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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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07720089
Enrollment
66
Registered
2026-07-22
Start date
2027-09-01
Completion date
2028-02-01
Last updated
2026-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Cancer Surgery, Cancer, Functional Outcomes, Recovery Outcomes, Surgery

Keywords

cancer, abdominal cancer surgery, surgery, recovery outcomes, functional outcomes

Brief summary

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.

Detailed description

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. Key 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.

Interventions

BEHAVIORALAlgorithmic 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.

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Generate and Finalize the Postoperative Functional Recovery Algorithmic Guidelines (AGs). The development of the AGs will include a structured, evidence-informed, and patient-engaged process led by the PI. These guidelines will serve as a practical framework for supporting patients through recovery after high-risk abdominal surgery for cancer. Determination of Team Members: The PI will identify and recruit a multidisciplinary working group. The team will include six subspecialty surgical oncologists with experience in implementation science and supportive care, in addition to medical oncologists and nurse scientists (PhD-trained) with expertise in cancer survivorship and patient-centered care. Selection of team members will emphasize diversity of expertise, discipline, and clinical content.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Surgeons who perform abdominal surgery for cancer at the study institution

Exclusion criteria

* Surgeons who do not perform abdominal surgery for cancer * Surgeons who are external to the study institution

Design outcomes

Primary

MeasureTime frameDescription
Rate of Surgeon Utilization of the Algorithmic Guidelines for Functional Recovery following Cancer Surgery6 monthsThe 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.

Countries

United States

Contacts

CONTACTAmber N Taylor (Clinical Research Regulatory Coordinator I), BS, MA
amberntaylor@uabmc.edu(205)996-4611
PRINCIPAL_INVESTIGATORKimberly E Kopecky, MD,MSCI

University of Alabama at Birmingham

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 27, 2026