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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Nutritional Status; Psychological Distress; Weight Change, Body
• Intervention / Treatment: Behavioral: Intervention Group

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 115
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julian W Holch, PD, MD; Phone Number: 089 4400 75246; Email: Julian.Holch@med.uni-muenchen.de
• Study Contact Backup: Name: Nicole Erickson, M.Sc.; Phone Number: 089 4400 75246; Email: nicole.erickson@med.uni-muenchen.de

Study Locations

• Germany
  • Barvaria
    • Munich, Barvaria, Germany, 81377
      • Recruiting
      • Comprehensive Cancer Center Ludwig Maximilian University Munich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Cancer patients with tumors in the GI tract undergoing chemo and/or Immunotherapy and are primarily treated on an outpatient basis
• ≥ 18 years
• Life expectancy ≥ 6 months
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
• Open for, and ability to use, of E-Health platforms (own and uses one or more electronic devices with access to internet)
• Able to take 75% of foods orally
• Valid declaration of consent to participate in the study

Exclusion Criteria:

• Cancer patients with other diagnoses or who are not receiving chemo or Immunotherapy or undergoing intensive therapy requiring longer in-patient stays (e.g: Intensive Care Patients)
• ≤ 18 years
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≥3
• More than 75% of Energy intake is not taken oral but instead via enteral or parenteral route.
• Operation planned during the course of the Study (next 3 months)
• Patient who do provide not or withdraw their consent
• Not open or willing to use E-Health tools

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Control (CG): receives Usual Care. Observational data regarding energy and fluid intake, weight, quality of life, symptoms, and distress status will be recorded in the Electronic Health Platform. They will have to ability to print and share this documentation with their HCP at their own discretion. Inflammation status will be recorded when data from routine blood draws is available
Active Comparator: Intervention Group; Intervention Group (IG): The intervention consists of a built-in automated analysis that provide patient-tailored nutrition recommendations and behavioural tipps. Described in detail this means that dependent on the severity of the nutrition related symptom burden (NRSB) recorded, the patients in the intervention group only are, for example provided with detailed written nutrition information and cooking recipes and/or asked to discuss the symptoms with their health care provider, dietitian, and/or physician, or even asked to seek immediate medical care. Analog to the control group, observational data regarding energy and fluid intake, weight, quality of life, symptoms, and distress status will be recorded in the Electronic Health Platform. They will have to ability to print and share this documentation with their HCP at their own discretion. Inflammation status will be recorded when data from routine blood draws is available	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.; Other Names: Electronic health information platform with active behavioural tipps

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stabilization of patient-reported nutrition nutrition status	A automated analysis embedded in the E-health tool will provide patient-tailored nutrition information and behavior advice aimed at stabilizing or improving nutrition status. Nutrition status will be measured using the scored Patient-Generated Subjective Global Assessment (scale of 1-36) whereas a higher score indicates a declining nutrition status	12 weeks from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and severity of patient-reported nutrition related symptoms between the groups	Difference of the number and severity of patient-reported nutrition related 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. 13 Symptoms will be measured for frequency and severity.	12 weeks from baseline
Weight change	Difference in percent of weight change between the groups	12 weeks from baseline
Quality of life improvement	Improvement of Quality of life as measured by the Functional Assessment of Cancer Therapy - General (FAKT-G) questionnaire. According the scale of 0-108 the higher the score, the better the QOL.	12 weeks from baseline
Improvement of nutrition intake	% of estimated energy intake	12 weeks from baseline
Discontinuations or delay in therapy reduction	no. of discontinuations or delay in therapy	12 weeks from baseline
Inflammation status	change in Glasgow Prognostic Score on a scale of 0-2 (only when C-reactive Protein und Albumin are available in the routine blood draw). A higher score indicates more inflammation	12 weeks from baseline
Distress status	change in Distress state measured by Distress Thermometer on a scale of 1-10. A higher the score indicates more Distress	12 weeks from baseline

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich
• Collaborators: Cankado GmbH
• Investigators: Principal Investigator: Nicole Erickson, M.Sc., CCC Ludwig Maximillian University Munich; Principal Investigator: Julian Holch, PD, MD, CCC Ludwig Maximillian University Munich

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Anticipated): December 28, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: June 24, 2021
• First Submitted That Met QC Criteria: July 12, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 12, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes
• Other Study ID Numbers: PaCC II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No