Introduction
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Generate short- and long-term data on clinical and patient-reported outcomes during and after breast cancer treatment.
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Provide an infrastructure for multiple randomized evaluations of interventions for breast cancer patients and survivors.
Materials and methods
Enrollment
Staged-informed consent
Clinical data
Patient-reported outcomes
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Quality of Life: European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30, including breast cancer specific module BR23 [17]
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Fatigue: Multidimensional Fatigue Inventory-20 [18]
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Anxiety and Depression: Hospital Anxiety and Depression Scale (HADS) [19]
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Physical activity: QUestionnaire to ASses Health enhancing physical activity (SQUASH) [20]
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Work ability: Work Ability Index (WAI) [21]
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Cosmetic outcome: Cosmetic Evaluation [22].
Results
% (n/N) | |
---|---|
Eligible patients | 1486 |
Cohort participation | 88% (1308/1486) |
broad consent for randomization
| 87% (1138/1308) |
Questionnaire return ratesa
| |
Baseline | 80% (1041/1308) |
3 months | 74% (868/1178) |
6 months | 73% (750/1027) |
12 months | 69% (537/773) |
18 months | 68% (339/498) |
24 months | 67% (146/217) |
Characteristics | Full cohort | Consent for future random allocation | No consent for future random allocation | Returned baseline questionnaire | Did not return baseline questionnaire |
---|---|---|---|---|---|
Number of participants | 1047a
| 910 | 137 | 838 | 209 |
Age at recruitment | |||||
Mean (range) | 58 (27–83) | 57 (27–83) | 60 (28–82) | 58 (26–83) | 54 (23–82) |
Surgery | |||||
Breast conserving | 82% (858/1047) | 82% (742/910) | 83% (114/137) | 84% (700/838) | 76% (158/209) |
Mastectomy | 17% (176/1047) | 17% (157/910) | 14% (19/137) | 15% (128/838) | 23% (48/209) |
ALND only | <0.5% (3/1047) | <0.5% (3/910) | 0% | <0.5% (1/838) | 1% (2/209) |
No surgery | 0.5% (6/1047) | <0.5% (4/910) | 1.5% (2/137) | 0.5% (6/838) | 0% |
Unknown | <0.5% (4/1047) | <0.5% (4/910) | <0.5% (1/137) | <0.5% (3/838) | 0.5% (1/209) |
Radiotherapyb
| |||||
Local | 83% (680/815) | 83% (584/700) | 83% (94/113) | 84% (561/666) | 80% (119/149) |
Loco-regional | 14% (116/815) | 14% (99/700) | 15% (17/113) | 13% (88/666) | 19% (28/149) |
Regional only | 1.5% (12/815) | 1% (10/700) | 2% (2/113) | 1.5% (11/666) | 0.5% (1/149) |
None | <0.5% (3/815) | <0.5% (3/700) | 0% | <0.5% (2/666) | 0.5% (1/149) |
Unknown | 0.5% (4/815) | 0.5% (4/700) | 0% | 0.5% (4/666) | 0% |
Tumor histologyc
| |||||
Ductal | 82% (734/899) | 81% (634/781) | 85% (98/116) | 82% (599/731) | 80% (135/168) |
Lobular | 11% (100/899) | 11% (89/781) | 10% (11/116) | 11% (78/731) | 13% (22/168) |
Ductolobular | 3% (27/899) | 3% (24/781) | 3% (3/116) | 3% (25/731) | 1% (2/168) |
Other | 4% (35/899) | 4% (31/781) | 3% (4/116) | 3% (24/731) | 5% (8/168) |
Unknown | <0.5% (3/899) | <0.5% (3/781) | 0% | 0.5% (5/731) | 0.5% (1/168) |
pT-stage | |||||
in situ | 12% (109/902) | 12% (94/780) | 13% (15/120) | 13% (93/729) | 9% (16/173) |
1 | 58% (542/902) | 59% (459/780) | 55% (66/120) | 59% (427/729) | 57% (99/173) |
2 | 20% (180/902) | 20% (153/780) | 23% (27/120) | 20% (142/729) | 22% (38/173) |
≥3 | 3% (26/902) | 3% (21/780) | 4% (5/120) | 3% (21/729) | 3% (5/173) |
X/0 | 7% (61/902) | 7% (53/780) | 6% (7/120) | 6% (46/729) | 9% (15/173) |
Screen-detected | |||||
Yes | 47% (302/638) | 47% (253/543) | 48% (45/93) | 48% (257/531) | 42% (45/107) |
No | 50% (321/638) | 51% (276/543) | 51% (47/93) | 50% (264/531) | 53% (57/107) |
Unknown | 2% (15/638) | 3% (14/543) | 1% (1/93) | 2% (10/531) | 5% (5/107) |
EORTC global health status/quality of life (baseline) | 74 (18) | 74 (18) | 75 (17) | 74 (17) | 75 (19) |
EORTC physical functioning (baseline) | 85 (16) | 85 (16) | 85 (15) | 84 (16) | 84 (15) |
EORTC fatigue (baseline) | 71 (22) | 71 (22) | 72 (22) | 71 (23) | 70 (22) |