Clinical trial NCT04971083: Patient-centered Nutrition Care II: An E-health Supported Symptom Based Nutrition Intervention
Official title: Intervention Phase: Patient-centered Nutrition Care (PaCC II)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nutritional Status
Psychological Distress
Quality of Life
Weight Change, Body
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: Cankado GmbH
First posted: 2021-07-21
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Stabilization of patient-reported nutrition nutrition status
timeFrame: 12 weeks from baseline
Secondary outcomes:
measure: Number and severity of patient-reported nutrition related symptoms between the groups
timeFrame: 12 weeks from baseline
measure: Weight change
timeFrame: 12 weeks from baseline
measure: Quality of life improvement
timeFrame: 12 weeks from baseline
measure: Improvement of nutrition intake
timeFrame: 12 weeks from baseline
measure: Discontinuations or delay in therapy reduction
timeFrame: 12 weeks from baseline
measure: Inflammation status
timeFrame: 12 weeks from baseline
measure: Distress status
timeFrame: 12 weeks from baseline
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Comprehensive Cancer Center Ludwig Maximilian University Munich
state: Barvaria
Study officials:
affiliation: CCC Ludwig Maximillian University Munich
name: Nicole Erickson, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: CCC Ludwig Maximillian University Munich
name: Julian Holch, PD, MD
role: PRINCIPAL_INVESTIGATOR
References: