MDASI Early-Phase Trials (Immunotherapy) Module
The MD Anderson Symptom Inventory for early-phase (immunotherapy) trials (MDASI-EPT) is a treatment-specific MDASI module. Use the MDASI-EPT to assess the severity of symptoms experienced by patients participating in early-phase (immunotherapy) trials and the interference with daily living caused by these symptoms.
Along with the core MDASI’s 13 symptom items and 6 interference items, the MDASI-EPT also assesses 7 symptoms relevant to early-phase (immunotherapy) trials.
| Core MDASI Symptoms | Early-Phase Trial Symptoms | MDASI Interference |
|---|---|---|
| Pain | Diarrhea | Relations with other people |
| Fatigue | Abdominal pain | Enjoyment of life |
| Nausea | Rash or skin change | Mood |
| Disturbed sleep | Headache | Walking |
| Distress (feeling upset) | Night sweats | Activity |
| Shortness of breath | Swelling in hands, legs, or feet | Work (including housework) |
| Difficulty remembering | Fever or chills | |
| Lack of appetite | ||
| Drowsiness | ||
| Dry mouth | ||
| Sadness | ||
| Vomiting | ||
| Numbness/tingling |
Order the MDASI-EPT
Use our convenient online form to order the MDASI-EPT for use in your clinical research, clinical practice, funded and non-funded academic research, commercial research, or reproduction in educational materials or other publications.
MDASI-EPT Features
- Purpose: To assess the severity of multiple early-phase (immunotherapy) trial symptoms and the impact of these symptoms on daily functioning
- Population: Patients with symptoms related to participation in early-phase trials (immunotherapy)
- Assessment areas: Severity of multiple symptoms and the impact of symptoms on daily functioning during the last 24 hours
- Method: Self-report or interview with research staff; paper-and-pencil or electronic data entry*
- Time required: Five minutes or less
- Scoring: Please see the MDASI User Guide
- Reliability: Cronbach alpha reliability ranges from 0.88 to 0.95
*Electronic data capture offers several benefits:
- Allows symptom monitoring when the patient is away from the hospital
- Is convenient for patients, who can choose web access, personalized patient portals, or smartphones to access questionnaires
- Minimizes missing data, especially in longitudinal studies
- Provides accurate, real-time symptom data at expected time points
- Generates immediate feedback, potentially allowing caregivers to address severe symptoms more effectively
MDASI-EPT Language Versions
Click on a linked language to view a sample in PDF format.
Don't see a language you need? Contact us at symptomresearch@mdanderson.org.
| Psychometrically and Linguistically Validated | Linguistically Validated |
|---|---|
| English | Spanish |
MDASI User Guide
In response to the US Food and Drug Administration's 2009 guidance for the pharmaceutical industry on the use of patient-reported outcomes measures in medical product development to support labeling claims, we have prepared a MDASI User Guide to document the development and psychometric properties of the MDASI and its modules. The User Guide addresses the recommendations in the FDA guidance and establishes the MDASI's adequacy as a measure to support medical product claims.
Selected MDASI-EPT References
Validation
Mendoza T, Sheshadri A, Altan M, et al. Evaluating the psychometric properties of the Immunotherapy module of the MD Anderson Symptom Inventory. J Immunother Cancer 8(2):e000931, 2020.
Wu X, Xie J, Lin X, et al. Translation and validation of Chinese version of MDASI immunotherapy for early-phase trials module: a cross-sectional study. BMC Nurs 22(1):176, 2023.
Cleeland CS, Mendoza TR, Wang XS, et al. Assessing symptom distress in cancer: the M. D. Anderson Symptom Inventory. Cancer 89:1634-1646, 2000.
Clinical Application
Mendoza TR, Hong DS, Peterson CB, et al. Patient-reported symptom burden in patients with rare cancers receiving pembrolizumab in a phase II Clinical Trial. Sci Rep 12(1):14367, 2022.
Every MDASI module contains:
all 13 core MDASI symptoms...
pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, difficulty remembering, lack of appetite, drowsiness, dry mouth, sadness, vomiting, numbness/tingling
...and all 6 MDASI interference items
general activity, mood, work, relations with others, walking, enjoyment of life
Newer cancer treatments such as immunotherapies disrupt the immune balance and aggravate the severity of symptoms and toxic adverse events. Using the MDASI-EPT, a patient-reported outcomes measure, is helping us more accurately assess such symptoms and toxicities and better monitor change in patient status.
Aung Naing, M.D.
Professor, Investigational Cancer Therapeutics