Completed

NCT Number: NCT05167682

Patient Empowerment for Major Surgery Preparation @ Home

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.

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Key information

Conditions

Transthoracic Esophagectomy

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Cologne

Cologne, 59037, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

Compliance of patients as feasibility of prehabilitation program

Time frame: 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 outcomes

Postoperative outcome

Time frame: 90 days after surgery

Postoperative outcome will be measured with occurrence of postoperative and patient-centric complications.

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Collaborators

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

Registry information

Acronym: PAPRIKA

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2024
First posted: Dec 22, 2021
Registry last updated: Jun 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.