Individualized Preoperative Rehabilitation Pilot (iPREHAB)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02082223|
Recruitment Status : Completed
First Posted : March 10, 2014
Last Update Posted : February 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Quality of Life Complex Gastrointestinal Surgery||Behavioral: Interventions to improve preop QOL/resilience deficits||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|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|
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.
- Feasibility [ Time Frame: 3 months post surgical ]Primary outcome is the feasibility of the interventions as measured through the end of study feedback form.
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
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Juliane Bingener-Casey, MD||Mayo Clinic|