Quality of Care of Oncological Patients With HPN

NCT ID: NCT03425435

Last Updated: 2022-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

143 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-15

Study Completion Date

2022-01-14

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Tumors and Home Parenteral Nutrition

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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QoL and developed questionnaires for healthcare research

Questionnaires

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fresenius Kabi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrea Schneider, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School, Germany

Locations

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Medizinische Hochschule Hannover

Hanover, , Germany

Site Status

Countries

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Germany

References

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Schneider A, Baur C, Zopf Y, Torok HP, Sina C, Prinz C, Monnich H, Madisch A, Maluck-Scholecke S, Rotzer I, Seipt C, Gotte A, Beer J, Jager E. Quality of care of oncological patients with home parenteral nutrition. Support Care Cancer. 2024 Nov 29;32(12):834. doi: 10.1007/s00520-024-09011-2.

Reference Type DERIVED
PMID: 39612012 (View on PubMed)

Other Identifiers

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HPNM-001-CNI

Identifier Type: -

Identifier Source: org_study_id

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