Nutritional StatusPaCC IINCT04971083
Patient-centered Nutrition Care II: An E-health Supported Symptom Based Nutrition Intervention
A study testing Intervention Group in people with Nutritional Status and Psychological Distress, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nutritional Status, Psychological Distress, Quality of Life
- What is being tested?
- Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Comprehensive Cancer Center Ludwig Maximilian University Munich
Munich, Barvaria, 81377
About this study
Official title: 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.
Read the 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.
- Being tested
- Intervention Group
- Medical subject headings
- Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupBehavioural
Also called Electronic health information platform with active behavioural tipps
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks from baseline
Secondary outcomes (7)
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.
Measured: 12 weeks from baseline
Weight change
Difference in percent of weight change between the groups
Measured: 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.
Measured: 12 weeks from baseline
Improvement of nutrition intake
% of estimated energy intake
Measured: 12 weeks from baseline
Discontinuations or delay in therapy reduction
no. of discontinuations or delay in therapy
Measured: 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
Measured: 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
Measured: 12 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start1 Jul 2021
- Primary completion28 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Cankado GmbH
- Responsible party
- Principal investigator, PD Dr. med. Volker Heinemann, Ludwig-Maximilians - University of Munich
- Investigators
- Nicole Erickson, M.Sc., Principal investigator, CCC Ludwig Maximillian University MunichJulian Holch, PD, MD, Principal investigator, CCC Ludwig Maximillian University Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971083
- Sponsor's protocol ID
- PaCC II
- Acronym
- PaCC II
- Status last verified
- Jul 2021
- First submitted
- 24 Jun 2021
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Phase: Patient-centered Nutrition Care (PaCC II)
- ClinicalTrials.gov ID
- NCT04971083
- Acronym / sponsor ID
- PaCC II / PaCC II
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- Cankado GmbH
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 28 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Intervention GroupIntervention 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention GroupAlso: Electronic health information platform with active behavioural tippsThis 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. | Behavioural | Intervention Group |
Primary outcome
Stabilization of patient-reported nutrition nutrition status
Time frame: 12 weeks from baseline
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
7 secondary outcomes
Number and severity of patient-reported nutrition related symptoms between the groups
Time frame: 12 weeks from baseline
Weight change
Time frame: 12 weeks from baseline
Quality of life improvement
Time frame: 12 weeks from baseline
Improvement of nutrition intake
Time frame: 12 weeks from baseline
Discontinuations or delay in therapy reduction
Time frame: 12 weeks from baseline
Inflammation status
Time frame: 12 weeks from baseline
Distress status
Time frame: 12 weeks from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Erickson, M.Sc. principal investigator
CCC Ludwig Maximillian University Munich
Julian Holch, PD, MD principal investigator
CCC Ludwig Maximillian University Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Nutritional Status and Psychological Distress, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julian W Holch, PD, MD (089 4400 75246, Julian.Holch@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stabilization of patient-reported nutrition nutrition status (time frame: 12 weeks from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021.