Table 2.
Fatigue measure | Directionality | Baseline | Day 14 | p-value* | Effect size |
---|---|---|---|---|---|
Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Total score | Higher is better | 107.9 ± 17.3 | 117.2 ± 19.6 | <0.001** | 0.50 |
FACIT-F: Physical well being | Higher is better | 19.9 ± 4.1 | 21.4 ± 4.7 | 0.006** | 0.32 |
FACIT-F: Social well being | Higher is better | 22.8 ± 5.7 | 23.1 ± 5.5 | 0.529 | 0.06 |
FACIT-F: Emotional well being | Higher is better | 18.5 ± 3.7 | 19.1 ± 3.5 | 0.144 | 0.18 |
FACIT-F: Functional well being | Higher is better | 16.0 ± 4.5 | 17.3 ± 4.9 | 0.005** | 0.35 |
FACIT-F: Fatigue subscale | Higher is better | 30.6 ± 9.2 | 35.9 ± 9.9 | <0.001** | 0.55 |
FACIT-F: Trial outcome index (fatigue)† | Higher is better | 66.6 ± 14.8 | 74.9 ± 17.3 | <0.001** | 0.52 |
FACIT-F: Functional Assessment of Cancer Therapy (FACT)-General‡ | Higher is better | 77.2 ± 12.3 | 81.3 ± 13.0 | 0.001** | 0.32 |
Brief Fatigue Inventory: Global fatigue score | Lower is better | 3.9 ± 1.6 | 2.9 ± 1.9 | 0.001** | −0.58 |
Brief Fatigue Inventory: Fatigue at its worst | Lower is better | 6.8 ± 1.9 | 5.2 ± 2.6 | <0.001 | −0.69 |
Symptom inventory: Fatigue | Lower is better | 5.8 ± 2.4 | 4.4 ± 2.3 | 0.002** | −0.62 |
Symptom inventory: Sleep problems | Lower is better | 4.7 ± 2.9 | 4.2 ± 3.0 | 0.374 | −0.18 |
Symptom inventory: Drowsiness | Lower is better | 5.2 ± 2.5 | 3.0 ± 2.3 | <0.001** | −0.89 |
Symptom inventory: Interference of symptoms with quality of life | Lower is better | 4.0 ± 2.9 | 2.3 ± 2.6 | 0.001** | −0.62 |
p-value derived from a two-sided, paired t-test between baseline and Day 14
p<0.01
Trial outcome index (fatigue) = physical + functional + fatigue subscales
Functional Assessment of Cancer Therapy (FACT)-General = physical + social + emotional + functional subscales; a common measure of quality of life