Individualized Preoperative Rehabilitation Pilot

NCT ID: NCT02082223

Last Updated: 2018-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2017-12-25

Brief Summary

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

Detailed Description

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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.

Conditions

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Quality of Life Complex Gastrointestinal Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Interventions to improve preop QOL/resilience deficits

Intervention Type BEHAVIORAL

Identify patients' and patients' care givers quality of life/resilience deficits and supply information and resources prior to undergoing complex GI surgery.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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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.

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Juliane Bingener-Casey

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juliane Bingener-Casey, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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13-005601

Identifier Type: -

Identifier Source: org_study_id

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