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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)*

ES

P†

AMD (95% CI)*

ES

P†

AMD (95% CI)*

ES

P†

AMD (95% CI)*

ES

P†

Fatigue (MFI)

General fatigue

UC

9.2 (3.4)

−1.72 (−2.72; − 0.71)

−0.28

0.002

− 0.92 (− 1.98; 0.13)

− 0.14

0.081

− 0.95 (−2.22; 0.31)

− 0.12

0.103

−1.46 (− 2.96; 0.05)

− 0.16

0.038

APAD

9.9 (3.7)

            

Physical fatigue

UC

9.2 (4.2)

−2.08 (−3.11; − 1.04)

− 0.33

0.001

−1.96 (−3.03; − 0.88)

− 0.30

0.002

−0.78 (−2.02; 0.46)

−0.10

0.207

−1.54 (−2.96; −0.11)

−0.18

0.034

APAD

9.5 (4.2)

            

Mental fatigue‡

UC

7.6 (3.4)

−0.15 (− 0.26; − 0.04)

− 0.22

0.015

− 0.18 (− 0.3; − 0.06)

−0.25

0.004

−0.15 (− 0.3; − 0.01)

−0.17

0.031

−0.09 (− 0.27; 0.09)

− 0.08

0.244

APAD

8.1 (3.7)

            

Reduced activities‡

UC

9 (3.8)

−0.2 (− 0.31; − 0.09)

− 0.30

0.002

− 0.17 (− 0.29; − 0.06)

− 0.25

0.010

− 0.21 (− 0.34; − 0.07)

−0.25

0.005

−0.17 (− 0.33; 0)

− 0.17

0.044

APAD

9.1 (3.9)

            

Reduced motivation‡

UC

6.7 (2.6)

−0.18 (− 0.29; − 0.07)

− 0.28

0.007

− 0.15 (− 0.26; − 0.04)

− 0.22

0.026

− 0.09 (− 0.22; 0.04)

− 0.11

0.203

− 0.1 (− 0.26; 0.05)

− 0.11

0.196

APAD

6.9 (3.4)

            

Quality-of-life (EORTC QLQ C30)

Global QoL

UC

69.5 (18.9)

7.08 (2.22; 11.95)

0.24

0.012

7.69 (2.6; 12.78)

0.25

0.008

7.58 (1.46; 13.69)

0.20

0.018

11.87 (4.52; 19.21)

0.26

0.002

APAD

66.9 (18)

            

Physical function

UC

88.8 (11.1)

8.54 (4.56; 12.5)

0.35

0.000

7.44 (3.34; 11.5)

0.30

0.001

2.84 (−2; 7.69)

0.10

0.199

8.69 (2.98; 14.4)

0.25

0.002

APAD

86.5 (13.7)

            

Role function

UC

84.5 (23.1)

13.5 (8.26; 18.6)

0.42

0.000

9.27 (3.83; 14.7)

0.28

0.003

3.98 (−2.48; 10.45)

0.10

0.198

8.61 (0.96; 16.3)

0.18

0.022

APAD

82.9 (18.9)

            

Emotional function

UC

66.3 (21.7)

9.38 (3.5; 15.3)

0.26

0.014

2.88 (−3.3; 9.05)

0.08

0.472

1.73 (−5.5; 8.97)

0.04

0.695

6.4 (−2.08; 14.9)

0.12

0.172

APAD

66.5 (19)

            

Cognitive function

UC

85.5 (17.9)

8.48 (3.13; 13.8)

0.26

0.008

3.87 (−1.7; 9.45)

0.11

0.219

2.26 (−4.18; 8.7)

0.06

0.486

5.64 (− 1.78; 13.1)

0.12

0.129

APAD

85.9 (18.6)

            

Social function

UC

82.1 (23.3)

6.22 (−0.13; 12.58)

0.16

0.234

7.04 (0.45; 13.62)

0.18

0.174

0.77 (−7.03; 8.56)

0.02

0.946

13.0 (3.80; 22.3)

0.23

0.025

APAD

84.7 (22.5)

            

Anxiety and depression (HADS)

Anxiety

UC

11.3 (3.3)

−1.57 (−2.28; − 0.87)

− 0.36

0.000

−1.08 (− 1.83; − 0.33)

− 0.24

0.009

− 0.23 (− 1.18; 0.72)

− 0.04

0.533

− 0.3 (− 1.48; 0.88)

− 0.04

0.515

APAD

11.9 (3.2)

            

Depression

UC

9.7 (3.3)

−1.36 (−2.05; −0.68)

−0.32

0.001

−1.66 (−2.37; −0.95)

−0.38

0.000

−0.4 (−1.28; 0.47)

−0.08

0.305

−0.59 (−1.69; 0.5)

−0.09

0.243

APAD

10.1 (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
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BMC Cancer

ISSN: 1471-2407

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