Malignant NeoplasmNCT03857620
Use of a Pre-Surgical Toolkit in Improving Surgical Care and Outcomes in Older Participants With Cancer
A study testing Best Practice, Informational Intervention and Questionnaire Administration in people with Malignant Neoplasm and Surgical Procedure, Unspecified, run by Alliance for Clinical Trials in Oncology at 44 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Malignant Neoplasm, Surgical Procedure, Unspecified, Health Care Provider
- What is being tested?
- Best Practice, Informational Intervention and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 44 sitesUnited States
- Study dates
- 24 Jul 2019to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients must have known or suspected cancer diagnosis and have one of the following cancer-directed operations planned:
- Gastrectomy
- Colectomy
- Proctectomy
- Esophagectomy
- Pancreatectomy
Show all 13Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106
Augusta University Medical Center
Augusta, Georgia, 30912
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Brookfield, Wisconsin, 53045
Miami Valley Hospital South
Centerville, Ohio, 45459
Geisinger Medical Center
Danville, Pennsylvania, 17822
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Fairview Southdale Hospital
Edina, Minnesota, 55435
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
Ascension Southeast Wisconsin Hospital - Franklin
Franklin, Wisconsin, 53132
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605
Queen's Medical Center
Honolulu, Hawaii, 96813
University of Kansas Cancer Center
Kansas City, Kansas, 66160
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie, Louisiana, 70006
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, 54548
Morristown Medical Center
Morristown, New Jersey, 07960
Louisiana State University Health Science Center
New Orleans, Louisiana, 70112
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Helen F Graham Cancer Center
Newark, Delaware, 19713
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453-2699
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422
Memorial Health University Medical Center
Savannah, Georgia, 31404
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, 38671
Mercy Hospital Springfield
Springfield, Missouri, 65804
CoxHealth South Hospital
Springfield, Missouri, 65807
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482
Overlook Hospital
Summit, New Jersey, 07902
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467
Carle Cancer Center
Urbana, Illinois, 61801
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103
About this study
Official title: Improving Surgical Care and Outcomes in Older Cancer Patients Through Implementation of an Efficient Pre-Surgical Toolkit (OPTI-Surg)
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Being tested
- Best Practice, Informational Intervention, Questionnaire Administration, Informational Intervention with Coaching
- Medical subject headings
- Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Receive usual care
Informational InterventionOther
Receive OPTI-Surg program materials
Questionnaire AdministrationOther
Ancillary studies
Informational Intervention with CoachingOther
Receive OPTI-Surg program materials plus individual coaching
| Study group | Role | What they receive |
|---|---|---|
| Arm I (usual care) | Active comparator | Healthcare providers/institutions perform usual care. Receives: Other: Best Practice; Other: Questionnaire Administration |
| Arm II (OPTI-Surg training and materials) | Experimental | Healthcare providers/institutions receive OPTI-Surg training and informational materials. Receives: Other: Informational Intervention; Other: Questionnaire Administration |
| Arm III (OPTI-Surg training and materials, coach) | Experimental | Healthcare providers/institutions receive OPTI-Surg training and informational materials and meet with a coach. Receives: Other: Questionnaire Administration; Other: Informational Intervention with Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks post surgery
Secondary outcomes (2)
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
Measured: 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.
Measured: Day of surgical consult
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start24 Jul 2019
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- George J. Chang, MD, MS, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857620
- Sponsor's protocol ID
- A231601CD
- Other IDs
- NCI-2018-01512, UG1CA189823
- Status last verified
- Aug 2026
- First submitted
- 26 Feb 2019
- Last updated
- 10 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37923529
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Surgical Care and Outcomes in Older Cancer Patients Through Implementation of an Efficient Pre-Surgical Toolkit (OPTI-Surg)
- ClinicalTrials.gov ID
- NCT03857620
- Acronym / sponsor ID
- A231601CD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Jul 2019 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 28 Feb 2019 (actual)
- Results
- Posted 21 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I (usual care) | Active comparator | Other: Best Practice, Other: Questionnaire AdministrationHealthcare providers/institutions perform usual care. |
| Arm II (OPTI-Surg training and materials) | Experimental | Other: Informational Intervention, Other: Questionnaire AdministrationHealthcare providers/institutions receive OPTI-Surg training and informational materials. |
| Arm III (OPTI-Surg training and materials, coach) | Experimental | Other: Questionnaire Administration, Other: Informational Intervention with CoachingHealthcare providers/institutions receive OPTI-Surg training and informational materials and meet with a coach. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeReceive usual care | Other | Arm I (usual care) |
| Informational InterventionReceive OPTI-Surg program materials | Other | Arm II (OPTI-Surg training and materials) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (usual care), Arm II (OPTI-Surg training and materials), Arm III (OPTI-Surg training and materials, coach) |
| Informational Intervention with CoachingReceive OPTI-Surg program materials plus individual coaching | Other | Arm III (OPTI-Surg training and materials, coach) |
Primary outcome
Physical Function 8 Weeks Post-surgery as Measured by the Caloric Expenditure Scale Per Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire
Time frame: 8 weeks post surgery
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.
2 secondary outcomes
Percentage of Participants With Postoperative Complications (Clavien-Dindo Grades I-V)
Time frame: 12 weeks
Compliance Rate With Administration of Edmonton Frail Scale (EFS)
Time frame: Day of surgical consult
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37923529Zahrieh 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.
Related trials for Malignant Neoplasm
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
RecruitingPhase 3
Somatostatin Analogues vs. Observation After Peptide Receptor Radionuclide Therapy (PRRT) in Nonfunctional Neuroendocrine Neoplasms
Neuroendocrine Neoplasm, Gastroenteropancreatic Neuroendocrine Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George J. Chang, MD, MS study chair
M.D. Anderson Cancer Center
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Informational Intervention and Questionnaire Administration in people with Malignant Neoplasm and Surgical Procedure, Unspecified, run by Alliance for Clinical Trials in Oncology at 44 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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 (time frame: 8 weeks post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03857620, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.