Quality of Care of Oncological Patients With HPN (NCT03425435) | Clinical Trial Compass
TerminatedNot Applicable
Quality of Care of Oncological Patients With HPN
Stopped: preterm stop due to low recruitment numbers during and still ongoing pandemic
Germany143 participantsStarted 2018-10-15
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient´s questionnaire
Timeframe: Outcome measures obtained 1, 4 and 12 weeks after discharge from hospital