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Pre-Surgical Toolkit for Cancer Care
Stevens Point, WI
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
Must not have
Patients under active treatment such as chemotherapy, targeted therapy, immunotherapy, radiation treatment, etc. for second primary, are not eligible
Patients undergoing emergent surgery are not eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day of surgical consult
Awards & highlights
No Placebo-Only Group
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.
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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 belowSelect...
I can speak English and fill out forms in English.
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I am scheduled for surgery to remove cancer from my stomach, colon, rectum, esophagus, pancreas, liver, bladder, kidney, or lung.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not currently receiving treatment for a second type of cancer.
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Select...
I am not having emergency surgery.
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Select...
I do not have a second type of cancer.
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I am not having surgery to relieve symptoms for my spread cancer.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Physical Function 8 Weeks Post-surgery as Measured by the Caloric Expenditure Scale Per Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire
Secondary study objectives
Compliance Rate With Administration of Edmonton Frail Scale (EFS)
Percentage of Participants With Postoperative Complications (Clavien-Dindo Grades I-V)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Closest Location:Miami Valley Hospital South· Centerville, OH· 10 miles
Who is running the clinical trial?
Alliance for Clinical Trials in OncologyLead Sponsor
519 Previous Clinical Trials
221,959 Total Patients Enrolled
National Cancer Institute (NCI)NIH
14,057 Previous Clinical Trials
41,149,116 Total Patients Enrolled
George J. Chang, MD, MSStudy ChairThe University of Texas MD Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have metastatic disease but am planned for a surgery aimed at curing it.I am not currently receiving treatment for a second type of cancer.I am having surgery to remove two primary cancers at the same time.I can speak English and fill out forms in English.I am scheduled for surgery to remove cancer from my stomach, colon, rectum, esophagus, pancreas, liver, bladder, kidney, or lung.I am not having emergency surgery.I do not have a second type of cancer.I am not having surgery to relieve symptoms for my spread cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (OPTI-Surg training and materials)
- Group 2: Arm III (OPTI-Surg training and materials, coach)
- Group 3: Arm I (usual care)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.