[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07720089":3,"trial-entities:NCT07720089":88,"trial-summary:NCT07720089":92},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":10,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":23,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":43,"secondary_outcomes":48,"sex":49,"minimum_age":50,"maximum_age":51,"healthy_volunteers":14,"eligibility_criteria":52,"std_ages":59,"locations":62,"central_contacts":80,"overall_officials":83,"references":86,"see_also_links":87},"NCT07720089","IRB-300016448","Developing Pilot Postoperative Guidelines for Improved Functional Outcomes After High-Risk Cancer Surgery","Development and Implementation of Pilot Postoperative Guidelines to Improve Functional Outcomes Following High-Risk Surgery for Cancer: A North American Prospective Feasibility Study","NOT_YET_RECRUITING","2027-08","2026-07","2026-08-03","University of Alabama at Birmingham","OTHER",false,"The objective of this study is to develop and evaluate the implementation of novel timeline-specific National Comprehensive Cancer Network (NCCN)-style clinical guidelines designed to improve functional outcomes after high-risk abdominal surgery for cancer.","This is a prospective, feasibility, and effectiveness trial to be conducted at The University of Alabama at Birmingham. We plan to develop algorithmic guidelines focused on proactive support of surgical recovery and will then recruit surgeons who care for adults undergoing high-risk abdominal surgery for cancer to study the preliminary effectiveness of implementing the algorithmic guidelines into postoperative care workflows at 4 pre-determined timepoints. A modified Delphi process will be used to ensure an expert consensus on the algorithmic guideline content is achieved through a rigorous and consensus-driven process. Two rounds of structured online voting will be conducted to rate and refine each algorithmic guideline component.\n\nKey feasibility outcomes include recruitment and retention rates, surgeon adherence, data completeness, and integration into routine workflows. Preliminary effectiveness will be measured using patient-reported outcomes, timeliness of referral to supportive providers and resources, use of supportive services, rates of surgical regret, and measures of functional recovery.",[18,19,20,21,22],"Cancer","Abdominal Cancer Surgery","Surgery","Recovery Outcomes","Functional Outcomes",[24,25,26,27,28],"cancer","abdominal cancer surgery","surgery","recovery outcomes","functional outcomes","INTERVENTIONAL","SUPPORTIVE_CARE",[32],"NA",{"count":34,"type":35},66,"ESTIMATED",[37],{"type":38,"name":39,"description":40,"armGroupLabels":41},"BEHAVIORAL","Algorithmic Guideline for Functional Recovery following Cancer Surgery","This is a pilot feasibility study to test the clinical use of a novel algorithmic guideline to support patient functional recovery following cancer surgery. To date, no algorithmic guideline exists to support functional recovery as a primary postoperative outcome.",[42],"Surgeons",[44],{"measure":45,"description":46,"timeFrame":47},"Rate of Surgeon Utilization of the Algorithmic Guidelines for Functional Recovery following Cancer Surgery","The primary outcome is surgeon use of the novel guideline to guide the postoperative clinical care of patients recovering from GI cancer surgery. This will be measured by in-clinic fidelity monitoring, i.e. researcher monitoring of clinical use of the developed guideline.","6 months",[],"ALL","18 Years",null,{"inclusion":53,"exclusion":55,"raw_text":58},[54],"Surgeons who perform abdominal surgery for cancer at the study institution",[56,57],"Surgeons who do not perform abdominal surgery for cancer","Surgeons who are external to the study institution","Inclusion Criteria:\n\n* Surgeons who perform abdominal surgery for cancer at the study institution\n\nExclusion Criteria:\n\n* Surgeons who do not perform abdominal surgery for cancer\n* Surgeons who are external to the study institution",[60,61],"ADULT","OLDER_ADULT",[63],{"facility":12,"city":64,"state":65,"zip":66,"country":67,"contacts":68,"geoPoint":77},"Birmingham","Alabama","35233","United States",[69,74],{"name":70,"role":71,"phone":72,"email":73},"Amber N Taylor ( Clinical Research Regulatory Coordinator), BS, MA","CONTACT","(205)996-4611","amberntaylor@uabmc.edu",{"name":75,"role":76},"Kimberly E Kopecky, MD, MSCI","PRINCIPAL_INVESTIGATOR",{"lat":78,"lon":79},33.52066,-86.80249,[81],{"name":82,"role":71,"phone":72,"email":73},"Amber N Taylor (Clinical Research Regulatory Coordinator I), BS, MA",[84],{"name":85,"affiliation":12,"role":76},"Kimberly E Kopecky, MD,MSCI",[],[],{"nct_id":4,"conditions":89,"biomarkers":91},[90],"Malignant Neoplasm",[],{"nct_id":4,"found":93,"summary":94,"prompt_version":104},true,{"design":95,"status":96,"heading":97,"summary":98,"follow_up":99,"word_count":100,"commitments":101,"compensation":102,"drugs_mentioned":103},"This is an interventional pilot feasibility study. It plans to enroll 66 participants.","completed","Pilot Guidelines for Functional Recovery After Cancer Surgery","This study is developing and testing new guidelines called the \"Algorithmic Guideline for Functional Recovery following Cancer Surgery.\" These guidelines aim to help patients recover better after high-risk abdominal surgery for cancer. The study will see if these guidelines improve how well patients function six months after surgery. This is a pilot study, meaning it's a first step to see if the guidelines are practical to use. The study plans to enroll 66 participants. Currently, the study status is unclear.","The primary outcome is measured at 6 months after surgery.",80,"Not specified in the trial record.","Not stated in the trial record.",[39],"v2"]