CancerNCT07720089
Developing Pilot Postoperative Guidelines for Improved Functional Outcomes After High-Risk Cancer Surgery
A study testing Algorithmic Guideline for Functional Recovery following Cancer Surgery in people with Cancer and Abdominal Cancer Surgery, run by University of Alabama at Birmingham at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Abdominal Cancer Surgery, Surgery
- What is being tested?
- Algorithmic Guideline for Functional Recovery following Cancer Surgery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2027to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgeons who perform abdominal surgery for cancer at the study institution
Who cannot join
- Surgeons who do not perform abdominal surgery for cancer
- Surgeons who are external to the study institution
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Amber N Taylor (Clinical Research Regulatory Coordinator I), BS, MA contact
United States2 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Amber N Taylor ( Clinical Research Regulatory Coordinator), BS, MA, (205)996-4611, amberntaylor@uabmc.edu
Kimberly E Kopecky, MD, MSCI
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Amber Taylor, BS, MA, 2059964611, amberntaylor@uabmc.edu
About this study
Official title: Development and Implementation of Pilot Postoperative Guidelines to Improve Functional Outcomes Following High-Risk Surgery for Cancer: A North American Prospective Feasibility Study
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.
Read the 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.
- Being tested
- Algorithmic Guideline for Functional Recovery following Cancer Surgery
- Keywords
- cancer, abdominal cancer surgery, surgery, recovery outcomes, functional outcomes
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Algorithmic Guideline for Functional Recovery following Cancer SurgeryBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Surgeons | Experimental | Surgeons will be given a postoperative decision support guideline for assessment of functional recovery Receives: Behavioral: Algorithmic Guideline for Functional Recovery following Cancer Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study startSep 2027 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimberly Kopecky, MD, MSCI, University of Alabama at Birmingham
- Investigators
- Kimberly E Kopecky, MD,MSCI, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07720089
- Sponsor's protocol ID
- IRB-300016448
- Other IDs
- UAB
- Status last verified
- Aug 2026
- First submitted
- 17 Jul 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient data is HIPAA.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Implementation of Pilot Postoperative Guidelines to Improve Functional Outcomes Following High-Risk Surgery for Cancer: A North American Prospective Feasibility Study
- ClinicalTrials.gov ID
- NCT07720089
- Acronym / sponsor ID
- IRB-300016448
- Keywords
- cancer, abdominal cancer surgery, surgery, recovery outcomes, functional outcomes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Sep 2027 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Surgeons | Experimental | Behavioral: Algorithmic Guideline for Functional Recovery following Cancer SurgerySurgeons will be given a postoperative decision support guideline for assessment of functional recovery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Surgeons who perform abdominal surgery for cancer at the study institution
Key exclusion criteria (2 listed)
- Surgeons who do not perform abdominal surgery for cancer
- Surgeons who are external to the study institution
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Algorithmic Guideline for Functional Recovery following Cancer SurgeryThis 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. | Behavioural | Surgeons |
Primary outcome
Rate of Surgeon Utilization of the Algorithmic Guidelines for Functional Recovery following Cancer Surgery
Time frame: 6 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No. Patient data is HIPAA.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amber N Taylor (Clinical Research Regulatory Coordinator I), BS, MA contact
Kimberly E Kopecky, MD,MSCI principal investigator
University of Alabama at Birmingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Algorithmic Guideline for Functional Recovery following Cancer Surgery in people with Cancer and Abdominal Cancer Surgery, run by University of Alabama at Birmingham at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amber N Taylor (Clinical Research Regulatory Coordinator I), BS, MA ((205)996-4611, amberntaylor@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Surgeon Utilization of the Algorithmic Guidelines for Functional Recovery following Cancer Surgery (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.