Table 2.
Patient-reported outcome measure | Baseline | Completion of radiation therapy | Six-months post completion of radiation therapy |
---|---|---|---|
FACT-B trial outcome index | 65.8 (14.5) n = 760 |
63.5 (14.6) n = 599 |
68.6 (14.4) n = 756 |
Satisfaction With Breast Cosmetic Outcomes | 3.3 (1.0) n = 747 |
3.1 (1.0) n = 596 |
3.3 (1.0) n = 750 |
BREAST-Q radiation module | — | 52.6 (29.3) n = 606 |
76.9 (23.0) n = 762 |
PROMIS fatigue | 50.3 (10.0) n = 752 |
53.7 (9.9) n = 607 |
49.4 (10.6) n = 754 |
PROMIS anxiety | 52.1 (9.2) n = 760 |
51.9 (9.2) n = 606 |
51.6 (9.3) n = 755 |
PROMIS ability to participate in social roles and activities | 50.0 (9.0) n = 756 |
49.7 (8.8) n = 603 |
53.0 (9.1) n = 758 |
PRO-CTCAE shortness of breath | |||
Severity | |||
None | 486 (65%) | 397 (66%) | 471 (62%) |
Mild | 187 (25%) | 151 (25%) | 191 (25%) |
Moderate | 64 (9%) | 47 (8%) | 74 (10%) |
Severe | 10 (1%) | 6 (1%) | 22 (3%) |
Very severe | 5 (1%) | 4 (1%) | 6 (1%) |
Interfere with usual activities | |||
Not at all | 551 (76%) | 451 (76%) | 540 (72%) |
A little bit | 115 (16%) | 102 (17%) | 139 (19%) |
Somewhat | 38 (5%) | 25 (4%) | 40 (5%) |
Quite a bit | 20 (3%) | 13 (2%) | 26 (3%) |
Very much | 4 (1%) | 5 (1%) | 5 (1%) |
PRO-CTCAE chest pain, chest tightness, or angina | |||
Frequency | |||
Never | 548 (73%) | 398 (66%) | 465 (61%) |
Rarely | 100 (13%) | 113 (19%) | 153 (20%) |
Occasionally | 73 (10%) | 65 (11%) | 102 (13%) |
Frequently | 25 (3%) | 27 (4%) | 33 (4%) |
Almost constantly | 6 (1%) | 4 (1%) | 10 (1%) |
Severity | |||
None | 528 (73%) | 401 (67%) | 470 (62%) |
Mild | 129 (18%) | 125 (21%) | 181 (24%) |
Moderate | 52 (7%) | 58 (10%) | 78 (10%) |
Severe | 14 (2%) | 12 (2%) | 19 (3%) |
Very severe | 2 (1%) | 4 (1%) | 6 (1%) |
Interfere with usual activities | |||
Not at all | 607 (84%) | 476 (79%) | 580 (77%) |
A little bit | 70 (10%) | 75 (13%) | 112 (15%) |
Somewhat | 26 (4%) | 30 (5%) | 35 (5%) |
Quite a bit | 18 (2%) | 13 (2%) | 16 (2%) |
Very much | 5 (1%) | 5 (1%) | 10 (1%) |
— not applicable. Entries in table denote mean (SD) or n (%). For FACT-B, higher scores represent better health-related quality of life. For PROMIS, higher scores represent more of the outcome, eg, more fatigue, more anxiety, better ability.
Abbreviations: FACT-B = Functional Assessment of Cancer Therapy-Breast; PRO-CTCAE = Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events; PROMIS = Patient-Reported Outcomes Measurement Information System.