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      Patient-led home-based follow-up after surgery for colorectal cancer: the protocol of the prospective, multicentre FUTURE-primary implementation study

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          Abstract

          Introduction

          Colorectal cancer (CRC) is the third most common type of cancer in the Netherlands. Approximately 90% of patients can be treated with surgery, which is considered potentially curative. Postoperative surveillance during the first 5 years after surgery pursues to detect metastases in an early, asymptomatic and treatable stage. Multiple large randomised controlled trials have failed to show any (cancer-specific) survival benefit of intensive postoperative surveillance compared with a minimalistic approach in patients with CRC. This raises the question whether an (intensive) in-hospital postoperative surveillance strategy is still warranted from both a patient well-being and societal perspective. A more modern, home-based surveillance strategy could be beneficial in terms of patients’ quality of life and healthcare costs.

          Methods and analysis

          The multicentre, prospective FUTURE-primary study implements a patient-led home-based surveillance after curative CRC treatment. Here, patients are involved in the choice regarding three fundamental aspects of their postoperative surveillance. First regarding frequency, patients can opt for additional follow-up moments to the minimal requirement as outlined by the current Dutch national guidelines. Second regarding the setting, both in-hospital or predominantly home-based options are available. And third, concerning patient–doctor communication choices ranging from in-person to video chat, and even silent check-ups. The aim of the FUTURE-primary study is to evaluate if such a patient-led home-based follow-up approach is successful in terms of quality of life, satisfaction and anxiety compared with historic data. A successful implementation of the patient-led aspect will be assessed by the degree in which the additional, optional follow-up moments are actually utilised. Secondary objectives are to evaluate quality of life, anxiety, fear of cancer recurrence and cost-effectiveness.

          Ethics and dissemination

          Ethical approval was given by the Medical Ethics Review Committee of Erasmus Medical Centre, The Netherlands (2021-0499). Results will be presented in peer-reviewed journals.

          Trial registration number

          NCT05656326.

          Related collections

          Most cited references25

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          Cross-cultural adaptation of health-related quality of life measures: Literature review and proposed guidelines

          Clinicians and researchers without a suitable health-related quality of life (HRQOL) measure in their own language have two choices: (1) to develop a new measure, or (2) to modify a measure previously validated in another language, known as a cross-cultural adaptation process. We propose a set of standardized guidelines for this process based on previous research in psychology and sociology and on published methodological frameworks. These guidelines include recommendations for obtaining semantic, idiomatic, experiential and conceptual equivalence in translation by using back-translation techniques and committee review, pre-testing techniques and re-examining the weight of scores. We applied these guidelines to 17 cross-cultural adaptation of HRQOL measures identified through a comprehensive literature review. The reporting standards varied across studies but agreement between raters in their ratings of the studies was substantial to almost perfect (weighted kappa = 0.66-0.93) suggesting that the guidelines are easy to apply. Further research is necessary in order to delineate essential versus optional steps in the adaptation process.
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            The development of a six‐item short‐form of the state scale of the Spielberger State—Trait Anxiety Inventory (STAI)

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              Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols

              Patient-reported outcome (PRO) data from clinical trials can provide valuable evidence to inform shared decision making, labeling claims, clinical guidelines, and health policy; however, the PRO content of clinical trial protocols is often suboptimal. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was published in 2013 and aims to improve the completeness of trial protocols by providing evidence-based recommendations for the minimum set of items to be addressed, but it does not provide PRO-specific guidance.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2023
                12 October 2023
                : 13
                : 10
                : e074089
                Affiliations
                [1 ]departmentDepartment of Surgical Oncology and Gastrointestinal Surgery , Ringgold_6993Erasmus MC , Rotterdam, The Netherlands
                [2 ]departmentDepartment of Surgery , Ringgold_89411Amphia Hospital , Breda, The Netherlands
                [3 ]departmentDepartment of Surgery , Ringgold_10192IJsselland Hospital , Capelle aan den IJssel, The Netherlands
                [4 ]departmentDepartment of Surgery , Ringgold_6992Franciscus Gasthuis , Rotterdam, The Netherlands
                [5 ]departmentDepartment of Surgery , Ringgold_4501Leiden Universitair Medisch Centrum , Leiden, The Netherlands
                [6 ]departmentDepartment of Psychosocial Research and Epidemiology , Ringgold_1228Netherlands Cancer Institute , Amsterdam, The Netherlands
                Author notes
                [Correspondence to ] Dr Dirk Grünhagen; d.grunhagen@ 123456erasmusmc.nl
                Author information
                http://orcid.org/0000-0002-4592-9409
                Article
                bmjopen-2023-074089
                10.1136/bmjopen-2023-074089
                10582858
                37827744
                75395ad1-ad33-4bc2-8f82-fc30814ddecb
                © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 28 March 2023
                : 19 September 2023
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100004622, KWF Kankerbestrijding;
                Award ID: 9030
                Categories
                Surgery
                1506
                1737
                Protocol
                Custom metadata
                unlocked

                Medicine
                quality of life,colorectal surgery,patient-centered care
                Medicine
                quality of life, colorectal surgery, patient-centered care

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