Table 3.

Health-related quality of life outcomes at baseline and change during six months

Outcome	Baseline (Mean ± SD)	Δ Baseline to Month 6 (LS Mean ± SE)	P Time Effect	Δ from Control (LS Mean ± SE)	P Group Effect
Short-Form 36
Physical Health Component Score
Control	73.9±25.0	−7.4±4.6	0.108	—	—
Low-Dose	80.0±18.3	−6.2±4.3	0.147	1.2±6.3	0.506
High-Dose	79.2±16.1	5.7±4.6	0.221	13.1±6.5	0.002
Test for trend		P=0.002
Mental Health Component Score
Control	73.5±18.8	2.7±3.0	0.359	—	—
Low-Dose	80.7±15.5	−0.7±2.8	0.812	−3.4±4.1	0.405
High-Dose	73.5±17.6	4.1±3.0	0.175	1.4±4.2	0.749
Test for trend		P=0.566
Functional Assessment of Cancer Therapy—Colorectal
Control	115.2±18.9	−4.8±2.8	0.089	—	—
Low-Dose	113.1±13.7	2.8±2.6	0.282	7.6±3.8	0.048
High-Dose	109.6±14.0	2.0±2.8	0.487	6.8±4.0	0.090
Test for trend		P=0.025
Pittsburgh Sleep Quality Index
Control	6.75±4.4	0.4±0.7	0.617	—	—
Low-Dose	4.46±3.0	0.1±0.7	0.910	−0.3±1.0	0.799
High-Dose	4.91±2.9	−0.7±0.8	0.376	−1.1±1.0	0.336
Test for trend		P=0.049
Fear of Cancer Recurrence Inventory
Control	52.2±26.0	−6.3±7.7	0.416	—	—
Low-Dose	57.1±23.3	−5.5±7.3	0.450	0.8±10.6	0.942
High-Dose	68.7±29.7	−20.9±7.9	0.008	−14.6±11.0	0.184
Test for trend		P=0.265
Fatigue Symptom Inventory
Control	6.9±11.9	0.1±2.5	0.982	—	—
Low-Dose	3.8±7.2	0.9±2.4	0.718	0.8±3.5	0.817
High-Dose	12.7±17.2	−5.9±2.6	0.021	−6.0±3.6	0.096
Test for trend		P=0.045
Bowel Function
Control	2.5±2.3	−1.1±0.4	0.012	—	—
Low-Dose	1.4±1.7	0.2±0.4	0.600	1.3±0.6	0.028
High-Dose	2.2±2.3	−0.7±0.4	0.131	0.4±0.6	0.490
Test for trend		P=0.369

SD, standard deviation; LS Mean, least squares mean; SE, standard error. Changes in outcomes are estimated using a linear mixed-effects regression model that adjusted for the baseline value of the dependent variable and cancer stage (randomization stratification factor).