Patient Empowerment for Major Surgery Preparation @ Home

Completed

• Conditions: Transthoracic Esophagectomy
• Interventions: Other: Prehabilitation program

• Registration Number: NCT05167682
• Lead Sponsor: University of Cologne

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-01
• Study First Submitted: 2021-07-22
• Study First Submitted QC: 2021-12-09
• Study First Posted: 2021-12-22
• Primary Completion: 2024-03-20
• Study Completion: 2024-03-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prehabilitation	Prehabilitation program	25 patients scheduled for tumor-esophagectomy (Ivor-Lewis) who are capable and have given consent to participate in a smartphone-based prehabilitation program.

Primary Outcome Measures

Name	Time	Method
Compliance of patients as feasibility of prehabilitation program	90 days after surgery	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

Secondary Outcome Measures

Name	Time	Method
Postoperative outcome	90 days after surgery	Postoperative outcome will be measured with occurrence of postoperative and patient-centric complications.

Trial Locations

Locations (1)

University Hospital of Cologne; 🇩🇪 Cologne, Germany