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NCT04602026 Clinical Trial

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

Malignant Solid Neoplasm Clinical Trial

— RIOT  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04602026
Other study ID # OSU-20057
Secondary ID NCI-2020-04925
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 14, 2020
Est. completion date December 31, 2024

Study information
Verified date February 2024
Source Ohio State University Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 66
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Best Practice
Receive standard of care
Behavioral:
• Exercise Intervention
Complete home exercise intervention
Procedure:
• Physical Therapy
Undergo physical therapy
Other:
• Questionnaire Administration
Ancillary studies

Locations
Country Name City State
United States Ohio State University Comprehensive Cancer Center Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary Morbidity Will be assessed using standardized case report forms. Baseline
Primary 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
Primary 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
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