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

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


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.



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.


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.

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


Yes No Not Sure

Inclusion Criteria

Patients must have known or suspected cancer diagnosis and have one of the following cancer-directed operations planned
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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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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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