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Patient-centered Nutrition Care II: An E-health Supported Symptom Based Nutrition Intervention

NCT04971083 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2021-07-21

No results posted yet for this study

Summary

The aim of this study is to utilize the E-Health platform (EHIP) containing behavioural tipps to enable the provision of early appropriate nutrition recommendations to patients undergoing cancer therapy thereby stabilizing the nutrition status as measured with the scored Patient-Generated Subjective Global Assessment. Furthermore, we plan to explore the causal pathway between the change in the number and severity of nutrition related symptoms, measure the difference in weight change in percent between the two groups, determine a change in the level of the distress status, and measure the change in functional status. This Information could provide a basis for future nutrition intervention strategies aimed at improving overall nutrition status of patients undergoing cancer therapy and could potentially improve clinical and functional outcomes of this population.

Conditions

  • Nutritional Status
  • Psychological Distress
  • Quality of Life
  • Weight Change, Body

Interventions

BEHAVIORAL

Intervention Group

This study is designed to provide patients a tool with which they can record the nutrition related symptom burden (NRSB) they are experiencing in real time. A pre-defined algorithm then provides them with tailored nutrition information and behavioural tipps based on the severity grade of the symptom recorded. The aim is to increase the chances that such symptoms, when clinically relevant, are addressed in a timely matter and thus the nutrition status is stabilized.

Sponsors & Collaborators

  • Cankado GmbH

    collaborator INDUSTRY

  • Ludwig-Maximilians - University of Munich

    lead OTHER

Principal Investigators

  • Nicole Erickson, M.Sc. · CCC Ludwig Maximillian University Munich

  • Julian Holch, PD, MD · CCC Ludwig Maximillian University Munich

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2023-12-28
Completion
2023-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04971083 on ClinicalTrials.gov