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      An Activity Tracker–Guided Physical Activity Program for Patients Undergoing Radiotherapy: Protocol for a Prospective Phase III Trial (OnkoFit I and II Trials)

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          Abstract

          Background

          The positive impact that physical activity has on patients with cancer has been shown in several studies over recent years. However, supervised physical activity programs have several limitations, including costs and availability. Therefore, our study proposes a novel approach for the implementation of a patient-executed, activity tracker–guided exercise program to bridge this gap.

          Objective

          Our trial aims to investigate the impact that an activity tracker–guided, patient-executed exercise program for patients undergoing radiotherapy has on cancer-related fatigue, health-related quality of life, and preoperative health status.

          Methods

          Patients receiving postoperative radiotherapy for breast cancer (OnkoFit I trial) or neoadjuvant, definitive, or postoperative treatment for other types of solid tumors (OnkoFit II trial) will be randomized (1:1:1) into 3-arm studies. Target accrual is 201 patients in each trial (50 patients per year). After providing informed consent, patients will be randomized into a standard care arm (arm A) or 1 of 2 interventional arms (arms B and C). Patients in arms B and C will wear an activity tracker and record their daily step count in a diary. Patients in arm C will receive personalized weekly targets for their physical activity. No further instructions will be given to patients in arm B. The target daily step goals for patients in arm C will be adjusted weekly and will be increased by 10% of the average daily step count of the past week until they reach a maximum of 6000 steps per day. Patients in arm A will not be provided with an activity tracker. The primary end point of the OnkoFit I trial is cancer-related fatigue at 3 months after the completion of radiotherapy. This will be measured by the Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire. For the OnkoFit II trial, the primary end point is the overall quality of life, which will be assessed with the Functional Assessment of Cancer Therapy-General sum score at 6 months after treatment to allow for recovery after possible surgery. In parallel, blood samples from before, during, and after treatment will be collected in order to assess inflammatory markers.

          Results

          Recruitment for both trials started on August 1, 2020, and to date, 49 and 12 patients have been included in the OnkoFit I and OnkoFit II trials, respectively. Both trials were approved by the institutional review board prior to their initiation.

          Conclusions

          The OnkoFit trials test an innovative, personalized approach for the implementation of an activity tracker–guided training program for patients with cancer during radiotherapy. The program requires only a limited amount of resources.

          Trial Registration

          ClinicalTrials.gov NCT04506476; https://clinicaltrials.gov/ct2/show/NCT04506476. ClinicalTrials.gov NCT04517019; https://clinicaltrials.gov/ct2/show/NCT04517019.

          International Registered Report Identifier (IRRID)

          DERR1-10.2196/28524

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          Most cited references40

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          The Clavien-Dindo classification of surgical complications: five-year experience.

          The lack of consensus on how to define and grade adverse postoperative events has greatly hampered the evaluation of surgical procedures. A new classification of complications, initiated in 1992, was updated 5 years ago. It is based on the type of therapy needed to correct the complication. The principle of the classification was to be simple, reproducible, flexible, and applicable irrespective of the cultural background. The aim of the current study was to critically evaluate this classification from the perspective of its use in the literature, by assessing interobserver variability in grading complex complication scenarios and to correlate the classification grades with patients', nurses', and doctors' perception. Reports from the literature using the classification system were systematically analyzed. Next, 11 scenarios illustrating difficult cases were prepared to develop a consensus on how to rank the various complications. Third, 7 centers from different continents, having routinely used the classification, independently assessed the 11 scenarios. An agreement analysis was performed to test the accuracy and reliability of the classification. Finally, the perception of the severity was tested in patients, nurses, and physicians by presenting 30 scenarios, each illustrating a specific grade of complication. We noted a dramatic increase in the use of the classification in many fields of surgery. About half of the studies used the contracted form, whereas the rest used the full range of grading. Two-thirds of the publications avoided subjective terms such as minor or major complications. The study of 11 difficult cases among various centers revealed a high degree of agreement in identifying and ranking complications (89% agreement), and enabled a better definition of unclear situations. Each grade of complications significantly correlated with the perception by patients, nurses, and physicians (P < 0.05, Kruskal-Wallis test). This 5-year evaluation provides strong evidence that the classification is valid and applicable worldwide in many fields of surgery. No modification in the general principle of classification is warranted in view of the use in ongoing publications and trials. Subjective, inaccurate, or confusing terms such as "minor or major" should be removed from the surgical literature.
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            Exercise Guidelines for Cancer Survivors

            The number of cancer survivors worldwide is growing, with over 15.5 million cancer survivors in the United States alone-a figure expected to double in the coming decades. Cancer survivors face unique health challenges as a result of their cancer diagnosis and the impact of treatments on their physical and mental well-being. For example, cancer survivors often experience declines in physical functioning and quality of life while facing an increased risk of cancer recurrence and all-cause mortality compared with persons without cancer. The 2010 American College of Sports Medicine Roundtable was among the first reports to conclude that cancer survivors could safely engage in enough exercise training to improve physical fitness and restore physical functioning, enhance quality of life, and mitigate cancer-related fatigue.
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              American College of Sports Medicine roundtable on exercise guidelines for cancer survivors.

              Early detection and improved treatments for cancer have resulted in roughly 12 million survivors alive in the United States today. This growing population faces unique challenges from their disease and treatments, including risk for recurrent cancer, other chronic diseases, and persistent adverse effects on physical functioning and quality of life. Historically, clinicians advised cancer patients to rest and to avoid activity; however, emerging research on exercise has challenged this recommendation. To this end, a roundtable was convened by American College of Sports Medicine to distill the literature on the safety and efficacy of exercise training during and after adjuvant cancer therapy and to provide guidelines. The roundtable concluded that exercise training is safe during and after cancer treatments and results in improvements in physical functioning, quality of life, and cancer-related fatigue in several cancer survivor groups. Implications for disease outcomes and survival are still unknown. Nevertheless, the benefits to physical functioning and quality of life are sufficient for the recommendation that cancer survivors follow the 2008 Physical Activity Guidelines for Americans, with specific exercise programming adaptations based on disease and treatment-related adverse effects. The advice to "avoid inactivity," even in cancer patients with existing disease or undergoing difficult treatments, is likely helpful.
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                Author and article information

                Contributors
                Journal
                JMIR Res Protoc
                JMIR Res Protoc
                ResProt
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                1929-0748
                September 2021
                22 September 2021
                : 10
                : 9
                : e28524
                Affiliations
                [1 ] Department of Radiation Oncology University Hospital Tübingen Tuebingen Germany
                [2 ] Edwin L Steele Laboratories for Tumor Biology, Department of Radiation Oncology Massachusetts General Hospital Harvard Medical School Boston, MA United States
                [3 ] Department of Sports Medicine University Medicine Tübingen Tuebingen Germany
                [4 ] Institute for Clinical Epidemiology and Applied Biostatistics University Hospital of Tübingen Tuebingen Germany
                [5 ] Department of Diagnostic Laboratory Medicine Institute for Clinical Chemistry and Pathobiochemistry University Hospital of Tübingen Tuebingen Germany
                [6 ] Department of Neurology & Interdisciplinary Neuro-Oncology University Hospital Tübingen Hertie Institute for Clinical Brain Research Tuebingen Germany
                [7 ] Department of Obstetrics and Gynecology University Hospital Tübingen Tuebingen Germany
                [8 ] Department of Psychosomatic Medicine and Psychotherapy Medical University Hospital Tübingen Tuebingen Germany
                [9 ] Comprehensive Cancer Center Section Psychooncology University Hospital Tuebingen Tuebingen Germany
                [10 ] Charité Center for Internal Medicine and Dermatology Department of Psychosomatic Medicine Charité-Universitätsmedizin Berlin Berlin Germany
                [11 ] Freie Universität Berlin Humboldt-Universität zu Berlin Berlin Institute of Health Berlin Germany
                [12 ] German Cancer Research Center Heidelberg and German Consortium for Translational Cancer Research Partner Site Tübingen Tuebingen Germany
                Author notes
                Corresponding Author: Franziska Hauth franziska.hauth@ 123456med.uni-tuebingen.de
                Author information
                https://orcid.org/0000-0002-2432-7716
                https://orcid.org/0000-0002-0295-9392
                https://orcid.org/0000-0002-6145-7069
                https://orcid.org/0000-0002-6366-4192
                https://orcid.org/0000-0001-6837-930X
                https://orcid.org/0000-0002-7830-9708
                https://orcid.org/0000-0002-4373-5539
                https://orcid.org/0000-0001-5732-2287
                https://orcid.org/0000-0002-2824-3720
                https://orcid.org/0000-0003-1227-1118
                https://orcid.org/0000-0003-3294-4340
                https://orcid.org/0000-0001-5779-9675
                https://orcid.org/0000-0003-0242-9428
                Article
                v10i9e28524
                10.2196/28524
                8495573
                34550079
                5b12c3c4-325d-4638-87ab-1e86094af3b0
                ©Franziska Hauth, Barbara Gehler, Andreas Michael Nieß, Katharina Fischer, Andreas Toepell, Vanessa Heinrich, Inka Roesel, Andreas Peter, Mirjam Renovanz, Andreas Hartkopf, Andreas Stengel, Daniel Zips, Cihan Gani. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 22.09.2021.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                History
                : 5 March 2021
                : 5 May 2021
                : 26 June 2021
                : 30 June 2021
                Categories
                Protocol
                Protocol

                cancer,fatigue,physical activity,quality of life,activity tracker,exercise program,radiotherapy,digital health

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