Table 4.
Patient reported quality of life outcomes linear mixed model analysis for change from baseline
| Scale* | Visit change | Intervention estimate (SE) | Control estimate (SE) | Difference estimate (95% CI)† | Overall effect (P value)‡ | |
|---|---|---|---|---|---|---|
| Visit | Intervention | |||||
| Functional assessment for cancer therapy for patients with breast cancer (FACT-B): | ||||||
| Trial outcome index |
V2−V1 | −2.4 (0.7) | −4.9 (0.6) | 2.5 (0.7 to 4.3) | <0.001 | 0.004 |
| V2a−V1 | −7.7 (0.8) | −9.6 (0.8) | 2.0 (−0.2 to 4.2) | |||
| V3−V1 | −6.1 (0.8) | −9.0 (0.8) | 2.9 (0.8 to 5.0) | |||
| Physical wellbeing |
V2−V1 | −2.4 (0.3) | −3.4 (0.3) | 1.0 (0.2 to 1.9) | <0.001 | 0.001 |
| V2a−V1 | −4.3 (0.4) | −5.3 (0.3) | 1.0 (0.0 to 2.0) | |||
| V3−V1 | −3.0 (0.3) | −4.6 (0.3) | 1.6 (0.7 to 2.5) | |||
| Social wellbeing |
V2−V1 | 0.0 (0.2) | −0.3 (0.2) | 0.3 (−0.3 to 0.9) | <0.001 | 0.51 |
| V2a−V1 | −0.5 (0.3) | −0.6 (0.2) | 0.1 (−0.6 to 0.8) | |||
| V3−V1 | −0.8 (0.2) | −0.9 (0.2) | 0.1 (−0.6 to 0.8) | |||
| Emotional wellbeing |
V2−V1 | 1.4 (0.2) | 1.4 (0.2) | 0.0 (−0.4 to 0.4) | 0.95 | 0.89 |
| V2a−V1 | 1.2 (0.2) | 1.6 (0.2) | −0.3 (−0.9 to 0.2) | |||
| V3−V1 | 1.6 (0.2) | 1.3 (0.2) | 0.3 (−0.2 to 0.8) | |||
| Functional wellbeing |
V2−V1 | −0.6 (0.3) | −1.5 (0.3) | 0.8 (0.1 to 1.6) | <0.001 | 0.15 |
| V2a−V1 | −2.8 (0.3) | −2.9 (0.3) | 0.1 (−0.8 to 1.0) | |||
| V3−V1 | −2.0 (0.3) | −2.5 (0.3) | 0.5 (−0.3 to 1.4) | |||
| EQ-5D-3L VAS |
V2−V1 | 1.3 (0.8) | −0.8 (0.8) | 2.1 (−0.1 to 4.2) | <0.001 | 0.031 |
| V2a−V1 | −2.4 (1.1) | −5.8 (1.1) | 3.4 (0.4 to 6.4) | |||
| V3−V1 | −3.6 (1.0) | −4.7 (1.0) | 1.1 (−1.6 to 3.8) | |||
| Stanford | V2−V1 | 0.3 (0.1) | 0.3 (0.1) | 0.0 (−0.3 to 0.3) | 0.009 | 0.57 |
| V2a−V1 | 0.2 (0.1) | −0.1 (0.1) | 0.2 (−0.1 to 0.6) | |||
| V3−V1 | 0.3 (0.1) | 0.3 (0.1) | 0.0 (−0.3 to 0.3) | |||
| Picker (adapted) |
V2−V1 | 6.0 (1.4) | 4.0 (1.4) | 2.0 (−2.0 to 5.9) | 0.093 | 0.67 |
| V2a−V1 | 7.0 (1.8) | 7.1 (1.7) | −0.1 (−5.1 to 4.9) | |||
| V3−V1 | 4.6 (1.6) | 4.2 (1.5) | 0.4 (−3.9 to 4.7) | |||
| GAD-7 | V2−V1 | −2.1 (0.2) | −2.1 (0.2) | 0.0 (−0.5 to 0.6) | 0.91 | 0.59 |
| V2a−V1 | −2.4 (0.2) | −2.0 (0.2) | −0.5 (−1.2 to 0.2) | |||
| V3−V1 | −2.1 (0.2) | −2.2 (0.2) | 0.1 (−0.6 to 0.7) | |||
| PHQ-9 | V2−V1 | 0.3 (0.2) | 0.7 (0.2) | −0.4 (−1.0 to 0.2) | <0.001 | 0.07 |
| V2a−V1 | 1.2 (0.3) | 1.7 (0.3) | −0.5 (−1.2 to 0.3) | |||
| V3−V1 | 0.6 (0.2) | 1.0 (0.2) | −0.5 (−1.1 to 0.2) | |||
SE=standard error; V1=baseline; V2=before start of second cycle; V2a=before start of second cycle of a taxane (if they switched regimens); V3=within 60 days of the end of chemotherapy; PHQ-9=patient health questionnaire 9; EQ-5D-3L VAS=three level version of the European quality of life five dimension visual analogue scale; GAD-7=generalised anxiety disorder 7; Stanford=Stanford self-management self-efficacy scale.
Score ranges for instruments: FACT-B total score (0-148); EQ-5D-3L VAS (0-100); Picker (adapted) (0-100); Stanford (1-10); GAD-7 (0-21); PHQ-9 (0-27).
Estimates of positive differences for FACT-B, EQ-5D-3L VAS, Stanford, and Picker scales, and negative differences for GAD and PHQ, suggest less decline for patients at the intervention centres
With general linear mixed modelling, the predictors are considered to have a fixed or random effect. Fixed effects include baseline score, intervention, visit, intervention-visit interaction, and size of centre group; centre is a random effect. Correlations for different patients in the same cluster and for different visits from the same patient have also been taken into account in the model. No interaction terms were found to be significant (P<0.05).