Table 1.
Baseline characteristics of the LISA study population—patients, tumor and treatment related characteristics in subjects in the lifestyle intervention arm and education only arm.
| Education only arm | Lifestyle intervention arm characteristic | |
|---|---|---|
| Randomized, N | 167 | 171 |
| Stratum | ||
| BMI (kg/m2) | ||
| 24–30, N (%) | 76 (45.5) | 73 (42.7) |
| >30, N (%) | 91 (54.5) | 98 (57.3) |
| Prior adjuvant chemotherapy | ||
| Yes, N (%) | 96 (57.5) | 96 (56.1) |
| No, N (%) | 71 (42.5) | 75 (43.9) |
| Intervention language | ||
| English, N (%) | 147 (88.0) | 151 (88.3) |
| French, N (%) | 20 (12.0) | 20 (11.7) |
| Demographics | ||
| Age | ||
| Mean (SD) | 60.4 (7.8) | 61.6 (6.7) |
| Race | ||
| White, N (%) | 162 (97.0) | 161 (94.2) |
| Asian, N (%) | 3 (1.8) | 3 (1.8) |
| Black, N (%) | 0 (0.0) | 4 (2.3) |
| Native, N (%) | 0 (0.0) | 1 (0.6) |
| Other, N (%) | 2 (1.2) | 2 (1.2) |
| Height (cm) | ||
| Mean (SD) | 161.6 (6.2) | 162.0 (6.4) |
| Weight (kg) | ||
| Mean (SD) | 81.0 (14.4) | 82.7 (15.3) |
| Body mass index | ||
| Mean (SD) | 31.1 (5.3) | 31.4 (5.0) |
| Median (range) | 30.4 (24.0–55.2) | 30.7 (24.0–60.7) |
| Smoking history | ||
| Currently, N (%) | 15 (9.0) | 9 (5.3) |
| Previous (<6 months), N (%) | 9 (5.4) | 8 (4.7) |
| Previous (>6 months), N (%) | 60 (35.9) | 72 (42.1) |
| Never, N (%) | 83 (49.7) | 82 (48.0) |
| Marital status | ||
| Currently married, N (%) | 119 (71.3) | 123 (71.9) |
| Single, N (%) | 12 (7.2) | 18 (10.5) |
| Widowed, N (%) | 12 (7.2) | 12 (7.0) |
| Divorced/separated, N (%) | 22 (13.2) | 18 (10.5) |
| Not given, N (%) | 2 (1.2) | 0 (0.0) |
| Living situation | ||
| Spouse/partner and children, N (%) | 24 (14.4) | 27 (15.8) |
| Spouse/partner only, N (%) | 91 (54.5) | 91 (53.2) |
| Children only, N (%) | 8 (4.8) | 7 (4.1) |
| Other relatives, N (%) | 5 (3.0) | 7 (4.1) |
| Other non-relatives, N (%) | 1 (0.6) | 2 (1.2) |
| Alone, N (%) | 35 (21.0) | 32 (18.7) |
| Other, N (%) | 3 (1.8) | 5 (2.9) |
| Tumour characteristics | ||
| T status | ||
| 1, N 9%) | 103 (61.7) | 114 (66.7) |
| 2, N (%) | 56 (33.5) | 47 (27.5) |
| 3, N (%) | 6 (3.6) | 10 (5.9) |
| Missing/NA | 1 (0.6) | 0 (0.0) |
| N status | ||
| 0, N (%) | 106 (63.5) | 107 (62.6) |
| 1, N (%) | 54 (32.3) | 49 (28.7) |
| 2, N (%) | 6 (3.6) | 14 (8.2) |
| 3a, N(%) | 1 (0.6) | 1 (0.6) |
| Overall grade | ||
| I, N (%) | 41 (24.6) | 38 (22.2) |
| II, N (%) | 73 (43.7) | 96 (56.1) |
| III, N (%) | 51 (30.5) | 37 (21.6) |
| Missing/NA, N (%) | 2 (1.2) | 0 (0.0) |
| ER status | ||
| Positive, N (%) | 166 (99.4) | 167 (97.7) |
| Negative, N (%) | 1 (0.6) | 4 (2.3) |
| PR status | ||
| Positive, N (%) | 145 (86.8) | 144 (84.2) |
| Negative, N (%) | 21 (12.6) | 27 (15.8) |
| Missing/NA, N (%) | 1 (0.6) | 0 (0.0) |
| HER2 status | ||
| Positive, N (%) | 25 (15.0) | 15 (8.8) |
| Negative, N (%) | 138 (82.6) | 153 (89.5) |
| Missing/NA, N (%) | 4 (2.4) | 3 (1.8) |
| Prior treatment | ||
| Irradiation therapy | ||
| No, N (%) | 42 (25.2) | 33 (19.3) |
| Yes, N (%) | 125 (74.9) | 138 (80.7) |
| Surgery type | ||
| Mastectomy, N (%) | 64 (38.3) | 60 (35.1) |
| Lumpectomy, N (%) | 113 (67.7) | 120 (70.2) |
| Axillary node dissection, N (%) | 94 (56.3) | 96 (56.1) |
| Sentinel node biopsy, N (%) | 113 (67.7) | 108 (63.2) |
| Systemic chemotherapy | ||
| No, N (%) | 69 (41.3) | 75 (43.9) |
| Yes, N (%) | 98 (58.7) | 96 (56.1) |
| Chemo- and endocrine therapy type | ||
| AC, N (%) | 17 (10.2) | 13 (7.6) |
| AC Taxol, N (%) | 29 (17.4) | 21 (12.3) |
| FEC 100, N (%) | 5 (3.0) | 11 (6.4) |
| FEC Taxotere, N (%) | 24 (14.4) | 28 (16.4) |
| CEF, N (%) | 2 (1.2) | 0 (0.0) |
| Tamoxifen, N (%) | 14 (8.4) | 11 (6.4) |
| Anastrozole, N (%) | 8 (4.8) | 8 (4.7) |
| Exemestane, N (%) | 2 (1.2) | 0 (0.0) |
| Herceptin, N (%) | 24 (14.4) | 12 (7.0) |
| Lapatinib, N (%) | 0 | 0 |
|
Months from diagnosis median (range) |
9.1 (2.0–37.0b) | 9.4 (1.6–92.0b) |
|
Months from definitive surgery median (range) |
7.3 (1.0–34.9) | 7.6 (0.2–91.6) |
BMI body mass index, SD standard deviation, NA not available, ER estrogen receptor, PR progesterone receptor, HER2 human epidermal growth factor receptor 2, AC Adriamycin-cyclophosphamide, FEC fluouracil-epirubicin-cyclophosphamide, CEF cyclophosphamide-epirubicin-fluouracil.
aN3 patients were included in initial protocol.
bOne patient was diagnosed 7.7 (waiver) years prior to trial randomization. Two lifestyle intervention arm patients and two education only arm subjects were diagnosed between 36 to 39 months prior to randomization, however, surgery was <36 months prior to randomization. All other patients were diagnosed <36 months prior to randomization.