Trial Outcomes & Findings for Use of a Pre-Surgical Toolkit in Improving Surgical Care and Outcomes in Older Participants With Cancer (NCT NCT03857620)

Last Updated: 2025-02-21

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

Target enrollment

325 participants

Primary outcome timeframe

8 weeks post surgery

Results posted on

2025-02-21

Participant Flow

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.

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.

Unit of analysis: Sites

Participant milestones

Participant milestones
Measure	Arm I (Usual Care) Healthcare providers/institutions perform usual care.	Arm II (OPTI-Surg Training and Materials) Healthcare providers/institutions receive OPTI-Surg training and informational materials.	Arm III (OPTI-Surg Training and Materials, Coach) Healthcare providers/institutions receive OPTI-Surg training and informational materials and meet with a coach.
Overall Study STARTED	94 13	114 14	117 11
Overall Study COMPLETED	68 10	83 9	92 10
Overall Study NOT COMPLETED	26 3	31 5	25 1

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I (Usual Care) Healthcare providers/institutions perform usual care.	Arm II (OPTI-Surg Training and Materials) Healthcare providers/institutions receive OPTI-Surg training and informational materials.	Arm III (OPTI-Surg Training and Materials, Coach) Healthcare providers/institutions receive OPTI-Surg training and informational materials and meet with a coach.
Overall Study Death	4	5	7
Overall Study Lost to Follow-up	2	5	3
Overall Study Disease progression or relapse after study registration	1	5	1
Overall Study Ineligible	5	0	2
Overall Study No malignancy	1	0	1
Overall Study Patient withdrawal/refusal prior to surgery	2	0	0
Overall Study Patient withdrawal/refusal after surgery performed	4	7	2
Overall Study Surgery not performed due to worsening performance status/medical ineligibility	4	4	3
Overall Study Surgery not performed, patient decision	0	3	1
Overall Study Surgery not performed, other reason	3	1	4
Overall Study Worsening performance status after surgery performed	0	1	1

Baseline Characteristics

Use of a Pre-Surgical Toolkit in Improving Surgical Care and Outcomes in Older Participants With Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Usual Care) n=94 Participants Healthcare providers/institutions perform usual care.	Arm II (OPTI-Surg Training and Materials) n=114 Participants Healthcare providers/institutions receive OPTI-Surg training and informational materials.	Arm III (OPTI-Surg Training and Materials, Coach) n=117 Participants Healthcare providers/institutions receive OPTI-Surg training and informational materials and meet with a coach.	Total n=325 Participants Total of all reporting groups
Age, Continuous	76.5 years STANDARD_DEVIATION 4.83 • n=5 Participants	75.6 years STANDARD_DEVIATION 4.73 • n=7 Participants	76.7 years STANDARD_DEVIATION 5.12 • n=5 Participants	76.3 years STANDARD_DEVIATION 4.91 • n=4 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	50 Participants n=7 Participants	55 Participants n=5 Participants	148 Participants n=4 Participants
Sex: Female, Male Male	51 Participants n=5 Participants	64 Participants n=7 Participants	62 Participants n=5 Participants	177 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	0 Participants n=7 Participants	8 Participants n=5 Participants	12 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	13 Participants n=7 Participants	12 Participants n=5 Participants	32 Participants n=4 Participants
Race (NIH/OMB) White	80 Participants n=5 Participants	97 Participants n=7 Participants	86 Participants n=5 Participants	263 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	13 Participants n=4 Participants
Region of Enrollment United States	94 participants n=5 Participants	114 participants n=7 Participants	117 participants n=5 Participants	325 participants n=4 Participants
Baseline Weight	77.1 kg STANDARD_DEVIATION 13.47 • n=5 Participants	81 kg STANDARD_DEVIATION 18.68 • n=7 Participants	82.4 kg STANDARD_DEVIATION 20.38 • n=5 Participants	80.4 kg STANDARD_DEVIATION 18.06 • n=4 Participants

PRIMARY outcome

Timeframe: 8 weeks post surgery

Population: 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.

Outcome measures

Outcome measures
Measure	Arm I (Usual Care) n=64 Participants Healthcare providers/institutions perform usual care.	Arm II (OPTI-Surg Training and Materials) n=68 Participants Healthcare providers/institutions receive OPTI-Surg training and informational materials.	Arm III (OPTI-Surg Training and Materials, Coach) n=67 Participants Healthcare providers/institutions receive OPTI-Surg training and informational materials and meet with a coach.
Physical Function 8 Weeks Post-surgery as Measured by the Caloric Expenditure Scale Per Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire Baseline	2.5 kcal Standard Deviation 2.53	2.3 kcal Standard Deviation 2.45	3.0 kcal Standard Deviation 2.96
Physical Function 8 Weeks Post-surgery as Measured by the Caloric Expenditure Scale Per Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire 8 weeks post-surgery	2.2 kcal Standard Deviation 1.94	2.2 kcal Standard Deviation 2.26	1.9 kcal Standard Deviation 1.76

SECONDARY outcome

Timeframe: 12 weeks

Population: All eligible participants who undergo major cancer surgery (no documentation of postoperative complications will be considered as not having any postoperative complications).

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

Outcome measures

Outcome measures
Measure	Arm I (Usual Care) n=78 Participants Healthcare providers/institutions perform usual care.	Arm II (OPTI-Surg Training and Materials) n=96 Participants Healthcare providers/institutions receive OPTI-Surg training and informational materials.	Arm III (OPTI-Surg Training and Materials, Coach) n=105 Participants Healthcare providers/institutions receive OPTI-Surg training and informational materials and meet with a coach.
Percentage of Participants With Postoperative Complications (Clavien-Dindo Grades I-V)	25.6 percentage of participants	44.8 percentage of participants	26.7 percentage of participants

SECONDARY outcome

Timeframe: Day of surgical consult

Population: 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.

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 measures

Outcome measures
Measure	Arm I (Usual Care) n=96 Participants Healthcare providers/institutions perform usual care.	Arm II (OPTI-Surg Training and Materials) n=105 Participants Healthcare providers/institutions receive OPTI-Surg training and informational materials.	Arm III (OPTI-Surg Training and Materials, Coach) Healthcare providers/institutions receive OPTI-Surg training and informational materials and meet with a coach.
Compliance Rate With Administration of Edmonton Frail Scale (EFS)	99 percentage of participants	100 percentage of participants	—

Adverse Events

Arm I (Usual Care)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 4 deaths

Arm II (OPTI-Surg Training and Materials)

Serious events: 3 serious events

Other events: 16 other events

Deaths: 5 deaths

Arm III (OPTI-Surg Training and Materials, Coach)

Serious events: 3 serious events

Other events: 13 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Arm I (Usual Care) n=94 participants at risk Healthcare providers/institutions perform usual care	Arm II (OPTI-Surg Training and Materials) n=114 participants at risk Healthcare providers/institutions receive OPTI-Surg training and informational materials	Arm III (OPTI-Surg Training and Materials, Coach) n=117 participants at risk Healthcare providers/institutions receive OPTI-Surg training and informational materials and meet with a coach
Cardiac disorders Cardiac arrest	0.00% 0/94 • 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.	0.88% 1/114 • Number of events 1 • 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.	0.00% 0/117 • 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.
Cardiac disorders Heart failure	0.00% 0/94 • 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.	0.00% 0/114 • 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.	0.85% 1/117 • Number of events 1 • 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.
Injury, poisoning and procedural complications Intestinal stoma leak	0.00% 0/94 • 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.	0.00% 0/114 • 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.	0.85% 1/117 • Number of events 1 • 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.
General disorders Death NOS	0.00% 0/94 • 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.	1.8% 2/114 • Number of events 2 • 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.	0.00% 0/117 • 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.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/94 • 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.	0.00% 0/114 • 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.	0.85% 1/117 • Number of events 1 • 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.

Other adverse events

Additional Information

George J. Chang, MD, MS

University of Texas MD Anderson Cancer Center

Phone: 713-563-1875

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place