Patients undergoing cancer chemotherapy Patients with heart disease (ischemic heart disease and heart failure)
Conditions
Interventions
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
Sponsors
Institute of Science Tokyo Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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Those who are deemed unsuitable by the attending physician, research supervisor or research staff Those who have withdrawn from the research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactHiromi Mori
Institute of Science Tokyo Hospital Department of Clinical Nutrition
Outcome results
None listed