Table 5.
Ability of the FACT-M to detect change and MIDs in the mMCC population
| FACT-M Subscales and Summary scores | Comparison of change in score from baseline to Week 7 Percent change in tumor size (mean change in score [ES[a]]) |
MIDs assessed at Week 7 | Published MIDs in melanoma population | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Change in tumor size | 0.2 x SDBL | 0.5 x SDBL | SEM[d] | Range(min-max) | |||||
| Reduction ≥ 30%[b]
(N = 14) |
Reduction between 0-30% (N = 7) |
Increase >0% (N = 16) | p-value[c] | ||||||
| FACT-G subscales | |||||||||
| Physical well-being (PWB) | 0.21 (0.05) | -1.00 (-0.18) | -1.75 (-0.31) | 0.631 | 1.14 | 2.85 | 2.15 | 0.21 - 2.85 | 2.00-3.00[e] |
| Social/Family well-being (SWB) | -0.49 (-0.10) | -0.45 (-0.12) | -1.74 (-0.28) | 0.624 | 1.01 | 2.52 | 2.21 | -0.49 - 2.52 | - |
| Emotional well-being (EWB) | 1.07 (0.22) | 1.29 (0.20) | -0.25 (-0.09) | 0.596 | 0.91 | 2.28 | 1.87 | 0.91 - 2.28 | 2.00[e] |
| Functional well-being (FWB) | 2.64 (0.42) | -0.14 (-0.02) | -2.81 (-0.42) | 0.005 | 1.27 | 3.19 | 2.26 | 1.27 - 3.19 | 2.00-3.00[e] |
| Melanoma-specific subscales | |||||||||
| Melanoma Subscale (MS) | 2.71 (0.26) | -2.43 (-0.36) | -2.94 (-0.42) | 0.051 | 1.80 | 4.50 | 3.46 | 1.80 - 4.50 | 2.00-4.00[f] |
| Melanoma surgery scale (MSS) | 2.07 (0.34) | -3.00 (-1.02) | -3.13 (-0.49) | 0.036 | 1.22 | 3.05 | 2.46 | 1.22 - 3.05 | 1.00-2.00[f] |
| Summary scales | |||||||||
| FACT-M TOI | 5.57 (0.31) | -3.57 (-0.21) | -7.50 (-0.42) | 0.038 | 3.86 | 9.64 | 4.84 | 3.86 - 9.64 | 5.00-9.00[f] |
| FACT-G total score | 3.44 (0.21) | -0.31 (-0.02) | -6.55 (-0.35) | 0.155 | 3.54 | 8.85 | 4.24 | 3.44 - 8.85 | 3.00-7.00[e] |
| FACT-M total score | 6.15 (0.26) | -2.74 (-0.12) | -9.49 (-0.38) | 0.074 | 5.05 | 12.62 | 5.26 | 5.05 - 12.62 | - |
| MCC-Specific scores | |||||||||
| Physical Function score (PF) | 0.71 (0.14) | -1.86 (-0.33) | -2.13 (-0.34) | 0.153 | 1.15 | 2.87 | 1.88 | 0.71 - 2.87 | - |
| Psychological Impact score (PI) | 0.79 (0.15) | 2.29 (0.39) | 0.31 (0.10) | 0.609 | 0.95 | 2.38 | 1.98 | 0.79 - 2.38 | - |
| MCC summary score | 1.50 (0.17) | 0.43 (0.04) | -1.81 (-0.21) | 0.530 | 1.91 | 4.76 | 2.91 | 1.50 - 4.76 | - |
ES effect size, MCC Merkel cell carcinoma, MID Minimally important difference, PAS PRO analysis set, SD BL Standard deviation of the score at baseline, SEM Standard error of measurement, TOI Trial Outcome Index
Ability to detect change and MIDs of the FACT-M were assessed in the PAS (N = 70).
[a]ES around 0.20: small change; ES around 0.50: moderate change; ES around 0.80: large change; [b]Reduction in tumor size ≥30% was used as the anchor for MID thresholds; [c] p-value from ANOVA comparing score change from baseline to week 7 between the three groups based on change in tumor size [d]SEM was calculated using Cronbach's alpha for internal consistency reliability; [e]Askew et al. 2009; [f]Cella et al 2002