Anders Hansen1,2, Karen Søgaard1, Lisbeth Rosenbek Minet2,3,4, Jens Ole Jarden5. 1. a Institute of Sports Science and Clinical Biomechanics , University of Southern Denmark , Odense , Denmark. 2. b Department of Rehabilitation , Odense University Hospital , Odense , Denmark. 3. c Research Unit of Rehabilitation, Institute of Clinical Research , University of Southern Denmark , Odense , Denmark. 4. d Research Centre, University College Lillebaelt , Odense , Denmark. 5. e Department of Neurology , Herlev University Hospital , Copenhagen , Denmark.
Abstract
PURPOSE: This report aims to assess the safety and feasibility of using an interdisciplinary rehabilitation intervention for a future randomized controlled trial in patients with gliomas in the initial treatment phase. METHOD: We conducted an outpatient two-part rehabilitation intervention that involved six weeks of therapeutic supervised training (part one) and six weeks of unsupervised training in a local gym following a training protocol (part two). RESULTS: Predefined feasibility objectives of safety (100%), consent rate (>80%), drop-out (<20%), adherence (>80%) and patient satisfaction (>80%) was achieved at part one. However, the failure to meet predefined feasibility objectives of drop-out, adherence and patient satisfaction of the unsupervised intervention at part two have led to a protocol revision for a future randomized controlled trial. CONCLUSION: This study demonstrates that an intensive rehabilitation intervention of physical therapy and occupational therapy in the initial treatment phase of patients with gliomas whose Karnofsky performance status is ≥70 is safe and feasible, if relevant inclusion criteria and precautionary screening are made. With the revised protocol, we are confident that the foundation for conducting a successful randomized controlled trial among these vulnerable patients has been established. Implications for rehabilitation Brain tumors constitute some of the most challenging cancer diagnoses presenting for rehabilitation intervention. Patients with gliomas experiences limitations in physical functioning, cognition, and emotional wellbeing. In a relatively small sample this study shows that supervised physical- and occupational therapy in patients with gliomas is safe and feasible in the initial treatment phase. Patients with gliomas can potentially improve functioning through interdisciplinary rehabilitation.
RCT Entities:
PURPOSE: This report aims to assess the safety and feasibility of using an interdisciplinary rehabilitation intervention for a future randomized controlled trial in patients with gliomas in the initial treatment phase. METHOD: We conducted an outpatient two-part rehabilitation intervention that involved six weeks of therapeutic supervised training (part one) and six weeks of unsupervised training in a local gym following a training protocol (part two). RESULTS: Predefined feasibility objectives of safety (100%), consent rate (>80%), drop-out (<20%), adherence (>80%) and patient satisfaction (>80%) was achieved at part one. However, the failure to meet predefined feasibility objectives of drop-out, adherence and patient satisfaction of the unsupervised intervention at part two have led to a protocol revision for a future randomized controlled trial. CONCLUSION: This study demonstrates that an intensive rehabilitation intervention of physical therapy and occupational therapy in the initial treatment phase of patients with gliomas whose Karnofsky performance status is ≥70 is safe and feasible, if relevant inclusion criteria and precautionary screening are made. With the revised protocol, we are confident that the foundation for conducting a successful randomized controlled trial among these vulnerable patients has been established. Implications for rehabilitation Brain tumors constitute some of the most challenging cancer diagnoses presenting for rehabilitation intervention. Patients with gliomas experiences limitations in physical functioning, cognition, and emotional wellbeing. In a relatively small sample this study shows that supervised physical- and occupational therapy in patients with gliomas is safe and feasible in the initial treatment phase. Patients with gliomas can potentially improve functioning through interdisciplinary rehabilitation.
Authors: Julia T Daun; Lauren C Capozzi; Gloria Roldan Urgoiti; Meghan H McDonough; Jacob C Easaw; Margaret L McNeely; George J Francis; Tanya Williamson; Jessica Danyluk; Emma McLaughlin; Paula A Ospina; Marie de Guzman Wilding; Lori Radke; Amy Driga; Christine Lesiuk; S Nicole Culos-Reed Journal: Contemp Clin Trials Commun Date: 2022-05-25
Authors: Pearl J C van Lonkhuizen; Kete M Klaver; Jeffrey S Wefel; Margriet M Sitskoorn; Sanne B Schagen; Karin Gehring Journal: Eur J Cancer Care (Engl) Date: 2019-05-14 Impact factor: 2.328