UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057363 |
|---|---|
| Receipt number | R000065428 |
| Scientific Title | Investigation of the effects of nutritional guidance and nutritional therapy interventions using patient-reported outcomes (PRO) |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/03/22 14:24:26 |
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Basic information
Public title
Survey on the effects of nutritional guidance and nutritional therapy based on patient evaluation
Acronym
POR-POMS test
Scientific Title
Investigation of the effects of nutritional guidance and nutritional therapy interventions using patient-reported outcomes (PRO)
Scientific Title:Acronym
POR-POMS test
Region
| Japan |
Condition
Condition
Patients undergoing cancer chemotherapy
Patients with heart disease (ischemic heart disease and heart failure)
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Cardiology |
| Hematology and clinical oncology | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Vascular surgery | Breast surgery | Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Cachexia, which is considered to be the end-stage manifestation of malnutrition, is linked to a decline in the quality of life and treatment response rates of cancer patients, as well as a worsening of their prognosis. Cachexia is a metabolic disorder syndrome that is resistant to treatment and difficult to improve with conventional nutritional support, and early nutritional therapy from pre-cachexia is also recommended in various disease treatment guidelines.
In Japanese cancer treatment, too, the need for early nutritional therapy to improve treatment response rates has been recognised, and the participation of specialist clinical dietitians in cancer nutritional management in treatment has become a requirement.
While nutritional therapy in cancer treatment has been reported to have positive effects such as improving nutritional intake, alleviating adverse events, and relieving anxiety about food, there have also been negative reports, such as a lack of awareness among patients and their families about the prevention of cachexia and doubts about the effectiveness of nutritional therapy. It is necessary for patients and their families to have a correct understanding of nutritional therapy so that they do not miss the opportunity for early intervention.
In recent years, there has been an emphasis on treatment plans based on patient-reported outcomes (PRO), but there are reports of the risk that many studies are based mainly on objective assessments by medical professionals, and that the patients' subjective views are not being properly reflected. This is also the case with research reports on cancer nutrition therapy to date, and while nutrition therapy is being given more importance, there is no concept of intervention based on PRO.
In this study, we will use PROs to examine the intervention effects of nutritional therapy on patients and consider the ideal form of nutritional therapy sought by cancer patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
PRO surveys will be conducted on the target patients over time using the Profile of Mood States (POMS2).
The target patients will be outpatients undergoing cancer chemotherapy, and outpatient nutritional guidance will be provided once a month for a total of three times (over a three-month period).
The POMS2 will be administered three times in total, before the nutritional guidance intervention and after the first and third nutritional guidance sessions, and the results will be collected and analysed.
The POMS2 is a mood scale evaluation method that can measure temporary mood and emotional states that change depending on the conditions of the subject, and simultaneously assesses six mood scales: Tension-Anxiety (TA), Depression-Dejection (DD), Anger-Hostility (AH), Vigor/Vigor-Activity (VA), Fatigue/Fatigue-Inertia (FI), and Confusion-Bewilderment (CB), and the total of the raw scores for these six factors is used to calculate the Total Mood Disturbance (TMD), which takes into account mood disorders, emotional or psychological distress, and subjective well-being.
Patients are asked to respond to 65 items related to the aforementioned mood scales using a 5-point Likert scale, and the scores for these items are added together to give the raw score for each scale. Since the upper and lower limits of the raw scores for each scale are different, the raw scores are converted into T-scores (standardised scores) for evaluation. T-scores are scores with a mean of 50 and a standard deviation of 10, and are set for each age group, so the scores for the subject's age are used.
The POMS2 is a tool for assessing a wide range of mood states, and it has evidence of its usefulness in research and clinical settings as a test that can assess relatively long-lasting emotional states and transient emotions that fluctuate and change, and it is used in various fields.
Key secondary outcomes
As a secondary outcome evaluation item, 1)in order to see the impact of psychological changes on symptoms associated with cancer treatment, the Edmonton Symptom Assessment System Revised Japanese version (ESAS-r-J) (an internationally standardised cancer symptom assessment tool that has also been validated in the Japanese version) (assessing pain, fatigue, sleepiness, nausea, loss of appetite, breathlessness, depression, anxiety, and overall condition) will be used to assess the patients at each nutrition guidance session (a total of three times).
2)In order to verify whether there are differences in psychological changes due to differences in the nutritional guidance policy, the POMS2 survey will also be conducted on patients with heart disease (ischemic heart disease and heart failure) who are undergoing restrictive dietary therapy, as with cancer, and who are at risk of developing cachexia as their condition progresses.
3)Other items include objective nutritional indicators (malnutrition diagnostic criteria (Global Leadership Initiative on Malnutrition: GLIM), blood and urine test data, physical measurements, food frequency questionnaires (FFQ), nutritional intake), nutritional guidance records, and basic patient information (medical history, comorbidities/past medical history, treatment history, family structure, living environment, financial situation, food preferences, activities of daily living (ADL), and prescription drug information.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
The target number of patients is 100 (breakdown: 50 outpatients undergoing cancer chemotherapy, 50 patients with heart disease (ischemic heart disease and heart failure) who are at risk of developing cachexia as their condition progresses, and who are on a restrictive diet), and outpatient nutritional guidance will be provided once a month for a total of three times (over a three-month period).
The POMS2 will be administered a total of three times, before the nutritional guidance intervention, the first time, and after the third nutritional guidance session, and will be collected and analysed.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
No history of nutritional guidance within the past six months
Cancer patients (regardless of cancer type or stage) undergoing outpatient drug therapy that carries a risk of adverse events related to appetite or food intake
Patients with cachexia or at risk of cachexia
Outpatient cancer patients undergoing treatment at Institute of Science Tokyo Hospital and for whom their doctor has requested nutritional guidance for cancer chemotherapy
Patients with heart disease who are undergoing outpatient treatment at Institute of Science Tokyo Hospital and have been instructed by their doctor to receive outpatient nutritional guidance (regardless of the stage of ischemic heart disease or heart failure (regardless of the stage of heart failure as classified by the New York Heart Association (NYHA) or the American College of Cardiology Foundation/American Heart Association (ACCF/AHA) classification system))
Those who are 20 years of age or older at the time of obtaining consent
Those who have given written consent to participate in the study
Key exclusion criteria
Those who did not give consent for the research (Nutritional guidance will be carried out as ordered by the doctor)
Those who are deemed unsuitable by the attending physician, research supervisor or research staff
Those who have withdrawn from the research
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Hamamoto |
Organization
Institute of Science Tokyo Hospital
Division name
Department of Medical Oncology
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5391
hamamoto.yasuo@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Hiromi |
| Middle name | |
| Last name | Mori |
Organization
Institute of Science Tokyo Hospital
Division name
Department of Clinical Nutrition
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5133
Homepage URL
https://reins.tmd.ac.jp/html/research_home_ja.html
mori.hiromi@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo Hospital
Institute
Department
Personal name
Hiromi Mori
Funding Source
Organization
Tokyo Kasei University Graduate School of Humanities and Life Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute of Science Tokyo Hospital
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
Tel
03-5803-4547
rinri.adm@tmd.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京科学大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 22 | Day |
Last modified on
| 2025 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065428
