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

Alliance for Clinical Trials in Oncology

Status: Active, not recruiting

Conditions: Health Care Provider; Malignant Neoplasm; Surgical Procedure, Unspecified; Carcinoma

Treatments: Other: Informational Intervention; Other: Questionnaire Administration; Other: Best Practice; Other: Informational Intervention with Coaching

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03857620

UG1CA189823 (U.S. NIH Grant/Contract)

NCI-2018-01512 (Registry Identifier)

A231601CD

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 325 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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325 participants in 3 patient groups

Arm I (usual care)

Active Comparator group

Description:

Healthcare providers/institutions perform usual care.

Treatment:

Other: Best Practice

Other: Questionnaire Administration

Arm II (OPTI-Surg training and materials)

Experimental group

Description:

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

Treatment:

Other: Questionnaire Administration

Other: Informational Intervention

Arm III (OPTI-Surg training and materials, coach)

Experimental group

Description:

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

Treatment:

Other: Informational Intervention with Coaching

Other: Questionnaire Administration