Quality of Care of Oncological Patients With HPN (VHPE-S)

January 17, 2022 updated by: Fresenius Kabi

Quality of Care of Oncological Patients With Home Parenteral Nutrition

Medical care for patients with home parenteral nutrition (HPN) is challenging. Among other aspects, the transition from the inpatient to the outpatient setting (discharge management), the organization of HPN at home or in a care facility (care management), the expertise required to care for patients with HPN and consistent compliance with standards are key to the quality of care for patients requiring HPN.

Hospital patients on parenteral nutrition (PN) to be continued at home are often discharged at very short notice. A good interlocking of all players is required to collect and distribute the relevant information, to secure proper training for those involved and to have all utilities and equipment at hand when the patient arrives.

This study collects nutritional and clinical parameters (including patient-reported parameters) along the continuum of care of HPN patients to evaluate the impact of the quality of care of HPN patients on their quality of life.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The HPN management will be evaluated by using a self-developed patient and a standardized quality of life questionnaire.

Patients will be recruited at the participating hospital by their treating physician before discharge and will continue their study participation after discharge.

The documentation period for the individual patients will be 3 months.

The questions of the patient´s questionnaire cover areas of interest like: satisfaction with discharge management, nutrition, satisfaction with HPN.

Study Type

Observational

Enrollment (Actual)

143

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hannover, Germany, 30623
        • Medizinische Hochschule Hannover

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with solid tumors with indication for home parenteral nutrition.

Description

Inclusion Criteria:

  • Men and women with an initial prescription for HPN during the current hospital stay
  • Planned PN must at least contain the macronutrients glucose and amino acids.
  • Solid, malignant tumor
  • Anticipated duration of the HPN is at least 28 days
  • Age ≥18 years
  • Full legal capacity or legal guardian available
  • Fluent in German language
  • Able to read and write in German language
  • Signed patient informed consent form
  • Indication for PN

Exclusion Criteria:

  • Contraindication for PN
  • ECOG performance status >3
  • Pregnant and breast-feeding women
  • Concurrent participation in another clinical study that requires deviations from the hospital's routine PN, nutrition and/or nursing procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient´s questionnaire
Time Frame: Outcome measures obtained 1, 4 and 12 weeks after discharge from hospital
Mean changes in total scores of QoL-questionnaire from baseline.
Outcome measures obtained 1, 4 and 12 weeks after discharge from hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fresenius Kabi

Investigators

  • Principal Investigator: Andrea Schneider, Dr. med., Hannover Medical School, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2018

Primary Completion (Actual)

January 14, 2022

Study Completion (Actual)

January 14, 2022

Study Registration Dates

First Submitted

February 1, 2018

First Submitted That Met QC Criteria

February 1, 2018

First Posted (Actual)

February 7, 2018

Study Record Updates

Last Update Posted (Actual)

February 1, 2022

Last Update Submitted That Met QC Criteria

January 17, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • HPNM-001-CNI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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