Introduction
Methodology
Study design and setting
Sample size
Inclusion and exclusion criteria of the studied sample
Data collection and variables
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First. A general interview that included the study of sociodemographic variables (age, sex, gender, educational level, employment situation and family unit), toxic habits (smoking, alcohol consumption), anthropometric data (Body Mass Index (BMI), comorbidity (medication, general illnesses, Charlson Comorbidity Index [27]). Concerning breast cancer, variables related to cancer (date of diagnosis, type of tumor, main characteristics, general condition) and cancer treatment (drug and the number of cycles received) were studied. The morphological classification (ductal or lobular) and according to the molecular subtype (Luminal A, B HER 2 positive or negative, triple negative and HER2 positive) were recorded [28‐30].
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Second. Podiatric examination in unloaded and standing position. The protocol was: a) visual assessment of nail, skin and structural conditions [31] following the Common Terminology Criteria for Adverse Events of the National Cancer Institute v.5 (NCI) [32, 33]; b) peripheral neuropathy exploration following the World Health Organization (WHO) scale [34] and the Semmes–Weinstein Monofilament [35] to assess the sensitivity; c) the Foot Posture Index [36] and d) the study of the footprint, using the Clarke Angle, Staheli and Chippaux-Smirak Index, to categorize the footprint as cavus, normal or flat. The footprint was obtained by pedigraph [37] . Additional File 1 shows the definitions and diagnostic criteria for nail, structural and skin conditions, following what was described by Moreno de la Fuente et al. [31] , Miller et al. [32], and the National Cancer Institute [33].
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Third. Two validated and self-administered questionnaires: Foot Health Status Questionnaire (FHSQ) [38, 39] and the Foot Function Index (FFI) [40, 41]. The first is used to study the foot and general health-related quality of life. It presents 19 questions with a Likert-type scale. The first 13 questions are collected in 4 dimensions: foot pain (4 questions), foot function (4 questions), footwear (3 questions) and general foot health (2 questions). A score is obtained for each domain ranging from 0 (worst conditions) to 100 (best conditions). The second questionnaire contains 23 questions divided into 3 subscales: pain (9 items), disability (9 items) and functional or activity limitation (5 items). Each question is evaluated on a scale from 0 to 9 where 0 is no pain/difficulty, and 9 would mean the worst pain imaginable and/or such difficulty that help is required. High values indicate greater pain, disability, and activity limitation, and therefore a worse state of health.
Ethical-legal aspects
Statistical analysis
Results
Sociodemographic and clinical characteristics
Mean (SD)
|
Median (Min–Max)
| |
---|---|---|
Age (years)
| 53,3 (12,1) | 50,0 (30–88) |
BMI ( (kg/m2) | 26,4 (5,0) | 25,5 (17,3–38,2) |
Charlson Comorbidity Index
| 4,4 (2,1) | 6,0 (0–8) |
Age-Adjusted Charlson Comorbidity Index
| 5,1 (2,5) | 6 (0–11) |
Time of evolution of cancer (months)
| 11,2 (18,5) | (2–139) |
n (%)
|
95% CI
| |
Civil status
| ||
Single | 22 (19,0) | 11,3–26,3 |
Married / Co-habitant | 78 (67,2) | 57,7–75,6 |
Widow | 8 (6,9) | 1,8–11,8 |
Divorced / Separated | 8 (6,9) | 1,8–11,8 |
Education level
| ||
No studies | 4 (3,4) | 0,9–8,5 |
Primary studies | 15 (12,9) | 6,3–19,3 |
Secondary/Higher Education | 60 (51,7) | 41,8–60,8 |
University studies | 37 (31,9) | 22,7–40,5 |
Employment situation
| ||
Active | 4 (3,4) | 0,9–8,5 |
Unemployed | 5 (4,3) | 1,4–9,7 |
Pension | 16 (13,8) | 7,0–20,3 |
Sick leave | 67 (57,8) | 47,9–66,6 |
Inability to work | 5 (4,3) | 1,4–9,7 |
Household | 14 (12,1) | 5,6–18,3 |
Smoking habit
| ||
Yes | 8 (6,9) | 1,8–11,8 |
Former smoker | 33 (28,4) | 19,6–36,8 |
Breast cancer
| ||
Invasive ductal | 107 (92,2) | 85,9–96,9 |
Invasive lobuar | 9 (7,8) | 2,4–12,9 |
Breast Cancer Subtype
| ||
Luminal A | 2 (1,7) | 0,2–6,0 |
Luminal B HER2 negative | 54 (46,2) | 36,7–55,6 |
Luminal B HER2 positive | 33 (28,2) | 19,6–36,8 |
Triple Negative | 21 (17,9) | 10,6–25,3 |
HER 2 positive | 7 (6,0) | 1,2–10,7 |
Metastasis
| 59 (50,4) | 39,2–58,2 |
Cancer therapy
| ||
Chemotherapy or after finishing it | 82 (70,2) | 61,4–78,8 |
Anti-HER2 Therapy after chemotherapy | 11 (9,4) | 3,7–15,1 |
Chemotherapy + Anti-HER 2 Therapy | 11 (9,4) | 3,7–15,1 |
Number of cycles received at time of visit
| ||
4 cycles | 34 (29,1) | 20,4–37,7 |
5 cycles | 17 (14,5) | 7,7–21,3 |
6 cycles | 11 (9,4) | 3,7–15,1 |
8 cycles | 25 (21,4) | 13,5–29,2 |
Others | 30 (25,6) | 17,3–34,0 |
Foot health problems: structural, nail, skin, and neuropathic origin
n (%)
|
95% CI
| |
---|---|---|
Structural Pathology Forefoot and Hindfoot
|
100 (85,5)
| 78,6–92,3 |
Edema | 43 (36,8) | 27,6–45,9 |
Morton's Neuroma | 3 (2,6) | 0,5–7,3 |
Claw toes | 62 (53,4) | 43,5–62,5 |
Hallux Extensus | 6 (5,1) | 0,7–9,5 |
Hallux Limitus | 27 (23,1) | 15,0–31,3 |
Second Finger Supraduct | 14 (12,0) | 5,6–18,3 |
Hallux Valgus (Manchester Scale) | 87 (74,4) | 66,0–82,7 |
Grade 1: no deformity | 30 (25,0) | 17,3–34,0 |
Grade 2: mild deformity | 47 (40,5) | 30,9–49,5 |
Grade 3: moderate deformity | 39 (33,6) | 24,4–42,3 |
Grade 4: severe deformity | 4 (3,4) | 0,9–8,5 |
Plantar Fasciitis | 15 (12,8) | 6,3–19,3 |
Calcaneal Spur | 2 (1,7) | 0,2–6,0 |
Achilles Tendinitis | 4 (3,4) | 0,9–8,5 |
Nail Pathology
|
106 (91,5)
| 84,9–96,3 |
Subungual Hematoma | 7 (6,0) | 1,3–10,7 |
Leukonychia | 7 (6,0) | 1,3–10,7 |
Onychoatrophy | 6 (5,2) | 0,7–9,5 |
Onychodystrophy | 8 (6,9) | 1,8–11,8 |
Onychogryphosis | 22 (19,0) | 11,3–26,3 |
Onychocryptosis | 46 (39,7) | 30,0–48,6 |
Onychocolosis | 44 (37,9) | 28,4–46,8 |
Onychomadesis | 13 (11,2) | 5,0–17,2 |
Nail Fall | 6 (5,2) | 0,7–9,5 |
Paronychia | 15 (12,9) | 6,3–19,3 |
Beau Lines | 18 (15,5) | 8,4–22,3 |
Subungual Hyperkeratosis | 31 (26,5) | 18,1–34,9 |
Terry Nails | 7 (6,0) | 1,3–10,7 |
Half and Half Nails | 22 (19) | 11,3–26,3 |
Color Change | 70 (59,8) | 50,5–69,1 |
Diffuse Melalonychia | 49 (41,9) | 31,7–50,4 |
Longitudinal Melalonychia | 14 (12,0) | 5,0–17,2 |
Onychorrhexis | 8 (6,8) | 1,3–10,7 |
Splinter Hemorrhage | 9 (7,7) | 2,4–12,9 |
Anonychia | 7 (6,0) | 1,3–10,7 |
Yellow Nail Syndrome | 16 (13,7) | 7,0–20,3 |
Skin Pathology
|
102 (87,9)
| 80,7–93,7 |
Xerosis | 73 (62,4) | 52,3–70,8 |
Hyperkeratosis | 77 (65,8) | 56,8–74,8 |
Heloma | 17 (14,5) | 7,7–21,3 |
Cracks | 17 (14,5) | 7,7–21,3 |
Hand-Foot Syndrome | 41 (35,9) | 26,0–44,1 |
Ulcers or wounds | 6 (5,2) | 0,7–9,5 |
Blisters | 17 (14,5) | 7,7–21,3 |
Erythema | 26 (22,2) | 12,8–28,2 |
Fragile skin | 27 (23,1) | 15,0–31,1 |
Skin atrophy | 10 (8,5) | 3,0–14,0 |
Peeling | 17 (14,5) | 7,7–21,3 |
n (%)
|
95% CI
| |
---|---|---|
Symptoms
|
88 (75,2)
|
67,0–83,5
|
Tingling/Crawling sensation | 65 (56,0) | 46,1–65,0 |
Abrasion | 8 (6,8) | 1,8–11,8 |
Needles | 23 (19,7) | 12,0–27,3 |
Imbalance | 9 (7,7) | 2,4–12,9 |
Numbness, lack of sensitivity | 17 (14,5) | 7,7–21,3 |
Muscular weakness | 18 (15,4) | 8,4–22,3 |
Pins | 15 (12,8) | 6,3–19,3 |
Muscle and joint stiffness | 30 (25,6) | 16,5–33,0 |
Dysesthesia-Paraesthesia | 20 (17,1) | 9,8–24,3 |
WHO Peripheral Neuropathy Scale
| ||
No symptoms | 29 (24,8) | 18,8–35,8 |
Paraesthesia or weakness without pain or loss of function | 25 (21,4) | 9,1–23,3 |
Pain that interferes with function, but not with ADLs | 45 (38,8) | 29,2–47,7 |
Pain that interferes with ADLs | 17 (14,5) | 7,7–21,3 |
Motor affectation and/or disabling pain | 1 (0,9) | 0,02–4,7 |
HFS Study Degree
| ||
WHO HFS Scale
| ||
Grade 1 | 6 (14,3) | 2,5–26,1 |
Grade 2 | 10 (23,8) | 9,7–37,9 |
Grade 3 | 14 (33,3) | 17,9–48,8 |
Grade 4 | 12 (28,6) | 13,7–43,4 |
NCI HFS Scale
| ||
Grade 1 | 6 (14,3) | 2,5–26,1 |
Grade 2 | 16 (38,1) | 22,2–54,0 |
Grade 3 | 20 (47,6) | 31,3–63,9 |
Sensitivity assessment using monofilament
| ||
First Toe | 30 (25,9) | 17,3–34,0 |
First Metatarsal Head | 29 (25,0) | 16,5–33,0 |
Third Metatarsal Head | 29 (25,0) | 16,5–33,0 |
Fifth Metatarsal Head | 26 (22,4) | 14,3–30,2 |
Left foot
|
Right foot
| |||
---|---|---|---|---|
n (%)
|
95% CI
|
n (%)
|
95% CI
| |
Foot Posture Index (
n
= 117)
| ||||
Supination | 4 (3,4) | 0,9–8,5 | 4 (3,4) | 0,9–8,5 |
Neutral | 34 (29,1) | 20,4–37,7 | 35 (29,9) | 21,2–38,6 |
Pronation | 79 (67,5) | 58,6–76,4 | 78 (66,7) | 57,7–75,6 |
Footprint Study (
n
= 116)
| ||||
Clarke Angle
| ||||
Cavus (< 31º) | 27 (23,1) | 15,1–31,4 | 37 (31,9) | 23,0–40,8 |
Normal (31º a 45º) | 73 (62,9) | 53,7–72,1 | 72 (62,1) | 52,8–71,3 |
Flat (> 45º) | 16 (13,8) | 7,1–20,5 | 7 (6,0) | 7,1–20,5 |
Chippaux-Smirak Index
| ||||
Cavus (> 25%) | 29 (25,0) | 16,7–33,3 | 21 (18,1) | 10,7–25,5 |
Normal (25% – 45%) | 72 (62,1) | 52,8–71,3 | 83 (71,6) | 62,9–80,2 |
Flat (> 45%) | 15 (12,9) | 6,4–19,5 | 12 (10,3) | 4,4–16,3 |
Staheli Index
| ||||
Cavus (< 0,6) | 66 (56,4) | 47,4–66,3 | 57 (49,1) | 39,6–58,7 |
Normal (0,6 – 0,69) | 24 (20,7) | 12,9–28,5 | 28 (24,1) | 15,9–32,3 |
Flat (> 0,69) | 26 (22,4) | 14,4–30,4 | 31 (26,7) | 18,2–35,2 |
Foot Hyperpressure (
n
= 116)
| ||||
1st toe | 32 (27,6) | 19,0–36,1 | 38 (32,8) | 23,8–41,7 |
1st metatarsal head | 56 (48,3) | 38,7–57,8 | 61 (62,6) | 43,1–62,1 |
2nd metatarsal head | 61 (52,6) | 43,1–62,1 | 65 (56,0) | 46,6–65,5 |
3rd metatarsal head | 61 (52,6) | 43,1–62,1 | 62 (53,4) | 43,9–63,0 |
4th metatarsal head | 49 (42,2) | 32,8–51,7 | 50 (43,1) | 33,7–52,5 |
5th metatarsal head | 46 (39,7) | 30,3–49,0 | 46 (39,7) | 30,3–49,0 |
Heel | 19 (16,4) | 9,2–23,5 | 15 (12,9) | 6,4–19,5 |
Internal Part Heel | 28 (24,1) | 15,9–32,3 | 34 (29,3) | 20,6–38,0 |
External Heel | 11 (9,5) | 3,7–15,2 | 10 (8,6) | 3,1–14,2 |
Foot health, quality of life, pain, and functionality
Mean (SD)
|
Median (Min–Max)
| |
---|---|---|
FFI
| 30,4 (19,6) | 28,0 (8,5–93,2) |
Items of FFI
| ||
Foot pain at the worst time | 5,0 (2,7) | 5,0 (1–10) |
foot pain at the end of the day | 4,8 ( 2,7) | 5,0 (1–10) |
FHSQ
| ||
Foot pain | 64,0 (23,9) | 68,7 (0–100,0) |
Foot function | 76,0 (22,8) | 75,0 (6,25 – 100) |
Footwear | 30,6 (33,5) | 16,7 (0,0 – 308,3) |
General health | 34,6 (16,7) | 25,0 (0,0 – 75,0) |
n (%)
|
95% CI
| |
Items of FHSQ
| ||
Degree of foot pain in the past week
| ||
Very mild or none | 47 (40,2) | 30,9–49,5 |
Mild | 29 (24,8) | 16,5–33,0 |
Moderate or severe | 41 (35,0) | 26,0–44,1 |
Frequency of sharp pain
| ||
Ocasionally or Never | 66 (56,4) | 47,0–65,8 |
Fairly Many Times | 17 (14,5) | 7,7–21,3 |
Very often or Always | 34 (32,1) | 20,4–37,7 |
Limitation to walk due to foot health
| ||
Slightly or Not at All | 84 (71,8) | 63,2–80,4 |
Moderately | 15 (12,8) | 6,3–19,3 |
Quite a bit or Extremely | 18 (15,4) | 8,4–22,3 |
General foot health status rating
| ||
Excellent or Very Good | 3 (2,6) | 0,5–7,3 |
Good | 48 (41,0) | 31,7–50,4 |
Fair or Poor | 66 (56,4) | 47,0–65,8 |
Difficulty finding shoes that do not hurt
| ||
Strongly Agree or Agree | 68 (58,1) | 48,7–67,5 |
Neither Agree nor Disagree | 7 (6,0) | 1,3–10,7 |
Disagree or Strongly Disagree | 42 (35,9) | 26,8–45,0 |
Limitation of health status in performing vigorous activities
| ||
Not Limited at All | 11 (9,4) | 3,7–15,1 |
Limited a Little | 61 (52,1) | 42,7–61,6 |
Limited a Lot | 45 (38,5) | 29,2–47,7 |
Limitation of health status in moderate activities, such as cleaning, walking…
| ||
Not Limited at All | 13 (11,1) | 5,0–17,2 |
Limited a Little | 72 (61,5) | 52,3–70,8 |
Limited a Lot | 32 (27,4) | 18,8–35,8 |
Interference of your health or emotional problems with your social activities
| ||
Slightly or Not at All | 82 (70,1) | 61,3–78,8 |
Moderately | 21 (17,9) | 10,6–25,3 |
Quite a bit or Extremely | 14 (12,0) | 5,7–18,3 |