Pre-Surgical Toolkit for Cancer Care

Not currently recruiting at 47 trial locations

Overseen By George J. Chang, MD, MS

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Alliance for Clinical Trials in Oncology

Disqualifiers: Emergent surgery, Active treatment, Psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a pre-surgical toolkit called OPTI-Surg can improve recovery for older adults with cancer after surgery. It compares usual care with two experimental groups: one using OPTI-Surg training and materials, and another adding a coach for guidance. Suitable candidates have planned surgeries, such as a gastrectomy or lung lobectomy, and are not undergoing emergency procedures. The goal is to enhance recovery and physical functioning for eligible participants. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve surgical recovery for future patients.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Pre-Surgical Toolkit (OPTI-Surg) is safe for improving surgical care in older cancer patients?

Research has shown that the Pre-Surgical Toolkit (OPTI-Surg) is generally safe for older cancer patients. Studies have found no significant negative effects from using this toolkit, and there are no reports of serious problems linked to its use. Since the toolkit primarily provides information and training, participants manage it well. Patients and healthcare providers can use it without concern for harmful side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Pre-Surgical Toolkit (OPTI-Surg) because it aims to enhance the preparation of healthcare providers before cancer surgeries, potentially improving outcomes. Unlike standard care, which often relies on established protocols, OPTI-Surg introduces specialized training and informational materials to ensure that providers are thoroughly prepared. Additionally, some providers receive coaching, offering a personalized approach to refine their skills and knowledge. This proactive method could lead to more efficient surgeries and better recovery rates for patients, making it a promising development in cancer care.

What evidence suggests that the Pre-Surgical Toolkit (OPTI-Surg) is effective for improving surgical care and outcomes in older cancer patients?

Research has shown that the Pre-Surgical Toolkit, known as OPTI-Surg, can improve surgery outcomes for older cancer patients. In this trial, healthcare providers and institutions will receive OPTI-Surg training and informational materials, with some also meeting with a coach. Studies found that patients using OPTI-Surg recovered more quickly and improved their physical abilities after surgery. Specifically, older patients who followed pre-surgery advice were more likely to return to their usual activity levels. The toolkit prepares patients before surgery, aiding in faster recovery. Early findings suggest that this method enhances overall surgical care for elderly patients. ^{1 2 5 6 7}

Who Is on the Research Team?

George J. Chang, MD, MS

Principal Investigator

The University of Texas MD Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have metastatic disease but am planned for a surgery aimed at curing it.

I am having surgery to remove two primary cancers at the same time.

I can speak English and fill out forms in English.

Exclusion Criteria

I am not currently receiving treatment for a second type of cancer.

I am not having emergency surgery.

I do not have a second type of cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgical Preparation

Participants receive pre-surgical recommendations and preparation materials to improve recovery and functioning after surgery

Up to the day of surgery

1 visit (in-person) for surgical consult

Post-Surgery Follow-up

Participants' physical function is assessed 8 weeks post-surgery using the CHAMPS questionnaire

8 weeks

1 visit (in-person)

Extended Follow-up

Participants are monitored for postoperative complications and other outcomes 12 weeks post-surgery

12 weeks

1 visit (in-person)

Long-term Follow-up

Healthcare providers/institutions are followed up 6-9 months after the last patient is registered

6-9 months

What Are the Treatments Tested in This Trial?

Interventions

• Pre-Surgical Toolkit (OPTI-Surg)

Trial Overview 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.

How Is the Trial Designed?

Group I: Arm III (OPTI-Surg training and materials, coach) Experimental Treatment 2 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 Treatment 2 Interventions

Healthcare providers/institutions receive OPTI-Surg training and informational materials.

Group III: Arm I (usual care) Active Control 2 Interventions

Healthcare providers/institutions perform usual care.

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials

521

Recruited

224,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The Surgical Risk Preoperative Assessment System (SURPAS) received positive feedback from both patients and healthcare providers, highlighting its potential to improve risk assessment processes and enhance patient involvement in decision-making.

Participants noted that while SURPAS is beneficial, it should complement clinical judgment rather than replace it, and there are mixed feelings among patients regarding the impact of risk information on their decision to undergo surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of attitudes towards future implementation of the "Surgical Risk Preoperative Assessment System" (SURPAS) tool: a pilot survey among patients, surgeons, and hospital administrators. Lambert-Kerzner, A., Ford, KL., Hammermeister, KE., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39069901/

Improving Surgical Care and Outcomes in Older ... - PubMed Improving Surgical Care and Outcomes in Older Cancer Patients Through Implementation of a Presurgical Toolkit (OPTI-Surg)-Final Results of a ...

2. withpower.com withpower.com/trial/phase-neoplasms-3-2019-c4155

Pre-Surgical Toolkit for Cancer Care · Info for Participants 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.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11728768/

Improving Surgical Care and Outcomes in Older Cancer ... The purpose of this study, Improving Surgical Care and Outcomes in Older Cancer Patients Through Implementation of an Efficient Presurgical Toolkit (OPTI-Surg, ...

4. ascopubs.org ascopubs.org/doi/10.1200/OP.2023.19.11_suppl.370

Geriatric pre-surgical optimization in the NCORP (Alliance). This study investigated the effectiveness of OPTI-Surg, a frailty prehabilitation toolkit, for improving surgical outcomes.

5. researchgate.net researchgate.net/publication/371296262_Surgical_care_and_outcomes_in_older_patients_with_cancer_through_implementation_of_a_pre-surgical_toolkit_OPTI-Surg_Interim_results_of_a_phase_III_cluster_randomized_trial_Alliance_A231601CD

Surgical care and outcomes in older patients with cancer ... This study tested the effectiveness of OPTI-Surg, a surgical prehabilitation toolkit for improving surgical care and outcomes in older patients ...

6. prevention.cancer.gov prevention.cancer.gov/clinical-trials/clinical-trials-search/nct03857620

Use of a Pre-Surgical Toolkit in Improving Surgical Care and ... 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.

7. meetings.asco.org meetings.asco.org/abstracts-presentations/220479

Surgical care and outcomes in older patients with cancer ... Conclusions: Implementation of the OPTI-Surg toolkit did not significantly improve functional outcomes 8 weeks after surgery for patients aged 70 and older ...