Remote Symptom Alerts and Patient-Reported Outcomes (PROS) in Real-World Breast Cancer Practice: Innovative Data to Derive Symptom Burden and Quality of Life
Abstract
:1. Introduction
2. Materials and Methods
2.1. Patient Population and PROmpt®
2.2. Symptom Prevalence and Alerts
2.3. Trajectory of Neuropathy
2.4. Statistical Analysis
3. Results
3.1. Demographic and Baseline Characteristics
3.2. Symptoms, QoL, and Alerts
3.3. Clinical Actions Documented in the Alerts
3.4. Trajectory of Neuropathy
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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All Patients (n = 646) | Reported at Least 1 Moderate or Severe Symptom (n = 519) | |
---|---|---|
No. of patients with at least one symptom alert, n (%) | 519 (80.3) | 519 (100) |
No. of symptoms reported during study period | 19,425 | 18,506 |
Total alerts generated during study period | 7641 | 7641 |
PROs follow-up time (weeks) | ||
Mean (SD) | 19.6 (21.7) | 22.3 (22.8) |
Median (Range) | 12.3 (0–152) | 16.1 (0–152) |
Age at enrollment (years) | ||
Mean (SD) | 55.6 (12.6) | 54.8 (12.7) |
Median (Range) | 56 (26–84) | 55 (26–81) |
Age at enrollment (years), n (%) | ||
<50 years old | 200 (31.0) | 174 (33.5) |
50–64 years old | 270 (41.8) | 211 (40.7) |
65–75 years old | 154 (23.8) | 118 (22.7) |
>75 years old | 22 (3.4) | 16 (3.1) |
Female, n (%) | 646 (100) | 519 (100) |
Race, n (%) | ||
American Indian or Alaskan Native | 7 (1.1) | 5 (1.0) |
Asian | 11 (1.7) | 10 (1.9) |
Black or African American | 132 (20.4) | 107 (20.6) |
Native Hawaiian or Other Pacific Islander | 1 (0.2) | 1 (0.2) |
White | 466 (72.1) | 370 (71.3) |
Other | 9 (1.4) | 7 (1.3) |
Unspecified | 20 (3.1) | 19 (3.7) |
Biomarker status, n (%) | ||
HR+/HER2− | 305 (47.2) | 247 (47.6) |
HR+/HER2+ | 100 (15.5) | 85 (16.4) |
Triple negative | 119 (18.4) | 90 (17.3) |
Unspecified | 122 (18.9) | 97 (18.7) |
Stage, n (%) | ||
Early stage (0–IIIA) | 399 (61.8) | 325 (62.6) |
Late stage (IIIB–IV) | 147 (22.8) | 114 (22.0) |
Unspecified | 100 (15.4) | 80 (15.4) |
Baseline frailty status, n (%) | ||
Fit | 503 (77.9) | 393 (75.7) |
Intermediate | 77 (11.9) | 69 (13.3) |
Frail | 44 (6.8) | 41 (7.9) |
Unspecified | 22 (3.4) | 16 (3.1) |
ECOG status, n (%) | ||
0 | 144 (22.2) | 120 (23.1) |
1 | 134 (20.7) | 108 (20.8) |
2+ | 61 (9.4) | 58 (11.2) |
Unspecified | 307 (47.7) | 233 (44.9) |
Treatment closest to first symptom alert, n (%) | ||
Chemotherapy | 164 (25.4) | 164 (31.6) |
Anti-HER2 therapy | 101 (15.6) | 101 (19.5) |
Mono Endocrine therapy (ET) | 91 (14.1) | 91 (17.5) |
PD-1/L1 inhibitors | 45 (7.0) | 45 (8.7) |
CDK 4/6 inhibitors | 36 (5.6) | 36 (6.9) |
Other | 33 (5.1) | 33 (6.4) |
Did not generate alerts | 127 (19.7) | 0 (0.0) |
Unspecified | 49 (7.6) | 49 (9.4) |
(a) | ||||||||||||||||
All | Early Stage (0–IIIA) | Late Stage (IIIB–IV) | ||||||||||||||
No. of patients with at least one symptom alert | 519 | 325 | 114 | |||||||||||||
Total alerts generated during study period | 7641 | 4439 | 2088 | |||||||||||||
No. of alerts per patient per week | ||||||||||||||||
Mean (SD) | 2.0 (1.5) | 2.1 (1.5) | 2.1 (1.6) | |||||||||||||
Median (Range) | 1.0 (1–16) | 1.0 (1–13) | 1.0 (1–16) | |||||||||||||
(b) | ||||||||||||||||
All | HER2−/HR+ | HER2+/HR+ | TNBC | |||||||||||||
No. of patients with at least one symptom alert | 519 | 247 | 85 | 90 | ||||||||||||
Total alerts generated during study period | 7641 | 3671 | 1245 | 1403 | ||||||||||||
No. of alerts per patient per week | ||||||||||||||||
Mean (SD) | 2.0 (1.5) | 2.0 (1.6) | 2.0 (1.5) | 2.1 (1.7) | ||||||||||||
Median (Range) | 1.0 (1–16) | 1.0 (1–13) | 1.0 (1–12) | 2.0 (1–16) | ||||||||||||
(c) | ||||||||||||||||
All | <50 | 50–64 | 65–75 | >75 | ||||||||||||
No. of patients with at least one symptom alert | 519 | 174 | 211 | 118 | 16 | |||||||||||
Total alerts generated during study period | 7641 | 2547 | 3398 | 1520 | 176 | |||||||||||
No. of alerts per patient per week | ||||||||||||||||
Mean (SD) | 2.0 (1.5) | 2.0 (1.6) | 2.1 (1.5) | 1.9 (1.4) | 1.7 (1.0) | |||||||||||
Median (Range) | 1.0 (1–16) | 1.0 (1–13) | 2.0 (1–16) | 1.0 (1–11) | 1.0 (1–5) | |||||||||||
(d) | ||||||||||||||||
All | Fit | Intermediate | Frail | ECOG 0 | ECOG 1 | ECOG 2+ | ||||||||||
No. of patients with at least one symptom alert | 519 | 393 | 69 | 41 | 120 | 108 | 58 | |||||||||
Total alerts generated during study period | 7641 | 5319 | 1400 | 621 | 1235 | 1579 | 1145 | |||||||||
No. of alerts per patient per week | ||||||||||||||||
Mean (SD) | 2.0 (1.5) | 2.0 (1.5) | 2.1 (1.4) | 2.5 (1.5) | 1.5 (0.9) | 1.9 (1.1) | 2.1 (1.3) | |||||||||
Median (Range) | 1.0 (1–16) | 1.0 (1–16) | 2.0 (1–11) | 2.0 (1–10) | 1.0 (1–7) | 2.0 (1–7) | 2.0 (1–9) |
All Patients (n = 177) | No PX PN (n = 103) | Had PX PN (n = 74) | |
---|---|---|---|
Total neuropathy alerts generated, n (%) | 801 (100) | 453 (56.6) | 348 (43.4) |
Age at first neuropathy (years) | |||
Mean (SD) | 55.8 (12.8) | 55.1 (13.3) | 56.7 (12.1) |
Median (Range) | 57 (26–79) | 56 (28–78) | 58.5 (26–79) |
Female, n (%) | 177 (100) | 103 (100) | 74 (100) |
Race, n (%) | |||
American Indian or Alaskan Native | 2 (1.1) | 0 (0.0) | 2 (2.7) |
Asian | 4 (2.3) | 2 (1.9) | 2 (2.7) |
Black or African American | 55 (31.1) | 31 (30.1) | 24 (32.4) |
Native Hawaiian or Other Pacific Islander | 1 (0.6) | 1 (1.0) | 0 (0.0) |
White | 103 (58.2) | 60 (58.3) | 43 (58.1) |
Other | 5 (2.8) | 4 (3.9) | 1 (1.4) |
Unspecified | 7 (4.0) | 5 (4.9) | 2 (2.7) |
Biomarker status, n (%) | |||
HR+/HER2− | 76 (42.9) | 46 (44.7) | 30 (40.5) |
HR+/HER2+ | 31 (17.5) | 15 (14.6) | 16 (21.6) |
Triple negative | 35 (19.8) | 21 (20.4) | 14 (18.9) |
Unspecified | 35 (19.8) | 21 (20.4) | 14 (18.9) |
Stage, n (%) | |||
Early stage (0–IIIA) | 104 (58.8) | 65 (63.1) | 39 (52.7) |
Late stage (IIIB–IV) | 45 (25.4) | 22 (21.4) | 23 (31.1) |
Unspecified | 28 (15.8) | 16 (15.5) | 12 (16.2) |
Prior use of CIPN drugs, n (%) | 94 (53.1) | 49 (47.6) | 45 (60.8) |
0–28 Days (n = 28) | >28 Days (n = 27) | |
---|---|---|
Age at first neuropathy, years | ||
Mean (SD) | 52.3 (12.5) | 52.4 (14.4) |
Median (Range) | 51 (31–78) | 49 (28–77) |
Late stage (IIIB–IV), n (%) | 5 (17.9) | 4 (14.8) |
Race, n (%) | ||
American Indian or Alaskan Native | 0 (0.0) | 0 (0.0) |
Asian | 0 (0.0) | 1 (3.7) |
Black or African American | 9 (32.1) | 6 (22.2) |
Native Hawaiian or Other Pacific Islander | 0 (0.0) | 0 (0.0) |
White | 15 (53.6) | 18 (66.7) |
Other | 3 (10.7) | 0 (0.0) |
Unspecified | 1 (3.6) | 2 (7.4) |
Time since diagnosis (months) | ||
Mean (SD) | 11.6 (24.9) | 18.4 (29.2) |
Median (Range) | 5.7 (1, 134) | 5.7 (2.6, 120) |
Median duration of treatment (months) | ||
Mean (SD) | 7.0 (18.6) | 18.9 (34.8) |
Median (Range) | 2.4 (0–98.9) | 4.4 (1.3–128) |
CIPN drugs use at alert, n (%) | 14 (50.0) | 16 (59.3) |
No. of neuropathy alerts per patient/week | ||
Mean (SD) | 1.0 (0.1) | 1.0 (0.2) |
Median (Range) | 1.0 (1–2) | 1.0 (1–2) |
Level of neuropathy interference at first alert, n (%) | ||
Not at all | 1 (3.6) | 0 (0.0) |
A little bit | 2 (7.1) | 2 (7.4) |
Somewhat | 17 (60.7) | 14 (51.9) |
Quite a bit | 7 (25.0) | 4 (14.8) |
Very much | 0 (0.0) | 4 (14.8) |
Not answered | 1 (3.6) | 3 (11.1) |
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Rusli, E.; Wujcik, D.; Galaznik, A. Remote Symptom Alerts and Patient-Reported Outcomes (PROS) in Real-World Breast Cancer Practice: Innovative Data to Derive Symptom Burden and Quality of Life. Bioengineering 2024, 11, 846. https://doi.org/10.3390/bioengineering11080846
Rusli E, Wujcik D, Galaznik A. Remote Symptom Alerts and Patient-Reported Outcomes (PROS) in Real-World Breast Cancer Practice: Innovative Data to Derive Symptom Burden and Quality of Life. Bioengineering. 2024; 11(8):846. https://doi.org/10.3390/bioengineering11080846
Chicago/Turabian StyleRusli, Emelly, Debra Wujcik, and Aaron Galaznik. 2024. "Remote Symptom Alerts and Patient-Reported Outcomes (PROS) in Real-World Breast Cancer Practice: Innovative Data to Derive Symptom Burden and Quality of Life" Bioengineering 11, no. 8: 846. https://doi.org/10.3390/bioengineering11080846