Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer.

BACKGROUND: Robust data on patient-reported outcome measures comparing treatments for clinically localized prostate cancer are lacking. We investigated the effects of active monitoring, radical prostatectomy, and radical radiotherapy with hormones on patient-reported outcomes. METHODS: We compared patient-reported outcomes among 1643 men in the Prostate Testing for Cancer and Treatment (ProtecT) trial who completed questionnaires before diagnosis, at 6 and 12 months after randomization, and annually thereafter. Patients completed validated measures that assessed urinary, bowel, and sexual function and specific effects on quality of life, anxiety and depression, and general health. Cancer-related quality of life was assessed at 5 years. Complete 6-year data were analyzed according to the intention-to-treat principle. RESULTS: The rate of questionnaire completion during follow-up was higher than 85% for most measures. Of the three treatments, prostatectomy had the greatest negative effect on sexual function and urinary continence, and although there was some recovery, these outcomes remained worse in the prostatectomy group than in the other groups throughout the trial. The negative effect of radiotherapy on sexual function was greatest at 6 months, but sexual function then recovered somewhat and was stable thereafter; radiotherapy had little effect on urinary continence. Sexual and urinary function declined gradually in the active-monitoring group. Bowel function was worse in the radiotherapy group at 6 months than in the other groups but then recovered somewhat, except for the increasing frequency of bloody stools; bowel function was unchanged in the other groups. Urinary voiding and nocturia were worse in the radiotherapy group at 6 months but then mostly recovered and were similar to the other groups after 12 months. Effects on quality of life mirrored the reported changes in function. No significant differences were observed among the groups in measures of anxiety, depression, or general health-related or cancer-related quality of life. CONCLUSIONS: In this analysis of patient-reported outcomes after treatment for localized prostate cancer, patterns of severity, recovery, and decline in urinary, bowel, and sexual function and associated quality of life differed among the three groups. (Funded by the U.K. National Institute for Health Research Health Technology Assessment Program; ProtecT Current Controlled Trials number, ISRCTN20141297 ; ClinicalTrials.gov number, NCT02044172 .).

What surgeons should tell patients with oesophago-gastric cancer: a cross sectional study of information needs.

BACKGROUND: Evidence shows that patients with cancer have many information needs, but specific requirements of patients undergoing surgery for oesophago-gastric (OG) cancer have not been well explored. This study surveyed information needs of patients with OG cancer and explored associations between patient characteristics and information needs. PATIENTS: A validated questionnaire assessing the importance of information about i) the nature, process and prognosis of the cancer, ii) tests, iii) treatments, and iv) physical and psychosocial outcomes (quality of life information) was completed by patients before and after OG cancer treatment. Items responses were transformed to a 0-100 score and linear regression explored associations between clinical and socio-demographic patient characteristics and patient information needs. RESULTS: Questionnaires from 136 respondents were received (response rate 60%, 25% pre-operative, 77% men, mean age 66). Most types of information were rated as important, with information about prognosis and quality of life issues being scored as highly important by over 112 (82%) patients. Linear regression showed that women rated information relating to treatment and psychosocial effects as more important than men (p < 0.038), but no other associations were identified. CONCLUSIONS: Most patients with OG cancer want detailed information, especially information about prognosis and quality of life. It is recommended that surgeons provide this for patients alongside information that the surgeon considers important.

Assessment and comparison of recovery after open and minimally invasive esophagectomy for cancer: an exploratory study in two centers.

BACKGROUND: Minimally invasive esophagectomy (MIE) may lead to early restoration of health-related quality of life, but few prospective comparative studies have been performed. This exploratory study compared recovery between totally minimally invasive esophagectomy (MIE), laparoscopically assisted esophagectomy (LAE) and open surgery (OE). METHODS: A prospective study in 2 specialist centers recruited consecutive patients undergoing OE, LAE, or MIE for high-grade dysplasia or cancer. Patients completed validated questionnaires, the Multi-Dimensional Fatigue Inventory (MFI-20), modified Katz Scale, and modified Lawton and Brody Scale (assessing activities of daily living) before and 6 weeks and 3 and 6 months after surgery. RESULTS: A total of 97 patients (26 women; median age 64 years) were scheduled for surgery that was abandoned in 11 due to occult low-volume metastatic disease. In the remaining 86 (OE = 19, LAE = 31, and MIE = 36), there were 4 in-hospital deaths (4 %), and 54 postoperative complications (OE = 12, LAE = 19, and MIE = 23). Overall questionnaire compliance was high (77 %) and baseline scores similar in all groups, although clinical differences between groups were observed with earlier tumors and more squamous cell cancers selected for MIE. Following surgery fatigue levels increased dramatically and activity levels reduced in all groups. These gradually recovered to baseline following MIE and LAE within 6 months, but the ability to perform activities of daily living and most parameters of fatigue had not returned to baseline levels in the OE group. CONCLUSIONS: This exploratory prospective nonrandomized study of recovery after different types of surgery for esophageal cancer showed possible small benefits to MIE. A much larger study is needed to confirm these findings.

Clinical and psychometric validation of the EORTC QLQ-CR29 questionnaire module to assess health-related quality of life in patients with colorectal cancer.

This international study aimed to test the measurement properties of the updated European Organisation for Research and Treatment of Cancer (EORTC) questionnaire module for colorectal cancer, the QLQ-CR29. The QLQ-CR29 was administered with the QLQ-C30, core questionnaire, to 351 patients from seven countries. Questionnaire scaling and reliability were established and clinical and psychometric validity examined. Patient acceptability and understanding were assessed with a debriefing questionnaire. Multi-trait scaling analyses and face validity refined the module to four scales assessing urinary frequency, faecal seepage, stool consistency and body image and single items assessing other common problems following treatment for colorectal cancer. Scales distinguished between clinically distinct groups of patients and did not correlate with QLQ-C30 scales, demonstrating construct validity. The QLQ-CR29 scores were reproducible over time in stable health. The EORTC QLQ-CR29 demonstrates sufficient validity and reliability to support its use to supplement the EORTC QLQ-C30 to assess patient-reported outcomes during treatment for colorectal cancer in clinical trials and other settings.

Validation of the European Organization for Research and Treatment of Cancer QLQ-LMC21 questionnaire for assessment of patient-reported outcomes during treatment of colorectal liver metastases.

BACKGROUND: There is a lack of valid patient-reported outcome (PRO) measures for hepatectomy or palliative treatment of colorectal hepatic metastases. This study examined the validity and reliability of the European Organization for Research and Treatment of Cancer Quality of Life questionnaire liver module (QLQ-LMC21) in patients with liver metastases from colorectal cancer. METHODS: Some 356 patients completed the core questionnaire (QLQ-C30), QLQ-LMC21 and a debriefing questionnaire before and 3 months after hepatectomy or palliative treatment. Construct, criterion and clinical validity were evaluated before and after treatment. RESULTS: Questionnaire compliance was high; less than 1 per cent of data were missing from individual items. Modifications to the hypothesized scale structure produced four scales and nine single items with good reliability, clinical, criterion and construct validity. The QLQ-LMC21 distinguished between patients selected for surgery or palliative treatment in nine of these 13. Significant changes in PROs were observed before and after treatment. The new module discriminated between clinically distinct groups of patients and measured aspects of quality of life not covered in the core questionnaire. CONCLUSION: The EORTC QLQ-LMC21 is a valid and reliable questionnaire module to use with the QLQ-C30 in assessing PROs in hepatectomy or palliative treatment for colorectal liver metastases.

The influence of an enhanced recovery programme on clinical outcomes, costs and quality of life after surgery for colorectal cancer.

OBJECTIVE: Optimizing peri-operative care using an enhanced recovery programme improves short-term outcomes following colonic resection. This study compared a prospective group of patients undergoing resection of colorectal cancer within an enhanced recovery programme, with a prospectively studied historic cohort receiving conventional care. PATIENTS AND METHODS: Sixty patients underwent elective resection within an enhanced recovery programme (ERP). This incorporated pre-operative counselling, epidural analgesia, early feeding and mobilization. Clinical outcomes were compared with 86 prospectively studied historic control patients receiving conventional care (CC). All patients completed EORTC QLQ-C30, QLQ-CR38 and health economics questionnaires up to three months after surgery. RESULTS: Baseline clinical data were similar in both groups. Postoperative hospital stay was significantly reduced in the ERP, with patients staying 49% as long as those in the CC group including convalescent hospital stay (95% CI 39% to 61%P < 0.001). There were no differences in the number of complications, readmissions or re-operations. There were no significant differences in quality of life or health economic outcomes. CONCLUSION: Patients undergoing colorectal resection within an ERP stay in hospital half as long as those receiving conventional care, with no increased morbidity, deterioration in quality of life or increased cost.

Randomized clinical trial comparing laparoscopic and open surgery for colorectal cancer within an enhanced recovery programme.

BACKGROUND: Laparoscopic resection of colorectal cancer may improve short-term outcome without compromising long-term survival or disease control. Recent evidence suggests that the difference between laparoscopic and open surgery may be less significant when perioperative care is optimized within an enhanced recovery programme. This study compared short-term outcomes of laparoscopic and open resection of colorectal cancer within such a programme. METHODS: Between January 2002 and March 2004, 62 patients were randomized on a 2 : 1 basis to receive laparoscopic (n = 43) or open (n = 19) surgery. All were entered into an enhanced recovery programme. Length of hospital stay was the primary endpoint. Secondary outcomes of functional recovery, quality of life and cost were assessed for 3 months after surgery. RESULTS: Demographics of the two groups were similar. Length of hospital stay after laparoscopic resection was 32 (95 per cent confidence interval (c.i.) 7 to 51) per cent shorter than for open resection (P = 0.018). Combined hospital, convalescent and readmission stay was 37 (95 per cent c.i. 10 to 56) per cent shorter (P = 0.012). The relative risk of complications, quality of life results and cost data were similar in the two groups. CONCLUSION: Despite perioperative optimization of open surgery for colorectal cancer, short-term outcomes were better following laparoscopic surgery. There was no deterioration in quality of life or increased cost associated with the laparoscopic approach.

Assessment of satisfaction with care after inpatient treatment for oesophageal and gastric cancer.

BACKGROUND: Patients' views are becoming increasingly important in the current health system. They provide information on effectiveness of healthcare and how it may be improved. This study aimed to measure patients' satisfaction with care received for treatment of oesophageal and gastric cancer, and to identify areas that contribute most to overall satisfaction scores. METHODS: Consecutive inpatients with oesophageal and gastric cancer treated in one surgical unit were recruited prospectively during a 2-year period. The European Organization for Research and Treatment of Cancer 'satisfaction with in-hospital care' questionnaire (QLQ-SAT32) was completed following discharge. Scores ranged from 0 to 100 for each satisfaction scale. Univariable and multivariable analysis was used to define the relationships between the different dimensions of satisfaction with care and the overall score. RESULTS: Ninety-one patients (mean age 67 years, 60 men) completed the questionnaire a mean of 40 days after treatment. The highest scores were for doctors (mean 72), nurses (mean 67) and overall satisfaction (mean 68). Univariable analysis showed that all dimensions of satisfaction with care contributed significantly to overall satisfaction (P < 0.001). Multivariable analyses, however, showed that most of the variation in overall satisfaction could be attributed to levels of satisfaction with doctors, nurses, and hospital comfort and cleanliness. CONCLUSION: Satisfaction with care in these surgical patients was high and could be measured using a multidimensional instrument. Overall satisfaction was not influenced equally by all aspects of care. The strongest contributors to overall satisfaction in this study were doctors, nurses and hospital cleanliness.

Feasibility of quality of life assessment in patients with upper gastrointestinal tract cancer.

Quality of life (QOL) is an important outcome after treatment for upper gastrointestinal tract cancer but few studies report good accrual and subsequent attrition is usually high. This study investigated the feasibility of a nurse-led service to obtain longitudinal QOL assessments and explored how clinical and sociodemographic factors influence patients' need for help to complete questionnaires. Fully informed patients were invited into the study. Baseline hospital assessments were scheduled by telephone and thereafter by post unless patients' health indicated the need for a home visit. In all, 128 out of 140 (91%) baseline QOL assessments were performed. Follow-up questionnaire completion was good, with 114 patients (89%) completing all but one of the expected assessments. At baseline, 41 (32%) patients required a lot of help to complete questionnaires. Patients requiring help were more likely to be undergoing palliative treatment than treatment aimed at cure (68 vs 33%; odds ratio 3.48, P<0.01). Patients' with advanced stage cancer of the upper gastrointestinal tract receiving palliative treatment require dedicated staff to ensure good compliance with longitudinal QOL data collection. It is essential to budget for this in clinical trails.

Measurement of outcome.

The outcomes of treatment of oesophageal cancer include traditional biological and physical measures, such as mortality and morbidity data, disease free and overall survival, clinical and pathological response rates and symptom control. Such factors are essential and should be recorded prospectively for clinical audit. Using this type of information alone to evaluate effectiveness of treatment is inadequate, however, because the diagnosis and treatment of oesophageal cancer has a major impact on functional well-being (including psycho-social function), general health perceptions and overall quality of life (QL)/satisfaction with health and health care. These aspects of patients' well-being need to be considered, in addition to standard outcomes in the evaluation of treatment of oesophageal cancer. Recent needs to judge the economic efficiency of health care by comparing health outcomes with costs may also be part of treatment appraisal. This article reviews surgical, oncological, patient-based and economic outcomes in oesophageal cancer.

The prognostic value of quality of life scores during treatment for oesophageal cancer.

BACKGROUND: Quality of life (QL) data are useful to evaluate the effectiveness of treatment. Accumulating evidence suggests that QL data may predict survival. AIMS: In this study we investigated if baseline QL scores and changes in QL scores before and after intervention are prognostic for patients with oesophageal cancer. PATIENTS: Between 1993 and 1995, 92 consecutive new patients with oesophageal cancer were studied; 89 were followed until death or the end of the study period (survival of seven patients was censored in May 1999). METHODS: All patients completed the European Organisation for Research and Treatment of Cancer (EORTC) core questionnaire (EORTC QLQ-C30) and the dysphagia scale of the oesophageal module (EORTC QLQ-OES24) before treatment and at regular intervals throughout the study. Cox's proportional hazards models assessed the impact of baseline QL variables and changes in QL scores on survival. RESULTS: Cox's proportional hazards models, adjusting for associations between QL scores, age, and TNM stage, found that physical function at baseline was significantly associated with survival (p=0.002). An increase in physical function score of 10 points corresponded to a 12% reduction in the likelihood of death at any given time (95% confidence intervals 4--18%). Further exploratory multivariable analyses suggested that improvement in emotional function six months after treatment was significantly related to longer survival (p<0.0001). CONCLUSIONS: These data provide evidence to support a relationship between patient rated scores of QL and survival. Further understanding of the associations between QL and clinical variables is needed.

Development of an EORTC questionnaire module to be used in quality of life assessment for patients with oesophageal cancer. The EORTC Quality of Life Study Group.

Quality of life (QOL) assessments in patients with oesophageal cancer should provide clinically meaningful data that can assist management decision making. This study describes the development of a specific module for oesophageal cancer to use with the European Organisation into Research and Treatment of Cancer (EORTC) QOL questionnaire, the EORTC QLQ-C30. Relevant QOL issues were generated from a literature search and interviews with patients and oesophageal cancer specialists. Issues were formulated into items compatible with those of the EORTC QLQ-C30. The provisional module was pretested in patients from the United Kingdom, Spain and Sweden. The resulting module, the QLQ-OES 24, includes 24 items conceptualised as containing six scales and five single items. The addition of an oesophageal cancer-specific module to the core questionnaire should improve the sensitivity and specificity of the core instrument to allow detection of even small benefits accrued from new treatment modalities.

Observer variation in assessment of quality of life in patients with oesophageal cancer.

Quality of life (QOL) assessment may improve the evaluation of treatment for oesophageal cancer but patient compliance using self completion questionnaires is often poor. The use of a proxy to estimate QOL might improve data collection from patients who are either unable or unwilling to complete the questionnaire. This study examined whether a doctor or patients' carers could accurately assess QOL using the QLQ-C30 questionnaire developed by the European Organisation for Research and Treatment of Cancer Study Group on Quality of Life. One doctor, 52 patients and 39 carers completed the instrument independently. Proxy and patient ratings were analysed for agreement using weighted kappa scores. Agreement was poor or moderate in most QOL scales and items (kappa < or = 60). This study demonstrates that a carer or doctor is not sufficiently accurate to postulate the patient's responses to the questionnaire. Quality of life data, therefore, should come from the patients themselves.