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Pre-Surgical Toolkit for Cancer Care

N/A
Waitlist Available
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be able to speak and complete questionnaires in English
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 9 months
Awards & highlights

Study Summary

This trial is testing a toolkit to improve surgical care and outcomes for elderly cancer patients. The toolkit may help improve patients' recovery rate and functioning after surgery.

Who is the study for?
This trial is for older adults with cancer who are planning to undergo major surgery like liver resection or lung lobectomy. They should be aiming for a cure, able to speak English, and complete questionnaires. Those with emergency surgeries, active treatment for another primary cancer, palliative intent, or mental impairments that prevent informed consent are not eligible.Check my eligibility
What is being tested?
The study tests a pre-surgical toolkit called OPTI-Surg designed to improve recovery and functioning after surgery in elderly cancer patients. It includes pre-surgery recommendations and coaching to help participants better prepare for their upcoming surgical procedures.See study design
What are the potential side effects?
Since this intervention involves informational material and coaching rather than medication or invasive procedures, typical medical side effects are not expected. However, there may be psychological impacts from receiving additional information about surgical care.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can speak English and fill out forms in English.
Select...
I am scheduled for surgery to remove cancer from my stomach, colon, rectum, esophagus, pancreas, liver, bladder, kidney, or lung.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Patient function per Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire
Secondary outcome measures
Compliance with administration of Edmonton Frail Scale (EFS)
Postoperative complications (Clavien-Dindo grades I-V)

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm III (OPTI-Surg training and materials, coach)Experimental Treatment2 Interventions
Healthcare providers/institutions receive OPTI-Surg training and informational materials and meet with a coach.
Group II: Arm II (OPTI-Surg training and materials)Experimental Treatment2 Interventions
Healthcare providers/institutions receive OPTI-Surg training and informational materials.
Group III: Arm I (usual care)Active Control2 Interventions
Healthcare providers/institutions perform usual care.

Find a Location

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,301 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,952,996 Total Patients Enrolled
George J. Chang, MD, MSStudy ChairThe University of Texas MD Anderson Cancer Center

Media Library

Pre-Surgical Toolkit (OPTI-Surg) Clinical Trial Eligibility Overview. Trial Name: NCT03857620 — N/A
Cancer Research Study Groups: Arm II (OPTI-Surg training and materials), Arm III (OPTI-Surg training and materials, coach), Arm I (usual care)
Cancer Clinical Trial 2023: Pre-Surgical Toolkit (OPTI-Surg) Highlights & Side Effects. Trial Name: NCT03857620 — N/A
Pre-Surgical Toolkit (OPTI-Surg) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03857620 — N/A
~56 spots leftby Jun 2025
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