Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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
  • 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 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Arm I (usual care)
Healthcare providers/institutions perform usual care.
  • Other: Best Practice
    Receive usual care
  • Other: Questionnaire Administration
    Ancillary studies
Experimental
Arm II (OPTI-Surg training and materials)
Healthcare providers/institutions receive OPTI-Surg training and informational materials.
  • Other: Informational Intervention
    Receive OPTI-Surg program materials
  • Other: Questionnaire Administration
    Ancillary studies
Experimental
Arm III (OPTI-Surg training and materials, coach)
Healthcare providers/institutions receive OPTI-Surg training and informational materials and meet with a coach.
  • Other: Questionnaire Administration
    Ancillary studies
  • Other: Informational Intervention with Coaching
    Receive OPTI-Surg program materials plus individual coaching

Recruiting Locations

Montefiore Medical Center-Einstein Campus
Bronx, New York 10461
Contact:
Site Public Contact
718-379-6866
aaraiza@montefiore.org

Montefiore Medical Center - Moses Campus
Bronx, New York 10467
Contact:
Site Public Contact
718-379-6866
aaraiza@montefiore.org

More Details

Status
Recruiting
Sponsor
Alliance for Clinical Trials in Oncology

Study Contact

George J. Chang, MD, MS
713-563-1875
gchang@mdanderson.org

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.