Individualized Preoperative Rehabilitation Pilot (iPREHAB)

February 27, 2018 updated by: Juliane Bingener-Casey, Mayo Clinic

Individualized Preoperative Rehabilitation (iPREHAB) Pilot

A pilot to test feasibility of improving patient/caretaker quality of life and resilience.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Our overall goal is to investigate if pre-operative interventions can address patients' and patients' care givers quality of life/resilience deficits and thus improve outcomes. This initial pilot study will test the feasibility of offering patients and their care givers prehabilitation interventions prior to complex gastrointestinal surgery such as pancreatectomy, esophagectomy, proctectomy, or hepatectomy.

Study Type

Interventional

Enrollment (Actual)

20

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
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

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 to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

  1. Patients who are being seen for pancreatic, esophageal, rectal or hepatic neoplastic disease, will undergo neo-adjuvant therapy and may require complex GI surgery and their care givers.
  2. Are able and willing to participate in all aspects of the study; and
  3. Have been provided with, understand the 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Preoperative Rehabilitation

Patient & caregiver input regarding 'single biggest concern right now' (modified BEACON buttons) will be elicited. Information gathered by the study team which includes a trained nursing coach and the patient/caregiver will together develop an individualized 'toolbox' of possible interventions to improve preoperative quality of life.

Candidate interventions include, but not limited to: Participation in SMART program, caregiver participation in Caregivers study protocol MC1295 (IRB 13-002943), nutritional recommendations (deficiencies, immuno-nutrition), low impact resistance training/tai chi, referral to financial or counseling services, establishment of information sources & plans for concerns not frequently covered in clinical practice such as sleeplessness, spiritual assistance.
Behavioral: Interventions to improve preop QOL/resilience deficits
Identify patients' and patients' care givers quality of life/resilience deficits and supply information and resources prior to undergoing complex GI surgery.
Other Names:
  • Candidate interventions include, but not limited to:
  • Participate in SMART (Stress Management And Resiliency Training) program
  • Caregiver participation in Caregivers study protocol (IRB 13-002943)
  • Nutritional recommendations (deficiencies, immuno-nutrition)
  • Low impact resistance training/tai chi
  • Referral to financial or counseling services
  • Establish information sources/plans for concerns not frequently covered in clinical practice such as sleeplessness, spiritual assistance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: 3 months post surgical
Primary outcome is the feasibility of the interventions as measured through the end of study feedback form.
3 months post surgical

Collaborators and Investigators

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

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Juliane Bingener-Casey, MD, Mayo Clinic

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

March 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

December 25, 2017

Study Registration Dates

First Submitted

March 6, 2014

First Submitted That Met QC Criteria

March 7, 2014

First Posted (Estimate)

March 10, 2014

Study Record Updates

Last Update Posted (Actual)

February 28, 2018

Last Update Submitted That Met QC Criteria

February 27, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 13-005601

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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