Twenty-seven items in four well-being subscales, each rated 0 to 4 over the past seven days. The FACT-G is the core of a family of cancer-specific questionnaires, from FACT-B for breast cancer to FACT-L for lung cancer.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Total (0 to 108)
74
Change from baseline
+6
Items answered
27/27
At a glance
In trials
Cancer trials usually choose one of two families of quality of life questionnaires: the FACT system or the EORTC system. Both are well validated. The FACT-G is organised around four dimensions of well-being and is widely used in North America; the EORTC QLQ-C30 has functional scales and symptom scales and is common in European trials. Many sponsors choose based on previous trials in the indication, so results can be compared.
Once chosen, add the disease-specific module rather than a second general questionnaire. A breast cancer trial using FACT-B gets the FACT-G plus breast cancer concerns in one instrument, with scores for each subscale, the total and the TOI.
Report subscales as well as the total. A treatment may improve physical well-being while emotional well-being is unchanged, and the total alone hides that. Pre-specify which score is primary.
FACT-G · Cycle 4
Physical well-being · past 7 days
Item GP1
GP1Structure
| Subscale | Items | Score range |
|---|---|---|
| Physical well-being (PWB) | 7 | 0 to 28 |
| Social/family well-being (SWB) | 7 | 0 to 28 |
| Emotional well-being (EWB) | 6 | 0 to 24 |
| Functional well-being (FWB) | 7 | 0 to 28 |
| FACT-G total | 27 | 0 to 108 |
Follow the official FACIT scoring guidelines supplied with the licence, including reverse scoring and proration rules.
In Capture
Schedule the FACT-G on day 1 of each cycle or at fixed weeks, with windows and reminders. Participants complete it on their own phone. The form records the licence number, holder and expiry, and raw item values export with labels for scoring in analysis.
Anchor it to treatment cycles in the free sandbox.
Missing data
Quality of life data in cancer trials goes missing for a reason: participants who feel worst or whose disease progresses are the least likely to complete questionnaires, and they often leave the treatment schedule. That makes missing data informative and can make a treatment look better than it is.
Keep collecting after treatment ends where the protocol allows, use reminders and windows so completion does not depend on clinic visits, and record the reason when an assessment is missed. Plan sensitivity analyses for missing data from the start. See ePRO software for compliance monitoring.
Before go-live
Through FACIT.org; details on the form.
Disease-specific version if one exists for the indication.
Total, a subscale or the TOI, pre-specified.
Cycle-anchored or fixed weeks, continuing after treatment ends.
Recorded for every missed questionnaire.
Supplied under the licence.
A score combining the physical and functional well-being subscales with a disease-specific subscale, often used as a focused endpoint.
The past seven days.
The Functional Assessment of Cancer Therapy – General, a 27-item quality of life questionnaire for people with cancer.
Items rated 0 to 4 are reverse scored where needed and summed within four subscales. The total runs from 0 to 108, with higher scores meaning better quality of life.
Physical, social/family, emotional and functional well-being.
Use requires a licence agreement through FACIT.org. Terms depend on the type of use.
Both are well validated. Many sponsors choose based on previous trials in the same indication so results can be compared.
Raw item values are stored with labels, and scores are derived in analysis using the official guidelines.
Licensed FACT questionnaires on participants' phones. Free sandbox.