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Table 2 Mean values at baseline, and between-group differences and at the end of chemotherapy, the end of radiotherapy and at 6-month and 1-year follow-up for PROs

From: Short- and long-term impact of adapted physical activity and diet counseling during adjuvant breast cancer therapy: the “APAD1” randomized controlled trial

 T0
Baseline
T1–18 weeks
Mid-intervention
T2–26 weeks
End of intervention
T3–52 weeks
6-month follow-up
T4–78 weeks
1-year follow-up
Mean (SD)AMD (95% CI)*ESP†AMD (95% CI)*ESP†AMD (95% CI)*ESP†AMD (95% CI)*ESP†
Fatigue (MFI)
General fatigueUC9.2 (3.4)−1.72 (−2.72; − 0.71)−0.280.002− 0.92 (− 1.98; 0.13)− 0.140.081− 0.95 (−2.22; 0.31)− 0.120.103−1.46 (− 2.96; 0.05)− 0.160.038
APAD9.9 (3.7)            
Physical fatigueUC9.2 (4.2)−2.08 (−3.11; − 1.04)− 0.330.001−1.96 (−3.03; − 0.88)− 0.300.002−0.78 (−2.02; 0.46)−0.100.207−1.54 (−2.96; −0.11)−0.180.034
APAD9.5 (4.2)            
Mental fatigueUC7.6 (3.4)−0.15 (− 0.26; − 0.04)− 0.220.015− 0.18 (− 0.3; − 0.06)−0.250.004−0.15 (− 0.3; − 0.01)−0.170.031−0.09 (− 0.27; 0.09)− 0.080.244
APAD8.1 (3.7)            
Reduced activitiesUC9 (3.8)−0.2 (− 0.31; − 0.09)− 0.300.002− 0.17 (− 0.29; − 0.06)− 0.250.010− 0.21 (− 0.34; − 0.07)−0.250.005−0.17 (− 0.33; 0)− 0.170.044
APAD9.1 (3.9)            
Reduced motivationUC6.7 (2.6)−0.18 (− 0.29; − 0.07)− 0.280.007− 0.15 (− 0.26; − 0.04)− 0.220.026− 0.09 (− 0.22; 0.04)− 0.110.203− 0.1 (− 0.26; 0.05)− 0.110.196
APAD6.9 (3.4)            
Quality-of-life (EORTC QLQ C30)
Global QoLUC69.5 (18.9)7.08 (2.22; 11.95)0.240.0127.69 (2.6; 12.78)0.250.0087.58 (1.46; 13.69)0.200.01811.87 (4.52; 19.21)0.260.002
APAD66.9 (18)            
Physical functionUC88.8 (11.1)8.54 (4.56; 12.5)0.350.0007.44 (3.34; 11.5)0.300.0012.84 (−2; 7.69)0.100.1998.69 (2.98; 14.4)0.250.002
APAD86.5 (13.7)            
Role functionUC84.5 (23.1)13.5 (8.26; 18.6)0.420.0009.27 (3.83; 14.7)0.280.0033.98 (−2.48; 10.45)0.100.1988.61 (0.96; 16.3)0.180.022
APAD82.9 (18.9)            
Emotional functionUC66.3 (21.7)9.38 (3.5; 15.3)0.260.0142.88 (−3.3; 9.05)0.080.4721.73 (−5.5; 8.97)0.040.6956.4 (−2.08; 14.9)0.120.172
APAD66.5 (19)            
Cognitive functionUC85.5 (17.9)8.48 (3.13; 13.8)0.260.0083.87 (−1.7; 9.45)0.110.2192.26 (−4.18; 8.7)0.060.4865.64 (− 1.78; 13.1)0.120.129
APAD85.9 (18.6)            
Social functionUC82.1 (23.3)6.22 (−0.13; 12.58)0.160.2347.04 (0.45; 13.62)0.180.1740.77 (−7.03; 8.56)0.020.94613.0 (3.80; 22.3)0.230.025
APAD84.7 (22.5)            
Anxiety and depression (HADS)
AnxietyUC11.3 (3.3)−1.57 (−2.28; − 0.87)− 0.360.000−1.08 (− 1.83; − 0.33)− 0.240.009− 0.23 (− 1.18; 0.72)− 0.040.533− 0.3 (− 1.48; 0.88)− 0.040.515
APAD11.9 (3.2)            
DepressionUC9.7 (3.3)−1.36 (−2.05; −0.68)−0.320.001−1.66 (−2.37; −0.95)−0.380.000−0.4 (−1.28; 0.47)−0.080.305−0.59 (−1.69; 0.5)−0.090.243
APAD10.1 (3.4)            
  1. Abbreviations: AMD Adjusted Mean Differences, EF Effect Size of difference between groups, CI Confidence Interval, MFI Multidimensional Fatigue Inventory, HADS Hospital Anxiety Depression Scale, APAD Adapted Physical Activity and Diet counseling intervention, UC Usual Care
  2. NOTE: Bold font indicates significant difference
  3. *Baseline value, surgery type and age-adjusted mean differences and their associated 95% confidence interval estimated with linear mixed model
  4. P-value for time*arm interaction estimated with linear mixed model
  5. Log transformed variables: Mental fatigue – MFI, Reduced activities – MFI, Reduced Motivation – MFI