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Trial record 1 of 1 for:    A231601CD
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Use of a Pre-Surgical Toolkit in Improving Surgical Care and Outcomes in Older Participants With Cancer

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ClinicalTrials.gov Identifier: NCT03857620
Recruitment Status : Recruiting
First Posted : February 28, 2019
Last Update Posted : August 3, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Malignant Neoplasm Surgical Procedure, Unspecified Health Care Provider Carcinoma Other: Best Practice Other: Informational Intervention Other: Questionnaire Administration Other: Informational Intervention with Coaching Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving Surgical Care and Outcomes in Older Cancer Patients Through Implementation of an Efficient Pre-Surgical Toolkit (OPTI-Surg)
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2025
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Patient function per Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire [ Time Frame: At 8 weeks post surgery ]
    The primary analysis will employ a generalized linear mixed model (with Gaussian link function) with a random practice effect to account for clustering within practice and baseline CHAMPS total score as a covariate to compare 8-week CHAMPS total score between the combined OPTI-Surg no-coach and coach arms versus usual care. This analysis will include all eligible elderly patients who undergo major cancer surgery, consent to complete CHAMPS questionnaires, and have baseline and 8-week function measured. The CHAMPS questionnaire includes 41 questions and 4 subscales measuring caloric expenditure and frequency/week of all exercise-related activities and only moderate-intensity exercise-related activities. The caloric activities subscales are scored by weighting the duration items using MET values and converting them to a caloric expenditure/week. The frequency/week subscales are scored by summing the frequency scores/week for each activity.


Secondary Outcome Measures :
  1. Postoperative complications (Clavien-Dindo grades I-V) [ Time Frame: Up to 12 weeks ]
    A generalized linear mixed model (with logit link function) with a random practice effect to account for clustering within practice will be used to compare postoperative complications within 12 weeks of surgery between the combined OPTI-Surg no-coach and coach arms versus usual care followed by pairwise comparisons. This analysis will include all eligible elderly patients who undergo major cancer surgery (no documentation of postoperative complications will be considered as not having any postoperative complications).

  2. Compliance with administration of Edmonton Frail Scale (EFS) [ Time Frame: Up to 9 months ]
    A generalized linear mixed model (with logit link function) with a random practice effect to account for clustering within practice will also be used to compare compliance rate (i.e., percentage) for screening between the no-coach and coach arms. The endpoint is whether the EFS was administered, not the EFS scores themselves.


Eligibility Criteria
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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03857620


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

Locations
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Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
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Study Chair: George J. Chang, MD, MS The University of Texas MD Anderson Cancer Center
More Information
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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT03857620    
Other Study ID Numbers: A231601CD
NCI-2018-01512 ( Registry Identifier: NCI Clinical Trial Reporting Program )
UG1CA189823 ( U.S. NIH Grant/Contract )
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: August 3, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms