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Active, Not Recruiting

NCT Number: NCT03857620

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Malignant Neoplasm Carcinoma Health Care Provider Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Surgical Procedure, Unspecified

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helen F Graham Cancer Center, Newark, Delaware, United States

Loading trial locations.

About this study

PRIMARY OBJECTIVES:

I. To compare 8-week postoperative function among elderly patients between sites randomized to implement the OPTI-Surg toolkit with or without a coach versus sites randomized to usual care.

SECONDARY OBJECTIVES:

I. To compare postoperative morbidity between sites randomized to implement the OPTI-Surg toolkit with or without a coach versus sites randomized to usual care.

II. To compare the penetration of the OPTI-Surg toolkit between sites randomized to implement the OPTI-Surg toolkit with a coach versus sites randomized to implement the OPTI-Surg toolkit without a coach.

Trial Design:

OUTLINE: Healthcare providers/institutions are randomized to 1 of 3 arms. Patients/participants receive the intervention based on which arm their healthcare provider is in.

ARM I: Healthcare providers/institutions perform usual care.

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

ARM III: Healthcare providers/institutions receive OPTI-Surg training and informational materials and meet with a coach.

After conclusion of study, participants are followed up at 8 and 12 weeks post surgery, and healthcare providers/institutions are followed up 6-9 months after the last patient is registered.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Patients with known metastatic disease with a plan for curative intent resection are eligible (e.g. curative liver resection for metastatic colorectal cancer).
  • Patients with double primaries undergoing planned curative operation for both are eligible (e.g. synchronous colon cancers undergoing colectomy to treat both).
  • Patients must be able to speak and complete questionnaires in English.

Exclusion criteria

  • Patients undergoing emergent surgery are not eligible.
  • Patients under active treatment such as chemotherapy, targeted therapy, immunotherapy, radiation treatment, etc. for second primary, are not eligible.
  • Patients with second primary are not eligible.
  • Patients with known metastatic disease who are undergoing palliative resection are not eligible.
  • Patients with psychiatric illness or other mental impairment that would preclude their ability to give informed consent or to participate in the prehabilitation program are not eligible.

Treatment and study plan

Best Practice

Other

Receive usual care

Informational intervention

Other

Receive OPTI-Surg program materials

Questionnaire Administration

Other

Ancillary studies

Informational Intervention with Coaching

Other

Receive OPTI-Surg program materials plus individual coaching

Primary outcomes

  1. Physical Function 8 Weeks Post-surgery as Measured by the Caloric Expenditure Scale Per Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire

    Time frame: 8 weeks post surgery

    The CHAMPS questionnaire includes 41 questions that measures frequency and duration of activities. The primary endpoint is the estimated Caloric Expenditure Per Week measure from the CHAMPS, which is calculated by weighting the duration variable of the 28 exercise-related activities using the corresponding metabolic equivalents (METs) value, then multiplying by 60 to convert METs/minute to METs/hour, then multiplying by participant weight in kg/200 to calculate the caloric expenditure/week score, and then summing the individual item caloric expenditure scores across all 28 items. This scale score was transformed into the unit of kcal. The minimum possible value of the scale is 0 and there is not a defined maximum possible value. Higher scores equate to more kilocalories burned per week, which is a better outcome in the context of this trial.

Secondary outcomes

  1. Percentage of Participants With Postoperative Complications (Clavien-Dindo Grades I-V)

    Time frame: 12 weeks

    Postoperative complications were assessed at 12 weeks following surgery using the Clavien-Dindo classification:

    Grade I: Any deviation from the normal postoperative course w/out the need for pharmacological treatment or surgical, endoscopic, and radiological interventions Grade II: Requiring pharmacological treatment w/ drug other than such allowed for Grade I complications Grade III: Requiring surgical, endoscopic or radiological intervention Grade IIIa: Intervention not under general anesthesia Grade IIIb: Intervention under general anesthesia Grave IV: Life-threatening complication Grade IVa: Single organ dysfunction Grade IVb: Multiorgan dysfunction Grave V: Death A generalized linear mixed model (with logit link function) with random practice effect to account for clustering within practice will be used to compare postoperative complications within 12 weeks of surgery between the combined OPTI-Surg no-coach & coach arms vs usual care followed by pairwise comparisons

  2. Compliance Rate With Administration of Edmonton Frail Scale (EFS)

    Time frame: Day of surgical consult

    EFS is a validated measure of frailty that identifies distinct frailty domains that are potential targets for additional pre-operative optimization. For frailty domains that score 1 or 2 points, optimization referrals will be recommended. Clinic or research staff at sites randomized to OPTI-Surg intervention arms will screen and identify eligible patients for administration of the EFS and provide printed surgery preparation materials. A generalized linear mixed model (with logit link function) with a random practice effect to account for clustering within practice will be used to compare compliance rate for screening between the no-coach and coach arms.

Sponsors and collaborators

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Improving Surgical Care and Outcomes in Older Cancer Patients Through Implementation of an Efficient Pre-Surgical Toolkit (OPTI-Surg)

Important dates

Study start
2019
Primary completion
2023
Study completion
2026
First posted
Feb 28, 2019
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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