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Direct improvement of quality of life using a tailored quality of life diagnosis and therapy pathway: randomised trial in 200 women with breast cancer.

ABSTRACT: BACKGROUND: Despite thousands of papers, the value of quality of life (QoL) in curing disease remains uncertain. Until now, we lacked tools for the diagnosis and specific treatment of diseased QoL. We approached this problem stepwise by theory building, modelling, an exploratory trial and now a definitive randomised controlled trial (RCT) in breast cancer, whose results we report here. METHODS: In all, 200 representative Bavarian primary breast cancer patients were recruited by five hospitals and treated by 146 care professionals. Patients were randomised to either (1) a novel care pathway including diagnosis of 'diseased' QoL (any QoL measure below 50 points) using a QoL profile and expert report sent to the patient's coordinating practitioner, who arranged QoL therapy consisting of up to five standardised treatments for specific QoL defects or (2) standard postoperative care adhering to the German national guideline for breast cancer. The primary end point was the proportion of patients in each group with diseased QoL 6 months after surgery. Patients were blinded to their allocated group. RESULTS: At 0 and 3 months after surgery, diseased QoL was diagnosed in 70% of patients. The QoL pathway reduced rates of diseased QoL to 56% at 6 months, especially in emotion and coping, compared with 71% in controls (P=0.048). Relative risk reduction was 21% (95% confidence interval (CI): 0-37), absolute risk reduction 15% (95% CI: 0.3-29), number needed to treat (NNT)=7 (95% CI: 3-37). When QoL therapy finished after successful treatment, diseased QoL often returned again, indicating good responsiveness of the QoL pathway. CONCLUSION: A three-component outcome system including clinician-derived objective, patient-reported subjective end points and qualitative analysis of clinical relevance was developed in the last 10 years for cancer as a complex intervention. A separate QoL pathway was implemented for the diagnosis and treatment of diseased QoL and its effectiveness tested in a community-based, pragmatic, definitive RCT. While the pathway was active, it was effective with an NNT of 7.

SUBMITTER: Klinkhammer-Schalke M

PROVIDER: S-EPMC3305975 | biostudies-other | 2012 Feb

REPOSITORIES: biostudies-other

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Project description:Medical treatment in patient-centred care in oncology is broadly managed and regulated in terms of guideline development, cancer centres, and quality assurance by cancer registries. In contrast to this quality management cycle (PDCA), there are no equal standards for patient-reported outcomes like quality of life (QoL). Therefore, the Tumour Centre Regensburg e.V., a population-based regional cancer registry covering a population of more than 2.2 million people in the Upper Palatinate and Lower Bavaria, Germany, designed and implemented a QoL pathway. In a complex intervention with QoL diagnosis and therapy (multidimensional therapeutic network), effectiveness for patients with breast cancer has been demonstrated. To provide local tailored QoL diagnosis and therapy to other cancer patients as well, external validity needs to be extended by adapting the QoL pathway to another tumour entity.The QoL pathway will be tested for colorectal cancer patients in a pragmatic randomised controlled trial. Two hundred twenty primary colorectal cancer patients, surgically treated in one of four hospitals, will be included. QoL is measured in all patients 0, 3, 6, 12, and 18 months after surgery (European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-CR29). In the intervention group, QoL scores are transformed into a QoL profile. This is sent to the coordinating practitioner (general practitioner, internist, or oncologist) with an expert report including treatment recommendations for QoL deficits. The control group receives routine follow-up care attending the guideline recommendations for colorectal cancer without profile or expert report. At the primary endpoint (12 months), the rates of patients with diseased QoL in both groups are compared.This randomised trial is the first complex intervention investigating the effectiveness of an intervention with QoL diagnosis and tailored QoL therapy in colorectal cancer patients. The results will show if this QoL pathway improves the patients' QoL during follow-up care of their disease.ClinicalTrials.gov, NCT02321813 (registered December 2014).

Project description:General practitioners with more positive role security and therapeutic commitment towards patients with hazardous or harmful alcohol consumption are more involved and manage more alcohol-related problems than others. In this study we evaluated the effects of our tailored multi-faceted improvement implementation programme on GPs' role security and therapeutic commitment and, in addition, which professional related factors influenced the impact of the implementation programme.In a cluster randomised controlled trial, 124 GPs from 82 Dutch general practices were randomised to either the intervention or control group. The tailored, multi-faceted programme included combined physician, organisation, and patient directed alcohol-specific implementation strategies to increase role security and therapeutic commitment in GPs. The control group was mailed the national guideline and patients received feedback letters. Questionnaires were completed before and 12 months after start of the programme. We performed linear multilevel regression analysis to evaluate effects of the implementation programme.Participating GPs were predominantly male (63%) and had received very low levels of alcohol related education before start of the study (0.4 h). The programme increased therapeutic commitment (p = 0.005; 95%-CI 0.13 - 0.73) but not role security (p = 0.58; 95%-CI -0.31 - 0.54). How important GPs thought it was to improve their care for problematic alcohol consumption, and the GPs' reported proportion of patients asked about alcohol consumption at baseline, contributed to the effect of the programme on therapeutic commitment.A tailored, multi-faceted programme aimed at improving GP management of patients with hazardous and harmful alcohol consumption improved GPs' therapeutic commitment towards patients with alcohol-related problems, but failed to improve GPs' role security. How important GPs thought it was to improve their care for problematic alcohol consumption, and the GPs' reported proportion of patients asked about alcohol consumption at baseline, both increased the impact of the programme on therapeutic commitment. It might be worthwhile to monitor proceeding of role security and therapeutic commitment throughout the year after the implementation programme, to see whether the programme is effective on short term but faded out on the longer term.ClinicalTrials.gov Identifier: NCT00298220.

Project description:The functional deficits in people with fibromyalgia can be related to the level of physical activity performed. This study investigated the effectiveness of an active exercise programme versus exercise for well-being improving pain, flexibility, static balance, perceived exertion and quality of life of women with fibromyalgia; Methods: A randomised, single-blind, controlled trial was conducted. A total of 141 of women diagnosed with fibromyalgia were enrolled and randomised to an active exercise program group (n = 47), where they performed physical active exercises, an exercise for well-being group (n = 47), which performed the Qi Gong exercises named 'the twenty Wang Ziping figures for health and longevity', and a control group (n = 47), which did not receive any intervention, for a period of 4 weeks. Measures were taken at baseline and after the treatment. The primary outcome measures were static balance and centre of gravity (Wii-Fit Nintendo ©), flexibility (test de Wells and Dillon), pain (Visual Analogue Scale) and quality of life (Spanish-Fibromyalgia Impact Questionnaire). The secondary outcome measure was the perceived exertion during activity (BORG Scale). In total, 93 participants completed the study. The mean value of the age was 52.24 ± 6.19. The post intervention results showed statistically significant improvements in the exercise for well-being and the active exercise programme groups vs. the control group in relation to pain (p = 0.006 active exercise programme group, p = 0.001 exercise for well-being group), static balance (p < 0.001 active exercise programme group) and quality of life (p < 0.001 active exercise programme group, p = 0.002 exercise for well-being group). In addition, the mean scores related to perceived fatigue during the sessions were 6.30 ± 1.88 for the active exercise programme group and 5.52 ± 1.55 for the exercise for well-being group. These differences were not significant. The active exercise program and exercise for well-being improved flexibility, static balance, pain and quality of life of women with fibromyalgia. The participants of the active exercise programme achieved better results that those of the exercise for well-being.

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Direct improvement of quality of life using a tailored quality of life diagnosis and therapy pathway: randomised trial in 200 women with breast cancer.

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