Table 3.
Intention-to-Treat Analysis (Unadjusted) of the Impact of the Cooling Cap on Body Image, EORTC QLQ-BR23 (N=113) – Systemic Therapy Side-Effects, EORTC QLQ-C30 Social Functioning/Emotional Functioning and QOL Sum-Score
| Quality of Life | Scalp Cooling Group (N=75) | Control Group (N=38) | Group-by-Time Interaction |
|---|---|---|---|
| Mean (95% CI) | Mean (95% CI) | ||
| Body Image Scale | P=0.463 | ||
| Time point 1 (baseline) | 25.3 (23.9–26.8) | 25.2 (23.1–27.2) | |
| Time point 2 (mid chemotherapy) | 23.1 (21.6–24.5) | 21.8 (19.8–23.9) | |
| Time point 3 (last CT cycle) | 23.1 (21.7–24.5) | 22.4 (20.4–24.5) | |
| Time point 4 (3 months after treatment completion) | 23.1 (21.7–24.5) | 24 (21.8–26.1) | |
| Time point 5 (6–9 months after CT completion) | 24.7 (23.2–26.1) | 25.9 (23.6–28.1) | |
| EORTC QLQ-BR23 | P=0.402 | ||
| Systemic Therapy Side-Effects | |||
| Time point 1 (baseline) | 13.3 (9.3–17.3) | 15.1 (9.6–20.6) | |
| Time point 2 (mid chemotherapy) | 44.5 (40.4–48.6) | 50.7 (44.9–56.6) | |
| Time point 3 (last CT cycle) | 46.9 (42.9–50.8) | 51.9 (45.9–57.9) | |
| Time point 4 (3 months after treatment completion) | 23.4 (19.1–27.6) | 21.2 (14.9–27.5) | |
| Time point 5 (6–9 months after CT completion) | 17.8 (13.7–21.9) | 16.5 (10.1–23.0) | |
| EORTC QLQ-C30 Social Functioning | P=0.635 | ||
| Time point 1 (baseline) | 74.9 (68.9–80.8) | 82.2 (73.9–90.4) | |
| Time point 2 (mid chemotherapy) | 67.5 (61.3–73.7) | 67.9 (58.9–76.8) | |
| Time point 3 (last CT cycle) | 63.3 (57.3–69.3) | 66.6 (57.6–75.6) | |
| Time point 4 (3 months after treatment completion) | 74 (67.7–80.3) | 73.2 (63.8–82.6) | |
| Time point 5 (6–9 months after CT completion) | 81.7 (75.5–87.9) | 84.3 (74.5–94.0) | |
| QLQ-C30 Emotional Functioning | P=0.725 | ||
| Time point 1 (baseline) | 67.7 (62.7–72.7) | 63.7 (56.6–70.8) | |
| Time point 2 (mid chemotherapy) | 69.9 (64.8–75.1) | 65.7 (58.2–73.2) | |
| Time point 3 (last CT cycle) | 70.6 (65.6–75.7) | 66.4 (58.8–73.9) | |
| Time point 4 (3 months after treatment completion) | 75.3 (70.0–80.6) | 77.1 (69.2–85.0) | |
| Time point 5 (6–9 months after CT completion) | 80.9 (75.6–86.1) | 77.5 (69.3–85.7) | |
| QLQ-C30 Summary Score | P=0.627 | ||
| Time point 1 (baseline) | 84.4 (80.8–88.0) | 83.6 (78.4–88.8) | |
| Time point 2 (mid chemotherapy) | 69.6 (65.9–73.3) | 66.2 (60.9–71.5) | |
| Time point 3 (last CT cycle) | 68.6 (65.0–72.2) | 62.8 (57.3–68.3) | |
| Time point 4 (3 months after treatment completion) | 79.4 (75.7–83.2) | 77.8 (72.3–83.4) | |
| Time point 5 (6–9 months after CT completion) | 83.9 (80.1–87.6) | 83.3 (77.3–89.2) |
Notes: P-values are reported for the group-by-time interaction, ie the group-difference in change over time.