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Use of a Pre-Surgical Toolkit in Improving Surgical Care and Outcomes in Older Participants With Cancer

StatusCompleted
PhaseNot applicable
Started2019-07-24
View on ClinicalTrials.gov ↗

Amendment history

2026-08-18
Study Status v38
Trial completed
Study completion confirmed: October 2023 (last estimated August 2026)
Completion dateestimated 2026-08-01→confirmed 2023-10-31
2026-04-17
Study Status v37
Completion date2025-10→2026-08-01
2025-01-31
Study Status, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v36
Results first postednot stated→2025-02-21
Secondary endpoints2 entries, revised
Percentage of Participants With Postoperative complicationsComplications (Clavien-Dindo gradesGrades I-V) Compliance withRate administrationWith Administration of Edmonton Frail Scale (EFS)
Primary endpoints1 entry, revised
PatientPhysical functionFunction per8 Weeks Post-surgery as Measured by the Caloric Expenditure Scale Per Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaireQuestionnaire
2024-04-08
Study Status v35
Start date2019-04-01→2019-07-24
2024-02-21
Study Status v34
Primary completion dateestimated 2023-10→confirmed 2023-10-31
Show 33 earlier versions
2023-04-03
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v33
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 450→confirmed 325
Study sitesdetails revised at 44 of 44 sites
2022-08-02
Study Status v32
Re-verified, no change to tracked fields
2022-07-15
Study Status, Contacts/Locations v31
Study sites44 entries, revised
Marshfield ClinicMedical Center-River Region at Stevens Point Center
2022-06-03
Study Status, Contacts/Locations v30
Study sitesdetails revised at 2 of 44 sites
2022-04-18
Study Status, Contacts/Locations v29
Study sitesdetails revised at 1 of 44 sites
2022-03-22
Study Status, Contacts/Locations v28
Study sitesdetails revised at 2 of 44 sites
2022-02-16
Study Status, Contacts/Locations v27
Study sitescontacts updated at 2 of 44 sites
2022-01-11
Study Status, Contacts/Locations v26
Study sitesdetails revised at 3 of 44 sites
2021-12-13
Study Status, Contacts/Locations v25
Study sitesdetails revised at 5 of 44 sites
2021-10-11
Study Status, Contacts/Locations v24
Study sitesdetails revised at 3 of 44 sites
2021-08-16
Study Status, Contacts/Locations v23
Study sitescontacts updated at 1 of 44 sites
2021-07-19
Study Status, Contacts/Locations v22
Study sitescontacts updated at 2 of 44 sites
2021-06-09
Study Status, Contacts/Locations v21
Study sites43→44
2021-04-16
Study Status, Eligibility, Contacts/Locations v20
Study sites40→43
Eligibility criteria+162 characters
[...] y Esophagectomy Pancreatectomy Hepatectomy Total cystectomy TotalPartial or total nephrectomy Lung lobectomy/pneumonectomy Patients with know [...] ria: 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 [...]
2021-03-05
Study Status, Contacts/Locations v19
Study sitesdetails revised at 1 of 40 sites
2021-02-25
Study Status v18
Primary completion date2021-10→2023-10
2021-01-08
Study Status, Contacts/Locations v17
Study sites36→40
2020-12-08
Study Status, Contacts/Locations v16
Study sitesdetails revised at 6 of 36 sites
2020-11-10
Study Status, Contacts/Locations v15
Study sites35→36
2020-10-08
Study Status, Contacts/Locations v14
Study sites34→35
2020-09-03
Study Status, Contacts/Locations v13
Study sites33→34
2020-07-22
Suspended→Recruiting Study Status, Contacts/Locations v12
Trial statusSuspended→Recruiting
Reason stoppedCOVID-19 Mitigation→not stated
Study sites29→33
2020-06-03
Study Status, Contacts/Locations v11
Study sites29 entries, revised
Fairview- Southdale Hospital
2020-04-09
Study Status, Contacts/Locations v10
Study sites26→29
2020-03-25
Recruiting→Suspended Study Status, Contacts/Locations v9
Trial statusRecruiting→Suspended
Reason stoppednot stated→COVID-19 Mitigation
Study sitesdetails revised at 26 of 26 sites
2020-03-04
Study Status, Contacts/Locations v8
Study sites25→26
2020-02-04
Study Status, Contacts/Locations v7
Study sites24→25
2020-01-07
Study Status, Eligibility, Contacts/Locations v6
Study sites22→24
Eligibility criteria+125 characters
[...] hagectomy Pancreatectomy Hepatectomy Total cystectomy Total Nephrectomynephrectomy Lung lobectomy/pneumonectomy Patients with known metastatic [...] sease 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). ⇅ moved Patients must be able to speak and complete questionnaires in English. Exclusion Criteria: Patients undergoing emergent surgery are not eligible. Patients with second prim [...] [...]
2019-11-19
Study Status, Contacts/Locations v5
Study sites16→22
2019-10-21
Study Status, Contacts/Locations v4
Study sites13→16
2019-09-18
Study Status, Contacts/Locations v3
Study sites6→13
2019-08-02
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2019-04→confirmed 2019-04-01
Study sites0→6
2019-03-06
Study Status, Arms and Interventions, Outcome Measures v1
Start date2019-03→2019-04
InterventionsBest Practice (Other), Informational Intervention (Other), Questionnaire Administration (Other)→Best Practice (Other), Informational Intervention (Other), Informational Intervention with Coaching (Other), Questionnaire Administration…
Secondary endpointsdetails revised at 1 of 2 entries
2019-02-26
Original filing
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.
Trial Details
NCT Number NCT03857620
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)
Conditions Malignant Neoplasm, Surgical Procedure, Unspecified, Health Care Provider, Carcinoma
Enrollment 325 participants
Start Date 2019-07-24
Primary Completion 2023-10-31 (estimated)
Study Completion 2023-10-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-10