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.
Brief Title
Use of a Pre-Surgical Toolkit in Improving Surgical Care and Outcomes in Older Participants With Cancer
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.
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.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Malignant Neoplasm
Surgical Procedure, Unspecified
Health Care Provider
Carcinoma
Eligibility 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.
* 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.
Inclusion 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.
* 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.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
70 Years
NCT Id
NCT03857620
Org Class
Other
Org Full Name
Alliance for Clinical Trials in Oncology
Org Study Id
A231601CD
Overall Status
Active, not recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Improving Surgical Care and Outcomes in Older Cancer Patients Through Implementation of an Efficient Pre-Surgical Toolkit (OPTI-Surg)
Primary Outcomes
Outcome Description
The CHAMPS questionnaire includes 41 questions that measures frequency and duration of activities. The primary endpoint is the estimated Caloric Expenditure Per Week measure from the CHAMPS, which is calculated by weighting the duration variable of the 28 exercise-related activities using the corresponding metabolic equivalents (METs) value, then multiplying by 60 to convert METs/minute to METs/hour, then multiplying by participant weight in kg/200 to calculate the caloric expenditure/week score, and then summing the individual item caloric expenditure scores across all 28 items. This scale score was transformed into the unit of kcal. The minimum possible value of the scale is 0 and there is not a defined maximum possible value. Higher scores equate to more kilocalories burned per week, which is a better outcome in the context of this trial.
Outcome Measure
Physical Function 8 Weeks Post-surgery as Measured by the Caloric Expenditure Scale Per Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire
Outcome Time Frame
8 weeks post surgery
Secondary Ids
Secondary Id
NCI-2018-01512
Secondary Id
UG1CA189823
Secondary Outcomes
Outcome Description
Postoperative complications were assessed at 12 weeks following surgery using the Clavien-Dindo classification:
Grade I: Any deviation from the normal postoperative course w/out the need for pharmacological treatment or surgical, endoscopic, and radiological interventions Grade II: Requiring pharmacological treatment w/ drug other than such allowed for Grade I complications Grade III: Requiring surgical, endoscopic or radiological intervention Grade IIIa: Intervention not under general anesthesia Grade IIIb: Intervention under general anesthesia Grave IV: Life-threatening complication Grade IVa: Single organ dysfunction Grade IVb: Multiorgan dysfunction Grave V: Death A generalized linear mixed model (with logit link function) with 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 \& coach arms vs usual care followed by pairwise comparisons
Grade I: Any deviation from the normal postoperative course w/out the need for pharmacological treatment or surgical, endoscopic, and radiological interventions Grade II: Requiring pharmacological treatment w/ drug other than such allowed for Grade I complications Grade III: Requiring surgical, endoscopic or radiological intervention Grade IIIa: Intervention not under general anesthesia Grade IIIb: Intervention under general anesthesia Grave IV: Life-threatening complication Grade IVa: Single organ dysfunction Grade IVb: Multiorgan dysfunction Grave V: Death A generalized linear mixed model (with logit link function) with 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 \& coach arms vs usual care followed by pairwise comparisons
Outcome Time Frame
12 weeks
Outcome Measure
Percentage of Participants With Postoperative Complications (Clavien-Dindo Grades I-V)
Outcome Description
EFS is a validated measure of frailty that identifies distinct frailty domains that are potential targets for additional pre-operative optimization. For frailty domains that score 1 or 2 points, optimization referrals will be recommended. Clinic or research staff at sites randomized to OPTI-Surg intervention arms will screen and identify eligible patients for administration of the EFS and provide printed surgery preparation materials. 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 compliance rate for screening between the no-coach and coach arms.
Outcome Time Frame
Day of surgical consult
Outcome Measure
Compliance Rate With Administration of Edmonton Frail Scale (EFS)
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
70
Investigators
Investigator Type
Principal Investigator
Investigator Name
Renee Huang
Investigator Email
rhuang@montefiore.org