The RIOT Trial: Re-Defining Frailty and Improving Outcomes With Prehabilitation for Pancreatic, Liver, or Gastric Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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PRIMARY OBJECTIVES: I. To develop a novel, multi-dimensional index of physiologic reserve and resilience specific to surgical cancer patients. II. To implement and assess a novel comprehensive multidimensional prehabilitation program on frail cancer surgery patients. OUTLINE: All patients enrolled (both frail and non-frail) will be randomized (1:1) at the time of enrollment to receive pre-operative exercise or non-preoperative exercises. Randomization will be stratified by frailty status. ARM I: Enrolled patients undergo a physical therapy consultation and complete home exercises 3 days per week, in addition to standard guidelines. ARM II: Enrolled patients follow standard guidelines. All patients are followed up at 2 weeks after surgery and then every 3 months.

Official Title
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Re-Defining Frailty and Improving Outcomes Through Prehabilitation (RIOT Trial)

Conditions
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Adult Liver Carcinoma, Gastric Carcinoma, Malignant Solid Neoplasm, Pancreatic Carcinoma

Intervention / Treatment
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* Other: Best Practice
* Behavioral: Exercise Intervention
* Procedure: Physical Therapy
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Non-English speaking Prisoners Persons unable to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (physical therapy consultation, exercise intervention)<br>Patients undergo a physical therapy consultation and complete home exercises 3 days per week. | Behavioral: Exercise Intervention<br>* Complete home exercise intervention<br>Procedure: Physical Therapy<br>* Undergo physical therapy<br>* Other names: PT;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Active Comparator: Arm II (best practice)<br>Patients receive standard of care. | Other: Best Practice<br>* Receive standard of care<br>* Other names: standard therapy;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |