Patient Empowerment for Major Surgery Preparation @ Home

NCT05167682 | Completed

• 1 other identifier: V02-20012021
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Transthoracic Esophagectomy

Keywords

Transthoracic esophagectomy; Prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postoperative outcome

  90 days after surgery

Study Arms (2)

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

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

Interventions

Prehabilitation program OTHER

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.

Prehabilitation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cologne: lead
• Department of General, Visceral, Tumor and Transplant Surgery, University Hospital Of Cologne: collaborator
• Centre for Prevention and Rehabilitation, University Hospital Cologne: collaborator
• Department of Endocrinology, Diabetology and Preventive Medicine: collaborator

Study Sites (1)

University Hospital of Cologne

Cologne, 59037, Germany

Location

Study Officials

• Wolfgang Schröder, Prof.

  Department of General, Visceral and Transplantational Surgery, University Hospital of Cologne

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. MD, Consultant in Nephrology

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: December 22, 2021
• Study Start: July 1, 2021
• Primary Completion: March 20, 2024
• Study Completion: March 31, 2024
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)