Thirteen items about tiredness and its effect on daily life over the past seven days, scored 0 to 52 where higher means less fatigue. Used across oncology, rheumatology, haematology and autoimmune trials. Build it with your licensed wording and licence details on the form.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Week 12 total
38 / 52
At a glance
In trials
Fatigue is one of the most burdensome symptoms of cancer and its treatment, of anaemia, and of chronic inflammatory diseases such as rheumatoid arthritis and lupus. It is also a common side effect. FACIT-Fatigue is short, well validated across these populations, and available in many languages, which is why it appears as a secondary endpoint in so many trials.
Because higher scores mean less fatigue, direction is the most common source of reporting errors. Label the direction clearly in the analysis plan and data dictionary, and make sure reverse scoring is applied exactly once.
FACIT scoring guidance allows a prorated score when more than half of the items are answered. On an electronic form, requiring every item avoids the problem, but agree the rule in the analysis plan either way.
FACIT-Fatigue · Week 12
Past 7 days · approved licensed version
Item 1
HI7Scoring
| Step | What happens |
|---|---|
| 1 | Each item is answered 0 to 4 for the past seven days. |
| 2 | Negatively worded items are reversed (4 minus the response); the two positively worded items are not. |
| 3 | Item scores are summed. |
| 4 | If some items are missing, the sum is prorated: sum × 13 ÷ items answered, when more than half are answered. |
| 5 | The result, 0 to 52, is reported with higher scores meaning less fatigue. |
Follow the official FACIT scoring guidelines supplied with your licence.
In Capture
Each licensed form records the licence number, licence holder and expiry. If the licence lapses, new collection is blocked. Participants complete the questionnaire on their own phone with reminders, and raw item values export with labels so scoring can be applied once, in analysis.
Copyright & licence
Approval pendingLicence number
Not recorded
Expiry date
Not recorded
Watermark shown to staff only. Participants never see it.
Record the licence details and test it on your phone.
Populations
General population averages sit in the low 40s, while people with cancer or inflammatory disease often score in the 20s or 30s. A cut-off around 30 has been used to identify clinically significant fatigue in some cancer populations, but thresholds are not universal. Use population-specific reference data and anchor-based estimates when defining responders.
In lupus, rheumatoid arthritis and anaemia trials, fatigue often improves alongside disease activity or haemoglobin, so it is worth analysing FACIT-Fatigue next to the clinical measures it depends on. See EDC for lupus and autoimmune trials.
Alternatives include PROMIS fatigue short forms and disease-specific fatigue scales. PROMIS Fatigue 8a is in Capture's library with licence tracking. Choose based on comparator data in your indication, and avoid collecting two fatigue measures without a clear reason for each.
Before go-live
Through FACIT.org; details recorded on the form.
Higher scores mean less fatigue.
Applied once, in analysis, per the guidelines.
Proration rule or all items required.
Weekly or at visits, matching the seven-day recall.
Supplied under the licence.
Yes. It is a self-report questionnaire suited to completion on the participant's own phone, scheduled to its seven-day recall.
Yes. It is widely used in conditions such as rheumatoid arthritis, lupus and anaemia.
Thirteen items rated 0 to 4 are reverse scored where needed and summed for a total of 0 to 52. Higher scores mean less fatigue.
About 3 to 4 points is commonly cited, though estimates vary by condition.
Use requires a licence agreement through FACIT.org. Terms depend on the type of use.
The past seven days.
FACIT-F combines the 27-item FACT-G with the 13 fatigue items. FACIT-Fatigue is the 13-item scale on its own.
Raw item values are stored with labels, and scoring rules are applied in analysis.
Licensed instruments with licence control. Free sandbox.