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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

Select...

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 9 months

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor

512 Previous Clinical Trials

217,313 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,828 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to participate in this medical trial?

"Affirmative, the information on clinicaltrials.gov states that this experiment is actively seeking patients. It was originally posted in April of 2019 and has since been updated in August 2022. The trial demands 450 participants to be enrolled across 35 sites."

Answered by AI

How many healthcare facilities have been enlisted to conduct this experiment?

"Presently, 35 trial sites are recruiting patients for this medical study. Examples include Franklin, Ann Arbor and Allentown as well as numerous other locations. To make the experience more convenient, it is recommended that you choose a clinical site near your residence if possible."

Answered by AI

What is the size of the participant pool involved in this experiment?

"To ensure success, 450 volunteers conforming to the established prerequisites are necessary for this trial. Potential participants can submit themselves from Ascension Southeast Wisconsin Hospital - Franklin in Franklin, WI and Saint Joseph Mercy Hospital in Ann Arbor, MI."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "Use of a Pre-Surgical Toolkit in Improving Surgical Care and Outcomes in Older Participants With Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03857620.

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