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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01512 | Registry Identifier | NCI Clinical Trial Reporting Program | |
| UG1CA189823 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (usual care) | Active Comparator | Healthcare providers/institutions perform usual care. |
|
| Arm II (OPTI-Surg training and materials) | Experimental | Healthcare providers/institutions receive OPTI-Surg training and informational materials. |
|
| Arm III (OPTI-Surg training and materials, coach) | Experimental | Healthcare providers/institutions receive OPTI-Surg training and informational materials and meet with a coach. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive usual care |
| |
| Informational Intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Function 8 Weeks Post-surgery as Measured by the Caloric Expenditure Scale Per Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire | 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. | 8 weeks post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Postoperative Complications (Clavien-Dindo Grades I-V) | 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 |
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Inclusion Criteria:
Patients must have known or suspected cancer diagnosis and have one of the following cancer-directed operations planned:
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:
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| Name | Affiliation | Role |
|---|---|---|
| George J. Chang, MD, MS | M.D. Anderson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helen F Graham Cancer Center | Newark | Delaware | 19713 | United States | ||
| MedStar Washington Hospital Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37923529 | Derived | Zahrieh D, Croghan IT, Inselman JW, Mandrekar SJ. Guidelines for Data and Safety Monitoring in Pragmatic Randomized Clinical Trials Using Case Studies. Mayo Clin Proc. 2023 Nov;98(11):1712-1726. doi: 10.1016/j.mayocp.2023.02.019. |
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This was a cluster-randomized trial at the practice level. Thirty sites with practice types of major abdominal (18 sites), thoracic (6 sites) or urologic (6 sites) were randomized initially in a 1:1:1 fashion to each arm. A total of 9 sites withdrew prior to accruing a patient due to inability to meet accrual expectations/had issues with resource allocation. Eight additional sites were randomized. A total of 29 sites remained with the study participation and accrued at least 1 patient.
Three-hundred and twenty-five participants (94 Arm I, 114 Arm II, 117 Arm III) were enrolled between April 2019 to September 2022 from 29 sites (10 Arm I, 9 Arm II, 10 Arm III). Recruitment was temporarily paused from March 25, 2020 to June 15, 2020 due to the COVID-19 pandemic. Data as of 3/15/2024 that was summarized for manuscript submission, is reported here.
| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Usual Care) | Healthcare providers/institutions perform usual care. |
| FG001 | Arm II (OPTI-Surg Training and Materials) | Healthcare providers/institutions receive OPTI-Surg training and informational materials. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 16, 2021 |
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| Other |
Receive OPTI-Surg program materials |
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Informational Intervention with Coaching | Other | Receive OPTI-Surg program materials plus individual coaching |
|
| 12 weeks |
| Compliance Rate With Administration of Edmonton Frail Scale (EFS) | 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. | Day of surgical consult |
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| Augusta University Medical Center | Augusta | Georgia | 30912 | United States |
| Memorial Health University Medical Center | Savannah | Georgia | 31404 | United States |
| Queen's Medical Center | Honolulu | Hawaii | 96813 | United States |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453-2699 | United States |
| Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | United States |
| Mercy Medical Center - Des Moines | Des Moines | Iowa | 50314 | United States |
| University of Kansas Cancer Center | Kansas City | Kansas | 66160 | United States |
| University of Kansas Hospital-Westwood Cancer Center | Westwood | Kansas | 66205 | United States |
| LSU Healthcare Network / Metairie Multi-Specialty Clinic | Metairie | Louisiana | 70006 | United States |
| Louisiana State University Health Science Center | New Orleans | Louisiana | 70112 | United States |
| Saint Joseph Mercy Hospital | Ann Arbor | Michigan | 48106 | United States |
| Spectrum Health at Butterworth Campus | Grand Rapids | Michigan | 49503 | United States |
| Fairview Southdale Hospital | Edina | Minnesota | 55435 | United States |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| North Memorial Medical Health Center | Robbinsdale | Minnesota | 55422 | United States |
| Baptist Memorial Hospital and Cancer Center-Desoto | Southhaven | Mississippi | 38671 | United States |
| Mercy Hospital Springfield | Springfield | Missouri | 65804 | United States |
| CoxHealth South Hospital | Springfield | Missouri | 65807 | United States |
| Morristown Medical Center | Morristown | New Jersey | 07960 | United States |
| Overlook Hospital | Summit | New Jersey | 07902 | United States |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | United States |
| Montefiore Medical Center-Einstein Campus | The Bronx | New York | 10461 | United States |
| Montefiore Medical Center - Moses Campus | The Bronx | New York | 10467 | United States |
| Novant Health Forsyth Medical Center | Winston-Salem | North Carolina | 27103 | United States |
| Sanford Roger Maris Cancer Center | Fargo | North Dakota | 58122 | United States |
| Miami Valley Hospital South | Centerville | Ohio | 45459 | United States |
| Lehigh Valley Hospital-Cedar Crest | Allentown | Pennsylvania | 18103 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Prisma Health Greenville Memorial Hospital | Greenville | South Carolina | 29605 | United States |
| Baptist Memorial Hospital and Cancer Center-Memphis | Memphis | Tennessee | 38120 | United States |
| VCU Massey Cancer Center at Stony Point | Richmond | Virginia | 23235 | United States |
| Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | 23298 | United States |
| Ascension Southeast Wisconsin Hospital - Elmbrook Campus | Brookfield | Wisconsin | 53045 | United States |
| Marshfield Medical Center-EC Cancer Center | Eau Claire | Wisconsin | 54701 | United States |
| Ascension Southeast Wisconsin Hospital - Franklin | Franklin | Wisconsin | 53132 | United States |
| Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | 54449 | United States |
| Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| Marshfield Clinic-Minocqua Center | Minocqua | Wisconsin | 54548 | United States |
| Marshfield Medical Center-Rice Lake | Rice Lake | Wisconsin | 54868 | United States |
| Marshfield Medical Center-River Region at Stevens Point | Stevens Point | Wisconsin | 54482 | United States |
| Marshfield Medical Center - Weston | Weston | Wisconsin | 54476 | United States |
| FG002 | Arm III (OPTI-Surg Training and Materials, Coach) | Healthcare providers/institutions receive OPTI-Surg training and informational materials and meet with a coach. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Usual Care) | Healthcare providers/institutions perform usual care. |
| BG001 | Arm II (OPTI-Surg Training and Materials) | Healthcare providers/institutions receive OPTI-Surg training and informational materials. |
| BG002 | Arm III (OPTI-Surg Training and Materials, Coach) | Healthcare providers/institutions receive OPTI-Surg training and informational materials and meet with a coach. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Baseline Weight | Mean | Standard Deviation | kg |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Physical Function 8 Weeks Post-surgery as Measured by the Caloric Expenditure Scale Per Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire | 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. | All eligible participants who undergo major cancer surgery, consent to complete CHAMPS questionnaires, have a baseline CHAMPS score and have a CHAMPS score at 8 weeks post-surgery +/- 2 weeks. | Posted | Mean | Standard Deviation | kcal | 8 weeks post surgery |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Postoperative Complications (Clavien-Dindo Grades I-V) | 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 | All eligible participants who undergo major cancer surgery (no documentation of postoperative complications will be considered as not having any postoperative complications). | Posted | Number | percentage of participants | 12 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Compliance Rate With Administration of Edmonton Frail Scale (EFS) | 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. | All eligible participants from Arm II (OPTI-Surg) and Arm III (OPTI-Surg plus Coach) who undergo major cancer surgery who are evaluable for postoperative complications outcome. Notes: Generalized linear mixed model analysis not performed. | Posted | Number | percentage of participants | Day of surgical consult |
|
Duration of the study, up to 1 year
The exclusion to CTEP-AERS Expedited Reporting Requirements was outlined in the study Protocol Section 9.3.3. The adverse events were assessed only between initial surgical consultation (baseline) and on the day of surgery and additional reporting per Section 9.3.3. The study intervention refers to the administration of the OPTI-Surg toolkit (Edmonton Frail Scale and the follow-up recommendations) and not the surgery itself, which is why this trial doesn't have a typical collection of AEs.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I (Usual Care) | Healthcare providers/institutions perform usual care | 4 | 94 | 0 | 94 | 5 | 94 |
| EG001 | Arm II (OPTI-Surg Training and Materials) | Healthcare providers/institutions receive OPTI-Surg training and informational materials | 5 | 114 | 3 | 114 | 16 | 114 |
| EG002 | Arm III (OPTI-Surg Training and Materials, Coach) | Healthcare providers/institutions receive OPTI-Surg training and informational materials and meet with a coach | 7 | 117 | 3 | 117 | 13 | 117 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Heart failure | Cardiac disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Intestinal stoma leak | Injury, poisoning and procedural complications | CTCAE 5.0 | Systematic Assessment |
| |
| Death NOS | General disorders | CTCAE 5.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Blood and lymphatic system disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Platelet count decreased | Blood and lymphatic system disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Arterial fibrilation | Cardiac disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Cardiac disorders - Other, specify | Cardiac disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Chest pain - cardiac | Cardiac disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Obstruction gastric | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Pancreatic fistula | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Fever | General disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Gen disord and admin site conds-Oth spec | General disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Pain | General disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE 5.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE 5.0 | Systematic Assessment |
| |
| Esophageal anastomotic leak | Injury, poisoning and procedural complications | CTCAE 5.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE 5.0 | Systematic Assessment |
| |
| Postoperative hemorrhage | Injury, poisoning and procedural complications | CTCAE 5.0 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE 5.0 | Systematic Assessment |
| |
| Cholesterol high | Investigations | CTCAE 5.0 | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE 5.0 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Hypertriglyceridemia | Metabolism and nutrition disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Cognitive disturbance | Nervous system disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Renal and urinary disorders - Oth spec | Renal and urinary disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Sleep apnea | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Surgical and medical proced - Oth spec | Surgical and medical procedures | CTCAE 5.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | CTCAE 5.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| George J. Chang, MD, MS | University of Texas MD Anderson Cancer Center | 713-563-1875 | gchang@mdanderson.org |
| Nov 5, 2024 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Mixed Models Analysis |
Generalized linear mixed effects model (w/ Gaussian link) w/ random practice effect to account for clustering by site & bsl CHAMPS score as covariate |
| 0.84 |
| Mean Difference (Final Values) |
| 0.07 |
| 2-Sided |
| 95 |
| -0.67 |
| 0.81 |
| Superiority |
| Mixed Models Analysis | Generalized linear mixed effects model (w/ Gaussian link) w/ random practice effect to account for clustering by site & bsl CHAMPS score as covariate | 0.19 | Mean Difference (Final Values) | -0.48 | 2-Sided | 95 | -1.21 | 0.26 | Superiority |
| Mixed Models Analysis | Generalized linear mixed effects model (w/ Gaussian link) w/ random practice effect to account for clustering by site & bsl CHAMPS score as covariate | 0.14 | Mean Difference (Final Values) | 0.55 | 2-Sided | 95 | -0.19 | 1.29 | Superiority |
Healthcare providers/institutions receive OPTI-Surg training and informational materials.
| OG002 | Arm III (OPTI-Surg Training and Materials, Coach) | Healthcare providers/institutions receive OPTI-Surg training and informational materials and meet with a coach. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|