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

Quality of Life Clinical Trial

Official title: Intervention Phase: Patient-centered Nutrition Care (PaCC II)

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Primary Endpoint:

Nutrition care, augmented with E-Health tools containing tailored behavioural tipps enable the maintenance of overall nutrition status 12 weeks from baseline as measured with the Scored Patient-Generated Subjective Global Assessment. .

Secondary Endpoints will include:

• difference in the two arms in % weight loss

• difference in the number and severity of further Patient Reported nutrition relation symptoms according to Patient Reported- Common Toxicity Criteria for adverse events (PRO-CTCAE™) developed by the Division of Cancer Control and Population Sciences in the National Cancer Institute Version date: 2/25/2019

• change in Quality of Life as measured by Functional Assessment of Cancer Therapy - General questionnaire

• improvement of nutrition status

• change in the % of estimated energy intake achieved

• difference of the number of discontinuations or delay in therapy

• difference of Glasgow Prognostic Score (only when C-reactive protein und Albumin are available in the routine blood draw)

• change in Distress status

Study Design:

This mono-centric prospective randomized study is designed to test the hypothesis of a causal pathway between nutritional interventions containing tailored behavioural tipps augmented with E-health tools on predefined outcomes (nutrition status, weight loss, extent and severity of nutrition related symptom burden (NRSB), distress status QoL) The study will utilize E-Health tools to ensure regular and early identification of potential nutrition related symptoms on the part of both the patient and the clinician. Within this framework, the trial will include cancer patients with tumors in the GI tract undergoing chemo and/or immune therapy who will receive therapy for a minimum of six weeks after recruitment.

Study Methods:

Control (CG): receives Usual Care (Nutrition intervention according to house standards:

Nutrition Risk Score ≥ 3, or patient, or clinician request). Additionally, patients will record their energy intake, weight, general state of being, symptoms, and distress status in the Electronic Health Platform (EHIP) and have to ability to print and share this documentation with their health care providers (HCP) at their own discretion.

Intervention Group (IG): analog to the control group, patients record their energy intake, weight, general state of being, symptoms, and distress status in the Electronic Health Platform (EHIP). A built-in automated analysis will provide patient-tailored nutrition recommendations. Dependent on the severity of the NRSB recorded, they are, for example, provided with detailed written nutrition information and cooking recipes aimed at and/or asked to discuss their symptoms with their dietitian, physician, or, if necessary, to seek immediate medical care. As in the control group, patients will also have the ability to print and share this documentation with their HCP at their own discretion. ;

Related Conditions & MeSH terms

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

• NCT number: NCT04971083
• Study type: Interventional
• Source: Ludwig-Maximilians - University of Munich
• Contact: Julian W Holch, PD, MD
• Phone: 089 4400 75246
• Email: Julian.Holch@med.uni-muenchen.de
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Completion date: December 31, 2023