Background
Methods
Patients
Study design
HRQOL questionnaires
Then-test assessment
Assessment of change in HRQOL level
-
Did not change globally
-
Deteriorated: very much, much, a little
-
Improved: a little, much, very much”
Statistical methods
Statistical considerations and missing data
Descriptive analysis
Detection of the recalibration effect of the RS
Observed and adjusted MID
Results
Patients
Number | Percent | |
---|---|---|
Hospital | ||
Dijon | 271 | 71.1 |
Nancy | 74 | 19.4 |
Reims | 18 | 4.7 |
Strasbourg | 18 | 4.7 |
Inclusion criteria | ||
Confirmed primary breast cancer | 242 | 63.5 |
Suspicion of primary breast cancer | 138 | 36.2 |
Unknown | 1 | 0.3 |
Cancer | ||
Confirmed | 337 | 89.2 |
Not confirmed | 41 | 10.0 |
Unknown | 3 | 0.8 |
Stage (AJCC) | ||
0 | 78 | 20.5 |
1 | 135 | 35.4 |
2 | 118 | 31 |
3 or 4 | 15 | 4 |
Unknown | 35 | 9.1 |
Lymph node dissection (LND) | ||
Axillary LND | 138 | 36.2 |
Sentinel lymph node biopsy | 131 | 34.4 |
ALND + SLNB | 32 | 8.4 |
No LND | 75 | 19.7 |
Unknown | 5 | 1.3 |
Surgery type | ||
Mastectomy | 124 | 32.6 |
No mastectomy | 241 | 63.3 |
Unknown | 16 | 4.2 |
Chemotherapy | ||
Yes | 155 | 40.7 |
No | 218 | 57.2 |
Unknown | 8 | 2.1 |
Radiotherapy | ||
Yes | 254 | 66.7 |
No | 119 | 31.2 |
Unknown | 8 | 2.1 |
Hormone therapy | ||
Yes | 170 | 44.6 |
No | 203 | 53.3 |
Unknown | 8 | 2.1 |
Detection of the recalibration component of the Response shift effect
QLQ-C30 | After 3 months | After 6 months | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Between T0 and T1 | Between T1 and T2 | |||||||||
N | RS (SD) | 95%CI |
P-value | ES | N | RS (SD) | 95% CI |
P-value | ES | |
GHS | 251 | 3.82 (17.85) | 0.02 | 0.20 | 251 | −0.03 (21.04) | 0.97 | 0 | ||
Little worse | 71 | 3.87 (15.86) | (1, 7) | 0.24 | 0.25 | 51 | −8.33 (19.22) | (−13, −4) | 0.03 | −0.42 |
No change | 43 | 6.78 (15.67) | (3, 11) | 0.08 | 0.40 | 50 | 8 (19.04) | (3, 13) | 0.03 | 0.42 |
Little better | 58 | 1.29 (17.51) | (−3, 5) | 0.67 | 0.08 | 67 | −0.25 (21.61) | (−5, 4) | 0.80 | −0.01 |
Physical functioning | 255 | 1.54 (12.95) | 0.30 | 0.11 | 255 | −5.2 (12.86) | 0 | −0.32 | ||
Little worse | 73 | −0.53 (11.11) | (−3, 2) | 0.49 | −0.05 | 53 | −9.56 (10.42) | (−12, −7) | 0 | −0.52 |
No change | 46 | 1.30 (13.67) | (−2, 5) | 0.17 | 0.09 | 51 | −2.29 (8.5) | (−4, 0) | 0.13 | −0.26 |
Little better | 57 | 3.83 (14.47) | (1, 7) | 0.45 | 0.28 | 69 | −3.94 (14.71) | (−7, −1) | 0.04 | −0.25 |
Role functioning | 253 | 6.06 (21.71) | 0 | 0.32 | 253 | −8.17 (27.07) | 0 | −0.29 | ||
Little worse | 73 | 6.62 (19.98) | (3, 11) | 0.04 | 0.46 | 51 | −15.69 (28.95) | (−22, −9) | 0 | −0.52 |
No change | 46 | 3.26 (16.34) | (−1, 7) | 0.07 | 0.19 | 51 | −1.96 (18.45) | (−6, 2) | 0.67 | −0.11 |
Little better | 55 | 10 (26.57) | (4, 16) | 0.05 | 0.45 | 68 | −5.88 (26.67) | (−11, 0) | 0.24 | −0.21 |
Emotional functioning | 254 | −7.56 (21.03) | 0 | −0.29 | 254 | 2.20 (22.68) | 0.20 | 0.09 | ||
Little worse | 72 | −9.34 (20.97) | (−13, −5) | 0 | −0.38 | 52 | −5.66 (19.77) | (−10, −1) | 0.16 | −0.24 |
No change | 44 | −8.52 (17.14) | (−13, −4) | 0.03 | −0.42 | 50 | 8.94 (21.58) | (4, 14) | 0.04 | 0.47 |
Little better | 59 | −11.11 (23.15) | (−16, −6) | 0.01 | −0.43 | 69 | 5.68 (21.83) | (1, 10) | 0.10 | 0.23 |
Cognitive functioning | 254 | −3.94 (16.85) | 0.01 | −0.19 | 254 | −3.08 (20.03) | 0.04 | −0.15 | ||
Little worse | 73 | −5.48 (20.04) | (−9, −2) | 0.08 | −0.26 | 52 | −10.58 (21.9) | (−16, −5) | 0.02 | −0.42 |
No change | 44 | −1.52 (10.67) | (−4, 1) | 0.69 | −0.11 | 50 | −2.33 (16.5) | (−6, 2) | 0.35 | −0.16 |
Little better | 57 | −5.85 (19.29) | (−10, −2) | 0.08 | −0.27 | 69 | 0.97 (18.28) | (−3, 5) | 0.98 | 0.05 |
Social functioning | 249 | 5.09 (19.43) | 0 | 0.28 | 249 | −5.96 (24.47) | 0.01 | −0.23 | ||
Little worse | 72 | 5.32 (19.94) | (1, 9) | 0.05 | 0.39 | 52 | −10.90 (25.54) | (−17, −5) | 0.02 | −0.40 |
No change | 42 | 3.17 (14.37) | (−1, 7) | 0.08 | 0.24 | 49 | −4.76 (16.67) | (−9, −1) | 0.40 | −0.22 |
Little better | 59 | 3.67 (20.55) | (−1, 8) | 0.59 | 0.18 | 68 | −1.23 (24.32) | (−6, 4) | 0.91 | −0.05 |
Financial difficulties | 240 | −1.11 (15.32) | 0.30 | −0.08 | 240 | 2.50 (16.26) | 0.22 | 0.12 | ||
Little worse | 69 | −1.45 (12.04) | (−4, 1) | 0.58 | −0.14 | 49 | 8.16 (24.09) | (2, 14) | 0.13 | 0.30 |
No change | 41 | −1.63 (7.27) | (−4, 0) | 0.31 | −0.31 | 47 | −0.71 (4.86) | (−2, 0) | 0.57 | −0.15 |
Little better | 58 | 0.57 (15.91) | (−3, 4) | 0.86 | 0.03 | 66 | −1.01 (16.51) | (−4, 2) | 0.82 | −0.05 |
Fatigue | 254 | −1.20 (19.42) | 0.51 | −0.06 | 254 | 10.83 (23.93) | 0 | 0.41 | ||
Little worse | 73 | −4.57 (21.36) | (−9, 0) | 0.31 | −0.33 | 53 | 19.92 (23.23) | (15, 25) | 0 | 0.85 |
No change | 46 | −2.17 (15.29) | (−6, 2) | 0.62 | −0.12 | 51 | 3.70 (20.08) | (−1, 8) | 0.32 | 0.20 |
Little better | 57 | −4.58 (21.29) | (−9, 0) | 0.35 | −0.23 | 68 | 9.97 (23.76) | (5, 15) | 0.01 | 0.44 |
Nausea and vomiting | 255 | −1.37 (13.59) | 0.26 | −0.13 | 255 | 3.59 (17.65) | 0 | 0.19 | ||
Little worse | 74 | −0.45 (15.35) | (−3, 3) | 0.71 | −0.05 | 53 | 4.09 (14.58) | (1, 7) | 0.09 | 0.26 |
No change | 46 | 0.72 (9.91) | (−2, 3) | 1 | 0.04 | 51 | 0.98 (10.23) | (−1, 3) | 0.10 | 0.10 |
Little better | 57 | −5.26 (15.16) | (−9, −2) | 0.05 | −0.87 | 70 | 6.67 (25.44) | (2, 12) | 0.05 | 29 |
Pain | 260 | −3.33 (22.51) | 0.14 | −0.16 | 260 | 5.83 (22.2) | 0 | 0.23 | ||
Little worse | 75 | −4.67 (21.32) | (−9, −1) | 0.29 | −0.24 | 54 | 15.43 (26.27) | (9, 21) | 0 | 0.56 |
No change | 46 | 1.45 (18.2) | (−3, 6) | 0.83 | 0.09 | 52 | 2.24 (13.21) | (−1, 5) | 0.30 | 0.18 |
Little better | 57 | −7.31 (23.57) | (−13, −2) | 0.16 | −0.35 | 70 | −0.24 (23.14) | (−5, 4) | 0.80 | −0.01 |
Dyspnea | 251 | 1.20 (15.16) | 0.59 | 0.06 | 251 | 3.98 (22.4) | 0.03 | 0.17 | ||
Little worse | 73 | 2.28 (15.04) | (−1, 5) | 0.38 | 0.11 | 52 | 3.85 (27.74) | (−3, 10) | 0.14 | 0.17 |
No change | 45 | 0 (12.31) | (−3, 3) | 0.77 | 0 | 51 | 0.65 (10.52) | (−2, 3) | 0.79 | 0.05 |
Little better | 55 | 0.61 (17.56) | (−3, 5) | 0.77 | 0.03 | 67 | 3.98 (22.11) | (−1, 8) | 0.51 | 0.17 |
Insomnia | 249 | 6.83 (30.64) | 0.01 | 0.22 | 249 | 3.08 (30.41) | 0.30 | 0.10 | ||
Little worse | 69 | 2.42 (29.33) | (−3, 8) | 0.49 | 0.08 | 52 | 10.9 (37.18) | (2, 2) | 0.07 | 0.33 |
No change | 46 | 7.25 (26.21) | (1, 14) | 0.27 | 0.25 | 50 | 3.33 (25.42) | (−3, 9) | 0.24 | 0.18 |
Little better | 55 | 7.88 (37.93) | (−1, 16) | 0.11 | 0.27 | 67 | −1.49 (29.83) | (−8, 5) | 0.74 | −0.05 |
Appetite loss | 249 | 2.28 (21.05) | 0.23 | 0.11 | 249 | 4.69 (22.2) | 0.03 | 0.19 | ||
Little worse | 73 | 0.91 (20.77) | (−3, 5) | 0.55 | 0.06 | 53 | 13.84 (24.84) | (8, 20) | 0 | 0.51 |
No change | 46 | 4.35 (13.35) | (1, 8) | 0.19 | 0.22 | 50 | 0.67 (15.78) | (−3, 4) | 0.98 | 0.03 |
Little better | 54 | 1.85 (22.82) | (−3, 7) | 0.79 | 0.09 | 68 | 1.96 (21.46) | (−2, 6) | 0.74 | 0.09 |
Constipation | 247 | 0 (22.61) | 0.87 | 0 | 247 | 4.18 (25.89) | 0.05 | 0.16 | ||
Little worse | 68 | −4.90 (18.45) | (−9, −1) | 0.19 | −0.26 | 48 | 4.17 (25.38) | (−2, 10) | 0.29 | 0.16 |
No change | 42 | 2.38 (18.61) | (−2, 7) | 0.42 | 0.11 | 48 | 2.08 (14.43) | (−1, 6) | 0.43 | 0.15 |
Little better | 58 | 0 (27.22) | (−6, 6) | 0.87 | 0 | 70 | 2.86 (35.32) | (−4, 10) | 0.71 | 0.10 |
Diarrhea | 248 | 2.42 (14.99) | 0.09 | 0.15 | 248 | 0.94 (20.28) | 0.42 | 0.06 | ||
Little worse | 71 | 3.29 (16.09) | (0, 6) | 0.28 | 0.18 | 48 | 3.47 (14.16) | (0, 7) | 0.22 | 0.23 |
No change | 43 | 1.55 (12.50) | (−2, 5) | 0.54 | 0.13 | 48 | −0.69 (14.57) | (−4, 3) | 0.98 | −0.07 |
Little better | 56 | 2.98 (17.15) | (−1, 7) | 0.34 | 0.16 | 69 | 0 (26.81) | (−5, 5) | 0.86 | 0 |
After 3 months | After 6 months | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Between T0 and T1 | Between T1 and T2 | |||||||||
QLQ-BR23 | N | RS (SD) | 95%CI |
P-value | ES | N | RS (SD) | 95%CI |
P-value | ES |
Body image | 232 | 6.50 (20.73) | 0.01 | 0.37 | 232 | −7.18 (22.33) | 0.01 | −0.23 | ||
Little worse | 70 | 5.04 (17.89) | (1, 9) | 0.11 | 0.32 | 47 | −11.17 (21.1) | (−16, −6) | 0.03 | −0.37 |
No change | 41 | 3.25 (14.54) | (−1, 7) | 0.11 | 0.20 | 46 | −3.62 (12.25) | (−7, −1) | 0.28 | −0.19 |
Little better | 49 | 9.98 (23) | (4, 15) | 0.11 | 0.62 | 65 | −2.74 (24.7) | (−8, 2) | 0.63 | −0.09 |
Sexual functioning | 198 | 0.76 (15.06) | 0.77 | 0.03 | 198 | 4.29 (18.88) | 0.10 | 0.19 | ||
Little worse | 56 | 0.60 (15.56) | (−3, 4) | 0.90 | 0.02 | 38 | 10.96 (19.86) | (6, 16) | 0.07 | 0.52 |
No change | 34 | 1.96 (15.77) | (−3, 7) | 0.73 | 0.08 | 41 | 0.41 (18.44) | (−4, 5) | 0.90 | 0.01 |
Little better | 43 | −1.94 (12.71) | (−5, 1) | 0.77 | −0.08 | 56 | 0.89 (16.02) | (−3, 4) | 0.88 | 0.05 |
Sexual enjoyment | 74 | −4.05 (20.74) | 0.26 | −0.16 | 74 | 3.15 (23.49) | 0.21 | 0.13 | ||
Little worse | 23 | −2.90 (24.44) | (−12, 6) | 0.59 | −0.16 | 16 | 2.08 (30.96) | (−11, 16) | 0.55 | 0.10 |
No change | 16 | −6.25 (13.44) | (−12, 0) | 0.51 | −0.23 | 23 | 1.45 (25.58) | (−8, 11) | 0.69 | 0.06 |
Little better | 11 | −3.03 (23.35) | (−16, 10) | 0.80 | −0.10 | 16 | 2.08 (14.75) | (−4, 9) | 0.83 | 0.08 |
Future perspectives | 236 | −7.91 (30.3) | 0.01 | −0.27 | 236 | 1.27 (30.77) | 0.64 | 0.04 | ||
Little worse | 68 | −16.18 (27.31) | (−22, −11) | 0 | −0.56 | 48 | −4.17 (31.98) | (−12, 4) | 0.49 | −0.13 |
No change | 43 | −13.18 (29.22) | (−21, −6) | 0.04 | −0.47 | 49 | 4.76 (34.69) | (−4, 13) | 0.47 | 0.18 |
Little better | 48 | −6.94 (32.95) | (−15, 1) | 0.22 | −0.28 | 63 | 7.41 (25.71) | (2, 13) | 0.18 | 0.23 |
Systemic therapy side effects | 252 | 0.42 (12.32) | 0.73 | 0.03 | 252 | 8.16 (16.76) | 0 | 0.42 | ||
Little worse | 72 | 0.96 (12.49) | (−1, 3) | 0.78 | 0.07 | 53 | 13.76 (19.15) | (9, 18) | 0 | 0.73 |
No change | 45 | −0.56 (8.12) | (−3, 1) | 0.90 | −0.04 | 52 | 2.22 (8.64) | (0, 4) | 0.53 | 0.19 |
Little better | 54 | 0 (12.64) | (−3, 3) | 0.47 | 0 | 65 | 8.13 (19.39) | (4, 12) | 0 | 0.45 |
Breast symptoms | 212 | −2.59 (19.13) | 0.69 | −0.18 | 212 | 8.54 (20.19) | 0 | 0.35 | ||
Little worse | 57 | 4 (17.94) | (0, 8) | 0.09 | 0.24 | 47 | 10.76 (19.94) | (6, 16) | 0.01 | 0.4 |
No change | 36 | −0.62 (11.35) | (−4, 3) | 0.68 | −0.07 | 42 | 7.34 (16.22) | (3, 12) | 0.02 | 0.47 |
Little better | 53 | −9.49 (21.49) | (−14, −5) | 0.12 | −0.76 | 59 | 5.84 (14.8) | (3, 9) | 0.17 | 0.23 |
Arm symptoms | 235 | −1.94 (16.33) | 0.50 | −0.14 | 235 | 3.81 (19.17) | 0.02 | 0.21 | ||
Little worse | 67 | 0.66 (18) | (−3, 4) | 0.55 | 0.05 | 48 | 10.19 (20.06) | (5, 15) | 0 | 0.47 |
No change | 41 | 1.36 (7.93) | (−1, 3) | 0.31 | 0.16 | 50 | 4 (10.88) | (1, 7) | 0.01 | 0.36 |
Little better | 55 | −3.13 (18.07) | (−7, 1) | 0.45 | −0.18 | 64 | 0 (17.51) | (−4, 4) | 0.71 | 0 |
-
For the insomnia dimension of the QLQ-C30 questionnaire, the RS effect was equal to 2.42 in mean at three months reflecting that patients had overestimated their baseline insomnia level, considering the retrospective measure at three months as the reference. The RS effect became more important after six months by increasing to 10.9 in mean reflecting an overestimation of the insomnia level at T1. Thus, the magnitude of the RS effect increased at six months as compared to three months, with a positive direction of the RS at both time points.
-
Regarding the body image dimension of the QLQ-BR23 module, the magnitude of the mean RS effect also increase between each follow-up time point from 5.04 to 11.17 in absolute value but with an opposite direction of RS was shown at T1 equal to 5.04 in mean compared with its value after six months by increasing to −11.17 with underestimation of body image pre-test score at T1.
-
A decrease of RS effect with underestimation of pain level at T0 and T1 from −7.31 after three months to −0.24 after six months for;
-
A decrease of RS effect from 9.98 with overestimation of baseline body image level to −2.74 with underestimation of body image pre-test score at T1.
Observed and adjusted MID
QLQ-C30 | After 3 months | After 6 months | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Between T0 and T1 | Between T1 and T2 | |||||||||
Observed changes | Adjusted changes | Observed changes | Adjusted changes | |||||||
(post-test - pre-test) | (post-test - then-test) | (post-test - pre-test) | (post-test - then-test) | |||||||
N | Mean (SD) | 95% CI | Mean (SD) | 95% CI | N | Mean (SD) | 95% CI | Mean (SD) | 95% CI | |
GHS | 251 | 251 | ||||||||
Little worse | 71 | −16.31 (16.99) | (−20, −13) | −12.44 (16.78) | (−16, −9) | 51 | 0.49 (15.4) | (−3, 4) | −7.84 (15.22) | (−11, −4) |
No change | 43 | −2.13 (16.17) | (−6, 2) | 4.65 (17.85) | (0, 9) | 50 | −1 (16.12) | (−5, 3) | 7 (14.71) | (4, 10) |
Little better | 58 | 0.29 (18.4) | (−4, 4) | 1.58 (14.93) | (−2, 5) | 67 | 7.21 (17.22) | (4, 11) | 6.97 (16.70) | (4, 10) |
Physical functioning | 255 | 255 | ||||||||
Little worse | 73 | −11.76 (10.99) | (−14, −10) | −12.28 (12.71) | (−15, −10) | 53 | 0.38 (11.43) | (−2, 3) | −9.18 (12.83) | (−12, −6) |
No change | 46 | −3.99 (10.17) | (−7, −1) | -2.68 (12.76) | (−6, 0) | 51 | 0.72 (6.97) | (−1, 2) | −1.57 (6.34) | (−3, 0) |
Little better | 57 | −4.53 (12.89) | (−7, −2) | -0.70 (11.86) | (−3, 2) | 69 | 0.85 (13.02) | (−2, 3) | −3.09 (14.03) | (−6, 0) |
Role functioning | 253 | 253 | ||||||||
Little worse | 73 | −25.57 (21.71) | (−30, −21) | -18.95 (23.78) | (−24, −14) | 51 | −1.96 (29.18) | (−9, 5) | −17.65 (29.14) | (−24, −11) |
No change | 46 | −2.90 (19.66) | (−8, 2) | 0.36 (21.80) | (−5, 6) | 51 | 3.92 (15.49) | (0, 8) | 1.96 (19.05) | (−3, 6) |
Little better | 55 | −9.09 (20.74) | (−14, −4) | 0.91 (24.72) | (−5, 6) | 68 | 5.88 (21.89) | (1, 1) | 0 (23.92) | (−5,5) |
Emotional functioning | 254 | 254 | ||||||||
Little worse | 72 | 3.05 (24.09) | (−2, 8) | -6.29 (22.02) | (−11, −2) | 52 | −0.53 (20.19) | (−5, 4) | −6.20 (16.43) | (−10, −2) |
No change | 44 | 19.44 (18.31) | (15, 24) | 10.92 (18.26) | (6, 16) | 50 | −0.78 (15.55) | (−4, 3) | 8.17 (21.26) | (3, 13) |
Little better | 59 | 15.07 (26.33) | (9, 21) | 3.95 (19.51) | (0, 8) | 69 | 1.53 (20.05) | (−2, 6) | 7.21 (19.13) | (3, 11) |
Cognitive functioning | 254 | 254 | ||||||||
Little worse | 73 | −5.48 (19.46) | (−9, −2) | -10.96 (18.26) | (−15, −7) | 52 | 0.96 (17.9) | (−3, 5) | −9.62 (19.06) | (−14, −5) |
No change | 44 | 0.76 (13.43) | (−3, 4) | -0.76 (12.43) | (−4, 2) | 50 | 2.67 (12.31) | (0, 6) | 0.33 (15.97) | (−3, 4) |
Little better | 57 | 5.26 (21.4) | (1, 1) | -0.58 (17.24) | (−4, 3) | 69 | 3.62 (13.37) | (1, 6) | 4.59 (17.82) | (1, 8) |
Social functioning | 249 | 249 | ||||||||
Little worse | 72 | −20.37 (21.34) | (−25, −16) | -15.05 (14.84) | (−18, −12) | 52 | 0.64 (24.47) | (−5, 6) | −10.26 (20.39) | (−15, −6) |
No change | 42 | −3.97 (21.08) | (−9, 2) | -0.79 (17.25) | (−5, 4) | 49 | 4.42 (19.18) | (0, 9) | −0.34 (12.50) | (−3, 3) |
Little better | 59 | −6.78 (19.6) | (−11, −3) | -3.11 (18.95) | (−7, 1) | 68 | 3.43 (20.68) | (−1, 8) | 2.21 (21.34) | (−2, 7) |
Fatigue | 254 | 254 | ||||||||
Little worse | 73 | 27.32 (21.87) | (23, 32) | 22.75 (22.38) | (18, 27) | 53 | 0.21 (16.34) | (−4, 4) | 20.13 (24.17) | (15, 26) |
No change | 46 | 7.73 (18.42) | (3, 12) | 5.56 (19.42) | (1, 10) | 51 | −1.53 (19.5) | (−6, 3) | 2.18 (19.75) | (−2, 7) |
Little better | 57 | 7.89 (19.47) | (4, 12) | 3.31 (17.97) | (−1, 7) | 68 | −7.68 (18.24) | (−11, −4) | 2.29 (22.92) | (−2, 7) |
Nausea and vomiting | 255 | 255 | ||||||||
Little worse | 74 | 8.78 (19.35) | (5, 13) | 8.33 (15.67) | (5, 11) | 53 | −3.14 (21.7) | (−8, 2) | 0.94 (17.73) | (−3, 5) |
No change | 46 | −0.72 (12.65) | (−4, 2) | 0 (8.61) | (−2, 2) | 51 | −2.29 (10.01) | (−5, 0) | −1.31 (12.40) | (−4, 2) |
Little better | 57 | 9.06 (21.38) | (4, 14) | 3.80 (17.82) | (0, 8) | 70 | −6.67 (23.98) | (−11, −2) | 0 (13.31) | (−3, 3) |
Pain | 260 | 260 | ||||||||
Little worse | 75 | 13.78 (24.87) | (9, 19) | 9.11 (23.14) | (5, 14) | 54 | 1.85 (22.35) | (−3, 7) | 17.28 (25.89) | (11, 23) |
No change | 46 | 3.99 (14.57) | (0, 8) | 5.43 (17.23) | (1, 10) | 52 | 3.21 (14.02) | (0, 6) | 5.45 (17.06) | (1, 9) |
Little better | 57 | 9.94 (20.62) | (5, 15) | 2.63 (21.08) | (−2, 7) | 70 | 2.14 (20.05) | (−2, 6) | 1.90 (22.97) | (−3, 6) |
Dyspnea | 251 | 251 | ||||||||
Little worse | 73 | 8.68 (24.86) | (4, 14) | 10.96 (23.61) | (6, 16) | 52 | 3.85 (26.94) | (−2, 10) | 7.69 (18.22) | (3, 12) |
No change | 45 | 0.74 (19.45) | (−4, 6) | 0.74 (18.10) | (−4, 5) | 51 | −0.65 (12.45) | (−4, 2) | 0 (11.55) | (−3, 3) |
Little better | 55 | 1.21 (19.21) | (−3, 6) | 1.82 (16.25) | (−2, 5) | 67 | 3.48 (22.57) | (−1, 8) | 7.46 (23.08) | (3, 12) |
Insomnia | 249 | 249 | ||||||||
Little worse | 69 | 5.80 (35.22) | (−1, 13) | 8.21 (28.24) | (3, 14) | 52 | 4.49 (30.98) | (−3, 12) | 15.38 (24.22) | (10, 21) |
No change | 46 | −10.14 (35.04) | (−19, −1) | −2.90 (25.17) | (−9, 3) | 50 | −1.33 (21.25) | (−6, 4) | 2 (28.89) | (−5, 9) |
Little better | 55 | −7.27 (34.95) | (−15, 1) | 0.61 (25.25) | (−5, 6) | 67 | 1 (30.13) | (−5, 7) | −0.50 (22.09) | (−5, 4) |
Appetite loss | 249 | 249 | ||||||||
Little worse | 73 | 10.05 (28.16) | (5, 16) | 10.96 (27.25) | (6, 16) | 53 | −10.06 (25.8) | (−16, −4) | 3.77 (20.32) | (−1, 8) |
No change | 46 | −2.90 (20.88) | (−8, 2) | 1.45 (17.15) | (−3, 6) | 50 | −2.67 (9.13) | (−5, −1) | −2 (12.44) | (−5, 1) |
Little better | 54 | 1.85 (22.82) | (−3, 7) | 3.70 (15.41) | (0, 7) | 68 | −2.45 (20.21) | (−7, 2) | −0.49 (14.67) | (−3, 2) |
Constipation | 247 | 247 | ||||||||
Little worse | 68 | 15.20 (30.16) | (9, 21) | 10.29 (27.77) | (5, 16) | 48 | −1.39 (24.75) | (−7, 5) | 2.78 (21.56) | (−2, 8) |
No change | 42 | 0 (19.48) | (−5, 5) | 2.38 (18.61) | (−2, 7) | 48 | −3.47 (12.38) | (−6, 0) | −1.39 (9.62) | (−4, 1) |
Little better | 58 | 0 (26.49) | (−6, 6) | 0 (16.52) | (−4, 4) | 70 | −2.86 (30.95) | (−9, 3) | 0 (26.62) | (−5, 5) |
Diarrhea | 248 | 248 | ||||||||
Little worse | 71 | 0 (21.08) | (−4, 4) | 3.29 (18.07) | (0, 6) | 48 | 0.69 (14.57) | (−3, 4) | 4.17 (13.09) | (1, 7) |
No change | 43 | −2.33 (15.25) | (−6, 2) | -0.78 (11.47) | (−4, 2) | 48 | −1.39 (9.62) | (−4, 1) | −2.08 (10.67) | (−5, 0) |
Little better | 56 | −0.6 (21.55) | (−5, 4) | 2.38 (20.94) | (−2, 7) | 69 | −1.93 (17.97) | (−6, 2) | −1.93 (20.52) | (−6, 2) |
Financial difficulties | 240 | 240 | ||||||||
Little worse | 69 | 9.66 (22.94) | (5, 14) | 8.21 (22.44) | (4, 13) | 49 | −3.40 (20.69) | (−8, 2) | 4.76 (21.52) | (0, 1) |
No change | 41 | 4.07 (13.32) | (1, 8) | 2.44 (8.79) | (0, 5) | 47 | 0 (0) | (NA) | −0.71 (4.86) | (−2, 0) |
Little better | 58 | 1.15 (22.48) | (−4, 6) | 1.72 (15.82) | (−2, 5) | 66 | 1.52 (9.12) | (0, 3) | 0.51 (16) | (−3, 4) |
After 3 months | After 6 months | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Between T0 and T1 | Between T1 and T2 | |||||||||
QLQ-BR23 | Observed changes | Adjusted changes | Observed changes | Adjusted changes | ||||||
(post-test - pre-test) | (post-test - then-test) | (post-test - pre-test) | (post-test - then-test) | |||||||
N | Mean (SD) | 95% CI | Mean (SD) | 95% CI | N | Mean (SD) | 95% CI | Mean (SD) | 95% CI | |
Body image | 232 | 232 | ||||||||
Little worse | 70 | −20.44 (27.41) | (−26, −15) | −15.40 (25.02) | (−20, −10) | 47 | 0.41 (16.58) | (−4, 4) | −10.76 (22.82) | (−16, −5) |
No change | 41 | −7.32 (15.16) | (−11, −3) | −4.07 (15.60) | (−8, 0) | 46 | 2.72 (10.1) | (0, 5) | −0.91 (12.82) | (−4, 2) |
Little better | 49 | −14.91 (24.41) | (−21, −9) | −4.93 (18.31) | (−9, −1) | 65 | 1.28 (22.93) | (−3, 6) | −1.45 (20.88) | (−6, 3) |
Sexual functioning | 198 | 198 | ||||||||
Little worse | 56 | 6.85 (20.79) | (2, 11) | 7.44 (21.06) | (3, 12) | 56 | −0.44 (12.55) | (−4, 3) | 10.53 (17.93) | (6, 15) |
No change | 34 | 3.92 (22.87) | (−3, 11) | 5.88 (22.80) | (−1, 13) | 34 | 2.03 (16.33) | (−2, 6) | 2.44 (16.48) | (−2, 7) |
Little better | 43 | 1.94 (15.94) | (−2, 6) | 0 (10.91) | (−3, 3) | 43 | −0.89 (18.1) | (−5, 3) | 0 (17.70) | (−4, 4) |
Sexual enjoyment | 74 | 74 | ||||||||
Little worse | 23 | 14.49 (19.66) | (7, 22) | 11.59 (19.09) | (5, 18) | 23 | 12.50 (29.5) | (0, 25) | 14.58 (20.97) | (5, 24) |
No change | 16 | 10.42 (33.82) | (−4, 25) | 4.17 (29.50) | (−9, 17) | 16 | 1.45 (21.27) | (−6, 9) | 2.90 (28.27) | (−7, 13) |
Little better | 11 | 12.12 (22.47) | (0, 24) | 9.09 (21.56) | (−3, 21) | 11 | −2.08 (22.67) | (−12, 8) | 0 (21.08) | (−9, 9) |
Future perspectives | 236 | 236 | ||||||||
Little worse | 68 | 7.35 (32.5) | (1, 14) | −8.82 (30.81) | (−15, −3) | 68 | 3.47 (30.16) | (−4, 11) | −0.69 (24.30) | (−7, 5) |
No change | 43 | 20.93 (32.55) | (13, 29) | 7.75 (26.06) | (1, 14) | 43 | 0 (23.57) | (−6, 6) | 4.76 (30.43) | (−3, 12) |
Little better | 48 | 10.42 (30.1) | (3, 18) | 3.47 (24.06) | (−2, 9) | 48 | 1.06 (25.38) | (−4, 6) | 8.47 (23.92) | (3, 13) |
Systemic therapy side effects | 252 | 252 | ||||||||
Little worse | 72 | 18.83 (21.51) | (15, 23) | 19.79 (18.60) | (16, 23) | 72 | −3.49 (18.26) | (−8, 1) | 10.27 (18.90) | (6, 15) |
No change | 45 | 4.41 (15.02) | (1, 8) | 3.84 (14.03) | (0, 7) | 45 | 0.23 (10.2) | (−2, 3) | 2.45 (7.89) | (1, 4) |
Little better | 54 | 6.02 (13.64) | (3, 9) | 6.02 (12.35) | (3, 9) | 54 | −4.19 (15.12) | (−7, −1) | 3.94 (19.39) | (0, 8) |
Breast symptoms | 212 | 212 | ||||||||
Little worse | 57 | 14.08 (27.69) | (8, 2) | 18.08 (22.21) | (13, 23) | 57 | −4.31 (16.81) | (−8, 0) | 6.44 (18.26) | (2, 11) |
No change | 36 | 10.34 (20.43) | (5, 16) | 9.72 (21.59) | (4, 16) | 36 | −3.57 (13.35) | (−7, 0) | 3.77 (14.28) | (0, 7) |
Little better | 53 | 16.61 (21.1) | (12, 21) | 7.13 (18.87) | (3, 11) | 53 | −2.21 (20.17) | (−7, 2) | 3.63 (20.65) | (−1, 8) |
Arm symptoms | 235 | 235 | ||||||||
Little worse | 67 | 7.88 (17.6) | (4, 11) | 8.54 (19.28) | (5, 12) | 67 | 0.58 (18.27) | (−4, 5) | 10.76 (19.53) | (6, 15) |
No change | 41 | 3.39 (13.54) | (0, 7) | 4.74 (14.14) | (1, 8) | 41 | 1.89 (13.82) | (−1, 5) | 5.89 (14.65) | (2, 9) |
Little better | 55 | 4.55 (17.51) | (1, 8) | 1.41 (13.83) | (−2, 5) | 55 | 0.69 (13.98) | (−2, 4) | 0.69 (16.93) | (−3, 4) |
Deterioration of HRQOL | Improvement of HRQOL | |||
---|---|---|---|---|
Observed changes | Adjusted changes | Observed changes | Adjusted changes | |
QLQ-BR23 QLQ - C30 | ||||
After 3 months | 5–26 | 8–19 | 0.3–10 | 0.6–4 |
After 6 months | 0.5–10 | 4–18 | 0.8–7 | 0–7 |
After 3 months | 7–20 | 7–18 | 2–15 | 0–7 |
After 6 months | 0.4–4 | 6–11 | 0.7–2 | 0–4 |
After 3 months | After 6 months | |||
---|---|---|---|---|
Observed changes | Adjusted changes | Observed changes | Adjusted changes | |
QLQ-C30 | ||||
Global Health Status | 16 | 12a
| 0.5 | 8a
|
Physical functioning | 12 | 12a
| 0.4 | 9a
|
Role functioning | 26 | 19a
| 2 | 18a
|
Cognitive functioning | 5 | 11a
| 1 | 10a
|
Social functioning | 20 | 15a
| 1 | 10a
|
Emotional functioning | 3.5 | 6a
| 0.5 | 6a
|
Fatigue | 27 | 23a
| 0.2 | 20a
|
Pain | 14 | 9a
| 2 | 17a
|
Dyspnea | 9 | 11a
| 4 | 8a
|
Insomnia | 6 | 8a
| 4 | 15a
|
Financial difficulties | 10 | 8a
| 3 | 5a
|
Appetite loss | 10 | 11a
| 10 | 4 |
Constipation | 15 | 10a
| 1 | 3 |
Nausea and vomiting | 9 | 8a
| 3 | 1 |
QLQ-BR23 | ||||
Body image | 20 | 15a
| 0.4 | 11a
|
Sexual functioning | 7 | 7a
| 0.4 | 11a
|
Systemic therapy side effects | 19 | 20a
| 3 | 10a
|
Breast symptoms | 14 | 18a
| 4 | 6a
|
Arm symptoms | 8 | 9a
| 0.6 | 11a
|
Sexual enjoyment | 14 | 12a
| 13 | 15a
|
Future perspectives | 7 | 9a
| 3 | 0.7 |