Daniel Steffens , Cherry Koh , Allan Smith , Helen Mohan , Sharon Carey , Stephen Smith , Thomas Poulton , Vicki Patton , Kate White , Liliana Laranjo , Mbathio Dieng , Xiaoqiu Liu , Linda Denehy , Kate Wilson , Margaret Allman-Farinelli , Phyllis Butow , Bernhard Riedel , Rachael L. Morton , Leanne Hassett , Qiang Li , Michael Solomon
{"title":"为接受大型胃肠道癌症手术的患者提供虚拟多模式枢纽（PRIORITY-CONNECT 2 试验）--随机I型混合效果实施试验","authors":"Daniel Steffens , Cherry Koh , Allan Smith , Helen Mohan , Sharon Carey , Stephen Smith , Thomas Poulton , Vicki Patton , Kate White , Liliana Laranjo , Mbathio Dieng , Xiaoqiu Liu , Linda Denehy , Kate Wilson , Margaret Allman-Farinelli , Phyllis Butow , Bernhard Riedel , Rachael L. Morton , Leanne Hassett , Qiang Li , Michael Solomon","doi":"10.1016/j.soi.2024.100082","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>The PRIORITY-CONNECT 2 pilot trial will establish the feasibility and acceptability of a virtual multimodal programme following gastrointestinal cancer surgery. The secondary aims are to obtain pilot data on the likely difference in key outcomes, data elements that will guide future implementation studies, and to identify barriers and facilitators that inform the development and execution of a substantive randomised clinical effectiveness trial of teleprehabilitation/rehabilitation.</p></div><div><h3>Methods</h3><p>This is a multicentre, assessor-blinded, pilot, randomised controlled trial utilising a Hybrid Type I effectiveness-implementation design. 20 participants undergoing major gastrointestinal cancer surgery will be randomised (1:1 allocation) to attend a virtual multimodal prehabilitation-rehabilitation hub (intervention group), delivered before (1–6 weeks) and after (up to 3 months) surgery plus usual care, or to usual care alone (control group). An individualised intervention will be delivered by an experienced multidisciplinary team including a physiotherapist, psychologist, dietitian, nurse, social worker, and a geriatrician. Outcomes will be collected at baseline, 1–2 days before surgery, during the hospital stay, day of discharge from hospital, and 3 months postoperatively. The primary outcomes will be feasibility and acceptability of the virtual multimodal hub. Secondary outcomes assess the rate of postoperative complications within 30 days after surgery, quality of life, the number of days at home within 30 and 90 days after surgery, healthcare use, and implementation outcomes.</p></div><div><h3>Discussion</h3><p>The PRIORITY-CONNECT 2 pilot trial will generate findings about the feasibility and acceptability of delivering an evidence-based virtual multimodal preoperative (prehabilitation) and postoperative (rehabilitation) intervention targeting patients having major gastrointestinal cancer surgery.</p></div><div><h3>Trial registration</h3><p>This trial was registered prospectively with the National Library of Medicine ClinicalTrials.gov Registry (NCT06212700) on 8th January 2024.</p></div>","PeriodicalId":101191,"journal":{"name":"Surgical Oncology Insight","volume":"1 3","pages":"Article 100082"},"PeriodicalIF":0.0000,"publicationDate":"2024-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2950247024000914/pdfft?md5=014352616eea8209bb91a60555707fc6&pid=1-s2.0-S2950247024000914-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Virtual multimodal hub for patients undergoing major gastrointestinal cancer surgery (PRIORITY-CONNECT 2 Pilot) - A pilot randomised type I hybrid effectiveness-implementation trial\",\"authors\":\"Daniel Steffens , Cherry Koh , Allan Smith , Helen Mohan , Sharon Carey , Stephen Smith , Thomas Poulton , Vicki Patton , Kate White , Liliana Laranjo , Mbathio Dieng , Xiaoqiu Liu , Linda Denehy , Kate Wilson , Margaret Allman-Farinelli , Phyllis Butow , Bernhard Riedel , Rachael L. Morton , Leanne Hassett , Qiang Li , Michael Solomon\",\"doi\":\"10.1016/j.soi.2024.100082\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>The PRIORITY-CONNECT 2 pilot trial will establish the feasibility and acceptability of a virtual multimodal programme following gastrointestinal cancer surgery. The secondary aims are to obtain pilot data on the likely difference in key outcomes, data elements that will guide future implementation studies, and to identify barriers and facilitators that inform the development and execution of a substantive randomised clinical effectiveness trial of teleprehabilitation/rehabilitation.</p></div><div><h3>Methods</h3><p>This is a multicentre, assessor-blinded, pilot, randomised controlled trial utilising a Hybrid Type I effectiveness-implementation design. 20 participants undergoing major gastrointestinal cancer surgery will be randomised (1:1 allocation) to attend a virtual multimodal prehabilitation-rehabilitation hub (intervention group), delivered before (1–6 weeks) and after (up to 3 months) surgery plus usual care, or to usual care alone (control group). An individualised intervention will be delivered by an experienced multidisciplinary team including a physiotherapist, psychologist, dietitian, nurse, social worker, and a geriatrician. Outcomes will be collected at baseline, 1–2 days before surgery, during the hospital stay, day of discharge from hospital, and 3 months postoperatively. The primary outcomes will be feasibility and acceptability of the virtual multimodal hub. Secondary outcomes assess the rate of postoperative complications within 30 days after surgery, quality of life, the number of days at home within 30 and 90 days after surgery, healthcare use, and implementation outcomes.</p></div><div><h3>Discussion</h3><p>The PRIORITY-CONNECT 2 pilot trial will generate findings about the feasibility and acceptability of delivering an evidence-based virtual multimodal preoperative (prehabilitation) and postoperative (rehabilitation) intervention targeting patients having major gastrointestinal cancer surgery.</p></div><div><h3>Trial registration</h3><p>This trial was registered prospectively with the National Library of Medicine ClinicalTrials.gov Registry (NCT06212700) on 8th January 2024.</p></div>\",\"PeriodicalId\":101191,\"journal\":{\"name\":\"Surgical Oncology Insight\",\"volume\":\"1 3\",\"pages\":\"Article 100082\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-07-29\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S2950247024000914/pdfft?md5=014352616eea8209bb91a60555707fc6&pid=1-s2.0-S2950247024000914-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Surgical Oncology Insight\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2950247024000914\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Surgical Oncology Insight","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2950247024000914","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Virtual multimodal hub for patients undergoing major gastrointestinal cancer surgery (PRIORITY-CONNECT 2 Pilot) - A pilot randomised type I hybrid effectiveness-implementation trial
Background
The PRIORITY-CONNECT 2 pilot trial will establish the feasibility and acceptability of a virtual multimodal programme following gastrointestinal cancer surgery. The secondary aims are to obtain pilot data on the likely difference in key outcomes, data elements that will guide future implementation studies, and to identify barriers and facilitators that inform the development and execution of a substantive randomised clinical effectiveness trial of teleprehabilitation/rehabilitation.
Methods
This is a multicentre, assessor-blinded, pilot, randomised controlled trial utilising a Hybrid Type I effectiveness-implementation design. 20 participants undergoing major gastrointestinal cancer surgery will be randomised (1:1 allocation) to attend a virtual multimodal prehabilitation-rehabilitation hub (intervention group), delivered before (1–6 weeks) and after (up to 3 months) surgery plus usual care, or to usual care alone (control group). An individualised intervention will be delivered by an experienced multidisciplinary team including a physiotherapist, psychologist, dietitian, nurse, social worker, and a geriatrician. Outcomes will be collected at baseline, 1–2 days before surgery, during the hospital stay, day of discharge from hospital, and 3 months postoperatively. The primary outcomes will be feasibility and acceptability of the virtual multimodal hub. Secondary outcomes assess the rate of postoperative complications within 30 days after surgery, quality of life, the number of days at home within 30 and 90 days after surgery, healthcare use, and implementation outcomes.
Discussion
The PRIORITY-CONNECT 2 pilot trial will generate findings about the feasibility and acceptability of delivering an evidence-based virtual multimodal preoperative (prehabilitation) and postoperative (rehabilitation) intervention targeting patients having major gastrointestinal cancer surgery.
Trial registration
This trial was registered prospectively with the National Library of Medicine ClinicalTrials.gov Registry (NCT06212700) on 8th January 2024.
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