Tumors and Home Parenteral NutritionVHPE-SNCT03425435
Quality of Care of Oncological Patients With HPN
An observational study of Tumors and Home Parenteral Nutrition, run by Fresenius Kabi at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumors and Home Parenteral Nutrition
- What is being tested?
- QoL and developed questionnaires for healthcare research
- How many people
- 143 participants
- Where
- 1 siteGermany
- Study dates
- 15 Oct 2018to 14 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with solid tumors with indication for home parenteral nutrition.
Who may be able to join
- 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
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- Fluent in German language
- Able to read and write in German language
- Signed patient informed consent form
- Indication for PN
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Tumors and Home Parenteral Nutrition
- Being tested
- QoL and developed questionnaires for healthcare research
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QoL and developed questionnaires for healthcare researchOther
Questionnaires
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient´s questionnaire
Mean changes in total scores of QoL-questionnaire from baseline.
Measured: Outcome measures obtained 1, 4 and 12 weeks after discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start15 Oct 2018
- Primary completion14 Jan 2022
- Study completion14 Jan 2022
Why it stopped: preterm stop due to low recruitment numbers during and still ongoing pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tumors and Home Parenteral NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrea Schneider, Dr. med., Principal investigator, Hannover Medical School, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425435
- Sponsor's protocol ID
- HPNM-001-CNI
- Acronym
- VHPE-S
- Status last verified
- Jan 2022
- First submitted
- 1 Feb 2018
- Last updated
- 1 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39612012
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Care of Oncological Patients With Home Parenteral Nutrition
- ClinicalTrials.gov ID
- NCT03425435
- Acronym / sponsor ID
- VHPE-S / HPNM-001-CNI
- Conditions
- Tumors and Home Parenteral Nutrition
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: preterm stop due to low recruitment numbers during and still ongoing pandemic
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Fresenius KabiIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 14 Jan 2022 (actual)
- Study completion
- 14 Jan 2022 (actual)
- First posted
- 7 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with solid tumors with indication for home parenteral nutrition.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QoL and developed questionnaires for healthcare researchQuestionnaires | Other | – |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: preterm stop due to low recruitment numbers during and still ongoing pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Derived from this study: PubMed 39612012Schneider 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Schneider, Dr. med. principal investigator
Hannover Medical School, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tumors and Home Parenteral Nutrition, run by Fresenius Kabi at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: preterm stop due to low recruitment numbers during and still ongoing pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient´s questionnaire (time frame: Outcome measures obtained 1, 4 and 12 weeks after discharge from hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03425435, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.