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Individualized Preoperative Rehabilitation Pilot (iPREHAB)

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ClinicalTrials.gov Identifier: NCT02082223
Recruitment Status : Completed
First Posted : March 10, 2014
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Juliane Bingener-Casey, Mayo Clinic

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

Condition or disease Intervention/treatment Phase
Quality of Life Complex Gastrointestinal Surgery Behavioral: Interventions to improve preop QOL/resilience deficits Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Individualized Preoperative Rehabilitation (iPREHAB) Pilot
Study Start Date : March 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : December 25, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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.




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082223


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Juliane Bingener-Casey, MD Mayo Clinic
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Responsible Party: Juliane Bingener-Casey, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT02082223    
Other Study ID Numbers: 13-005601
First Posted: March 10, 2014    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Keywords provided by Juliane Bingener-Casey, Mayo Clinic:
Quality of life
Deficits
Complex gastrointestinal surgery