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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-14

Study Completion Date

2024-12-09

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.

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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.

Conditions

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Adult Liver Carcinoma Gastric Carcinoma Malignant Solid Neoplasm Pancreatic Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm I (physical therapy consultation, exercise intervention)

Patients undergo a physical therapy consultation and complete home exercises 3 days per week.

Group Type EXPERIMENTAL

Exercise Intervention

Intervention Type BEHAVIORAL

Complete home exercise intervention

Physical Therapy

Intervention Type PROCEDURE

Undergo physical therapy

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Arm II (best practice)

Patients receive standard of care.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Receive standard of care

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Best Practice

Receive standard of care

Intervention Type OTHER

Exercise Intervention

Complete home exercise intervention

Intervention Type BEHAVIORAL

Physical Therapy

Undergo physical therapy

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy Physiatric Procedure Physical Medicine Procedure Physical Therapeutics Physical Therapy Procedure Physiotherapy Physiotherapy Procedure PT

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