An international validation study of the EORTC brain cancer module (EORTC QLQ-BN20) for assessing health-related quality of life and symptoms in brain cancer patients

AimsThe psychometric properties of the EORTC QLQ-BN20, a brain cancer-specific HRQOL questionnaire, have been previously determined in an English-speaking sample of patients. This study examined the validity and reliability of the questionnaire in a multi-national, multi-lingual study.MethodsQLQ-BN20 data were selected from two completed phase III EORTC/NCIC clinical trials in brain cancer (N = 891), including 12 languages. Experimental treatments were surgery followed by radiotherapy (RT) and adjuvant PCV chemotherapy or surgery followed by concomitant RT plus temozolomide (TMZ) chemotherapy and adjuvant TMZ chemotherapy. Standard treatment consisted of surgery and postoperative RT alone. The psychometrics of the QLQ-BN20 were examined by means of multi-trait scaling analyses, reliability estimation, known groups validity testing, and responsiveness analysis.ResultsAll QLQ-BN20 items correlated more strongly with their own scale (r > 0.70) than with other QLQ-BN20 scales. Internal consistency reliability coefficients were high (all α ? 0.70). Known-groups comparisons yielded positive results, with the QLQ-BN20 distinguishing between patients with differing levels of performance status and mental functioning. Responsiveness of the questionnaire to changes over time was acceptable.ConclusionThe QLQ-BN20 demonstrates adequate psychometric properties and can be recommended for use in conjunction with the QLQ-C30 in assessing the HRQOL of brain cancer patients in international studies.     

An international field study of the EORTC QLQ-PR25: a questionnaire for assessing the health-related quality of life of patients with prostate cancer

AimTo evaluate the psychometrics of the EORTC QLQ-PR25, a questionnaire assessing the health-related quality of life of prostate cancer patients.MethodsThe QLQ-PR25 and the QLQ-C30 were administered to 642 prostate cancer patients from 13 countries treated with curative or palliative intent. The QLQ-PR25 assesses urinary, bowel and sexual symptoms and functioning, and the side-effects of hormonal treatment.ResultsFive hundred and nine patients were available for the final analysis. Multitrait scaling analyses confirmed the hypothesised scale structure of the QLQ-PR25. Internal consistency reliability was good (coefficient α = 0.70–0.86) for the urinary symptoms and sexual function scales, but lower for the bowel function and side-effects of hormonal treatment scales (α < 0.70). The module discriminated clearly between clinically distinct patient subgroups, and was responsive to changes in health status over time.ConclusionIn general, the QLQ-PR25 demonstrates acceptable psychometric properties and clinical validity. Some caution should be used in interpreting the bowel function and side-effects of hormonal therapy scales; results can be reported at the individual item and scale level.     

The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for patients with Bone Metastases: The EORTC QLQ-BM22

AimThe aim of this study was to develop a bone metastases module to supplement the European Organisation for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-C30) or the EORTC QLQ-C15-PAL for patients with bone metastases.MethodsPhases 1–2 of module development were conducted in Canada, Australia and Germany according to EORTC QOL group guidelines. Phase 3 was conducted in nine countries in seven languages.ResultsSixty-one health-related quality of life (HRQOL) issues were generated from health care professionals (n = 152) and patients (n = 413). This resulted in a 22-item provisional module. Further testing in 170 patients from nine countries resulted in the EORTC QLQ-BM22 module, containing 22 items, conceptualised into both symptom scales, with five painful sites and three pain characteristics, and also functional scales, with eight functional interference and six psychosocial aspects.ConclusionThis study provides a provisional comprehensive HRQOL measurement tool for future trials, which will continue to undergo further validation.     

Development of the European Organisation for Research and Treatment of Cancer quality of life questionnaire module for older people with cancer: The EORTC QLQ-ELD15

Background and aimThere is a lack of instruments that focus on the specific health-related quality of life (HRQOL) issues that affect older people with cancer. The aim of this study was to develop a HRQOL questionnaire module to supplement the European Organisation for Research and Treatment of Cancer (EORTC) core questionnaire, the EORTC QLQ-C30 for older (>70 years) patients with cancer.MethodsPhases 1–3 were conducted in seven countries following modified EORTC Quality of Life Group guidelines for module development. Phase 1: potentially relevant issues were identified by a systematic literature review, a questionnaire survey of 17 multi-disciplinary health professionals and two rounds of qualitative interviews. The first round included 9 patients aged >70. The second round was a comparative series of interviews with 49 patients >70 years with a range of cancer diagnoses and 40 patients aged 50–69 years matched for gender and disease site. In Phase 2 the issues were formulated into a long provisional item list. This was administered in Phase 3 together with the QLQ-C30 to two further groups of cancer patients aged >70 (n = 97) or 50–69 years (n = 85) to determine the importance, relevance and acceptability of each item. Redundant and duplicate items were removed; issues specific to the older group were selected for the final questionnaire.ResultsIn Phase 1, 75 issues were identified. These were reduced in Phase 2 to create a 45 item provisional list. Phase 3 testing of the provisional list led to the selection of 15 items with good range of response, high scores of importance and relevance in the older patients. This resulted in the EORTC QLQ-ELD15, containing five conceptually coherent scales (functional independence, relationships with family and friends, worries about the future, autonomy and burden of illness).ConclusionThe EORTC QLQ-ELD15 in combination with the EORTC QLQ-C30 is ready for large-scale validation studies, and will assess HRQOL issues of most relevance and concern for older people with cancer across a wide range of cancer sites and treatment stages.     

The EORTC QLQ-OH17: A supplementary module to the EORTC QLQ-C30 for assessment of oral health and quality of life in cancer patients

AimsAssessment of oral and dental problems is seldom routine in clinical oncology, despite the potential negative impact of these problems on nutritional status, social function and quality of life (QoL). The aim was to develop a supplementary module to the European Organisation for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-C30) focusing on oral health and related QoL issues in all cancer diagnoses.MethodsThe module development followed the EORTC guidelines. Phases 1&;2 were conducted in France, Germany, Greece, Netherlands, Norway and United Kingdom, while seven countries representing seven languages were included in Phase 3.ResultsEighty-five QoL-items were identified from systematic literature searches. Semi-structured interviews with health-care professionals experienced in oncology and oral/dental care (n = 18) and patients (n = 133) resulted in a provisional module with 41 items. In phase 3 this was further tested in 178 European patients representing different phases of disease and treatment. Results from the interviews, clinical experiences and statistical analyses resulted in the EORTC QLQ-OH17. The module consists of 17 items conceptualised into four multi-item scales (pain/discomfort, xerostomia, eating, information) and three single items related to use of dentures and future worries.ConclusionThis study provides a useful tool intended for use in conjunction with the EORTC QLQ-C30 for assessment of oral and dental problems. The increased awareness may lead to proper interventions, thereby preventing more serious problems and negative impact on QoL. The reliability and validity, the cross-cultural applicability and the psychometric properties of the module will be tested in a larger international study.     

The EORTC cancer in-patient satisfaction with care questionnaire: EORTC IN-PATSAT32

Objectives  The EORTC Quality of Life (QL) Group has developed a questionnaire (the EORTC IN-PATSAT32) to assess the satisfaction of cancer inpatients with hospital-based care. In this study we assess the psychometric properties of the EORTC IN-PATSAT32 applied to a sample of Spanish patients. Materials and methods  Eighty cancer patients with different tumour sites completed the EORTC QLQ-C30 and EORTC IN-PATSAT32 questionnaires. Psychometric evaluation of the structure, reliability and validity was conducted. Results  Multitrait scaling analysis showed that most itemscale correlation coefficients met the standards of convergent and discriminant validity. Cronbach’s coefficients were good (0.77–0.97) for all scales except hospital access. Correlations between the scales and single items of the QLQ-C30 and EORTC IN-PATSAT32 were generally low. Correlations between the Oberst scales and an item on intention to recommend the hospital or ward to others with the EORTC IN-PATSAT32 were moderate. Patients with higher scores on the Oberst scales and the item on intention to recommend the hospital or ward showed higher satisfaction with care levels in all EORTC IN-PATSAT32 areas but one. Conclusions  The EORTC IN-PATSAT32 appears to be a reliable and valid instrument when applied to a sample of Spanish cancer patients. These results are in line with those of the EORTC validation study.     

Clinical and psychometric validation of a questionnaire module, the EORTC QLQ-OG25, to assess health-related quality of life in patients with cancer of the oesophagus, the oesophago-gastric junction and the stomach

AimTo combine and test the EORTC questionnaires for assessing quality of life (HRQL) for oesophageal (QLQ-OES18) and stomach cancer (QLQ-STO22), into a single questionnaire for tumours of the oesophagus, oesophago–gastric junction or stomach.MethodsThe QLQ-OES18, QLQ-STO22 and seven modified items were administered to 300 patients with oesophageal (n = 148), junctional (n = 66), or gastric cancer (n = 86). Semi-structured interviews assessed item and scale preference and multi-trait scaling analyses confirmed the scale structure of the new module (QLQ-OG25). This was further tested for validity.ResultsThe QLQ-OG25 has six scales, dysphagia, eating restrictions, reflux, odynophagia, pain and anxiety. Scales have good reliability (α range 0.67–0.87) and they distinguish between tumour sites and disease stage. Scales do not correlate highly with scores from the core questionnaire, thus indicating that the module was addressing separate HRQL aspects.ConclusionThe QLQ-OG25 is recommended to supplement the EORTC QLQ-C30 when assessing HRQL in patients with oesophageal, junctional or gastric cancer.     

Treatment-related differences in health related quality of life and disease specific symptoms among colon cancer survivors: Results from the population-based PROFILES registry

BackgroundThe goal of this study was to compare health related quality of life (HRQoL) and disease-specific symptoms between colon cancer patients treated with surgery only (SU) and surgery and adjuvant chemotherapy (SU + adjCT). Results were stratified for those aged <70 and ⩾70 years. HRQoL of patients was also compared with an age- and sex-matched normative population.MethodsPatients diagnosed with colon cancer between January 2000 and June 2009, as registered within the population-based Eindhoven Cancer Registry, received a questionnaire on HRQoL (European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire version 3.0 (QLQ-C30)) and disease-specific symptoms (EORTC QLQ-Colorectal 38 (EORTC QLQ-CR38)) in 2010. The first was also completed by the normative population (n = 685).Results1606 (72%) colon cancer survivors responded to our questionnaire. 1542 colon cancer patients treated with SU (n = 1031) or SU + adjCT (n = 493) were included in this study. In colon cancer patients aged <70 years and aged ⩾70 no statistical significant differences on the subscales of the EORTC QLQ-C30 or the EORTC QLQ-CR38 were observed between patients treated with SU and SU + adjCT. Colon cancer patients aged <70 years either treated with SU or SU + adjCT reported significantly more insomnia, diarrhoea and financial problems compared with the normative population. No differences in HRQoL were found between colon cancer patients aged ⩾70 years either treated with SU or SU + adjCT and the normative population.ConclusionNo differences in HRQoL and disease-specific symptoms were found between patients treated with SU versus SU + adjCT in both younger and elderly colon cancer patients. Withholding patients adjCT, based on concerns for long-term HRQoL or disease-specific symptoms does therefore not seem plausible.     

Quality of life with talazoparib versus physician’s choice of chemotherapy in patients with advanced breast cancer and germline BRCA1/2 mutation: patient-reported outcomes from the EMBRACA phase III trial

BackgroundIn the EMBRACA phase III trial, talazoparib (1 mg daily, orally) demonstrated a statistically significant improvement in PFS versus physician’s choice of chemotherapy (PCT; capecitabine, eribulin, gemcitabine, or vinorelbine) in patients with HER2-negative advanced breast cancer carrying a germline BRCA1/2 mutation; we evaluated patient-reported outcomes (PROs).Patients and methodsPatients were randomized 2 : 1 to receive talazoparib or PCT. PROs were assessed at day 1 (baseline), the start of each treatment cycle (every 3 weeks), and at the end of treatment, using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) and its breast cancer module, QLQ-BR23. Prespecified exploratory analyses included a longitudinal mixed-effect model comparing treatment arms and a time to definitive clinically meaningful deterioration (TTD) analysis carried out in the global health status/quality of life (GHS/QoL), and all functional and symptom scales from the EORTC QLQ-C30 and -BR23 questionnaires. Between-arm TTD comparisons were made using a stratified log-rank test and a Cox proportional hazards model.ResultsBaseline scores were similar between arms. Statistically significant estimated overall improvement from baseline in GHS/QoL was seen for talazoparib compared with statistically significant deterioration for PCT {3.0 [95% confidence interval (CI) 1.2, 4.8] versus −5.4 [95% CI −8.8, −2.0]; between arms, P < 0.0001}. A statistically significant greater delay was observed in TTD in GHS/QoL, favoring talazoparib over PCT [hazard ratio, 0.38 (95% CI 0.26, 0.55; median, 24.3 versus 6.3 months, respectively; P < 0.0001)]. A statistically significant overall change and a statistically significant delay in TTD, all favoring talazoparib, were also observed in multiple functions and symptoms.ConclusionPatients who received talazoparib had significant overall improvements and significant delay in TTD in multiple cancer-related and breast cancer-specific symptoms, functions, and GHS/QoL.ClinicalTrials.govNCT01945775.     

An international prospective study of the EORTC cancer in-patient satisfaction with care measure (EORTC IN-PATSAT32)

Little is known about patients' satisfaction with care in oncology hospitals across cultural contexts. Within the EORTC, we developed a 32-item satisfaction with care questionnaire to measure patients' appraisal of hospital doctors and nurses, as well as aspects of care organisation and services. This study assessed the psychometric characteristics of the questionnaire, the EORTC IN-PATSAT32, in a large, international sample of patients with cancer. Patients discharged from a surgery or medical oncology ward in nine countries were invited to complete at home the EORTC IN-PATSAT32 as well as other instruments for psychometric testing. Of 762 eligible patients recruited, 15% failed to return the questionnaire. Of the 647 compliant patients, 63% completed the questionnaires within 15 min and 82% required no help in its completion. Multitrait scaling analysis revealed excellent internal consistency and convergent validity, although some scales within the IN-PATSAT32 were relatively highly correlated. Test-retest data on 113 patients showed high reliability for most scales. Scales of the IN-PATSAT32 and of the QLQ-C30 were not significantly correlated, suggesting that the two questionnaires are assessing quite distinct concepts. The scales of the IN-PATSAT32 were able to discriminate clearly between patients with differing care expectations and differing intentions to recommend their hospital to others. This study supports the acceptability to patients, and the psychometric robustness of the EORTC IN-PATSAT32 questionnaire. Further studies are needed to assess the responsiveness of the questionnaire to changes in the structure and process of care over time.     

Persistence of docetaxel-induced neuropathy and impact on quality of life among breast cancer survivors

BackgroundThis study evaluates persistence and severity of docetaxel-induced neuropathy (peripheral neuropathy (PN)) and impact on health related quality of life in survivors from early-stage breast cancer.MethodsOne thousand and thirty-one patients with early-stage breast cancer, who received at least one cycle of docetaxel and provided information on PN during treatment, completed questionnaires on PN as an outcome (Common Toxicity Criteria (CTC) scores, European Organisation for Research and Treatment of Cancer Chemotherapy-Induced Peripheral Neuropathy 20 (EORTC CIPN20) and EORTC Quality of Life Questionnaire (QLQ)-C30) after 1–3 years.FindingsUpon completion of docetaxel treatment, 241 patients (23%) reported PN, grades 2–4. PN persisted for 1–3 years among 81 (34%) while PN regressed to grades 0–1 among 160 (66%). Among 790 patients (77%) without PN, 76 (10%) developed PN 1–3 years later while 714 (90%) stayed free from PN. Significant risk factors for persistent PN were age ⩾55 (p = 0.001), maximum grade of PN during docetaxel treatment (p < 0.0001), persistent muscle and joint pain (p < 0.0001), stomatitis (p = 0.047) and fatigue (p = 0.001). Persistent PN had a significant negative correlation with health-related quality of life (HRQOL), functional scales and symptom scales.InterpretationsOverall, 15% of breast cancer survivors treated with docetaxel report PN 1–3 years after treatment with a significant negative impact on HRQOL.     

Health-related quality of life 14 years after preoperative short-term radiotherapy and total mesorectal excision for rectal cancer: Report of a multicenter randomised trial

BackgroundPreoperative short-term radiotherapy (PRT) in combination with total mesorectal excision (TME) has shown to improve local control in rectal cancer treatment, however without a survival benefit and at the cost of increased morbidity. The current study investigates the long-term health-related quality of life (HRQL) of patients 14 years after treatment in the Dutch TME trial.MethodsIn the TME trial (1996–1999) 1530 Dutch patients with rectal cancer were treated with TME and randomly assigned to PRT (5 × 5 Gy). In 2012 HRQL was evaluated in surviving patients (n = 606) using a questionnaire combining EORTC QLQ-C30, EORTC QLQ-CR29 and additional questions.FindingsResults were obtained from 478 patients (82%), with a median follow up of 14 years. PRT + TME patients without stoma reported more faecal leakage and higher stool frequency, resulting in increased need of pads. Furthermore, irradiated males reported more erection problems. However, radiotherapy did not have negative effects on overall functioning. Compared with Dutch population, patients in both treatment arms reported a small decrease in overall functioning and males reported less sexual activity, interest and enjoyment and more erection difficulties. Irradiated females reported more vaginal dryness and more pain at intercourse compared with Dutch population.InterpretationLong-term HRQL evaluation shows that treatment-related symptoms are still present 14 years after treatment for rectal cancer. Radiotherapy increased bowel dysfunction in patients without stoma. Compared with the Dutch population, both groups reported increased sexual dysfunction. Despite these treatment-related symptoms, there was no difference in overall functioning and global health between TME and PRT + TME.     

Adjuvant sunitinib in patients with high-risk renal cell carcinoma: safety,therapy management,and patient-reported outcomes in the S-TRAC trial

BackgroundAdjuvant sunitinib has significantly improved disease-free survival versus placebo in patients with renal cell carcinoma at high risk of recurrence post-nephrectomy (hazard ratio 0.76; 95% confidence interval, 0.59–0.98; two-sided P = 0.03). We report safety, therapy management, and patient-reported outcomes for patients receiving sunitinib and placebo in the S-TRAC trial.Patients and methodsPatients were stratified by the University of California, Los Angeles Integrated Staging System and Eastern Cooperative Oncology Group performance status score, and randomized (1 : 1) to receive sunitinib (50 mg/day) or placebo. Single dose reductions to 37.5 mg, dose delays, and dose interruptions were used to manage adverse events (AEs). Patients’ health-related quality of life, including key symptoms typically associated with sunitinib, were evaluated with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).ResultsPatients maintained treatment for 9.5 (mean, SD 4.4) and 10.3 (mean, SD 3.7) months in the sunitinib and placebo arms, respectively. In the sunitinib arm, key AEs occurred ∼1 month (median) after start of treatment and resolved within ∼3.5 weeks (median). Many (40.6%) AEs leading to permanent discontinuation were grade 1/2, and most (87.2%) resolved or were resolving by 28 days after last treatment. Patients taking sunitinib showed a significantly lower EORTC QLQ-C30 overall health status score versus placebo, although this reduction was not clinically meaningful. Patients reported symptoms typically related to sunitinib treatment with diarrhea and loss of appetite showing clinically meaningful increases.ConclusionsIn S-TRAC, AEs were predictable, manageable, and reversible via dose interruptions, dose reductions, and/or standard supportive medical therapy. Patients on sunitinib did report increased symptoms and reduced HRQoL, but these changes were generally not clinically meaningful, apart from appetite loss and diarrhea, and were expected in the context of known sunitinib effects.Clinical trial registrationClinicalTrials.gov, NCT00375674.     

The EORTC Quality of Life Questionnaire for patients with prostate cancer: EORTC QLQ-PR25. Validation study for Spanish patients

Objectives  The EORTC Quality of Life (QL) Group has developed a questionnaire, the EORTC QLQ-PR25, for evaluating QL in prostate cancer. The aim of this study is to assess the psychometric properties of the EORTC QLQPR25 when applied to a sample of Spanish patients. Materials and methods  One hundred and thirty-seven prostate cancer patients with localised disease who started radiotherapy with radical intention combined with or without hormonotherapy prospectively completed the EORTC QLQ-C30 and EORTC QLQ-PR25 questionnaires three times: on the first and last day of radiotherapy and in the follow-up period. Psychometric evaluation of the questionnaires’ structure, reliability and validity was conducted. Results  Multitrait scaling analysis showed that many of the item-scale correlation coefficients met the standards of convergent and discriminant validity. Exceptions appeared mainly in the scales for bowel symptoms and for hormonal-treatment-related symptoms. Cronbach’s coefficients of the scales were good (0.72–0.86) for the urinary symptoms and sexual function scales but they were lower (<0.70) for the bowel and hormonal treatment scales. Most scales of the EORTC QLQ-PR25 had low to moderate intercorrelations. Correlations between the scales of the QLQ-C30 and the module were generally low. Group comparison analyses showed better QL in patients with higher Performance Status. Changes in QL appeared throughout the measurements. These were in line with the treatment process. Conclusions  The EORTC QLQ-PR25 was a reliable and valid instrument when applied to a sample of Spanish prostate cancer patients. These results are in line with those of the EORTC validation study.     

Equating EORTC QLQ-C30 and FACT-G scores and its use in oncological research

ObjectiveTo investigate the equivalence of the European Organization for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-C30) and the Functional Assessment for Cancer Therapy – General (FACT-G) on the basis of corresponding subscales, and where appropriate to derive a scheme for converting QLQ-C30 scores into FACT-G scores and vice versa for use in oncological research.MethodA calibration sample of 737 cancer patients (mean age 51.4 +/- 7.6 (SD), 63% female, 25% with current chemotherapy) who filled in both quality of life (QOL) questionnaires was used. Both classical test theory and the Rasch measurement model were applied.ResultsThree of the four subscales common to both QOL instruments (physical, emotional, functional) proved suitable for equating (acceptable inter-correlations of corresponding subscales physical (r = 0.77), emotional domain (r = 0.60) role/functional (r = 0.63) relative to their internal consistency, sufficient unidimensionality of pooled subscales, satisfactory fit to the Rasch model). Conversion tables for these subscales were generated.ConclusionsThe conversion tables developed in this study (physical, emotional and functional/role domain) appear promising for the comparison between EORTC QLQ-C30 and FACT-G scores of patient samples.     

Validation of EORTC IN-PATSAT 32 in Morocco: Methods and Processes

Background. The EORTC IN-PATSAT32 questionnaire was developed by the EORTC Quality of Life (QL) Group to assess the satisfaction of patients affected by cancer and hospitalized in oncology centers. The aim of this study is to assess the psychometric properties of the EORTC IN-PATSAT32 administered to Moroccan patients. Methods. A total of 133 hospitalized patients affected by cancer in different sites completed the translated EORTC IN-PATSAT32 questionnaire in oncology hospitals. The internal consistence reliability, reproducibility and construct validity were assessed. Results. The homogeneity was good for all scales with Cronbach’s coefficients from 0.72 to 0.95 for all scales. Reproducibility test-retest was very satisfactory and the intra-class correlations coefficients (ICCs) for the scales were all above 0.70 except for the single general satisfaction with a ICC of 0.67. All items were highly correlated with own rather than other scales. Conclusion. The results of this study confirm that the Moroccan Arabic version of the EORTC IN-PATSAT32 has acceptable reliability and validity, comparable to those reported for other languages.     

Validation of a measurement tool to assess awareness of breast cancer

AimUntil now, there has been no universally accepted and validated measure of breast cancer awareness. This study aimed to validate the new Breast Cancer Awareness Measure (BCAM) which assesses, using a self-complete questionnaire, knowledge of breast cancer symptoms and age-related risk, and frequency of breast checking.MethodsWe measured the psychometric properties of the BCAM in 1035 women attending the NHS Breast Screening Programme: acceptability was assessed using a feedback questionnaire (n = 292); sensitivity to change after an intervention promoting breast cancer awareness (n = 576), and test–retest reliability (n = 167). We also assessed readability, and construct validity using the ‘known-groups’ method.ResultsThe readability of the BCAM was high. Over 90% of women found it acceptable. The BCAM was sensitive to change: there was an increase in the proportion of women obtaining the full score for breast cancer awareness one month after receiving the intervention promoting breast cancer awareness; this was greater among those who received a more intensive version (less intensive version (booklet): 9.3%, 95% confidence interval (CI): 4.5–14.1%; more intensive version (interaction with health professional plus booklet): 30%, 95% CI: 23.4–36.6%). Test–retest reliability of the BCAM was moderate to good for most items. Cancer experts had higher levels of cancer awareness than non-medical academics (50% versus 6%, p = 0.001), indicating good construct validity.ConclusionsThe BCAM is a valid and robust measure of breast cancer awareness suitable for use in surveys of breast cancer awareness in the general population and to evaluate the impact of awareness-raising interventions.     

Effect of completion-time windows in the analysis of health-related quality of life outcomes in cancer patients

BackgroundWe examined if cancer patients' health-related quality of life (HRQoL) scores on the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 are affected by the specific time point, before or during treatment, at which the questionnaire is completed, and whether this could bias the overall treatment comparison analyses.Patients and methodsA ‘completion-time window’ variable was created on three closed EORTC randomised control trials in lung (non-small cell lung cancer, NSCLC) and colorectal cancer (CRC) to indicate when the QLQ-30 was completed relative to chemotherapy cycle dates, defined as ‘before’, ‘on’ and ‘after’. HRQoL mean scores were calculated using a linear mixed model.ResultsStatistically significant differences (P < 0.05) were observed on 6 and 5 scales for ‘on’ and ‘after’ comparisons in the NSCLC and two-group CRC trial, respectively. As for the three-group CRC trial, several statistical differences were observed in the ‘before’ to ‘on’ and the ‘on’ to ‘after’ comparisons. For all three trials, including the ‘completion-time window’ variable in the model resulted in a better fit, but no substantial changes in the treatment effects were noted.ConclusionsWe showed that considering the exact timing of completion within specified windows resulted in statistical and potentially clinically significant differences, but it did not alter the conclusions of treatment comparison in these studies.     

Body composition and survival in the early clinical trials setting

PurposeDelineate the relationships between body composition parameters, 90-day mortality and overall survival, and correlate them with known prognostic factors in an early clinical trials clinic.Patients and methodsWe studied 306 consecutive patients with various tumours; body composition was analysed by computerised tomography images. Survival was measured from the first clinic visit, at 90-day period and until death/last follow-up visit.ResultsMedian patient age was 56 years; 159 patients were men. Ninety-day mortality rate was 12%. Median overall survival was 9 months. In multivariate analyses, high MD Anderson Cancer Center (MDACC) score (p < 0.0001) [lactate dehydrogenase (LDH) > normal, albumin < normal, Eastern Cooperative Oncology Group (ECOG) performance status > 1, metastatic sites > 2, gastrointestinal (GI) tumours], low skeletal muscle index (SMI) (p = 0.0406) and male gender (p = 0.0077) were independent predictors of poor survival. If Royal Marsden Hospital (RMH) score (LDH > normal, albumin < normal, metastatic sites > 2) was used in lieu of MDACC score, it was also significant (p = 0.0003). Including SMI and gender in the MDACC or RMH score improved the accuracy of the original model (p = 0.006 and p = 0.0037, respectively).ConclusionPatients with low SMI have shorter survival. Gender and SMI strengthens the accuracy of MDACC or RMH scores as prognostic tools. Prospective validation of these findings is warranted.