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

February 8, 2024 updated by: Mark Rubinstein, Ohio State University Comprehensive Cancer Center

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (physical therapy consultation, exercise intervention)
Patients undergo a physical therapy consultation and complete home exercises 3 days per week.
Other: Questionnaire Administration
Ancillary studies
Behavioral: Exercise Intervention
Complete home exercise intervention
Procedure: Physical Therapy
Undergo physical therapy
Other Names:
  • PT
  • Physiatric Procedure
  • Physical Medicine Procedure
  • Physical Therapeutics
  • Physical Therapy Procedure
  • Physiotherapy
  • Physiotherapy Procedure
Active Comparator: Arm II (best practice)
Patients receive standard of care.
Other: Questionnaire Administration
Ancillary studies
Other: Best Practice
Receive standard of care
Other Names:
  • standard of care
  • standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frailty assessment
Time Frame: 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.
Baseline
Morbidity
Time Frame: Baseline
Will be assessed using standardized case report forms.
Baseline
Complication burden
Time Frame: 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).
Baseline
Health-related quality of life (composite measure)
Time Frame: 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.
Baseline, 2 weeks, 3, 6, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Mark Rubinstein, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2020

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

October 20, 2020

First Submitted That Met QC Criteria

October 20, 2020

First Posted (Actual)

October 26, 2020

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSU-20057
  • NCI-2020-04925 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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