Digital solution in the follow-up of early breast cancer a randomized study

Figures & data

Figure 1. Flow chart of the patients and study design.

Table 1. Patient characteristics.

	Total	Group A^a	Group B^b
	n = 142 (%)	n = 71 (%)	n = 71 (%)
Age years median (range)	60.5 (35.3–79.7)	62.4 (37.8-79.3)	59.3 (35.3–79.7)
Education
Master degree or higher	106 (74.8%)	56 (78.9%)	50 (70.4%)
Other	36 (25.4%)	15 (21.1%)	21 (29.6%)
T-Stage
Tis	3 (2.1%)	1 (1.4%)	2 (2.8%)
T1	103 (72.5%)	56 (78.9%)	47 (66.2%)
T2	28 (19.7%)	10 (14.1%)	18 (25.4%)
T3	5 (3.5%)	2 (2.8%)	3 (4.2%)
Tx	3 (2.1%)	2 (2.8%)	1 (1.4%)
Nodal stage
N0	74 (52.1%)	36 (50.7%)	38 (53.5%)
N0i+	4 (2.8%)	2 (2.8%)	2 (2.8%)
N1mi	10 (7.0%)	3 (4.2%)	7 (9.9%)
N1	38 (26.8%)	21 (29.6%)	17 (23.9%)
N2	9 (6.3%)	5 (7.0%)	4 (5.6%)
N3	4 (2.8%)	3 (4.2%)	1 (1.4%)
Unknown	3 (2.1%)	1 (1.4%)	2 (2.8%)
Histological type
Ductal	93(65.5%)	48 (67.6%)	45 (63.4%)
Lobular	32 (22.5%)	14 (19.7%)	18 (25.4%)
Other	17 (12.0%)	9 (12.7%)	8 (11.3%)
Histological grade
G1	36 (25.4%)	17 (23.9%)	19 (26.8%)
G2	58 (40.8%)	27 (38.0%)	31 (43.7%)
G3	47 (33.1%)	26 (36.6%)	21 (29.6%)
Missing	1 (0.7%)	1 (1.4%
Estrogen receptor- positivity
< 10%	17 (12.0%)	12 (16.9%)	5 (7.0%)
≥ 10%	122 (85.9%)	58 (81.7%)	64 (90.1%)
Not done	3 (2.1%)	1 (1.4%)	2 (2.8%)
Progesterone- receptor- positivity
< 10%	36 (25.4%)	22 (31.0%)	14 (19.7%)
≥ 10%	103 (72.5%)	48 (67.6%)	55 (77.5%)
Not done	3 (2.1%)	1 (1.4%)	2 (2.8%)
HER-2
Negative	133 (93.7%)	68 (95.8%)	65 (91.5%)
Positive	6 (4.2%)	2 (2.8%)	4 (5.6%)
Not done	3 (2.1%)	1 (1.4%)	2 (2.8%)
Mastectomy	29 (20.4%)	12 (16.9%)	17 (23.9%)
Breast-conserving	112 (78.9%)	59 (83.1%)	53 (74.6%)
Biopsy	1 (0.7%)	0 (0%)	1 (1.4%)
Axillary surgery
Sentinel node biopsy	87 (61.3%)	41 (57.7%)	46 (64.8%)
Dissection	52 (36.6%)	29 (40.8%)	23 (32.4%)
None	3 (2.1%)	1 (1.4%)	2 (2.8%)
Postoperative
adjuvant chemotherapy	73 (51.4%)	36 (50.7%)	37 (52.1%)
Neoadjuvant chemotherapy	4 (2.8%)	3 (4.2%)	1 (1.4%)
Trastuzumab	4 (2.8%)	1 (1.4%)	3 (4.2%)
Radiotherapy	142 (100%)	71 (100%)	71 (100%)
Endocrine treatment	111 (78.2%)	56 (78.9%)	55 (77.5%)

^aDigital solution for the first 6 months and phone calls for months 6–12.

^bPhone calls for the first 6 months and digital solution for months 6–12.

Table 2. Contacts and satisfaction score during both follow-up modalities at 6 and 12 months.

		Group A Digital solution 6 months n = 71	Group B Phone calls 6 months n = 71	Group B Digital solution 12 months n = 71	Group A Phone calls 12 months n = 71
Mean number of contacts (SD)		2.49 (1.80)	1.79 (1.13)	2.34 (2.38)	1.41 (0.79)
Mean contact time (SD)		24.3 (19.6)	15.3 (10.9)	21.6 (20.5)	13.2 (9.6)
Mean patient satisfaction score (standard deviation)
Group A Digital solution 6 months n = 70	Group B Phone calls 6 months n = 70	Group B Digital solution 12 months n = 70	Group A Phone calls 12 months n = 70	Difference between follow-up modalities	Interaction between follow-up time and randomization group	Difference between randomization groups
3.31 (0.73)	3.26 (0.76)	3.42 (0.60)	3.40 (0.70)	p = 0.59	p = 0.04	p = 0.88

Table 3. Quality of life during both follow-up modalities at 6 and 12 months.

Mean EORTC QLQ-C30 global QoL score (standard deviation)
Group A Digital solution 6 months n = 71	Group B Phone calls 6 months n = 71	Group B Digital solution 12 months n = 71	Group A Phone calls 12 months n = 71	Difference between follow-up modalities p	Interaction between follow-up and randomization groups p	Difference between randomizatiom groups p
Baseline
74.8 (15.0)	71.4 (15.4)	71.4 (15.4)	74.8 (15.0)
After follow-up
71.7 (15.0)	70.5 (18.8)	68.4 (16.4)	73.1 (14.4)	0.15	0.77	0.23
Mean 15D QoL score (standard deviation)
Group A Digital solution 6 months n = 70	Group B Phone calls 6 months n = 70/69^a	Group B Digital solution 12 months n = 70/69^a	Group A Phone calls 12 months n = 70	Difference between follow-up modalities p	Interaction between follow-up and randomization groups p	Difference between randomization groups p
Baseline
0.88 (0.08)	0.87 (0.08)	0.87 (0.08)	0.88 (0.08)
After follow-up
0.88 (0.08)	0.87 (0.09)	0.86 (0.10)	0.87 (0.09)	0.59	0.09	0.49

^a n Baseline/n After follow-up.

Data availability statement

All data generated or analyzed during this study are included in this published article.