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Background evidence highlights rising oropharyngeal cancer incidence, major treatment side effects such as dysphagia, and associations between swallowing impairment, survival, nutrition, and psychosocial well-being. The study outlines aims, design, objectives, endpoints, eligibility, methodology, data acquisition, sample size, analysis, safety reporting, ethics, and data handling, supported by detailed appendices for standardized assessments and protocol version history.",{"@graph":63,"@context":119},[64,80,102],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":11,"@type":70,"position":76},"https://docshare.wps.com/template/presentations/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/changes-to-function-and-quality-of-life-and-patient-experience-for-patients-undergoing-treatments-for-recurrent-oropharyngeal-cancer-funqolr-study-protocol-ccr5242/278475/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/changes-to-function-and-quality-of-life-and-patient-experience-for-patients-undergoing-treatments-for-recurrent-oropharyngeal-cancer-funqolr-study-protocol-ccr5242/278475.png","ImageObject",442,249,{"name":88,"@type":89},"Levi","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-10-20","2026-09-15",true,{"@type":98,"interactionType":99,"userInteractionCount":101},"InteractionCounter",{"@type":100},"ViewAction",7,{"@type":103,"mainEntity":104},"FAQPage",[105,111,115],{"name":106,"@type":107,"acceptedAnswer":108},"What is the study CCR5242 focused on?","Question",{"text":109,"@type":110},"CCR5242 examines changes in function and quality of life, together with patient experience, for people receiving treatments for recurrent oropharyngeal cancer.","Answer",{"name":112,"@type":107,"acceptedAnswer":113},"Why is dysphagia considered important in this protocol?",{"text":114,"@type":110},"Dysphagia is highlighted as a profound side effect of head and neck cancer and/or its treatment, affecting swallowing ability up to one year and linking to outcomes such as survival risk, pneumonia, nutrition, and quality of life.",{"name":116,"@type":107,"acceptedAnswer":117},"What are included appendices in the protocol?",{"text":118,"@type":110},"The protocol includes appendices covering standardized procedures such as the Performance Status Scale SOP, IDDSI Functional Diet Score, 100ml Water Swallow Test, FEES-DIGEST, and a protocol version history.","https://schema.org",{"og:url":78,"og:type":121,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":123,"canonical":78},"index,follow",{"doc_id":125,"site_id":56},278475,1791721881,{"code":4,"msg":5,"data":128},{"doc_id":125,"user_id":129,"nickname":88,"user_avatar":130,"doc_module":9,"category_id":8,"category_name":11,"doc_title":59,"doc_description":61,"doc_content":131,"file_id":132,"file_url":133,"file_type":134,"file_size":135,"view_count":101,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":136,"language":137,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":138,"faqs":139,"seo_title":140,"seo_description":61,"update_tm":141,"read_time":15},7971461740909,"https://ap-avatar.wpscdn.com/davatar_155a257f0dc6eb9ab79c44ca47cae57d","Study Protocol  \nStudy title: Changes to function and quality of life and patient experience for patients undergoing treatments for recurrent oropharyngeal cancer CCR5242 .  \nShort Title: FUNQOLR (FUNctiional and QOL changes with Recurrent oropharyngeal cancer)  \n\n| Chief Investigator: | Professor Vinidh Paleri |\n| --- | --- |\n| Principal Investigator: | Professor Vinidh Paleri |\n| Co-investigators: | Grainne Brady, Dr Justin Roe, Dr Mary Wells, Professor Pernilla Lagergren |\n\nSponsor: The Royal Marsden NHS Foundation Trust, Fulham Road, London SW3 6JJ Management: The Royal Marsden NHS Foundation Trust, Fulham Road, London SW3 6JJ  \nAcademic Host: Imperial College London.  \n\n| Protocol Reference: | CCR5242 |\n| --- | --- |\n| Version Number & Date: | V6.0 22.5.2024 |\n| Superseded Version Number & Date (If applicable) | V5.0 28.02.2023 |\n\nContents Page  \nContents Page ................................ ................................ ................................ .................. 2  \n1. Background ............................................................................................................ 3  \n2. Rationale ............................................................................................................... 5  \n3. Aims ....................................................................................................................... 5  \n4. Study Design .......................................................................................................... 6  \n5. Study objectives ..................................................................................................... 6  \n6. Study end points ..................................................................................................... 7  \n7. Inclusion/ exclusion criteria .................................................................................... 8  \n8. Methodology ......................................................................................................... 9  \n9. Data Acquisition ................................................................................................... 11  \n10. Sample size .......................................................................................................... 15  \n11. Data analysis ....................................................................................................... 15  \n12. Patient and public involvement ............................................................................ 16  \n13. Study organisation/ Trial Monitoring and Management Strategy ......................... 17  \n14. Safety reporting ................................................................................................... 19  \n15. Regulatory & Ethics Committee Approval ............................................................. 19  \n16. Data handling and record keeping ........................................................................ 20  \n17. Financing, Indemnity & Insurance ......................................................................... 20  \n18. Publication policy ................................................................................................. 21  \n19. Abbreviations ....................................................................................................... 22  \n20. References ........................................................................................................... 23  \nAppendix 1: Performance Status Scale in Head and Neck cancer standard operating procedure (SOP) ............................................................................................................. 26  \nAppendix 2: IDDSI Functional Diet Score: SOP .................................................................. 28  \nAppendix 3: 100ml Water Swallow Test (100ml WST) SOP ............................................... 30  \nAppendix 4: Dynamic Imaging Grade of Swallowing Toxicity for Fibreoptic Endoscopic Evaluation of Swallowing (FE","cbCaisE9PJXCUr1q","https://ap.wps.com/l/cbCaisE9PJXCUr1q","pdf",946318,34,"English","# Background\n# Rationale\n# Aims\n# Study Design\n# Study objectives\n# Study end points\n# Inclusion/ exclusion criteria\n# Methodology\n# Data Acquisition\n# Sample size\n# Data analysis\n# Patient and public involvement\n# Study organisation/ Trial Monitoring and Management Strategy\n# Safety reporting\n# Regulatory & Ethics Committee Approval\n# Data handling and record keeping\n# Financing, Indemnity & Insurance\n# Publication policy\n# Abbreviations\n# References\n# Appendix 1\n## Performance Status Scale in Head and Neck cancer SOP\n# Appendix 2\n## IDDSI Functional Diet Score: SOP\n# Appendix 3\n## 100ml Water Swallow Test (100ml WST) SOP\n# Appendix 4\n## FEES-DIGEST SOP\n# Appendix 5\n## Protocol Version History","[{\"question\":\"What is the study CCR5242 focused on?\",\"answer\":\"CCR5242 examines changes in function and quality of life, together with patient experience, for people receiving treatments for recurrent oropharyngeal cancer.\"},{\"question\":\"Why is dysphagia considered important in this protocol?\",\"answer\":\"Dysphagia is highlighted as a profound side effect of head and neck cancer and/or its treatment, affecting swallowing ability up to one year and linking to outcomes such as survival risk, pneumonia, nutrition, and quality of life.\"},{\"question\":\"What are included appendices in the protocol?\",\"answer\":\"The protocol includes appendices covering standardized procedures such as the Performance Status Scale SOP, IDDSI Functional Diet Score, 100ml Water Swallow Test, FEES-DIGEST, and a protocol version history.\"}]","Changes to Function and Quality of Life and Patient Experience for Patients Undergoing Treatments for Recurrent Oropharyngeal Cancer - FUNQOLR Study Protocol CCR5242 | PDF",1789510293]