Patient Empowerment for Major Surgery Preparation @ Home

Study Overview
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Brief Summary
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The PAPRIKA project is a feasibility study with duration of 10 months. The aim of the study is to recruit 25 patients over the age of 65 who will undergo tumor-related esophagectomy and will follow a prehabilitation program to prevent postoperative complications and improve patient-centric complications and patient-centered outcomes. After determination of the oncologic treatment plan in the tumor board and functional assessment, patient will undergo an interdisciplinary assessment , which will be performed by the PAPRIKA team consisting of physiotherapists, internists/geriatricians, speech and occupational therapists, nutritionists and surgeons. On the basis of this interdisciplinary assessment an individualized catalog of procedures will be created. Patient have to follow to this catalog of procedures until surgery. Procedures catalog contains behavioral changes, physical training, nutritional counseling, conditioning of pulmonary function and optimization of drug treatment of underlying diseases. The individual treatments will be weekly reevaluated and if necessary the procedures will be adjusted by treatment teams. The prehabilitation procedures will be communicated with the patient via a smartphone app, which is specially developed for the prehabilitation program. The implementation will be documented. The primary aim of this study is to evaluate the compliance of the patients regarding to the prescribed procedures and the use of the smartphone app (feasibility). As secondary aim postoperative outcome will be compared with the results of a historical cohort for quality control.

Official Title
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Patient Empowerment for Major Surgery Preparation @ Home

Conditions
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Transthoracic Esophagectomy

Intervention / Treatment
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* Other: Prehabilitation program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients ,undergoing transthoracic esophagectomy (Ivor Lewis), in ≥ 4 weeks Age >65 years American Society of Anaesthesiologists - Score: 2-3 Ability to give informed consent Written informed consent Exclusion Criteria: Planned operation in less than 4 weeks after enrollment Urgent surgery indication Patients with good to excellent general and nutritional condition (0 points in the pre-screening of the modified NRS OR 1 point in the pre-screening and <2 points in the main screening). Patients deemed by the PAPRIKA team to be physically or mentally incapable of completing the exercise program.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prehabilitation<br>25 patients scheduled for tumor-esophagectomy (Ivor-Lewis) who are capable and have given consent to participate in a smartphone-based prehabilitation program. | Other: Prehabilitation program<br>* Patient will be asked to follow to catalog of procedures till surgery. Procedures catalog contains behavioral changes, physical training, nutritional counseling, conditioning of pulmonary function and optimization of drug of underlying diseases.<br>|
| Historical Cohort<br>Patients ≥ 65 years of age who have undergone tumor-related esophagectomy at the University Hospital of Cologne between 05/2016 and 04/2020, who have not participated in any form of prehabilitation procedures | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance of patients as feasibility of prehabilitation program | Percentage of patients will be assessed, who have successfully completed all study visits and have installed and used the smart phone app at least once | 90 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative outcome | Postoperative outcome will be measured with occurrence of postoperative and patient-centric complications. | 90 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transthoracic esophagectomy, Prevention