Clinical trial · Interventional
Use of a Pre-Surgical Toolkit in Improving Surgical Care and Outcomes in Older Participants With Cancer
Improving Surgical Care and Outcomes in Older Cancer Patients Through Implementation of an Efficient Pre-Surgical Toolkit (OPTI-Surg)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260911-000001
Summary
Brief summary (as posted)
This trial studies how well the use of a pre-surgical toolkit (OPTI-Surg) works in improving surgical care and outcomes in older participants with cancer. In many elderly patients, surgery can greatly affect physical condition and the ability to return to pre-surgery levels of physical functioning. Providing pre-surgical recommendations may help improve participants' recovery rate and functioning after surgery.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Health Care Provider | — | UNRESOLVED | — |
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Surgical Procedure, Unspecified | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Practice | Other | — | UNRESOLVED |
| Informational Intervention | Other | — | UNRESOLVED |
| Informational Intervention with Coaching | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Arm I (usual care)
- description
- Healthcare providers/institutions perform usual care.
- interventionNames
- Other: Best Practice
- Other: Questionnaire Administration
- type
- EXPERIMENTAL
- label
- Arm II (OPTI-Surg training and materials)
- description
- Healthcare providers/institutions receive OPTI-Surg training and informational materials.
- interventionNames
- Other: Informational Intervention
- Other: Questionnaire Administration
- type
- EXPERIMENTAL
- label
- Arm III (OPTI-Surg training and materials, coach)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have known or suspected cancer diagnosis and have one of the following cancer-directed operations planned: * Gastrectomy * Colectomy * Proctectomy * Esophagectomy * Pancreatectomy * Hepatectomy * Total cystectomy * Partial or total nephrectomy * Lung lobectomy/pneumonectomy * Patients with known metastatic disease with a plan for curative intent resection are eligible (e.g. curative liver resection for metastatic colorectal cancer). * Patients with double primaries undergoing planned curative operation for both are eligible (e.g. synchronous colon cancers undergoing colectomy to treat both). * Patients must be able to speak and complete questionnaires in English. Exclusion Criteria: * Patients undergoing emergent surgery are not eligible. * Patients under active treatment such as chemotherapy, targeted therapy, immunotherapy, radiation treatment, etc. for second primary, are not eligible. * Patients with second primary are not eligible. * Patients with known metastatic disease who are undergoing palliative resection are not eligible. * Patients with psychiatric illness or other mental impairment that would preclude their ability to give informed consent or to participate in the prehabilitation program are not eligible.
References
Publications (1)
- DERIVEDZahrieh D, Croghan IT, Inselman JW, Mandrekar SJ. Guidelines for Data and Safety Monitoring in Pragmatic Randomized Clinical Trials Using Case Studies. Mayo Clin Proc. 2023 Nov;98(11):1712-1726. doi: 10.1016/j.mayocp.2023.02.019. PMID 37923529