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

NCT ID: NCT04971083

Last Updated: 2021-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2023-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: ACTIVE_COMPARATOR

Intervention Group

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Electronic health information platform with active behavioural tipps

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cankado GmbH

INDUSTRY

Sponsor Role: collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role: lead

Responsible Party

PD Dr. med. Volker Heinemann

Professor Doktor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicole Erickson, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

CCC Ludwig Maximillian University Munich

Julian Holch, PD, MD

Role: PRINCIPAL_INVESTIGATOR

CCC Ludwig Maximillian University Munich

Locations

Comprehensive Cancer Center Ludwig Maximilian University Munich

Munich, Barvaria, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Julian W Holch, PD, MD

Role: CONTACT

Julian.Holch@med.uni-muenchen.de

089 4400 75246

Nicole Erickson, M.Sc.

Role: CONTACT

nicole.erickson@med.uni-muenchen.de

089 4400 75246

Other Identifiers

PaCC II

Identifier Type: -

Identifier Source: org_study_id