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

NCT04971083 | Unknown

• 1 other identifier: PaCC II
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number and severity of patient-reported nutrition related symptoms between the groups

  12 weeks from baseline

• Weight change

  12 weeks from baseline

• Quality of life improvement

  12 weeks from baseline

• Improvement of nutrition intake

  12 weeks from baseline

• Discontinuations or delay in therapy reduction

  12 weeks from baseline

Study Arms (2)

Usual Care

NO INTERVENTION

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

Intervention Group

ACTIVE COMPARATOR

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

Interventions

Intervention Group 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.

Also known as: Electronic health information platform with active behavioural tipps

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead
• Cankado GmbH: collaborator

Study Sites (1)

Comprehensive Cancer Center Ludwig Maximilian University Munich

Munich, Barvaria, 81377, Germany

RECRUITING

MeSH Terms

Conditions

Body Weight Changes

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicole Erickson, M.Sc.

  CCC Ludwig Maximillian University Munich

  PRINCIPAL INVESTIGATOR

• Julian Holch, PD, MD

  CCC Ludwig Maximillian University Munich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julian W Holch, PD, MD

CONTACT

089 4400 75246; Julian.Holch@med.uni-muenchen.de

Nicole Erickson, M.Sc.

CONTACT

089 4400 75246; nicole.erickson@med.uni-muenchen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doktor

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 21, 2021
• Study Start: July 1, 2021
• Primary Completion: December 28, 2023
• Study Completion: December 31, 2023
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)