side effects, leading to an improvement in overall QOL. However, most studies have utilized a pretest-posttest design that is sufficiently insensitive to recognize the exercise dose needed to generate significant change in QOL. PURPOSE: The purpose of this study was to investigate the exercise dose required to significantly improve QOL in cancer survivors. METHODS: Twenty cancer survivors (15 female, 5 male, 43–79 years of age) served as subjects. Subjects participated in a ten-week low to moderate intensity (25–40% heart rate reserve) exercise program for 14–20 minutes, three times a week. QOL was assessed weekly with the Quality of Life Index for Patients with Cancer. This scale is composed of 14 items evaluating physical condition, normal activities, and personal attitudes on general quality of life. RESULTS: ANOVA results revealed a significant increase in QOL over the ten weeks (p = .0001). Followup analysis (Scheffe post-hoc test) revealed a significant improvement in overall QOL by week 6 (p < .05). Of the 14 sub-scale components that compose the overall QOL score, the subjects improved most on their perceived strength, ability to sleep and their ability to perform daily tasks. CONCLUSIONS: These results indicate that low to moderate intensity aerobic exercise is beneficial in improving QOL and at least six weeks of aerobic activity are needed to see a significant improvement in QOL. This relatively low dose-response relationship should be beneficial in optimizing cancer survivor adherence to an exercise program.

Quality of life improves with treatment in the Canadian Trial of Atrial Fibrillation

Background The impact of atrial fibrillation (AF) and its treatment on health-related quality of life (QOL) is not well understood. We assessed QOL in patients with symptomatic AF participating in the Canadian Trial of Atrial Fibrillation. Methods Self-report QOL questionnaires including the Short-Form-36 (SF-36), symptom checklist (SCL) and AF Severity Scale (AFSS) were completed at baseline and 3, and 12 months after randomization. Results The study group was aged 65 ± 10 years and 59% were male. By design, 50% of patients were randomized to amiodarone (n = 132), 25% to sotalol (n = 66), and 25% to propafenone (n = 66). Most patients had normal left ventricular function (89%). Physical (41.9 ± 9.3 to 43.7 ± 9.2, P =.001) and mental health (47.5 ± 10.5 to 49.0 ± 9.8, P =.023) summary measures from the SF-36 improved significantly from baseline to 3 months. Arrhythmia symptom frequency and severity (SCL) also improved markedly from baseline to 3 months (symptom frequency 20.4 ± 9.4 to 16.2 ± 9.5 and symptom severity 16.7 ± 8.2 to 12.9 ± 7.4, both P <.001). QOL improvements were not significantly different among the groups randomized to amiodarone, sotalol, or propafenone. However, patients with no symptomatic recurrences of AF had higher scores at 3 months on measures of global well-being than those with recurrences in the first 3 months (7.4 ± 1.8 vs 6.9 ± 1.8, P <.05). There were no significant QOL changes from the 3 to 12 month assessment. Conclusion In patients with symptomatic AF, QOL improves after treatment, independent of the specific drug used for treatment. This is especially true for patients in whom treatment prevents AF recurrence. (Am Heart J 2002;143:984-90.)

A Prospective Longitudinal Study of Quality of Life After Resection of Hepatocellular Carcinoma

Hepatic resection improves quality of life (QOL) in patients with resectable hepatocellular carcinoma (HCC). A prospective longitudinal study. A university teaching hospital. Sixty-six consecutive patients undergoing resection of HCC, and 10 patients with unresectable HCC found after surgical exploration who were subsequently treated with transarterial chemoembolization (control group). Serial measurements of preoperative and postoperative QOL using the Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire for up to 2 years after surgery (at 3, 6, 9, 12, 18, and 24 months). Among the 66 patients with resectable HCC, the mean postoperative QOL scores at 3 months after surgery were significantly higher than the mean preoperative QOL scores in domains related to physical, social, and emotional well-being and relationship with physicians. The mean total QOL score increased from 83.5 (SD, 9.4) before surgery to 94.1 (SD, 7.7) at 3 months after surgery (P <.001). No significant change of QOL scores at 3 months after surgery was observed in the control group. Twenty patients in the resected group died of early recurrence within 2 years after surgery, but their mean postoperative QOL scores remained higher than the preoperative QOL scores for most assessment times. In contrast, in the control group, the mean total QOL scores became significantly lower than the preoperative scores, starting 9 months after surgery. Forty-six patients in the resected group completed all QOL assessments. At all postoperative assessments, their mean QOL scores were higher than preoperative scores. Recurrence developed in 13 of the 46 patients within the 2-year study, and there was significant deterioration of QOL over time among these 13 (P <.001), whereas no significant change in QOL over time was observed among the 33 recurrence-free patients. Of various clinicopathologic factors, only advanced pTNM stage was significantly predictive of deterioration of QOL over time after resection of HCC. Hepatic resection results in significant enhancement of QOL in patients with HCC. Development of recurrence is the main factor leading to deterioration in QOL over time after resection of HCC.