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      Effects of an exercise intervention in primary care after robot-assisted radical cystectomy for urinary bladder cancer: a randomised controlled trial

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          Abstract

          Introduction

          After radical cystectomy physical activity is important to reduce risk of complications, but patients with urinary bladder cancer have difficulties in achieving general recommendations on physical activity and exercise. The aim of this randomised controlled trial was therefore to evaluate the effects of a physical exercise programme in primary care, following discharge from hospital after robot-assisted radical cystectomy for urinary bladder cancer.

          Materials and Methods

          Patients with urinary bladder cancer scheduled for robot-assisted radical cystectomy at Karolinska University Hospital, Sweden between September 2019 and October 2022 were invited to join the study. At discharge, they were randomised to intervention or active control group. The intervention group was planned to start exercise with physiotherapist in primary care during the third week; the programme included aerobic and strengthening exercises, twice a week for 12 weeks, and daily walks. The control group received unsupervised home-based exercise with daily walks and a sit-to-stand exercise. Assessments were conducted before surgery, at discharge and after four months regarding the primary outcome physical function (Six-minute walk test), and secondary outcomes physical activity, pain, health-related quality of life, fatigue, and psychological wellbeing.

          Results

          Ninety patients were included, mean (sd) age 71.5 (8.5) years. An intention-to-treat analysis showed no intervention effect on the primary outcome physical function, or on pain or psychological wellbeing, but effect on physical activity with a difference from discharge to four months with a median (IQR) of 4790 (3000) and 2670 (4340) daily steps in the intervention and control group, respectively ( p = 0.046), and for fatigue, and health-related quality of life, in favour of the intervention group.

          Conclusion

          Both the intervention and control groups improved physical function, but the patients who exercised in primary care experienced additional positive effects on physical activity, fatigue, and health-related quality of life. Hence, exercise in primary care after discharge from hospital could be a promising method after radical cystectomy for urinary bladder cancer.

          Trial registration

          The study was registered in Clinical Trials with registration number NCT03998579, 20,190,607.

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          Most cited references37

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          The hospital anxiety and depression scale.

          A self-assessment scale has been developed and found to be a reliable instrument for detecting states of depression and anxiety in the setting of an hospital medical outpatient clinic. The anxiety and depressive subscales are also valid measures of severity of the emotional disorder. It is suggested that the introduction of the scales into general hospital practice would facilitate the large task of detection and management of emotional disorder in patients under investigation and treatment in medical and surgical departments.
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            ATS statement: guidelines for the six-minute walk test.

            (2002)
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              The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology.

              In 1986, the European Organization for Research and Treatment of Cancer (EORTC) initiated a research program to develop an integrated, modular approach for evaluating the quality of life of patients participating in international clinical trials. We report here the results of an international field study of the practicality, reliability, and validity of the EORTC QLQ-C30, the current core questionnaire. The QLQ-C30 incorporates nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale. Several single-item symptom measures are also included. The questionnaire was administered before treatment and once during treatment to 305 patients with nonresectable lung cancer from centers in 13 countries. Clinical variables assessed included disease stage, weight loss, performance status, and treatment toxicity. The average time required to complete the questionnaire was approximately 11 minutes, and most patients required no assistance. The data supported the hypothesized scale structure of the questionnaire with the exception of role functioning (work and household activities), which was also the only multi-item scale that failed to meet the minimal standards for reliability (Cronbach's alpha coefficient > or = .70) either before or during treatment. Validity was shown by three findings. First, while all interscale correlations were statistically significant, the correlation was moderate, indicating that the scales were assessing distinct components of the quality-of-life construct. Second, most of the functional and symptom measures discriminated clearly between patients differing in clinical status as defined by the Eastern Cooperative Oncology Group performance status scale, weight loss, and treatment toxicity. Third, there were statistically significant changes, in the expected direction, in physical and role functioning, global quality of life, fatigue, and nausea and vomiting, for patients whose performance status had improved or worsened during treatment. The reliability and validity of the questionnaire were highly consistent across the three language-cultural groups studied: patients from English-speaking countries, Northern Europe, and Southern Europe. These results support the EORTC QLQ-C30 as a reliable and valid measure of the quality of life of cancer patients in multicultural clinical research settings. Work is ongoing to examine the performance of the questionnaire among more heterogenous patient samples and in phase II and phase III clinical trials.
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                Author and article information

                Contributors
                andrea.porserud@ki.se
                Journal
                BMC Cancer
                BMC Cancer
                BMC Cancer
                BioMed Central (London )
                1471-2407
                24 July 2024
                24 July 2024
                2024
                : 24
                : 891
                Affiliations
                [1 ]Division of Physiotherapy, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, ( https://ror.org/056d84691) Stockholm, Sweden
                [2 ]Women’s Health and Allied Health Professionals Theme, Medical Unit Occupational Therapy & Physiotherapy, Karolinska University Hospital, ( https://ror.org/00m8d6786) Stockholm, Sweden
                [3 ]Department of Molecular Medicine and Surgery, Karolinska Institutet, ( https://ror.org/056d84691) Stockholm, Sweden
                [4 ]Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, ( https://ror.org/00m8d6786) Stockholm, Sweden
                [5 ]Division of Urology, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, ( https://ror.org/056d84691) Stockholm, Sweden
                [6 ]GRID grid.425979.4, ISNI 0000 0001 2326 2191, Academic Primary Health Care Centre, , Region Stockholm, ; Stockholm, Sweden
                [7 ]GRID grid.445308.e, ISNI 0000 0004 0460 3941, Department of Health Promoting Science, , Sophiahemmet University, ; Stockholm, Sweden
                Article
                12647
                10.1186/s12885-024-12647-2
                11267740
                d1c3637c-bbdf-418b-81ce-7f739e754345
                © The Author(s) 2024

                Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 4 April 2024
                : 16 July 2024
                Funding
                Funded by: Karolinska Institute
                Categories
                Research
                Custom metadata
                © BioMed Central Ltd., part of Springer Nature 2024

                Oncology & Radiotherapy
                cancer,physical rehabilitation,primary care,quality of life,surgery
                Oncology & Radiotherapy
                cancer, physical rehabilitation, primary care, quality of life, surgery

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