Patient Empowerment for Major Surgery Preparation @ Home (PAPRIKA)

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.

Study Overview

• Status: Recruiting
• Conditions: Transthoracic Esophagectomy
• Intervention / Treatment: Other: Prehabilitation program

• Study Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

• Study Contact: Name: Wolfgang Schröder, Prof.; Phone Number: +49 221 478-4803; Email: wolfgang.schroeder@uk-koeln.de
• Study Contact Backup: Name: Paul Brinkkötter, Prof.; Email: paul.brinkkoetter@uk-koeln.de

Study Locations

• Germany
  • Cologne, Germany, 59037
    • Recruiting
    • University Hospital of Cologne
    • Contact: Paul Brinkkötter, Prof.; Email: paul.brinkkoetter@uk-koeln.de
    • Contact: Wolfgang Schröder, Prof.; Email: wolfgang.schroeder@uk-koeln.de
    • Principal Investigator: Wolfgang Schröder, Prof.
    • Principal Investigator: Paul Brinkkötter, Prof.
    • Sub-Investigator: Christiane Bruns, Prof.
    • Principal Investigator: Linus Völker, MD
    • Sub-Investigator: Eckhard Schönau, Prof.
    • Sub-Investigator: Michael Faus, MD
    • Sub-Investigator: Heike Güldenhöfer
    • Sub-Investigator: Ruth Hanßen, MD
    • Sub-Investigator: Laura Wobbe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Male and female subjects with planned transthoracic esophagectomy in more than 4 weeks

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prehabilitation; 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; 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.
Historical Cohort; 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?

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

Collaborators and Investigators

• Sponsor: University of Cologne
• Collaborators: Department of General, Visceral, Tumor and Transplant Surgery, University Hospital Of Cologne; Centre for Prevention and Rehabilitation, University Hospital Cologne; Department of Endocrinology, Diabetology and Preventive Medicine
• Investigators: Study Chair: Wolfgang Schröder, Prof., Department of General, Visceral and Transplantational Surgery, University Hospital of Cologne; Principal Investigator: Paul Brinkkötter, Prof., Department of Internal Medicine II, University Hospital of Cologne; Principal Investigator: Linus Völker, MD, Department of Internal Medicine II, University Hospital of Cologne

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: July 22, 2021
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (Actual): December 22, 2021

Study Record Updates

• Last Update Posted (Actual): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 29, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Prevention; Transthoracic esophagectomy
• Other Study ID Numbers: V02-20012021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No