The RIOT Trial: Re-Defining Frailty and Improving Outcomes With Prehabilitation for Pancreatic, Liver, or Gastric Cancer
RIOT
Re-Defining Frailty and Improving Outcomes Through Prehabilitation (RIOT Trial)
2 other identifiers
interventional
66
1 country
1
Brief Summary
This trial studies how well a prehabilitation program works to improve patient outcomes after surgery compared to the normal standard of care prehabilitation in frail patients undergoing surgery for pancreatic, liver, or gastric cancer. Frailty is defined as the pathophysiology of aging or through the accumulation of physiologic and functional deficits. Prehabilitation programs seek to optimize the medical and physical state of patients prior to undergoing surgery with the goal of improving outcomes following surgery. Despite evidence for its importance in health outcomes for frail patients, prehabilitation programs have not been well studied in cancer surgery populations. This trial may provide researchers with more information on how to improve patient outcomes after cancer surgery through the use of prehabilitation programs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 14, 2020
CompletedFirst Submitted
Initial submission to the registry
October 20, 2020
CompletedFirst Posted
Study publicly available on registry
October 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 9, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 9, 2024
CompletedApril 4, 2025
April 1, 2025
4.2 years
October 20, 2020
April 2, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Frailty assessment
A rapid assessment for frailty using the widely used 5-item fatigue, resistance, ambulation, illness, \& loss of weight (FRAIL) questionnaire will be performed. Patients are identified as frail by scoring 2 or more points on the FRAIL questionnaire. The frailty assessment will be aimed at identifying factors related to the 6 characteristics of frailty: physical performance, gait speed, mobility, nutritional status, mental health and cognition.
Baseline
Morbidity
Will be assessed using standardized case report forms.
Baseline
Complication burden
Will be calculated using the Comprehensive Complication Index (CCI). This method is more powerful than standard binary measures of morbidity (presence/absence of individual events) as it presents a quantitative score based on an aggregate weighted total ranging from 0 (no complications) to 100 (death).
Baseline
Health-related quality of life (composite measure)
Will be recorded by administration of the Patient Reported Outcomes Measurement Information System (PROMIS) health-related quality of life questionnaire. PROMIS is a validated set of patient-centered measures that evaluates and monitors life domains (physical, mental, social health) and provide standardized patient reported outcome resources for use in clinical research and practice.
Baseline, 2 weeks, 3, 6, 12 months
Study Arms (2)
Arm I (physical therapy consultation, exercise intervention)
EXPERIMENTALPatients undergo a physical therapy consultation and complete home exercises 3 days per week.
Arm II (best practice)
ACTIVE COMPARATORPatients receive standard of care.
Interventions
Receive standard of care
Complete home exercise intervention
Undergo physical therapy
Ancillary studies
Eligibility Criteria
You may qualify if:
- Scheduled for any abdominal (e.g., pancreatic, liver or gastric) cancer surgery or established in the GI surgical oncology clinics or
- Scheduled for neoadjuvant therapy prior with the plan to be scheduled for surgery
You may not qualify if:
- Non-English speaking
- Prisoners
- Persons unable to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Related Publications (1)
Hamad A, Zhang H, Zhang Y, Shen C, Fa P, Huang H, Ejaz A, Tsung A. Understanding the mechanism behind preoperative exercise therapy in patients with gastrointestinal cancers: a prospective randomized clinical trial. BMC Sports Sci Med Rehabil. 2025 Mar 14;17(1):50. doi: 10.1186/s13102-025-01094-6.
PMID: 40087747DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Rubinstein, PhD
Ohio State University Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 20, 2020
First Posted
October 26, 2020
Study Start
September 14, 2020
Primary Completion
December 9, 2024
Study Completion
December 9, 2024
Last Updated
April 4, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share