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

  • STATUS
    Recruiting
  • End date
    Oct 9, 2025
  • participants needed
    450
  • sponsor
    Alliance for Clinical Trials in Oncology
Updated on 4 October 2022
cancer
metastatic disease
metastasis
cancer diagnosis
primary cancer
lung lobectomy

Summary

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.

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.

Details
Condition Malignant Neoplasm, Surgical Procedure, Unspecified, Health Care Provider, Carcinoma
Treatment questionnaire administration, informational intervention, Best Practice, Informational Intervention with Coaching
Clinical Study IdentifierNCT03857620
SponsorAlliance for Clinical Trials in Oncology
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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

Exclusion Criteria

Patients undergoing emergent surgery are not eligible
Patients with second primary are not eligible
Patients under active treatment such as chemotherapy, targeted therapy, immunotherapy, radiation treatment, etc. for 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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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