This trial is active, not recruiting.

Conditions quality of life, complex gastrointestinal surgery
Treatment interventions to improve preop qol/resilience deficits
Sponsor Mayo Clinic
Start date March 2014
End date June 2015
Trial size 20 participants
Trial identifier NCT02082223, 13-005601


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose supportive care
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.
interventions to improve preop qol/resilience deficits Candidate interventions include, but not limited to:
Identify patients' and patients' care givers quality of life/resilience deficits and supply information and resources prior to undergoing complex GI surgery.

Primary Outcomes

time frame: 3 months post surgical

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

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.

Additional Information

Official title Individualized Preoperative Rehabilitation (iPREHAB) Pilot
Principal investigator Juliane Bingener-Casey, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.