Title {1} | CANOPTIPHYS study protocol: Optimising PHYSical function before CANcer surgery: effects on complications and quality of life after gastrointestinal cancer surgery in older people at risk. A multicentre, randomised, parallel-group superiority study. |
Trial registration {2a and 2b}. |
2a: ClinicalTrials.gov Identifier: NCT04878185 2b: Se Item 2a. |
Protocol version {3} | May 7, 2021, version 1. |
Funding {4} |
Financial support for the study is provided through grants from the non-profit organisations The Swedish Cancer Society (period for support: 2020-2023) and The Swedish Research Council (period for support: 2020-2023). Both organisations provide support through grants aimed at salary expenses (data collection personnel at recruitment sites, doctoral- and postdoctoral positions) and costs related to material (lab equipment). None of the funding organisations has any vested interest in the outcome of the study. Financial support was also provided through The Erling-Persson Foundation (a framework funding grant to AT, Grant # 140604). |
Author details {5a} |
MA, JD: Department of Neurobiology, Care Sciences and Society, Division of Physiotherapy, Karolinska Institutet, Stockholm, Sweden. ME: Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden; Department of Pelvic Cancer, Colorectal Surgery Unit, Karolinska University Hospital, Stockholm, Sweden AT: Department of Clinical Sciences at Danderyds Hospital, Karolinska Institutet & Department of Surgery, Ersta Hospital, Stockholm, Sweden CS: Division of Surgery, Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden. MS: Department of Clinical Sciences at Danderyds Hospital, Karolinska Institutet & Department of Surgery, Ersta Hospital, Stockholm, Sweden MN-B: Department of Neurobiology, Care Sciences and Society, Division of Physiotherapy, Karolinska Institutet, Stockholm, Sweden; Theme Women’s Health and Allied Health Professionals, Medical Unit Occupational Therapy & Physiotherapy, Karolinska University Hospital, Stockholm, Sweden. ER: Department of Neurobiology, Care Sciences and Society, Division of Physiotherapy, Karolinska Institutet, Stockholm, Sweden; Theme Women’s Health and Allied Health Professionals, Medical Unit Occupational Therapy & Physiotherapy, Karolinska University Hospital, Stockholm, Sweden; Stockholm Region Council, FOU nu, Research and Development Unit for the Elderly, Järfälla, Sweden. |
Name and contact information for the trial sponsor {5b} | Karolinska Institutet, 171 77 Stockholm |
Role of sponsor {5c} | Study sponsors and funding parties will have no role in or authority over any aspect of the design, collection, management, analysis, and interpretation of data; writing of the report; and decisions regarding the publication process. |