Table 2.
QOL-ACD-B and FACT-ES subordinate items in repeated measures mixed model analyses and the stratification analyses
| Itema | Baseline | Repeated measures mixed model analysisb | ||||
|---|---|---|---|---|---|---|
| Group × visit interaction model | Main effect model | |||||
| Group × visit interaction | Between-group comparison per visitd | |||||
| Week 0c | Week 144 | Week 192 | Week 240 | Between the groups | ||
| QOL-ACD-B | ||||||
| 1. Did you have any pain or numbness in your breast, armpit or arm on the side of illness? |
p = 0.567
(− 0.08) |
p = 0.040 |
p = 0.703 (0.07) |
p = 0.007
(0.39) |
p = 0.195 (0.17) |
p = 0.096 |
| 2. Did you have any bloating in your arm on the side of the illness? |
p = 0.250
(− 0.16) |
p = 0.076 |
p = 0.187 (0.19) |
p = 0.237 (0.19) |
p = 0.003
(0.49) |
p = 0.032 |
| 3. Were you able to raise your arm completely on the side of the illness? |
p = 0.095
(− 0.24) |
p = 0.581 | p = 0.933 | p = 0.457 | p = 0.978 | p = 0.848 |
| 4. Did you worry about skin problems (redness, swelling, hot flashes, itchiness, etc.) at the area of your breast on the side of the illness? |
p = 0.886
(0.02) |
p = 0.189 | p = 0.705 | p = 0.106 | p = 0.040 | p = 0.164 |
| 5. Did you have any pain associated with your illness or treatment? |
p = 0.938
(− 0.01) |
p = 0.151 | p = 0.376 | p = 0.014 | p = 0.245 | p = 0.078 |
| 6. (Answer this question only if you have had operations.) Have you been satisfied with the appearance of your breast (and/or scar)? |
p = 0.990
(0.00) |
p = 0.438 | p = 0.852 | p = 0.243 | p = 0.711 | p = 0.669 |
| 7. Have you been satisfied with the explanation you have received from your doctor(s) about your condition and/or treatment? |
p = 0.632
(0.07) |
p = 0.883 | p = 0.429 | p = 0.480 | p = 0.764 | p = 0.442 |
| 8. Have you been satisfied with the facilities and staff, other than your doctor(s), at the hospital where you were diagnosed and/or treated? |
p = 0.216
(0.18) |
p = 0.058 |
p = 0.216 (0.21) |
p = 0.213 (− 0.19) |
p = 0.593 (0.07) |
p = 0.691 |
| 9. Do you feel that you have adequately accepted your illness? |
p = 0.988
(0.00) |
p = 0.405 | p = 0.445 | p = 0.224 | p = 0.997 | p = 0.547 |
| 10. Have you been determined to fight your illness? |
p = 0.540
(− 0.09) |
p = 0.929 | p = 0.637 | p = 0.581 | p = 0.451 | p = 0.488 |
| 12. Have you suffered from fatigue? |
p = 0.549
(0.08) |
p = 0.364 | p = 0.654 | p = 0.590 | p = 0.320 | p = 0.894 |
| 13. Were you bothered by hot flashes or sweating on your body or forehead? |
p = 0.154
(− 0.20) |
p = 0.047 |
p = 0.018
(0.34) |
p < 0.001
(0.71) |
p = 0.001
(0.58) |
p = 0.001 |
| Age ≤ 44 years |
p = 0.068
(− 0.35) |
p = 0.013 |
p = 0.093 (0.33) |
p < 0.001
(0.87) |
p = 0.016
(0.60) |
p = 0.015 |
| Age ≥ 45 years |
p = 1.000
(0.00) |
p = 0.484 |
p = 0.075 (0.38) |
p = 0.030
(0.51) |
p = 0.011
(0.58) |
p = 0.017 |
| 18. Were you concerned that other members of your family would suffer from the same illness? |
p = 0.933
(− 0.01) |
p = 0.380 | p = 0.465 | p = 0.589 | p = 0.037 | p = 0.094 |
| FACT-ES | ||||||
| ES1. I have hot flashes. |
p = 0.137
(− 0.23) |
p < 0.001 |
p = 0.118 (0.27) |
p < 0.001
(0.92) |
p = 0.001
(0.49) |
p < 0.001 |
| Age ≤ 44 years |
p = 0.036
(− 0.44) |
p < 0.001 |
p = 0.134 (0.38) |
p < 0.001
(1.27) |
p = 0.001
(0.71) |
p < 0.001 |
| Age ≥ 45 years |
p = 0.809
(0.05) |
p = 0.039 |
p = 0.488 (0.16) |
p = 0.009
(0.62) |
p = 0.243 (0.25) |
p = 0.158 |
| ES2. I have sweats. |
p = 0.842
(− 0.03) |
p = 0.196 | p = 0.222 | p = 0.017 | p = 0.092 | p = 0.089 |
| ES3. I have night sweats. |
p = 0.234
(0.18) |
p = 0.391 | p = 0.886 | p = 0.302 | p = 0.324 | p = 0.568 |
| ES4. I have vaginal discharge. |
p = 0.284
(0.16) |
p = 0.425 | p = 0.893 | p = 0.775 | p = 0.421 | p = 0.755 |
| ES5. I have vaginal itching/irritation. |
p = 0.834
(− 0.03) |
p = 0.119 | p = 0.077 | p = 0.918 | p = 0.675 | p = 0.317 |
| ES6. I have vaginal bleeding or spotting. |
p = 0.179
(0.21) |
p = 0.632 | p = 0.387 | p = 0.547 | p = 0.169 | p = 0.291 |
| ES7. I have vaginal dryness. |
p = 0.099
(− 0.25) |
p = 0.988 | p = 0.654 | p = 0.582 | p = 0.647 | p = 0.574 |
| ES8. I have pain or discomfort with intercourse. |
p = 0.537
(− 0.10) |
p = 0.919 |
p = 0.051 (0.31) |
p = 0.048
(0.37) |
p = 0.033
(0.38) |
p = 0.016 |
| Age ≤ 44 years |
p = 0.675
(− 0.09) |
p = 0.744 | p = 0.190 | p = 0.129 | p = 0.061 | p = 0.068 |
| Age ≥ 45 years |
p = 0.660
(− 0.11) |
p = 0.992 | p = 0.118 | p = 0.190 | p = 0.211 | p = 0.088 |
| ES9. I have lost interest in sex. |
p = 0.524
(0.10) |
p = 0.633 | p = 0.942 | p = 0.363 | p = 0.743 | p = 0.577 |
| ES10. I have gained weight. |
p = 0.564
(0.09) |
p = 0.025 |
p = 0.646 (−0.08) |
p = 0.074 (0.19) |
p = 0.791 (0.01) |
p = 0.873 |
| An9. I feel lightheaded (dizzy). |
p = 0.874
(0.02) |
p = 0.179 | p = 0.861 | p = 0.164 | p = 0.672 | p = 0.695 |
| O2. I have been vomiting. |
p = 0.186
(0.20) |
p = 0.189 | p = 0.988 | p = 0.776 | p = 0.178 | p = 0.796 |
| C5. I have diarrhea. |
p = 0.432
(0.12) |
p = 0.723 | p = 0.855 | p = 0.825 | p = 0.444 | p = 0.583 |
| An10. I get headaches. |
p = 0.307
(0.16) |
p = 0.211 | p = 0.600 | p = 0.138 | p = 0.643 | p = 0.392 |
| Tax1. I feel bloated. |
p = 0.328
(0.15) |
p = 0.239 | p = 0.167 | p = 0.825 | p = 0.813 | p = 0.553 |
| ES11. I have breast sensitivity/tenderness. |
p = 0.065
(0.28) |
p = 0.772 | p = 0.682 | p = 0.257 | p = 0.236 | p = 0.271 |
| ES12. I have mood swings. |
p = 0.136
(0.23) |
p = 0.561 | p = 0.343 | p = 0.988 | p = 0.851 | p = 0.672 |
| ES13. I am irritable. |
p = 0.953
(− 0.01) |
p = 0.828 | p = 0.516 | p = 0.319 | p = 0.581 | p = 0.416 |
| BM1. I have pain in my joints. |
p = 0.571
(− 0.09) |
p = 0.145 | p = 0.482 | p = 0.386 | p = 0.384 | p = 0.767 |
Bold p ≤ 0.05 except for p ≤ 0.10 for group by visit interaction (2-sides)
aIndividual analysis was not separately performed for items 11 and 14 to 17 of QOL-ACD-B due to the lower response rate to the items
– item11: Have you experienced hair loss?
– item14: Were you bothered by any change (trouble) in ways you taste foods?
– item15: Did you feel any inconvenience because you were unable to choose clothes that you wanted to wear?
– item16: Do you feel reluctant to disrobe in the presence of other people, such as at a spa?
– item17: Are you satisfied with your sex life?
bRepeated measures mixed-effects model analysis: the model analysis was applied to the change in each QOL score at weeks 144, 192, and 240 from week 96 using the baseline (week 0) as the covariate in the mFAS
cThe two-sample t test p value and Cohen’s d statistics in the parenthesis were for “between-group difference in the week 0 QOL score”
dModel analysis p value and Cohen’s d statistics: Cohen’s d was estimated for “between-group differences in QOL changes at weeks 144, 192, and 240 from week 96,” only when the “group × visit interaction” or “difference between 2 groups in the main effect model” was found to be significant