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Table 4 Ability to detect change of the FACT-M in the MCC population by comparing change in score from baseline to week 7 across change groups defined by percentage change in tumor size (n = 105) and change in EQ VAS (n = 121), respectively

From: Update on the psychometric properties and minimal important difference (MID) thresholds of the FACT-M questionnaire for use in treatment-naïve and previously treated patients with metastatic Merkel cell carcinoma

FACT-M subscale, summary and MCC-specific scores

Percent change in tumor size; mean (effect size)

Change in EQ VAS (MID = 7); mean (effect size)

Reduction  ≤ − 30%[a] (N = 47)

Reduction  > − 30% to ≤0

(N = 14)

Increase > 0%

(N = 44)

p-value[b]

Improved ≥7 points (n = 35)

Stable > − 7 to < 7 (n = 56)

Worsened ≤ − 7 points (n = 30)

p-value[b]

FACT-G subscales

 Physical well-being

−0.02 (− 0.01)

−0.50 (− 0.11)

− 1.86 (− 0.36)

0.101

0.46 (0.10)

−0.54 (− 0.11)

−3.17 (− 1.03)

< 0.001

 Social/Family well-being

0.47 (0.09)

− 0.21 (− 0.06)

− 1.55 (− 0.24)

0.209

0.72 (0.15)

− 1.19 (− 0.21)

− 0.13 (− 0.02)

0.272

 Emotional well-being

1.38 (0.35)

0.79 (0.14)

0.23 (0.05)

0.292

2.37 (0.63)

0.99 (0.20)

−2.03 (− 0.65)

<.0001

 Functional well-being

0.06 (0.01)

− 0.43 (− 0.06)

− 2.16 (− 0.30)

0.164

0.34 (0.05)

− 0.91 (− 0.12)

−2.24 (− 0.40)

0.165

Melanoma-specific subscales

 Melanoma subscale

1.64 (0.21)

−2.64 (− 0.44)

− 2.32 (− 0.27)

0.006

1.74 (0.24)

− 0.18 (− 0.02)

−4.63 (− 0.69)

<.0001

 Melanoma surgery scale

1.50 (0.36)

−1.79 (− 0.48)

−1.16 (− 0.15)

0.043

0.69 (0.12)

0.02 (0.02)

− 0.67 (− 0.09)

0.619

Summary scales

 FACT-M TOI

1.68 (0.10)

− 3.57 (− 0.23)

− 6.34 (− 0.32)

0.012

2.54 (0.16)

− 1.63 (− 0.08)

−10.04 (− 0.76)

< 0.001

 FACT-G Total score

1.89 (0.13)

− 0.36 (− 0.02)

− 5.34 (− 0.29)

0.026

3.90 (0.26)

− 1.65 (− 0.09)

−7.56 (− 0.56)

0.001

 FACT-M Total score

3.53 (0.17)

−3.00 (− 0.14)

− 7.65 (− 0.30)

0.009

5.64 (0.27)

−1.83 (− 0.07)

−12.20 (− 0.67)

<.0001

MCC-Specific scores

 Physical function score (PF)

−0.30 (− 0.06)

−1.64 (− 0.32)

−2.18 (− 0.33)

0.100

−0.09 (− 0.01)

−0.95 (− 0.15)

−3.60 (− 0.79)

0.002

 Psychological impact score (PI)

1.40 (0.32)

1.21 (0.22)

0.30 (0.07)

0.393

2.94 (0.71)

0.98 (0.20)

−2.10 (−0.62)

<.0001

 MCC summary score

1.11 (0.14)

−0.43 (− 0.04)

−1.89 (− 0.19)

0.129

2.86 (0.33)

0.04 (0.00)

−5.70 (− 0.91)

<.0001

  1. MCC = Merkel cell carcinoma; MID = Minimal important difference; TOI = Trial Outcome Index
  2. [a] reduction in tumor size ≥30% was used as one anchor for MID thresholds; [b] p-value from ANOVA comparing score change from baseline to week 7 between the three groups based on change in tumor size or change in EQ VAS respectively