Table 4 Mean change from randomization to eight months follow-up and between-group difference. The point estimates in bold indicate a statistically significant (p < 0.01) and clinically relevant difference/meaningful change. Improvements are indicated by positive changes for function domains and negative changes for symptom domains

QLQ-C30 function domains

Positive values indicate better functioning

Negative values favour observation group

GHS/QoL

1.77 (-5.14; 8.69)

0.615

1.36 (-3.71; 6.43)

0.599

0.41 (-8.16; 8.99)

0.925

Physical

1.13 (-3.43; 5.69)

0.628

6.47 (3.05; 9.89)

< 0.001

-5.34 (-10.94; 0.26)

0.062

Role

7.74 (0.23; 15.25)

0.043

12.18 (5.39; 18.96)

< 0.001

-4.44 (-14.52; 5.65)

0.389

Social

3.81 (-1.67; 9.28)

0.173

9.34 (5.07; 13.62)

< 0.001

-5.54 (-12.41; 1.34)

0.114

Emotional

0.57 (-3.14; 4.27)

0.765

0.00 (-3.35; 3.35)

0.999

0.56 (-4.44; 5.57)

0.826

Cognitive

-1.80 (-5.85; 2.25)

0.383

2.23 (-1.82; 6.28)

0.281

-4.03 (-9.79; 1.73)

0.170

QLQ-C30 Symptom domains

Negative values indicate reduced symptoms

Positive values favor observation group

Appetite loss

-1.11 (-8.21; 5.99)

0.76

-12.87 (-19.21;-6.52)

< 0.001

11.75 (2.47; 21.04)

0.013

Constipation

-0.95 (-6.00; 4.11)

0.714

-0.86 (-5.54; 3.82)

0.719

-0.09 (-7.01; 6.84)

0.980

Diarrhoea

-0.86 (-7.72; 6.00)

0.806

-4.81 (-11.62; 2.01)

0.167

3.95 (-5.78; 13.67)

0.426

Dyspnoea

-1.23 (-7.68; 5.22)

0.709

-6.79 (-13.60; 0.01)

0.050

5.56 (-4.01; 15.14)

0.255

Fatigue

-2.53 (-8.30; 3.24)

0.390

-9.09 (-13.61; -4.57)

< 0.001

6.56 (-0.72; 13.84)

0.078

Nausea and vomiting

0.34 (-4.57; 5.26)

0.891

-5.91 (-10.59; -1.22)

0.013

6.25 (-0.31; 12.81)

0.062

Pain

1.73 (-4.04; 7.50)

0.557

-1.90 (-7.14; 3.33)

0.476

3.63 (-4.07; 11.34)

0.356

Insomnia

2.76 (-3.75; 9.27)

0.406

-2.70 (-8.50; 3.10)

0.362

5.46 (-3.19; 14.10)

0.216

Financial difficulties

-2.61 (-6.69; 1.47)

0.211

-0.15 (-3.13; 2.82)

0.920

-2.46 (-7.57; 2.66)

0.346

QLQ-MY20 function domains

Positive values indicate better functioning

Negative values favor observation group

Future perspectives

7.64 (3.17; 12.11)

0.001

7.58 (3.16; 12.00)

0.001

0.06 (-6.33; 6.44)

0.986

Body image

8.24 (0.90; 15.58)

0.028

13.60 (7.05; 20.14)

< 0.001

-5.36 (-15.30; 4.59)

0.291

QLQ-MY20 symptom domains

Negative values indicate reduced symptoms/side effects

Positive values favor observation group

Disease symptoms

3.07 (-0.20; 6.35)

0.066

0.72 (-2.54; 3.97)

0.666

2.36 (-2.23; 6.94)

0.314

Side effects of treatment

-5.21 (-8.53; -1.89)

0.002

-7.09 (-9.80; -4.38)

< 0.001

1.88 (-2.39; 6.16)

0.388

FACT/GOG-Ntx subscale

Positive values indicate less peripheral neuropathy

Negative values favour observation group

FACT/GOG-Ntx subscale

-0.63 (-2.11-0.84)

0.399

0.85 (0.12–1.57)

0.022

-1.48 (-3.14-0.18)

0.080