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

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

  • Malignant Neoplasm
  • Surgical Procedure, Unspecified
  • Health Care Provider
  • Carcinoma

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 - 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.

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

More Details

Status
Active, not recruiting
Sponsor
Alliance for Clinical Trials in Oncology

Study Contact

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.