Linear Analogue Self-assessment Research Articles

Relationship Between Fatigue And Measures Of Emotional Distress In Exercising Cancer Survivors

Fatigue, a common and persistent side effect of cancer and cancer treatment, is a complex phenomenon consisting of both physiological and psychological components. Physiological contributors to fatigue include muscular atrophy, anemia, sleep abnormalities, and weight gain. Psychologically, fatigue has been linked to depression, anxiety, and decreased self-efficacy. A common response to fatigue is a reduction in physical activity. However, recent investigations have shown a decrease in fatigue in exercising cancer patients and survivors. The extent to which the reduction in fatigue due to exercise is related to other measures of psychological distress has not been extensively studied in this population. PURPOSE The purpose of this study was to examine the changes and relationships occurring in fatigue and emotional distress in response to an exercise program. METHODS Twenty-nine survivors of cancer (26 female and 3 male, 40–79 years of age) served as subjects. The subjects performed low to moderate (30–60% heart rate reserve) intensity aerobic exercise, three times a week for ten weeks. The Linear Analogue Self-Assessment (LASA) Scale was administered to subjects prior to the onset and at the conclusion of the ten weeks of exercise. This scale is composed of 6 items measuring fatigue, anxiety, confusion, depression, energy, and anger. RESULTS Fatigue and anxiety decreased significantly over the study period (p = .030 and .004 respectively). The measure of energy significantly increased (p <.001). Measures of confusion, depression, and anger all decreased however the results were not statistically significant (p = .128, .280, .123 respectively). A moderate positive relationship was found between the percent changes in fatigue and depression (r= .61, p = .001) and the percent changes in fatigue and anxiety (r = .37, p = .05). A moderate negative relationship was found between the percent changes in fatigue and energy (r = −.48, p= .01). CONCLUSIONS Low to moderate intensity aerobic exercise was effective in reducing fatigue and anxiety in this group of cancer survivors. Furthermore, the relationships found in this study suggest that as fatigue is reduced anxiety and depression are also reduced. Additionally, the inverse relationship between fatigue and energy level as a result of exercise participation is important. Exercise programs such as the one used in this study may be effective in reducing fatigue in cancer survivors and this reduction is related to other measures of emotional distress including depression and anxiety. Program components that reduce fatigue and elevate mood are important in the rehabilitation of cancer survivors.

Relationships of Mood Disturbance, Symptom Experience, and Attentional Function in Women with Breast Cancer Based upon the Theory of Unpleasant Symptoms

The purpose of this study was to identify direct, mediating, and moderating relationships of mood disturbance, symptom experience, and attentional function in Korean women with breast cancer based upon a middle-range theory of unpleasant symptoms. This study used a cross-sectional, correlational design. A convenience sample of 125 women receiving chemotherapy for breast cancer was recruited from a university hospital in South Korea. The women completed questionnaires on mood disturbance, symptom experience, and attentional function using the Linear Analogue Self-Assessment Scale, the Symptom Experience Scale, and the Attentional Function Index, respectively. Each mood disturbance and symptom experience showed a significant relationship with attentional function. Symptom experience did not act as a mediator between mood disturbance and attentional function, but it did act as a moderator: patients with a higher level of mood disturbance exhibited a lower level of attentional function when their symptoms were at the level of medium, but not when their symptoms were either high or low. This suggests that clinical interventions for attenuating the influence of mood disturbance on attentional function may be effective only in women experiencing medium level of symptoms.

A randomized trial comparing axillary clearance versus no axillary clearance in older patients (≥ 60 years) with breast cancer: First results of International Breast Cancer Study Group Trial 10–93

505 Background: Axillary clearance is associated with undesirable side-effects. We therefore investigated if avoiding axillary surgery in older women would result in improved quality of life (QL) and similar disease-free survival (DFS) and overall survival (OS). Methods: Between 1993 and 2002, women ≥ 60 years old with clinically N0 operable breast cancer were randomized to primary surgery plus axillary clearance (Sx+Ax) followed by tamoxifen (Tam) versus Sx without Ax followed by Tam. The primary endpoint was QL reported by the patient (using linear analogue self-assessment [LASA] scales) and by physician assessment at sequential time points. Results: 473 patients (234 to Sx+Ax, 239 to Sx) were randomized to meet the target accrual of 472 patients. The median age was 74 years in both arms. Other characteristics were also balanced: 80% ER-positive; 45% mastectomies; 33% breast-conserving surgery with radiotherapy (RT); 22% breast-conserving surgery without RT. The table below gives the results of 2 of the LASAs and 2 of the physician-reported side-effects. In all of these assessments the largest differences were observed from baseline to post-operative, with patients randomized to Sx+Ax having worse QL and more side effects, but the differences tended to approach baseline values in 6 to 12 months. At a median follow-up of 6 years, results for Sx+Ax vs. Sx were similar for DFS (total events: 84 vs. 77; 5-year DFS: 71% vs. 70%; relative risk (RR) [Sx+Ax/Sx]: 1.12; 95% CI: 0.82–1.53; p=0.46) and OS (total deaths: 65 vs. 62; 5-year OS: 78% vs. 80%; RR [Sx+Ax/Sx]: 1.10; 95% CI: 0.77–1.55; p=0.61). Conclusions: Avoiding axillary clearance for women ≥ 60 years old who have clinically N0 disease and receive Tam results in similar efficacy with improved QL. No significant financial relationships to disclose.

A randomized trial comparing axillary clearance versus no axillary clearance in older patients (≥ 60 years) with breast cancer: First results of International Breast Cancer Study Group Trial 10–93

505 Background: Axillary clearance is associated with undesirable side-effects. We therefore investigated if avoiding axillary surgery in older women would result in improved quality of life (QL) and similar disease-free survival (DFS) and overall survival (OS). Methods: Between 1993 and 2002, women ≥ 60 years old with clinically N0 operable breast cancer were randomized to primary surgery plus axillary clearance (Sx+Ax) followed by tamoxifen (Tam) versus Sx without Ax followed by Tam. The primary endpoint was QL reported by the patient (using linear analogue self-assessment [LASA] scales) and by physician assessment at sequential time points. Results: 473 patients (234 to Sx+Ax, 239 to Sx) were randomized to meet the target accrual of 472 patients. The median age was 74 years in both arms. Other characteristics were also balanced: 80% ER-positive; 45% mastectomies; 33% breast-conserving surgery with radiotherapy (RT); 22% breast-conserving surgery without RT. The table below gives the results of 2 of the LASAs and 2 of the physician-reported side-effects. In all of these assessments the largest differences were observed from baseline to post-operative, with patients randomized to Sx+Ax having worse QL and more side effects, but the differences tended to approach baseline values in 6 to 12 months. At a median follow-up of 6 years, results for Sx+Ax vs. Sx were similar for DFS (total events: 84 vs. 77; 5-year DFS: 71% vs. 70%; relative risk (RR) [Sx+Ax/Sx]: 1.12; 95% CI: 0.82–1.53; p=0.46) and OS (total deaths: 65 vs. 62; 5-year OS: 78% vs. 80%; RR [Sx+Ax/Sx]: 1.10; 95% CI: 0.77–1.55; p=0.61). Conclusions: Avoiding axillary clearance for women ≥ 60 years old who have clinically N0 disease and receive Tam results in similar efficacy with improved QL. No significant financial relationships to disclose.

Relationships of mood disturbance and social support to symptom experience in Korean women with breast cancer

The purpose of this study was to identify how mood disturbance and social support were related to the symptoms experienced by Korean women with breast cancer. A cross-sectional, correlational design was used for the study. A convenience sample of 134 Korean women receiving chemotherapy for breast cancer was recruited. The participants completed questionnaires on symptom experience using the Symptom Experience Scale, mood disturbance using the Linear Analogue Self-Assessment Scale, and social support using the Social Support Scale. Mood disturbance and social support had a significant interaction effect on symptom experience. A higher level of mood disturbance led to a higher level of symptoms when the level of social support was average or low, which implies that clinical interventions for attenuating the impact of mood disturbance on symptom experience might be effective only for women perceiving average or low levels of social support.

The hospice patient's primary caregiver: What is their quality of life?

Objectives The purpose of this study was to (1) assess the quality of life (QOL) of the primary caregivers of hospice patients and (2) to analyze the ability of the hospice staff to accurately judge caregiver QOL. Methods A longitudinal pilot study of QOL of caregivers of patients entering hospice was undertaken. Caregivers and hospice personnel completed numerous questionnaires every 2 weeks until patient death. Global QOL and component constructs, as well as the demands of illness on the caregiver and profile of moods, were assessed. Simple descriptive statistics at each time point and summary measures (area under the curve) were calculated to describe the QOL profile of caregivers and staff perceptions of the caregivers. Cronbach's alpha coefficient was applied to verify tool internal consistency in a hospice population. Correlation coefficients were supplemented by Bland–Altman procedures for comparing scales measuring the same construct to compare the scores given by caregivers about themselves and staff ratings of the caregivers. The study had 80% power to detect an intracase difference between caregiver and staff ratings of the caregiver of 0.4 times the standard deviation using a two-sided paired t test with a 5% type I error rate. Results Caregiver QOL was relatively high and stable over time. Caregiver's QOL was correlated with the patient's overall QOL/hospice staff accurately evaluated caregiver QOL. Conclusions By drawing attention to issues that affect the caregiver, we can improve delivery of hospice care and positively impact QOL for both caregiver and patient. Linear analog self-assessment scales are valuable tools for hospice staff to assess caregivers.

Prospective study of neuropsychologic testing and quality-of-life assessment of adults with primary malignant brain tumors

Purpose: To identify the characteristics of adult patients with newly diagnosed primary brain tumors associated with identifiable deficits in neuropsychologic function to target interventions to improve function and quality of life (QOL). Methods and materials: Adult patients with newly diagnosed primary brain tumors and their caregivers were enrolled and underwent a battery of standardized neuropsychologic tests, allowing for qualitative and quantitative assessment and sensitive to the effects of the brain tumor, QOL, or caregiver stress. Results: We enrolled 68 patients with no prior radiotherapy. Patients with left hemisphere tumors reported significantly more memory problems and depressive symptoms. They also exhibited poorer attention and were more distractible, with poorer verbal fluency and poorer verbal learning. Patients with glioblastoma multiforme demonstrated poorer psychomotor speed and visual tracking than patients with non–glioblastoma multiforme histologic features. Patients and caregivers perceived QOL in a similar fashion, with significant correlation between patient and caregiver on hope testing and general QOL on the Linear Analog Self-Assessment Scale. Conclusion: Patients with left hemisphere tumors and glioblastoma multiforme histologic features demonstrated testable differences in neuropsychologic function and QOL that may be amenable to improvement with medical therapy or tailored rehabilitation programs. Caregiver assessments can predict patient QOL, which may be useful in patients with declining status.

The Palliative Benefit of Irinotecan in 5-Fluorouracil—Refractory Colorectal Cancer: Its Prospective Evaluation by a Multicenter Canadian Trial

Most patients with colorectal cancer (CRC) who have failed initial 5-fluorouracil (5-FU) chemotherapy have worsening of disease-related symptoms (DRS) and quality of life (QOL). Irinotecan has a reported response rate of 10%–20% in such patients. The aim of this phase II trial was to prospectively determine the palliative benefit of irinotecan utilizing DRS as primary endpoints of response. Patients had advanced CRC refractory to 5-FU with at least 1 DRS defined as (1) Karnofsky performance status (KPS) 60%–80%, (2) baseline analgesic use ≥ 10 mg morphine/day (or equivalent), or (3) disease-related pain score > 1 cm on a 10-cm linear analogue self-assessment (LASA) scale. Patients received irinotecan 125 mg/m 2 weekly for 4 weeks on an every-6-weeks schedule. The primary endpoint was palliative response defined as ≥ 50% decrease in pain score or analgesic usage, or 10% increase in KPS, from baseline for 4 weeks. QOL was assessed by the European Organization for Research and Treatment of Cancer Quality-of-Life Questionaire Core 30 (EORTC QLQ-C30) version 2 instrument. A total of 65 patients were entered onto the study. Median baseline parameters were KPS 70%, analgesic score 11 mg/day, and pain score 2.4 cm. A palliative response was achieved in 27 patients (42%), improvement in pain score predominated. LASA and EORTC QLQ-C30 instruments showed parallel changes in DRS. The radiological response rate was 11% (complete responses and partial responses, n = 46); 23 patients achieved stable disease. Median overall survival was 7.2 months. Irinotecan provides a rate of palliative benefit higher than the radiological response rate. Patient-oriented palliative endpoints can be useful in assessing the benefit of agents in early-phase clinical trials.

Patients' Estimation of Overall Treatment Burden: Why Not Ask the Obvious?

PURPOSE: We investigated the clinical validity of patients’ estimation of overall treatment burden. This measure was expected to be responsive to the wide spectrum of reactions on treatment and thus less precise for specific effects. PATIENTS AND METHODS: After the first chemotherapy within a randomized, double-blind trial of the prophylaxis for delayed emesis (SAKK 90/95), 249 patients documented nausea and vomiting daily for 6 days. Over the whole period, they estimated nausea/vomiting (N/V) burden and overall treatment burden by linear analog-self assessment (LASA) indicators and documented other side effects. RESULTS: At day 6, the two burden indicators were moderately correlated (r = 0.58) in accordance with their different concepts. No, partial, or total control of delayed emesis (days 2 to 6) was reflected in a consistent pattern by both indicators, with a stronger and more significant effect (P < .001) on changes in N/V burden than overall treatment burden. In contrast, toxicity other than N/V, as...

Response shift in the perception of health for utility evaluation: an explorative investigation

We previously showed that patients with newly diagnosed colon cancer change the internal standards on which they base their quality of life estimation. In the present investigation, we explored whether this response shift similarly affects the perception of health for utility evaluation in cancer clinical trials. After radical resection of adenocarcinoma of the colon (pT1-4 pN>0 M0 and pT3-4 pN0 M0) and perioperative chemotherapy, patients were randomised to three treatment arms: observation only (A), 5-fluorouracil (5-FU) 450 mg/m 2 plus levamisol (B), or 5-FU 600 mg/m 2 (C). Subjective health was assessed by a linear analogue self-assessment (LASA) scale anchored at ‘perfect health–worst health’ developed for serial assessment of utility values (Hürny C, van Wegberg B, Bacchi M, et al. Subjective health estimations (SHE) in patients with advanced breast cancer: an adapted utility concept for clinical trials. Br J Cancer 1998, 77, 985–991). Patients estimated their pre-surgery health among various quality of life indicators both before surgery and retrospectively thereafter, and their pre-adjuvant health both at the beginning of randomly assigned chemotherapy or observation and retrospectively approximately 2 months later. Thereafter, current subjective health was assessed. Paired t-tests were used to test the hypotheses of no change. Patients' estimated pre-surgery health was worse after surgery than before ( n=127, mean change=−6.7, standard deviation (S.D.)=30, P=0.01), and their estimated pre-adjuvant health was worse under treatment or observation than at the beginning ( n=132, mean change=−7.1, S.D.=23.8, P=0.001), in agreement with the quality of life indicators. Chemotherapy had no impact on these changes attributed to a response shift. Conventionally assessed changes between the beginning of adjuvant treatment or observation and 2 months later indicated no change in subjective health. Change scores relative to patients' retrospective estimation revealed an improvement ( n=122, mean change=6.6, S.D.=24.8, P=0.004) in this period. Patients with colon cancer substantially reframe their internal standard of health as they do for quality of life. This explorative finding questions the assumption, generally made in decision models, that health estimates for utility evaluation are independent of time. Given that patients may change their standards, comparisons of health estimates across different populations and clinical situations are to be interpreted with caution.

OUTPATIENT FLEXIBLE CYSTOSCOPY IN MEN: A RANDOMIZED STUDY OF PATIENT TOLERANCE

We evaluate the pain of immediate versus delayed outpatient flexible cystoscopy in men after topical local anesthesia application. A total of 100 consecutive men with superficial bladder tumors were randomized to immediate or delayed surveillance flexible cystoscopy after intraurethral instillation of lidocaine gel. Patients recorded the level of pain experienced during cystoscopy on a 4-point pain scale and on a 10-point visual linear analog self-assessment scale. Of the 100 patients 50 underwent immediate and 50 underwent delayed cystoscopy. The mean pain score on a scale of 1-no to 4-severe pain was 1.7 after immediate cystoscopy compared with 1.6 after delayed cystoscopy (p = 0.9). The mean linear analog self-assessment score on a scale of 1-no to 10-most pain was 2.1 after immediate cystoscopy versus 1.8 after delayed cystoscopy (p = 0.7). There was no difference in pain perception in men undergoing immediate or delayed outpatient flexible cystoscopy using the same local anesthetic.

Clinical relevance of single item quality of life indicators in cancer clinical trials.

We investigated the hypothesis that global single-item quality-of-life indicators are less precise for specific treatment effects (discriminant validity) than multi-item scales but similarly efficient for overall treatment comparisons and changes over time (responsiveness) because they reflect the summation of the individual meaning and importance of various factors. Linear analogue self-assessment (LASA) indicators for physical well-being, mood and coping were compared with the Hospital Anxiety and Depression Scale (HAD), the Mood Adjective Check List (MACL) and the emotional behaviour and social interaction scales of the Sickness Impact Profile (SIP) in 84 patients with early breast cancer receiving adjuvant therapy. Discriminant validity was investigated by multitrait-multimethod correlation, responsiveness by standardized response mean (SRM). Discriminant validity of the indicators was present at baseline but less under treatment. Responsiveness was demonstrated by the expected pattern among treatments (P = 0.008). In patients without chemotherapy, the SRMs indicated moderate (0.5–0.8) to large (>0.8) improvements in physical well-being (0.70), coping (0.92), HAD anxiety (0.89) and depression (1.19), and MACL mental well-being (0.68). In patients with chemotherapy for the first 3 months, small but clinically significant improvements (>).2) included mood (0.38), coping (0.41), HAD axiety (0.31) and MACL mental well-being (0.35). Patients with 6 months chemotherapy showed no changes. The indicators also reflected mood disorders (HAD) and marked psychosocial dysfunction (SIP) at baseline and under treatment according to pre-defined cut-off levels. Global indicators were confirmed to be efficient for evaluating treatments overall and changes over time. The lower reliability of single as opposed to multi-item scales affects primarily their discriminant validity. This is less decisive in large sample sizes. © 2001 Cancer Research Campaign http://www.bjcancer.com

Quality of life as subjective experience: Reframing of perception in patients with colon cancer undergoing radical resection with or without adjuvant chemotherapy

Purpose and background: We examined whether patients with colon cancer undergoing surgery with or without adjuvant chemotherapy change the internal standards on which they base their quality-of-life (QL) estimation, and, if they do so, whether this reframing alters interpretation of QL findings. These questions were addressed within a randomized clinical trial of the Swiss Group for Clinical Cancer Research (SAKK 40/93).Patients and methods: After radical resection of adenocar-cinoma of the colon (pT1–4pN>0M0 and pT3–4pN0M0) and perioperative chemotherapy, patients were randomized to three treatment arms: observation only (A), 5-FU 450 rag/m2plus Levamisol (B), or 5-FU 600 mg/m2 (C). QL was measured by linear analogue self-assessment indicators. Patients estimated their pre-surgery QL both before surgery and retrospectively thereafter, and their pre-adjuvant QL both at the beginning of randomly assigned chemotherapy or observation and retrospectively about two months later. Thereafter, current QL was assessed. Paired t-tests were used to test the hypotheses of no change.Results: Overall, 187 patients with at least one pair of corresponding questionnaires were analyzed. Patients estimated their pre-surgery QL after surgery significantly lower than before and their pre-adjuvant QL under treatment or observation also lower than at the beginning. In the adjuvant phase, in contradiction to our hypothesis, chemotherapy had almost no impact on these changes attributed to reframing. Conventionally assessed changes indicated an improvement in QL. Patients with treatment C reported less improvement in functional performance than those with B or those under observation (P = 0.04). Patients with treatment B indicated a greater worsening in nausea/vomiting than those with C, whereas patients with observation only showed an improvement (P = 0.0009). After adjustment of current QL scores under treatment or observation to patients' retrospective estimation, the treatment effects were diluted but the overall improvement was substantially amplified in most QL indicators.Conclusions: Patients with colon cancer substantially re-frame their perception in estimating QL both under radical resection and under adjuvant chemotherapy or observation. This effect is an integral part of patients' adaptation to disease and treatment. An understanding of this phenomenon is of particular relevance for patient care. Its role in evaluating QL endpoints in clinical trials needs further investigation.

Dexamethasone Treatment of Bone Pain in Metastatic Prostate Cancer: Assessment of Pain Indices and Quality of Life

Background : Steroid therapy has been considered as co-analgesic for palliative treatment of metastatic bone pain in terminal cancer. We designed prospective study to observe analgesic efficacy of dexamethasone, to evaluate different analgesic assessment methods and its correlation to actual improvement of quality of life. Methods : Thirty seven men with symptomatic bone pain of prostate cancer were treated with dexamethasone infusions (10mg twice a day) for 2 weeks. Response to treatment was assessed by daily analgesic intake, by the McGill-Melzack pain questionnaire(MPQ), and by a series of 17 linear analog self-assessment scales(LASA) relating to pain and to various aspects of quality of life. Biochemical and radiological markers were measured. Results : Fourteen patients (38%) had improvement in indices used to assess pain at 2 weeks after starting dexamethasone. Reduction in pain indices was associated with improvement in other dimensions of quality of life and in the scale for overall well-being. Even though radiological and biochemical markers showed no correlation, symptomatic relief of pain was associated with a decrease in serum concentration of adrenal androgens. Conclusion : We conclude that 1) dexamethasone treatment may cause useful relief of pain in some of patients with bone pain of prostate cancer; 2) this relief of pain is associated with suppression of adrenal androgens; 3) measures of pain and quality of life can be used to assess benefits of systemic therapy with dexamethasone; and 4) this effects of dexamethasone should be further investigated in bone pain of other metastatic cancer. (Korean J Anesthesiol 1998; 34: 394∼402)

Quality of life assessment in patients receiving adjuvant therapy for breast cancer: The IBCSG approach

The International Breast Cancer Study Group (IBCSG) has developed and approach for assessing the impact of adjuvant therapy on quality of life (QL) within the framework of international, multilingual clinical trials. The major steps are summarized. Conceptual, methodological and practical issues are discussed with reference to results of two trials closed to accrual (IBCSG VI, VII) and one subsequent ongoing trial (IBCSG IX). QL was assessed in pre- and post-menopausal patients with operable breast cancer. Various single-item linear analogue self-assessment (LASA) scales were used as indicators of components of QL, including global indicators of well-being, functioning and health perception, and specific indicators of symptoms of disease and treatment. In trials VI and VII, QL was assessed at baseline, during adjuvant treatment and follow-up, and at recurrence. Based on this experience, the QL form was revised for subsequent trials and further investigated in a subsample of patients randomized into trial IX. In trials VI and VII, the QL indicators were responsive to the impact of biomedical factors at baseline, various adjuvant treatments, changes over the first 18 months, and recurrence. In trial IX, the revised QL form was well accepted by patients and staff. Completing this form did not exceed five minutes. QL differences between on and off cytotoxic treatment strengthen the claim that these measures are responsive. Correlations and logistic regression analyses show the expected relationship among the various global and specific indicators. Results from two trials closed to accrual and an ongoing trial confirm the feasibility, validity and clinical relevance of the IBCSG approach for studying the impact of adjuvant breast cancer therapy on QL in international clinical trials.

A comparative study of post-operative psychosocial function in women with primary operable breast cancer randomized to breast conservation therapy or mastectomy

In a randomized patient series of 184 women suffering from primary operable breast carcinoma, psychosocial adjustment to breast-conserving therapy (BCT) vs mastectomy (M) was analysed retrospectively, including: (i) a comparison of intergroup characteristics; (ii) patient experience of the quality of professional pre-operative information; and (iii) the extent to which influence on choice of treatment was required. Using LASA (Linear Analogue Self-Assessment Scale), STAI (State-Trait Anxiety Inventory), and a semi-structured interview, no psychosocial benefits were found in BCT compared with M. Mean observation time was 31 months (range: 15-65). Body image was less impaired in BCT than in M. Both groups scored highly on professional information, but reported reduced ability to take in such information in the peri-operative period. Both groups tended to depend on the surgeon when choosing between surgical options. Irrespective of primary therapy, women must still confront the fact that they have had cancer, a life-threatening disease which may recur. A need for further research into peri-operative information procedures was demonstrated, and some suggestions were derived concerning the surgeon's role in deciding on surgical options.

Quality of life in prostate cancer patients.

Quality of life in prostate cancer patients.

Improved quality of life with megestrol acetate in patients with endocrine-insensitive advanced cancer: A randomised placebo-controlled trial

To investigate the effect of two doses of megestrol acetate (MA) compared with placebo on quality of life (QoL) and nutritional status (NS) in patients with advanced endocrine-insensitive cancer. Two hundred forty patients were randomised to double-blind MA 480 mg/day, MA 160 mg/day, or matching placebo for 12 weeks. Nutritional status (including weight, skinfold thickness and midarm circumference) and QoL (using 6 linear analogue self-assessment (LASA) scales) were assessed at randomisation and after four, eight and 12 weeks. A QoL ranking incorporating QoL and death was also used ranging from 1 = dead to 5 = much better QoL. One hundred seventy-four patients were assessable at week four, 136 at week eight and 103 patients at week 12. Patients receiving MA reported substantially better appetite (P = 0.001), mood (P = 0.001) and overall quality of life (P < 0.001), and possibly less nausea and vomiting (P = 0.08) than patients receiving placebo, based on a test for trend. A larger benefit was seen with the higher dose which (unlike the lower dose) was significantly better in pairwise comparisons with placebo for appetite, mood and overall QoL (each P < or = 0.001). Despite some missing data on QoL scores, QoL ranking was available on 227 (95%) of patients with significantly higher QoL ranking associated with MA (P = 0.002). Improvements in QoL occurred early within four weeks and were sustained. No statistically significant differences were observed in NS measurements, including weight (P = 0.29). Side effects of therapy were minor and did not differ significantly across treatments. Megestrol acetate given at 480 mg/day is useful palliation in patients with endocrine-insensitive advanced cancer. It improves appetite, mood and overall quality of life in these patients, although not through a direct effect on nutritional status.

Linear Analogue Self-Assessment and Procrustean Measurement: A Critical Review of Visual Analogue Scaling in Pain Assessment

Visual analogue scales (VASs) are one of the most widely used self-report measures of clinical pain. This article reviews the empirical literature on linear analogue self-assessment (LASA) and critically examines the features that appear to have made it such an attractive measurement option in pain assessment. It is concluded that analogue scaling does not withstand critical scrutiny as a primary measure of either pain intensity or pain affect and that, in most circumstances, the overall clinical utility of VASs is inferior to that of more structured pain indices.

Impact of adjuvant therapy on quality of life in women with node-positive operable breast cancer

Summary Background Adjuvant therapy for early breast cancer is effective but may be toxic. Our aim was to investigate the impact of the presence, timing, and duration of adjuvant chemotherapy on patients' perceptions of their quality of life (QL). Methods International Breast Cancer Study Group trial VI assessed adjuvant chemotherapy in 1475 premenopausal and perimenopausal patients, and trial VII assessed adjuvant tamoxifen or chemoendocrine therapy in 1212 postmenopausal patients with node-positive breast cancer. Patients were asked to complete a QL questionnaire_ single-item linear analogue self-assessment scales measured physical wellbeing, mood, appetite, and perceived adjustment/coping. QL was assessed in this way at the beginning of treatment, 2 months after the start of treatment, every 3 months, and at 1 and 6 months after recurrence. Findings Baseline QL scores decreased as the number of involved axillary nodes increased (for example, mean mood score: 66·1 for women with one positive node, 66·4 for two to four positive nodes, 61·3 for five to nine positive nodes, and 59·1 for ten or more positive nodes; p=0·008 for trends), and were lower in patients with oestrogen-receptor-negative than in patients with oestrogen-receptor-positive tumours (61·4 vs 66·3, pO·0009). All treatment groups showed substantial improvement in QL scores during adjuvant therapy. Patterns of QL scores reflected presence, duration, and timing of cytotoxic treatment. Longer initial cytotoxic therapy delayed improvement in QL scores. Later cytotoxic therapy had transient adverse effects. Anticipation of future therapy also affected QL scores. Interpretation Overall, chemotherapy had a measurable adverse effect on QL, but this effect was transient and minor compared with patients' adaptation/coping after diagnosis and surgery. This finding should encourage patients and doctors to choose appropriate adjuvant therapy with less concern for initial toxicity.