Re-Defining Frailty and Improving Outcomes Through Prehabilitation in Patients With Pancreatic, Liver, or Gastric Cancer, The RIOT Trial
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
PRIMARY OBJECTIVES:
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To develop a novel, multi-dimensional index of physiologic reserve and resilience specific to surgical cancer patients.
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To implement and assess a novel comprehensive multidimensional prehabilitation program on frail cancer surgery patients.
OUTLINE: Non-frail patients are assigned to Arm 1. Frail patients are randomized to Arms 2 or 3.
ARM I: Non-frail patients receive standard of care.
ARM II: Frail patients receive standard of care.
ARM III: Frail patients undergo a physical therapy consultation and complete home exercises 3 days per week.
After completion of study treatment, patients are followed up at 2 weeks after surgery and then every 3 months.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Arm I (best practice) Non-frail patients receive standard of care. |
Other: Best Practice
Receive standard of care
Other Names:
Other: Questionnaire Administration
Ancillary studies
|
| Active Comparator: Arm II (best practice) Frail patients receive standard of care. |
Other: Best Practice
Receive standard of care
Other Names:
Other: Questionnaire Administration
Ancillary studies
|
| Experimental: Arm III (physical therapy consultation, exercise intervention) Frail patients undergo a physical therapy consultation and complete home exercises 3 days per week. |
Behavioral: Exercise Intervention
Complete home exercise intervention
Procedure: Physical Therapy
Undergo physical therapy
Other Names:
Other: Questionnaire Administration
Ancillary studies
|
Outcome Measures
Primary Outcome Measures
- Frailty assessment [Baseline]
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.
- Morbidity [Baseline]
Will be assessed using standardized case report forms.
- Complication burden [Baseline]
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).
- Health-related quality of life (composite measure) [Baseline, 2 weeks, 3, 6, 12 months]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Scheduled for pancreatic, liver or gastric cancer surgery
Exclusion Criteria:
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Non-English speaking
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Prisoners
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Persons unable to provide informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ohio State University Comprehensive Cancer Center | Columbus | Ohio | United States | 43210 |
Sponsors and Collaborators
- Ohio State University Comprehensive Cancer Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Aslam Ejaz, MD, MPH, Ohio State University Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- OSU-20057
- NCI-2020-04925
- P30CA016058