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OpenTrials
Completed

NCT Number: NCT02082223

Individualized Preoperative Rehabilitation Pilot

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

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Key information

Conditions

Quality of Life Complex Gastrointestinal Surgery

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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.
  • Are able and willing to participate in all aspects of the study; and
  • Have been provided with, understand the consent.

Treatment and study plan

Interventions to improve preop QOL/resilience deficits

Behavioral

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.

Primary outcomes

  1. Feasibility

    Time frame: 3 months post surgical

    Primary outcome is the feasibility of the interventions as measured through the end of study feedback form.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Individualized Preoperative Rehabilitation (iPREHAB) Pilot

Acronym: iPREHAB

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Mar 10, 2014
Registry last updated
Feb 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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