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
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|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|
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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|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|
Active Comparator: Arm I (usual care)
Healthcare providers/institutions perform usual care.
Other: Best Practice
Receive usual care
Other: Questionnaire Administration
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
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
Other: Informational Intervention with Coaching
Receive OPTI-Surg program materials plus individual coaching
- 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.
- 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).
- 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.
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|Ages Eligible for Study:||70 Years and older (Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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 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.
- 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.
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
|Contact: George J. Chang, MD, MSemail@example.com|
|Study Chair:||George J. Chang, MD, MS||The University of Texas MD Anderson Cancer Center|
|Responsible Party:||Alliance for Clinical Trials in Oncology|
|Other Study ID Numbers:||
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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|