Sphincter-sparing surgery after preoperative radiotherapy for low rectal cancers: feasibility, oncologic results and quality of life outcomes

The present study assesses the choice of surgical procedure, oncologic results and quality of life (QOL) outcomes in a retrospective cohort of 53 patients with low-lying rectal cancers (within 6 cm of the anal verge) treated surgically following preoperative radiotherapy (RT, median dose 45 Gy) with or without concomitant 5-fluorouracil. QOL was assessed in 23 patients by using two questionnaires developed by the QOL Study Group of the European Organization for Research and Treatment of Cancer: EORTC QLQ-C30 and EORTC QLQ-CR38. After a median interval of 29 days from completion of RT, abdominoperineal resection (APR) was performed in 29 patients (55%), low anterior resection in 23 patients (20 with coloanal anastomosis) and transrectal excision in one patient. The 3-year actuarial overall survival and locoregional control rates were 71.4% and 77.5% respectively, with no differences observed between patients operated by APR or restorative procedures. For all scales of EORTC QLQ-C30 and EORTC QLQ-CR38, no significant differences in median scores were observed between the two surgical groups. Although patients having had APR tended to report a lower body image score (P = 0.12) and more sexual dysfunction in male patients, all APR patients tended to report better physical function, future perspective and global QOL. In conclusion, sphincter-sparing surgery after preoperative RT seems to be feasible, in routine practice, in a significant proportion of low rectal cancers without compromising the oncologic results. However, prospective studies are mandatory to confirm this finding and to clarify the putative QOL advantages of sphincter-conserving approaches. © 2000 Cancer Research Campaig

Small-cell lung cancer patients are just ‘a little bit’ tired: response shift and self-presentation in the measurement of fatigue

Background: Response shift has gained increasing attention in the measurement of health-related quality of life (QoL) as it may explain counter-intuitive findings as a result of adaptation to deteriorating health. Objective: To search for response shift type explanations to account for counter-intuitive findings in QoL measurement. Methods: Qualitative investigation of the response behaviour of small-cell lung cancer (SCLC) patients (n = 23) in the measurement of fatigue with The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) question 'were you tired'. Interviews were conducted at four points during 1st line chemotherapy: at the start of chemotherapy, 4 weeks later, at the end of chemotherapy, and 6 weeks later. Patients were asked to 'think aloud' when filling in the questionnaire. Results: Fifteen patients showed discrepancies between their answer to the EORTC question 'were you tired' and their level of fatigue spontaneously reported during the interview. These patients chose the response options 'not at all' or 'a little' and explained their answers in various ways. In patients with and without discrepancies, we found indications of recalibration response shift (e.g. using a different comparison standard over time) and of change in perspective (e.g. change towards a more optimistic perspective). Patients in the discrepancy group reported spontaneously how they dealt with diagnosis and treatment, i.e. by adopting protective and assertive behaviour and by fighting the stigma. They distanced themselves from the image of the stereotypical cancer patient and presented themselves as not suffering and accepting fatigue as consequence of treatment. Conclusion: In addition to response shift, this study suggests that 'self-presentation' might be an important mechanism affecting QoL measurement, particularly during phases when a new equilibrium needs to be found

Listen to their answers! Response behaviour in the measurement of physical and role functioning

Background: Quality of life (QoL) is considered to be an indispensable outcome measure of curative and palliative treatment. However, QoL research often yields findings that raise questions about what QoL measurement instruments actually assess and how the scores should be interpreted. Objective: To investigate how patients interpret and respond to questions on the EORTC-QLQ-C30 over time and to find explanations to account for counterintuitive findings in QoL measurement. Methods: Qualitative investigation was made of the response behaviour of small-cell lung cancer patients (n = 23) in the measurement of QoL with the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30). Focus was on physical functioning (PF, items 1 to 5), role functioning (RF, items 6 and 7), global health and QoL rating (GH/QOL, items 29 and 30). Interviews were held at four points: at the start of the chemotherapy, 4 weeks later, at the end, and 6 weeks after the end of chemotherapy. Patients were asked to 'think aloud' when filling in the questionnaire. Results: Patients used various response strategies when answering questions about problems and limitations in functioning, which impacted the accuracy of the scale. Patients had scores suggesting they were less limited than they actually were by taking the wording of questions literally, by guessing their functioning in activities that they did not perform, and by ignoring or excluding certain activities that they could not perform. Conclusion: Terminally ill patients evaluate their functioning in terms of what they perceive to be normal under the circumstances. Their answers can be interpreted in terms of change in the appraisal process (Rapkin and Schwartz 2004; Health and Quality of Life Outcomes, 2, 14). More care should be taken in assessing the quality of a set of questions about physical and role functioning. © 2008 The Author(s)

Response shift due to diagnosis and primary treatment of localized prostate cancer: a then-test and a vignette study

Aim Whether a prostate cancer diagnosis induces response shift has not been established so far. Therefore, we assessed response shift in men who were diagnosed with localized prostate cancer. Patients and methods Out of 3,892 men who completed a questionnaire before screening, 82 were subsequently diagnosed with prostate cancer. Response shift was assessed in 52 (response 63%) by the then-test (EuroQol self-rating of health, Short-Form 36 mental health and vitality) and a novel method: rating of vignettes relating to side effects of prostate cancer treatment (urinary, bowel and erectile dysfunction). Three then-tests were conducted: two referencing pre-diagnosis (measured pre

Repeated use of rich pictures to explore changes in subjective experiences over time of patients with advanced cancer

BACKGROUND: The combination of verbal and visual tools may help unravel the experiences of advanced cancer patients. However, most previous studies have focused on a specific symptom, at only one moment in time. We recently found that a specific visual tool, originating from systems thinking, that is, rich pictures (RPs), could provide a more comprehensive view of the experiences of patients with advanced cancer. AIMS: To examine whether the repeated use of RPs can make changes in subjective experiences of patients living with advanced cancer visible over time. METHODS AND RESULTS: We performed a prospective study with a generic qualitative approach that was mostly informed by the process of grounded theory. We invited patients to make an RP twice, at the start of the study, and again after 2 months. Both RP drawing sessions were directly followed by a semi‐structured interview. Patients with all types of solid tumors, above the age of 18, and with a diagnosis of advanced, incurable cancer, were eligible. Eighteen patients participated and 15 patients were able to draw an RP twice. In eight RP‐sets, considerable differences between the first and second RP were noticeable. Two patterns were distinguished: (1) a change (decline or improvement) in physical health (five patients), and/or (2) a change in the way patients related to cancer (three patients). CONCLUSION: RPs are a valuable qualitative research method that can be used to explore the experiences of patients with advanced cancer, not only at a single point in time but also over time

Preoperative and Early Postoperative Quality of Life Predict Survival in Potentially Curable Patients with Esophageal Cancer

Background: In patients with esophageal cancer, evidence for prognostic significance of preoperative quality of life (QoL) is limited, while the prognostic significance of postoperative QoL has not been investigated at all. Aim: To determine whether preoperative and postoperative QoL measurements can predict survival independently from clinical and pathological factors, in patients with potentially curable esophageal adenocarcinoma. Methods: A randomized controlled trial was performed from 1994 to 2000 in two academic medical centres, comparing transthoracic and transhiatal esophagectomy. QoL questionnaires were sent before and 3 months after surgery (Medical Outcome Study Short Form-20 and Rotterdam Symptom Checklist). Uni- and multivariate Cox regression analyses were used to examine firstly the prognostic value of preoperative QoL and several clinical factors, and secondly of postoperative QoL, several clinical factors, and pathological staging. Results: Out of 220 randomized patients, 199 participated in the QoL-study. In the multivariate preoperative model physical symptom scale (p = 0.021), tumor length (p = 0.034), and endosonographic T-stage (p = 0.003) were predictive for overall survival. In the postoperative multivariate analysis, social functioning (p = 0.035), pain (p = 0.026), and activity level (p = 0.037) predicted survival, besides pathological T-stage (p < 0.001) and N-stage (p < 0.001). Conclusion: In the present paper the first large consecutive series of potentially curable esophageal cancer patients is presented in whom prospectively collected QoL data before and after potentially curative surgical resection were used to predict survival. Both preoperative (physical symptoms) and postoperative (social functioning, pain, and activity level) QoL subscales are independent predictors of survival in potentially curable patients with esophageal adenocarcinoma

Prognostic value of patient-reported quality of life for survival in oesophagogastric cancer:Analysis from the population-based POCOP study

BACKGROUND: Accumulating evidence of trials demonstrates that patient-reported health-related quality of life (HRQoL) at diagnosis is prognostic for overall survival (OS) in oesophagogastric cancer. However, real-world data are lacking. Moreover, differences in disease stages and tumour-specific symptoms are usually not taken into consideration. The aim of this population-based study was to assess the prognostic value of HRQoL, including tumour-specific scales, on OS in patients with potentially curable and advanced oesophagogastric cancer. METHODS: Data were derived from the Netherlands Cancer Registry and the patient reported outcome registry (POCOP). Patients included in POCOP between 2016 and 2018 were stratified for potentially curable (cT1-4aNallM0) or advanced (cT4b or cM1) disease. HRQoL was measured with the EORTC QLQ-C30 and the tumour-specific OG25 module. Cox proportional hazards models assessed the impact of HRQoL, sociodemographic and clinical factors (including treatment) on OS. RESULTS: In total, 924 patients were included. Median OS was 38.9 months in potentially curable patients (n = 795) and 10.6 months in patients with advanced disease (n = 129). Global Health Status was independently associated with OS in potentially curable patients (HR 0.89, 99%CI 0.82-0.97), together with several other HRQoL items: appetite loss, dysphagia, eating restrictions, odynophagia, and body image. In advanced disease, the Summary Score was the strongest independent prognostic factor (HR 0.75, 99%CI 0.59-0.94), followed by fatigue, pain, insomnia and role functioning. CONCLUSION: In a real-world setting, HRQoL was prognostic for OS in patients with potentially curable and advanced oesophagogastric cancer. Several HRQoL domains, including the Summary Score and several OG25 items, could be used to develop or update prognostic models

Establishing anchor-based minimally important differences (MID) with the EORTC quality-of-life measures: a meta-analysis protocol.

INTRODUCTION: As patient assessment of health-related quality of life (HRQOL) in cancer clinical trials has increased over the years, so has the need to attach meaningful interpretations to differences in HRQOL scores between groups and changes within groups. Determining what represents a minimally important difference (MID) in HRQOL scores is useful to clinicians, patients and researchers, and can be used as a benchmark for assessing the success of a healthcare intervention. Our objective is to provide an evidence-based protocol to determine MIDs for the European Organisation for Research and Treatment for Cancer Quality of life Questionnaire core 30 (EORTC QLQ-C30). We will mainly focus on MID estimation for group-level comparisons. Responder thresholds for individual-level change will also be estimated. METHODS AND ANALYSIS: Data will be derived from published phase II and III EORTC trials that used the QLQ-C30 instrument, covering several cancer sites. We will use individual patient data to estimate MIDs for different cancer sites separately. Focus is on anchor-based methods. Anchors will be selected per disease site from available data. A disease-oriented and methodological panel will provide independent guidance on anchor selection. We aim to construct multiple clinical anchors per QLQ-C30 scale and also to compare with several anchor-based methods. The effects of covariates, for example, gender, age, disease stage and so on, will also be investigated. We will examine how our estimated MIDs compare with previously published guidelines, hence further contributing to robust MID guidelines for the EORTC QLQ-C30. ETHICS AND DISSEMINATION: All patient data originate from completed clinical trials with mandatory written informed consent, approved by local ethical committees. Our findings will be presented at scientific conferences, disseminated via peer-reviewed publications and also compiled in a MID 'blue book' which will be made available online on the EORTC Quality of Life Group website as a free guideline document