The RIOT Trial: Re-Defining Frailty and Improving Outcomes With Prehabilitation for Pancreatic, L… (NCT04602026) | Clinical Trial Compass
CompletedNot Applicable
The RIOT Trial: Re-Defining Frailty and Improving Outcomes With Prehabilitation for Pancreatic, Liver, or Gastric Cancer
United States66 participantsStarted 2020-09-14
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frailty assessment
Timeframe: Baseline
2
Morbidity
Timeframe: Baseline
3
Complication burden
Timeframe: Baseline
4
Health-related quality of life (composite measure)
Timeframe: Baseline, 2 weeks, 3, 6, 12 months
Trial details
NCT IDNCT04602026
SponsorOhio State University Comprehensive Cancer Center