Pre-Surgical Toolkit for Cancer Care

Recruiting at 44 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

325 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

How is the Pre-Surgical Toolkit (OPTI-Surg) treatment different from other treatments for cancer care?

The Pre-Surgical Toolkit (OPTI-Surg) is unique because it focuses on preparing patients for surgery by assessing their readiness, which is not typically addressed by other treatments. This approach aims to enhance patient understanding and readiness for surgery, potentially leading to better outcomes. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Pre-Surgical Toolkit (OPTI-Surg) for cancer care?

The research highlights the importance of patient-reported outcome measures (PROMs) in evaluating surgical care, which can include aspects like quality of life and patient satisfaction. These measures are increasingly used to assess the effectiveness of surgical interventions, suggesting that similar approaches could support the evaluation of the Pre-Surgical Toolkit (OPTI-Surg) in cancer care. ^{6 7 8 9 10}

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. United States pubmed.ncbi.nlm.nih.gov

Patient body image, self-esteem, and cosmetic results of minimally invasive robotic cardiac surgery. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluating surgical outcomes. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Outcomes assessment: a primer. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Barriers and facilitators to measuring patient reported outcomes in an academic breast cancer clinic: An application of the RE-AIM framework. [2023]

5. England pubmed.ncbi.nlm.nih.gov

New outcome measures in perioperative care. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Scale Development and Psychometric Evaluation of the Preoperative Assessment of Readiness Tool. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Using a clinical pathway approach to document patient teaching for breast cancer surgical procedures. [2007]

8. England 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Mastectomy or lumpectomy? Helping women make informed choices. [2017]

10. United States pubmed.ncbi.nlm.nih.gov

Operative surgical education: results of a society of surgical oncology fellowship survey and proposal for an operative database. [2019]