Minimal important differences in the EORTC QLQ-C15-PAL to determine meaningful change in palliative advanced cancer patients.

AIMS: Quality of life (QOL) is important for advanced cancer patients. Brief questionnaires are advantageous to reduce patient burden. In large clinical trials, statistically significant small changes can be achieved; however, whether such change is clinically relevant is unknown. The purpose of this study was to determine the minimal important differences (MID) of the European Organisation for Research and Treatment of Cancer quality of life core 15 palliative questionnaire (EORTC QLQ-C15-PAL). METHODS: Patients undergoing palliative radiotherapy completed the EORTC QLQ-C15-PAL at baseline and 1 month later. Anchor and distribution-based assessments were employed to determine the MID associated with this instrument. The anchor of overall QOL was used to determine meaningful change. RESULTS: In all, 276 patients were included in MID calculation. Mean age was 65 years and primary lung, breast or prostate cancers were most common. Statistically significant MID for improvement was seen in emotional functioning and pain (20.9 and 15.6, respectively). MID for deterioration required a 20.4, 24.5, 17.1 and 23.0 change in physical functioning, fatigue, pain and appetite loss, respectively, to constitute meaningful change. Distribution-based estimates of MID were closest to the standard error of measurement. MID for brain and bone metastases patients yielded MID larger than previously determined in the incorporation of all patients. CONCLUSION: Meaningful change in the EORTC QLQ-C15-PAL is important for clinicians to determine the impact of treatment on the QOL of patients and can aid in determining the sample size required for clinical trials. Future studies should investigate MID in subgroups using symptom-specific modules.

Validation of the Brain Symptom and Impact Questionnaire (BASIQ) to assess symptom and quality of life in brain metastases.

OBJECTIVE: To validate the Brain Symptom and Impact Questionnaire (BASIQ) version 1.0 for brain metastases. METHODS: Patients with brain metastases and their healthcare professionals (HCPs) assessed the relevance of the BASIQ on a 0-10 scale with 10 as extremely relevant. RESULTS: A total of 52 patients and 20 HCPs participated in this study. In total, 95% of HCPs and 85% of patients found all items relevant. Balance and walking ability were rated relevant by 100% of patients and HCPs. Headache, nausea, energy, memory and ability to do housework were also rated relevant by 100% of HCPs. Over 95% of patients determined the items of ability to do housework, tiredness, energy, vision, memory and putting ideas into words as relevant. There were no items rated below 7 by patients or below 5 by HCPs. CONCLUSION: This study indicates that BASIQ version 1.0 has valid content items encompassing disease-related symptom and impact on daily living.

Fatigue scores in patients with brain metastases receiving whole brain radiotherapy.

PURPOSE: Whole brain radiotherapy (WBRT) is a treatment strategy used commonly to relieve burdensome symptoms and improve quality of life (QOL) in patients with multiple brain metastases. The purpose of this study is to determine changes in fatigue score following WBRT as it is a common symptom experienced in this population. METHODS: Fatigue and overall QOL scores were collected prospectively in patients for up to 3 months post-WBRT by several questionnaires at different times including the following: Edmonton Symptom Assessment System (ESAS), Brain Symptom and Impact Questionnaire (BASIQ), Spitzer Questionnaire, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), EORTC brain module (EORTC QLQ-BN20+2), EORTC QLQ-C15-PAL, and Functional Assessment of Cancer Therapy-General (FACT-G). Questionnaires were grouped for analysis by Wilcoxon Signed Rank test according to the scale of ranking into 0-10, 1-4, and 0-4. RESULTS: Thirty-six patients were interviewed with the ESAS or BASIQ. The median age was 65 years old, and median Karnofsky Performance Status (KPS) was 70. There was a significant increase in fatigue score from baseline to month 1 (p=0.02), and months 2 and 3 had no significant change. There was a significant correlation between fatigue and overall QOL score at baseline and month 1 (p=0.01, p<0.0001), respectively. Two hundred and twenty-eight patients were surveyed with Spitzer, C15-PAL, BN20+2, QLQ-C30, or FACT-G. Median age was 64 years old and median KPS was 80. Compared to baseline, fatigue score was significantly higher at month 1 (p<0.0001) and month 2 (p=0.001), with no significant change at month 3. Significant correlation was found between fatigue and overall QOL at baseline, months 1, 2 (p<0.0001), and 3 (p=0.0009). For all groups, there was no significant change in fatigue score between patients with or without dexamethasone (Dx), except for the fatigue changed score of the group with scale 0-4. CONCLUSIONS: Fatigue was significantly increased from baseline to month 1 in all patients, and most patients experienced no difference in fatigue if they were receiving Dx. Increased fatigue was significantly related with decreased overall QOL.

Comparison of the EORTC QLQ-BM22 and the BOMET-QOL quality of life questionnaires in patients with bone metastases.

AIMS: Bone metastases are a common complication of advanced cancer and often result in a decrease in patients' quality of life. Very few specific modules have been created to accurately assess quality of life in this patient group. The purpose of this study was to compare two questionnaires, the European Organization for Research and Treatment of Cancer quality of life questionnaire for patients with bone metastases (EORTC QLQ-BM22) and the bone metastases quality of life questionnaire (BOMET-QOL. METHODS: A literature search was conducted in Medline, Health and Psychosocial Instruments, Embase and Embase Classic to identify studies that discussed the development, validation and reliability of the (EORTC) QLQ-BM22 and the BOMET-QOL. Studies that discussed the development and validity of the questionnaire along with studies using these tools were included. RESULTS: Both questionnaires were developed in collaboration with patients and health-care professionals. The QLQ-BM22 is over twice the length of the BOMET-QOL, with 22 questions as compared to 10. The QLQ-BM22 has four subscales while the BOMET-QOL has no subscales. The QLQ-BM22 gives a more in-depth analysis of symptoms and well-being and includes issues such as mobility, side effects, complications of treatment and dependency. The BOMET-QOL is shorter and gives an overall assessment of pain and mobility. Scoring, item format, organization and response options vary between the questionnaires but the recall period for both is the previous week. Both questionnaires have been determined valid and reliable. CONCLUSION: The QLQ-BM22 and the BOMET-QOL are designed specifically for patients with bone metastases and each has strengths and weaknesses. Use of one over the other is ultimately dependent on trial design and investigators' goals.

Minimal important differences in the EORTC QLQ-C30 in patients with advanced cancer.

AIMS: Quality of life (QOL) is important in patients with advanced cancer. The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 is a general QOL tool used in cancer patients. Often, with a large enough sample, statistical significance of changecan be reached, however the clinical significance is often unknown. This study aimed to determine the magnitude of change that is meaningful to advanced cancer patients in the EORTC QLQ-C30. METHODS: Patients completed the EORTC QLQ-C30 at baseline and 1 month post-radiation to assess changes in their QOL. Minimal important differences (MID) were calculated through anchor and distribution-based methods for improvement and deterioration. The two anchors of overall health and overall QOL were used to determine meaningful change. RESULTS: Statistically significant meaningful changes were seen in the use of both anchors. The overall health anchor produced a greater number of scales and symptoms that reached a statistically significant meaningful change. Meaningful change for improvement with these two anchors ranged from 9.1 units (cognitive functioning) to 23.5 units (pain), and for deterioration it ranged from 7.2 units (physical functioning) to 13.5 units (role functioning). Distribution-based estimates were closest to 0.5 SD. CONCLUSION: Knowledge of meaningful change on the EORTC QLQ-C30 allows physicians to assess patients' changes over time, along with evaluating the impact of treatment on a patient's QOL. This knowledge gives insight into whether the treatment is effective and, ultimately, whether it should be continued. Knowledge of MID may assist in the determination of sample size for future trials.

Minimal clinically important differences in the brief pain inventory in patients with bone metastases.

PURPOSE: The brief pain inventory (BPI) is often used to assess pain and functional interference as a result of pain in cancer patients. Minor improvements or deteriorations in BPI may be statistically significant due to large sample sizes but may not necessarily be clinically relevant. The purpose of this study was to determine the minimal clinically important differences (MCID) in the functional BPI in patients with pain due to bone metastases. METHODS: BPI scores were collected from patients with painful bone metastases who visited the Rapid Response Radiotherapy Program for palliative radiotherapy. Pain and functional interferences scores were also collected monthly for three months. Patients were categorized into "complete or partial response," "pain progression," and "indeterminate response" based on their pain scores as recommended by the latest consensus definitions. Anchor-based determination of MCIDs of functional interference scores was calculated by determining the difference between the mean follow-up scores and the mean baseline scores for patients from each of the three response groups. Distribution-based estimates were obtained utilizing 0.2, 0.3, and 0.5 standard deviation (SD) effect sizes and the standard error of measurement. The anchor-based method results were compared with the distribution-based method results. RESULTS: Statistically significant MCIDs were determined for all of the functional interference items of BPI for patients with "complete or partial response"; whereas, no statistically significant MCIDs in BPI scores could be determined for patients with "pain progression." Some of the functional interference items of BPI had statistically significant MCIDs for patients with "indeterminate response," although these were generally smaller than patients with complete or partial response. Using the distribution-based approach, an effect size of 0.5 SD was the closest estimate for determining the MCID for both patients with complete or partial response and those with indeterminate response. CONCLUSIONS: The MCIDs determined for pain improvement were rather large, where as statistically significant MCIDs could not be detected for pain deterioration. Knowledge of MCIDs utilizing the BPI will allow physicians to evaluate the impact of treatment (or no treatment) on a patient's functional abilities. Knowledge of MCIDs may allow for sample size determination in future clinical trials.

Minimal clinically important differences in the Edmonton symptom assessment system in patients with advanced cancer.

CONTEXT: Longitudinal symptom monitoring is important in the setting of patients with advanced cancer. Scores over time may naturally fluctuate, although a patient may feel the same. OBJECTIVES: The purpose of this study was to determine the minimal levels of change required to be clinically relevant (minimal clinically important difference [MCID]) using the Edmonton Symptom Assessment System (ESAS). METHODS: Between 1999 and 2009, patients completed the ESAS before palliative radiotherapy and at follow-up. MCIDs were calculated using both the anchor- and distribution-based methods for improvement and deterioration; 95% confidence intervals for the differences in mean change scores between adjacent categories also were calculated. RESULTS: A total of 276 patients completed the ESAS at baseline and during at least one follow-up visit. At the four-week follow-up, decrease of 1.2 and 1.1 units in pain and depression scales, respectively, constituted clinically relevant improvement, whereas increase of at least 1.4, 1.8, 1.1, 1.1, and 1.4 units, respectively, in pain, tiredness, depression, anxiety, and appetite loss items were required for deterioration. At the subsequent follow-ups, these values were similar. Overall, the MCID for improvement tended to be smaller than that for deterioration. The distribution-based method estimates tended to be larger than the 0.3 SD estimates, but closer to the 0.5 SD estimates. CONCLUSION: MCIDs allow health care professionals to determine the success of treatment in improving the patient's quality of life. MCIDs may prompt health care professionals to intervene with new treatment. Future studies should confirm our findings with a variety of anchors.

Symptom clusters in patients with metastatic cancer: a literature review.

This article reviews the literature reporting empirically determined symptom clusters in patients with metastatic cancer. A literature search was conducted on symptom clusters within heterogeneous metastatic cancer patient populations using MEDLINE, EMBASE, and CINAHL. Studies examining predetermined symptom clusters were excluded. A total of eight relevant studies published between 2005 and 2011 were identified. The number of symptom clusters extracted varied from two to eight clusters per study, comprising of two to eight symptoms per cluster. There were no clusters consistently identified within all eight studies. Notable differences in symptoms assessed, assessment tools, statistical analysis, patient demographics were observed between the studies. The lack of consensus among the inter-study symptom clusters are likely due to the differences in patient population as well as study methodology. Further exploration in metastatic symptom cluster research will ideally improve patient outcomes by facilitating improved symptom management in future clinical practice.

Meaningful change in oncology quality-of-life instruments: a systematic literature review.

Quality of life (QoL) is increasingly being recognized as an important end point in oncology clinical trials. The purpose of this study was to review the literature on what constitutes a meaningful change in oncology QoL instruments. A literature search was conducted in Medline, Embase, Cochrane Central Register of Controlled Trials and Cochrane Database of Systematic Reviews. Articles determining clinically meaningful change were selected. Twenty six publications were identified. Common anchors included performance status, global rating of change and overall QoL. The distribution approach utilized standard deviations and standard error of measurement. Limitations included optimism bias and a change in patients' internal frame of reference. Currently, there is an inconsistency between meaningful change studies. Analyses should be conducted in population-specific samples, as meaningful change varies depending on patient characteristics. Consistently, meaningful change for improvement has been smaller than that for deterioration, suggesting that patients are more responsive to improvement.

Health Care Professionals' Evaluation of Quality of Life Issues in Patients With Brain Metastases.

BACKGROUND: The Functional Assessment of Cancer Therapy - Brain (FACT-Br) is a brain specific Quality of life (QOL) tool used for patients in the primary and metastatic cancer population. The purpose of this report is to evaluate the QOL issues health care professionals (HCPs) find most important when caring for brain metastases patients. METHODS: HCPs were asked to rate whether each of the 23 FACT-Br subscale items were relevant to patients or not. In the survey, HCPs indicated the 5 to 10 top issues affecting the QOL of patients with brain metastases. Demographic information such as gender, years of experience, and health care specialty were recorded. RESULTS: A total of 46 HCPs participated in the study, 89% of HCPs ranked the need for help in caring for themselves as the most relevant item for patients with brain metastases. Other highly relevant items included the concern of getting headaches (81%) and weakness in arms or legs (78%). The lowest rated items included the ability to put thoughts together (8%), ability to write as they used to (11%) and also the ability to read as they used to (14%). CONCLUSION: It is very important to determine the issues that HCPs think are most important to patients in an attempt to harmonize these with those of patients. Future studies should compare the items that HCPs rate as most relevant to those that patients rate to ensure agreeability.

The utilization of telephone follow-up in the advanced cancer population: a review of the literature.

BACKGROUND: Palliative cancer patients often require clinic or hospital follow-up after any treatment intervention they may have received. This is typically done in person at either a hospital or a clinic. In these advanced cancer patients, this may be burdensome and result in attrition. Telephone follow-up is becoming more frequently used as an adjunct to clinical follow-up. It can be conducted for both clinical trials, as well as interventional purposes. The purpose of this study was to review the literature and examine the utility and effectiveness of telephone follow-up in the advanced cancer population. METHODS: A literature search was conducted on Medline (1980 - April week 4 2012), Embase (1980 - week 17 2012), the Cochrane Central Register of Controlled Trials (April 2012) and CINAHL (1981-July 31 2012). RESULTS: A total of 11 studies were identified that were published between 2001 and 2011. All studies were in the clinical trial setting. Studies that utilized telephone follow-up in the advanced cancer population, as well as studies that compared the feasibility of telephone follow-up with hospital follow-up, were included in this review. Follow-up at week 4 (month 1) was the most common interval for patient contact. Information collected during the contact varied with the study; however, the most commonly used tool was the Edmonton Symptom Assessment System. Other information included analgesic diary, patient feedback, satisfaction with the care and post-treatment side effects, along with a variety of quality of life questionnaires. Some studies provided information to the patient about protocols for care, advice and coping strategies. Attrition was common even with the use of telephone contact in place of clinical follow-up. CONCLUSION: Telephone follow-up is a feasible alternative to traditional hospital follow-ups for assessment of symptom palliation. There are fewer burdens on the patient, allowing for a better maintenance of quality of life and lower rates of attrition in clinical trials. Patients had an overall positive opinion of the use of this alternative approach with no common disadvantages. A combination of follow-up strategies, such as clinic follow-up and telephone contact for those not attending, may result in a more comprehensive assessment.