Development and Evaluation of a Satisfaction Questionnaire About Therapeutic Textile Devices Used for Breast Cancer-Related Lymphedema

Abstract

Background:

There is a need for an appropriate instrument to measure the satisfaction of patients about therapeutic textile devices used for breast cancer-related lymphedema (BCRL).

Methods and Results:

A new satisfaction questionnaire about therapeutic textile devices used for BCRL was developed and psychometrically tested. An approach to criterion validity by contrast of hypothesis was made. Different average scores were expected depending on the type of therapeutic textile device: Kinesio taping, compression garment, and multilayer low-stretch bandage. Items were analyzed in nine phases: apparent validity, missing responses, internal consistency, factor analysis, reproducibility, confirmation of factor analysis, contrast of hypothesis, variability, and time for completion. One hundred fifty women were sampled in a consecutive order. A final questionnaire was drafted that fulfilled the validation hypothesis, including 20 items that explored 4 dimensions: mood, patient comfort, patient compliance, and perceived benefits. The total Cronbach's α was 0.87. The intraclass correlation coefficient was 0.93 for test–retest and 0.91 for inter-rater. Neither ceiling nor floor effects were observed. The average burden for the respondent and interviewer was 5.6 (standard deviation [SD] = 3.8) and 2.2 (SD = 1.3) minutes, respectively.

Conclusion:

This preliminary analysis supports the content validity, reliability, and validity of construct of the questionnaire.

Introduction

Breast cancer-related lymphedema (BCRL) is the most frequently diagnosed lymphedema worldwide, with an estimated 1.7 million cases in 2012.¹ More than one in five breast cancer-related survivors will develop BCRL on the homolateral upper limb.² As key members of the health care team, physiotherapists must learn to train patients during their treatments for BCRL for appropriately individualizing the patient's management planning.³

BCRL is treated in different ways and almost always involves the use of some type of therapeutic textile device on the affected upper limb. Complex physical therapy is the gold standard treatment and comprises two phases: the first phase, or intensive phase, which lasts 4 weeks on average and includes lymphatic drainage and using a multilayer low-stretch bandage; in the second phase, or maintenance phase, a compression garment is prescribed for home use.⁴ Kinesio taping is another textile device that is used in the treatment of BCRL when the bandage is contraindicated or rejected by the patient.⁵ Life-long self-management is necessary to control lymphedema given that the underlying problem of reduced lymph-drainage capacity cannot be rectified.⁶

Although generally perceived as beneficial, therapeutic textile devices used for lymphedema seem to cause more inconveniences to women than any other treatment.⁷ They also cause discomfort, making work and daily activities difficult, but only a few quantitative studies show the level of satisfaction of patients with each device. Previous studies have observed differences in the quality of life according to the type of device, although it was measured via interviews and nonspecific BCRL questionnaires.^8–10 The multilayer bandage and compression garments not only restrict movement but, in addition, users are physically limited by the need to prevent these devices from getting wet, dirty, or spoiled.¹¹ Women also dislike wearing the same garment for clean and dirty tasks, so often they end up being removed for different activities, especially gauntlets. Another problem that women refer to is discomfort due to friction and tightness, particularly during hot weather. Regarding psychological discomfort, for many women the textile device makes the lymphedema visible rather than the swelling itself. Arm pieces are more easily hidden with clothes, whereas hand parts are highly visible, which affects their decision about when to wear them.⁷ On the other hand, the Kinesio taping seems to be more comfortable and convenient in daily activities⁹ but can produce skin peeling and skin redness as a result of being stuck directly to it.^12,13

There are numerous questionnaires that explore the functionality of the shoulder in breast cancer survivors,¹⁴ including specific ones for BCRL.^15–20 However, none has been found by the authors that include at least one question about satisfaction and health-related quality of life of the devices used for BCRL. Given the gap in knowledge, having a tool that allows for estimating patients' satisfaction with these devices can be helpful.

The aim of this investigation was to develop a new satisfaction questionnaire in Spanish about therapeutic textile devices used for BCRL (SQ-TTD-BCRL) to assess the degree of satisfaction with the different devices (multilayer low-stretch bandage, Kinesio taping, or compression garments) among women with BCRL, including an evaluation of their influence on mood, sexual satisfaction, perceived comfort, patient compliance with the therapy, and perceived benefits in symptoms associated with BCRL.

Methods

A cross-sectional study was designed and approved by the ethics committee of the hospital where the trial was conducted (IRB approval 12/015). An approach to the criterion validity by contrast of hypothesis was proposed: The average difference in the score should be ≥16% between two of the three devices compared (bandage, Kinesio taping, and compression garment), which was set as the minimum value of clinical significance. GRRAS checklist was used to enhance the quality and transparency of this research (Supplementary Appendix S1).

Sample

Consecutive sampling was carried out with patients ≥18 years old who attended the breast pathology rehabilitation service in an outpatient tertiary-level hospital, diagnosed with BCRL, and who were using some type of therapeutic textile device. To be included in the trial, patients with compression garments had to prove that the textile adjusted correctly, women performing self-bandaging had to be properly trained by our lymphedema physiotherapists, and those being treated with Kinesio Taping received training from our physiotherapists on the application method by Sijmonsma.^{21, 22} Patients with cognitive impairment or psychiatric illness were excluded.

Five groups of participants were recruited. First, 11 women were included in the pilot questionnaire. Then, for the validation by contrast of hypothesis, the necessary sample size was calculated to be 96 participants (32 for each of the three devices) to find an observable mean difference ≥16% in the total scores between two devices, with a power of 80%, and a confidence interval of 95% (95% CI). Finally, 21 individuals were recruited to evaluate the test–retest reliability, 12 for inter-rater reliability, and 10 for the interviewer and respondent burden.

Data collection

Potentially eligible women were invited by their lymphedema physiotherapist to participate, of whom none refused. This physiotherapist was responsible for delivering the questionnaires to the research subjects, which was self-completed, except in the evaluation phase of inter-rater reliability, where another physiotherapist with no experience in BCRL treatment also delivered them. Both physiotherapists were members of the research team. Participants completed the self-reported questionnaire in writing.

Data analysis

The data were processed and analyzed with Libre Office software and R using the RKWard interface and with SPSS 17.0 software.

For the comparison of sociodemographic and clinical variables between groups using different devices, a one-way ANOVA test was employed for age and a Pearson's chi-squared test was used for qualitative variables.

Included items were presented and analyzed in nine phases (Fig. 1):

FIG. 1.

Diagram of the analysis of the parametric properties of the Satisfaction Questionnaire about Therapeutic Textile Devices used for Breast Cancer-Related Lymphedema.

Phase 1. Apparent validity

Patient satisfaction is defined by Medical Subject Heading (MeSH) as the degree to which the individual regards a health care service or product or the manner in which the provider delivers it as useful, effective, or beneficial. Hence, all the items of the questionnaire should form part of this concept.

The authors of this work created 70 items based on their extensive clinical experience in BCRL treatment, available evidence from questionnaires on functionality of the upper limb,¹⁴ and the impact that therapeutic textile devices have on quality of life as expressed by women with BCRL in former qualitative studies.^11,23–25 All the items had five possible answers (“always,” “almost always,” “sometimes,” “almost never,” and “never”) that scored from 1 to 5 points, respectively. The advantage of odd responses is that you can include “indifferent,” which belongs to the continuum from less to more.²⁶ The scores of the positive-sense items were inverted so that higher total scores indicated worse satisfaction with the device.

The items were grouped into five dimensions: mood, sexual satisfaction, patient comfort, patient compliance, and perceived benefits. Mood is defined as a transient, low-intensity, nonspecific, and subtle affective state that often has no definite cause.²⁷ The alteration of mood in patients with BCRL presents different components related to body image disturbance, loss of attractiveness, shame, visibility and constant reminder of cancer, and anger and frustration due to daily time-consuming wrapping.

The loss of attractiveness, tightness, pain, and heaviness, together with reduced spontaneous arm mobility produced by the devices themselves, interfere in sexual relations, so including sexual satisfaction as a dimension to explore was considered important.^24,28 The construct of sexual satisfaction not only includes physical and physiological responses, but it also aims at highlighting whether a person has reached a level of fulfilment with their sexual life.²⁹

Patient comfort as an MeSH term is defined as the patient care intended to prevent or relieve suffering in conditions that ensure optimal quality of life. Comfort is also defined in nursing care as the satisfaction (actively, passively, or co-operatively) for relief, ease, or transcendence arising from stressful health care situations in terms of basic human needs.³⁰ The discomfort that women associate with the use of textile devices is significant: difficulties with daily activities that involve fine motor dexterity or heavy lifting, trying to keep compression garments clean or dry and undamaged, trouble with clothes, pain, marks on the skin, etc.^11,24

Finally, barriers to compliance with the use of textile devices and perceived benefits are frequently reported as the reasons to increase adherence to therapy in the interviews answered by these women.^11,24,25,31 Patient compliance is defined as an MeSH term as the voluntary cooperation of the patient in following a prescribed regimen. Perceived benefit refers to the perception of the positive consequences resulting from a specific action,²⁷ although the same treatment outcome can be perceived differently (positively or negatively) by different women, which has implications for complying with self-management.⁷

The questionnaire was first submitted to an advisory panel of experts who did not add any new items but recommend rewriting 15 items of the questionnaire and adding 3 qualifying questions. Then, the questionnaire was delivered for completion to a pilot group of 11 women with BCRL who used a textile device of any kind. They were asked to consult with the questionnaire administrator about the items they did not understand. These items were explained to them, and subjects were asked how they would express them better. Participants were also requested to suggest additional items about other aspects of their daily life affected by the use of the device. There were no unanswered questions in the pilot study. The most poorly understood items (27 in total) were discarded, 2 questions were re-written, and no new questions were added, thus leaving a test of 43 items.

Then, the questionnaire was delivered to all subjects in the sample (n = 96) for validation by contrast of hypothesis. They also were asked: “Do you think that this questionnaire improves communication with your doctor and/or your physiotherapist?” and “Does the questionnaire reflect well the advantages and disadvantages caused by the therapy?.” There were three response options: “yes,” “sometimes,” and “no.” For the statistical analysis, a Pearson's chi-squared test was applied.

In addition, four classifying questions were formulated regarding sociodemographic and clinical characteristics of the sample to check whether they affected the score. Spearman's rank correlation coefficient was calculated for age, and a one-way ANOVA was conducted for the rest of the sociodemographic and clinical variables.

Phase 2. Missing responses

The items that were not answered by >35% of the participants were eliminated from the questionnaire.

Phase 3. Internal consistency

An item-total correlation test, followed by a principal component analysis, was conducted within the classical test theory.

Phase 4. Factor analysis for construct validity

The number of factors was set at four, and an exploratory factor analysis was conducted with promax rotation. In addition, items that did not present favorable values in the analysis were discarded. In the factor-analysis framework, the property of measurement invariance of measurement signifies that, for all the groups to be compared, the assessed instrument measures the same dimensions with the same factorial structure. In our case, the measurement invariance would imply that the items conform to the model in all the groups and have the same quality and measurement properties across groups. The reliability of the scores derived from the factorial analysis was tested by using Cronbach's α.³²

Phase 5. Reproducibility

To evaluate the test–retest reliability, the questionnaire from phase 3 was delivered to 21 participants with stable BCRL, as defined by Schmitz et al.,³³ and repeated between 7 and 15 days later. All questions that worsened the intraclass correlation coefficient (ICC) of the dimension they belonged to were withdrawn. Finally, the lymphedema physiotherapist and another physiotherapist from a different department delivered the resulting questionnaire to 12 women to study the inter-rater reliability.

Phase 6. Confirmation of construct validity tested by factor analysis

To confirm that the parametric properties of the final questionnaire were acceptable, the factorial validity for the final questionnaire was checked again by re-testing the item-total correlation, the factor analysis, and the total variance.

Phase 7. Approach to criterion validity by contrast of hypothesis

The hypothesis was that an average difference of score ≥16% would be observed between participants using two different types of device.

Phase 8. Variability

Floor or ceiling effects would be present if >15% of the respondents reported the lowest or highest possible score, respectively.³⁴

Phase 9. Respondent and interviewer burden

The final version of the questionnaire was passed to 10 participants, and the average time spent by the respondents and the interviewers were calculated.

Ethical considerations

This study was conducted according to the Declaration of Helsinki.³⁵ Approval was obtained from the Ethics Committee of the hospital where the trial was carried out (ID 16/014). All included subjects gave written informed consent before commencement of the study.

Results

Sociodemographic and clinical data of the sample are presented in Table 1. There were no significant differences between the three groups, except for two variables: the age between the participants who used compression garments and those who used Kinesio taping (difference of 8.8 years, standard deviation [SD] = 3.4, p = 0.034), and the work situation, with fewer active workers in the compression garment and the Kinesio taping groups than in the multilayer bandage group (p = 0.031).

Table 1.

Sociodemographic and Clinical Variables at Baseline

N	Type of TTD			p	Total
	MLB	CG	KT		Total
	32	32	32		96
Age, [mean (SD) (range)]	64.7 (14.3) (40–88)	67.3 (12.2) (49–88)	58.5 (14.4) (42–88)	0.034 ^a	63.5 (14.1) (33–88)
Work situation, n (%)				0.031 ^b
Unemployed	24 (75)	25 (78)	16 (50)		65 (67.7)
Active worker	8 (25)	7 (22)	16 (50)		31 (32.2)
Level of studies, n (%)				0.643^b
Unfinished HS	6 (18.8)	7 (21.9)	3 (9.4)		16 (16.7)
HS	10 (31.2)	9 (28.1)	12 (37.5)		31 (33.6)
Mid-level studies	10 (31.2)	13 (40.6)	10 (31.2)		33 (35.8)
University	6 (18.8)	3 (9.4)	7 (21.9)		16 (16.7)
In relationship, n (%)				0.751^b
Yes	27 (84.3)	25 (79.1)	27 (84.4)		79 (82.3)
No	5 (15.6)	7 (21.9)	5 (15.6)		17 (17.7)
Type of surgery				0.841^b
Lumpectomy	5 (15.6)	5 (15.6)	5 (15.6)		15 (15.6)
Mastectomy without reconstruction	20 (62.5)	17 (53.1)	16 (50)		53 (55.2)
Mastectomy with reconstruction	7 (21.9)	10 (31.3)	11 (34.4)		28 (29.2)
Phase of lymhedema				0.135^b
II	28 (87.5)	29 (90.6)	32 (100)		89 (92.7)
III	4 (12.5)	3 (9.4)	0 (0)		7 (7.3)
Hand with BCRL, n (%)				0.312^b
Hand not affected	13 (40.6)	16 (50.0)	10 (31.2)		39 (40.6)
Hand affected	19 (59.4)	16 (50.0)	22 (68.7)		57 (59.4)
Time with BCRL, n (%)				0.135^b
Less than 1 year	6 (18.8)	1 (3.1)	5 (15.6)		12 (12.5)
1 year or more	26 (81.2)	31 (96.9)	27 (84.4)		84 (87.5)
Time from first use of TTD, n (%)				0.287^b
Less than 1 year	9 (28.1)	4 (12.5)	6 (18.6)		19 (19.8)
1 year or more	23 (71.9)	28 (87.5)	26 (81.2)		77 (80.2)

Statistically significant difference with a p-value <0.05 in bold.

One-way ANOVA, p < 0.05: significant difference between CG and KT (p = 0.035 post hoc Bonferroni).

Pearson's chi-squared test, p < 0.05: significant difference between CG and KT (p = 0.019) and between MLB and KT (p = 0.039).

BCRL, breast cancer-related-related lymphedema; CG, compression garment; KT, Kinesio taping; MLB, multilayer low-stretch bandage; SD, standard deviation; TTD, therapeutic textile device.

Phase 1. Apparent validity

To the question: “Do you think that this questionnaire improves communication with your doctor and/or physiotherapist?,” 92.7% (p < 0.001) of the respondents answered affirmatively. To the question: “Does the questionnaire reflect well the advantages and disadvantages caused by the therapy?,” 91.7% (p < 0.001) of the participants answered affirmatively.

No relationship was observed between the total score and the clinical and sociodemographic variables studied (Table 2).

Table 2.

Relationship Between the Total Score in the Satisfaction Questionnaire about Therapeutic Textile Devices for Breast Cancer-related Lymphedema and the Clinical and Sociodemographic Variables of the Participants

N = 96	p
Age	0.384^a
Work situation	0.433^b
Level of studies	0.131^b
Personal relationship	0.233^b
Areas with BCRL	0.217^b
Time suffering from BCRL	0.948^b
Time since first use of the TTD	0.721^b

Spearman's rank correlation test.

One-way ANOVA.

Phase 2. Missing responses

Five items were not answered by >35% of the subjects, which therefore were not included in the analysis: three items on sexual satisfaction (so the dimension of sexual satisfaction was eliminated), one on work activity, and one on driving vehicles (Table 3). Thirty-eight items remained in the questionnaire.

Table 3.

Reasons for Questions Removal From the Initial Questionnaire

Phase 1	Item	Rationale for removal
Phase 2	My sex life is just as satisfying as before I started using a TTD.^a	22 missing responses
	My partner avoids sexual intercourse when I wear the TTD.
	I avoid sex when I wear the TTD, because I do not like my partner to see me like that.
	With the TTD, I can perform my daily work without problems (respond only if you are currently employed).	65 missing responses
	The TTD allows me to drive.	43 missing responses
Phase 3	Using TTD is the worst sequel to breast cancer.	Negative correlation coefficient
	I can use the TTD alone, without anyone's help.	Negative correlation coefficient
	My friends or relatives encourage me to use the TTD.	Item correlation-total <0.255
	I do not care if people ask me why I wear the TTD.
	The TTD slips down, gets out of place and/or unstuck.
Phase 4	The TTD allows me to do activities that I did not dare do before I wore it for fear that my arm would become more swollen.	It does not fit on any subscale
	Using the TTD makes me lose strength in the arm.	Worsening of the Cronbach's α on the mood subscale (p < 0.05)
	I do not wear the TTD when I want to dress up (example, go to a wedding or go dancing).
Phase 5	I wear the clothes I like regardless of whether I cover the TTD so that it looks less noticeable or not.	Worsening of the ICC^b on the mood subscale
	People notice more that my arm is swollen when I wear the TTD than when I do not.
	I feel more depressed since I've been using the TTD.
	I find it just as easy to find clothes that suit me when I wear the TTD than when I do not wear it.	Worsening of the ICC^b on the comfort subscale
	The TTD allows me to practice my sport and/or hobbies.
	I need to remove the TTD to clean myself properly.
	I waste a lot of time putting on the TTD.
	I am willing to continue using the TTD as long as the physiotherapist/doctor indicates me to.	Worsening of the ICC^b on the compliance subscale
	Thanks to the use of TTD, my lymphedema is stable and does not get worse.	Worsening of the ICC^b on the perceived benefit subscale
	I want to continue or go back to using the TTD, because I notice that it is good for lymphedema.	Worsening of the ICC^b on the perceived benefit subscale

TTD: Therapeutic Textile Device.

ICC: Intraclass correlation coefficient.

Phase 3. Internal consistency

In the item-total correlation test, two items were discarded due to negative item-total correlation coefficient and worsening of the total Cronbach's α. Other three items were eliminated, because they did not correlate well with the total score (corrected item-total correlation <0.267) (Table 3). Thirty-three items remained in the questionnaire.

Phase 4. Factor analysis for construct validity

In the factor analysis, the included dimensions were mood, patient comfort, patient compliance, and perceived benefits. The total variance was 63%. One question was discarded, because it did not fit well in any dimension and the other two because they worsened the Cronbach's α for the dimension they belonged to (p < 0.05) (Table 3). The item about injuries produced by the devices (item 10 of the final questionnaire) was finally kept despite an estimated value of 0.244 for the coefficient of the dimension. This decision was based on the importance it can have in deciding whether a patient is prescribed a type of device since a wound creates the risk of developing erysipelas in the upper limb with BCRL.³⁶ After this phase, 30 items remained.

Phase 5. Reproducibility

After evaluating the test–retest reliability with 2 different administrators in 21 participants, 10 questions were eliminated that worsened the ICC of each dimension (Table 3). A final test–retest ICC of 0.938 (95% CI, 0.856–0.974) was obtained for the questionnaire with the 20 remaining items.

This questionnaire was passed to 12 women to evaluate the inter-rater reliability, and an ICC of 0.913 (95% CI 0.738–0.973) was obtained. Therefore, no more questions were eliminated. The final version of the SQ-TTD-BCRL comprised 20 items, having a total score ranging from a minimum of 20 and a maximum of 100 points, with a lower score reflecting greater satisfaction with the device.

Phase 6. Confirmation of construct validity

The exploratory model, the corrected item-total correlation, and factor analyses were repeated for the final questionnaire with 20 items. The decrease in the number of items improved the variability of the factorial model since the total variance was 72.6%. In the exploratory model, for the hypothesis that four factors were sufficient, the p-value was 0.060. In the item-total correlation test, a Cronbach's α value of 0.87 (95% CI 0.84–0.90) was obtained (Table 4). In the factor analysis, Cronbach's α values were calculated to be 0.73 (95% CI 0.65–0.80) for the dimension of mood, 0.83 (95% CI 0.79–0.87) for patient comfort, 0.76 (95% CI 0.67–0.84) for patient compliance, and 0.67 (95% CI 0.57–0.77) for perceived benefits.

Table 4.

Parametric Properties of the Final Questions

Dimension	Text of the item	The score is inverted	Raw_alpha^a	R.cor^b
Mood	1. I stay at home when I wear the TTD^c, because I am embarrassed to be seen with it.	No	0.87	0.42
	2. It gives me a complex me to wear the TTD.	No	0.87	0.45
	3. I feel just as attractive with the TTD than without it.	Yes	0.87	0.47
	4. It makes me angry to wear the TTD.	No	0.86	0.58
	5. I feel more nervous when I wear the TTD.	No	0.86	0.77
	6. The TTD is a constant reminder of cancer for me.	No	0.87	0.30
Patient comfort	7. I feel comfortable wearing the TTD.	Yes	0.85	0.78
	8. On hot days, I can stand the TTD well.	No	0.86	0.59
	9. I sleep worse with the TTD than without it (nap or night).	No	0.86	0.56
	10. The TTD causes skin wounds (abrasions, chafing).	No	0.87	0.27
	11. The TTD sticks on some areas and leaves marks or redness, but it does not hurt me.	No	0.86	0.48
	12. The TTD causes me pain.	No	0.86	0.63
	13. The TTD overwhelms me when I wear it.	No	0.86	0.70
	14. The TTD does not prevent me from doing all the housekeeping tasks.	Yes	0.87	0.40
	15. I have a hard time getting dressed and undressed with the TTD.	No	0.86	0.57
Patient compliance	16. I agree to wear the TTD for as long as I was told to.	Yes	0.85	0.81
Patient compliance	17. I comply with the daily hours that the physiotherapist/doctor has told me I should wear the TTD.	Yes	0.86	0.56
Perceived benefits	18. I think wearing the TTD regularly in the long term improves my lymphedema.	Yes	0.87	0.32
	19. I feel less heaviness in the arm when I wear the TTD.	Yes	0.87	0.38
	20. I feel the arm is more protected from injuries when I wear the TTD.	Yes	0.87	0.20

Raw_alpha: item-total correlation.

R.cor: corrected item-total correlation for item overlap and scale reliability.

TTD: Textile Therapeutic Device.

NB: SQ-TTD-BCRL has been developed in Spanish and translated for the purpose of this manuscript.

Phase 7. Approach to criterion validity by contrast of hypothesis

In the present study, the validation hypothesis was met since an average difference in the score of ≥16% was obtained between bandage and compression garment and also between bandage and taping (Table 5).

Table 5.

Hypothesis for Sample Size Calculation

	MLB	CG	KT
Percentage % mean (95% CI)	43.86 (36.88–50.84)	26.56 (20.13–32.97)	19.88 (15.72–24.05)
	MLB minus CG	MLB minus KT	CG minus KT
Difference of percentages % mean (95% CI)	17.30 (7.19–27.42)	23.98 (13.87–34.09)	6.68 (−3.43 to 16.79)
HYPOTHESIS MET	Yes	Yes	No

Ratio (%) of mean score to the maximum possible score for each device.

In 12 of the 20 items, significant differences were found in the scores for each type of device (p < 0.05), with the bandage showing the highest average scores in all the items. In the post hoc analysis of the 12 items, the bandage always presented significant differences with at least one of the other two devices (compression garment or taping), whereas significant differences between compression garment and taping were only found in four items (Table 6).

Table 6.

Overall Response for Each Item Depending on the Type of TTD

Item	Any TTD (n = 96) [mean (SD)]	MLB (n = 32) [mean (SD)]	CG (n = 32) [mean (SD)]	KT (n = 32) [mean (SD)]	p ^a	p-value ^b MLB vs. CG	p-value ^b MLB vs. KT	p-value ^b CG vs. KT
1	2.0 (1.4)	2.7 (1.7)	1.7 (1.1)	1.6 (1.2)	0.004	0.016	0.004	1.000
2	1.8 (1.3)	2.2 (1.4)	1.5 (1.0)	1.8 (1.4)	0.108
3	2.4 (1.5)	2.8 (1.5)	2.2 (1.4)	2.2 (1.5)	0.102
4	1.8 (1.1)	2.1 (1.3)	1.8 (1.1)	1.5 (0.9)	0.109
5	1.7 (1.2)	2.3 (1.4)	1.6 (1.1)	1.2 (06)	0.002	0.032	<0.001	0.529
6	2.7 (1.6)	2,8 (1.6)	2.6 (1.6)	2.8 (1.7)	0.904
7	2.5 (2.5)	3.7 (1.3)	2.2 (1.3)	1.6 (1.0)	<0.001	<0.001	<0.001	0.084
8	2.8 (1.4)	3.8 (1.1)	2.7 (1.3)	1.9 (1.2)	<0.001	0.002	<0.001	0.041
9	2.6 (1.6)	3.5 (1.7)	2.8 (1.6)	1.6 (1.0)	<0.001	0.160	<0.001	0.004
10	1.4 (0.9)	1.3 (0.8)	1.5 (1.0)	1.5 (1.0)	0.783
11	2.5 (1.5)	3.0 (1.6)	2.9 (1.4)	1.7 (1.0)	<0.001	1000	<0.001	0.001
12	1.9 (1.2)	2.3 (1.3)	1.9 (1.4)	1.4 (0.7)	0.017	0.744	0.012	0.227
13	2.3 (1.5)	3.1 (1.7)	2.2 (1.4)	1.7 (1.1)	0.001	0.058	0.001	0.413
14	2.4 (1.5)	3.5 (1.3)	2.0 (1.3)	1.7 (1.2)	<0.001	<0.001	<0.001	0.854
15	2.5 (1.6)	3.8 (1.5)	2.2 (1.4)	1.4 (1.0)	<0.001	<0.001	<0.001	0.065
16	2.2 (1.4)	3.0 (1.5)	2.0 (1.3)	1.8 (1.2)	0.002	0.016	0.002	1.000
17	1.6 (1.2)	2.0 (1.2)	1.6 (1.0)	1.4 (1.2)	0.217
18	2.0 (1.4)	2.1 (1.2)	1.9 (1.4)	2.1 (1.4)	0.524
19	2.6 (1.6)	3.0 (1.6)	2.2 (1.5)	2.6 (1.5)	0.079
20	2.0 (1.4)	2.0 (1.3)	1.5 (0.9)	2.6 (1.6)	0.017	0.035	0.035	0.005

Kruskal–Wallis test to compare the score of each item for the three different types of TTD.

Comparison by post hoc pairs with Bonferroni correction.

Statistically significant difference with a p-value <0.05 in bold.

NB: TTD-BCRL-SQ has been developed in Spanish and translated for the purpose of this manuscript.

Phase 8. Variability

No ceiling or floor effect was observed: Only one patient reported the minimum score and another patient the maximum score (1.04% in both cases).

Phase 9. Respondent and interviewer burden

The average of the respondent burden was 5.6 minutes (SD = 3.8) and for the interviewer 2.2 minutes (SD = 1.3).

Discussion

The conducted analysis supports the content validity, reliability, and construct validity of the SQ-TTD-BCRL. Four dimensions were evaluated by the factor analysis (mood, patient comfort, patient compliance, and perceived benefits) in the studied population.

Mood and perceived benefits are the dimensions that correlated the worst in the factor analysis (correlation coefficient = 0.14). This could happen because a therapy that the patient considers to be beneficial does not necessarily imply that it cannot adversely affect their mood.

The dimension of sexual satisfaction was eliminated, because >35% of patients did not answer the items about it. This could be due to the fact that 17.5% did not have a partner and because 54.3% were >65 years of age. In terms of questions about paid work, the high number of patients over 65 years frequently made those questions irrelevant and, therefore, not completed. Regarding the item about driving, 40% of women did not have a driving license, so there were too many unanswered questions leading to its exclusion.

Regarding the corrected item-total correlation, items 9, 10, and 19 obtained correlation coefficients of 0.285, 0.244, and 0.267, respectively, which were slightly lower than 0.3, the minimum value recommended in the scientific literature. However, these three items were considered to be of great clinical relevance and hence they were not eliminated: Item 10 was especially important since a possible wound in a BCRL can, in turn, trigger erysipelas³⁶; item 9 was considered necessary to know whether a patient can meet the guideline of using the device for 24 hours, as recommended by many authors^37–40; and item 19 reflected the subjective feeling of heaviness, one of the most frequent and important symptoms associated with BCRL.²⁸

The average age of the studied population (63.5, SD = 14 years) may have influenced the drafting of the questionnaire and was slightly higher than that found in other Spanish BCRL trials (52.9, SD = 11.6–61.4, SD = 11.5 years),^8,41–43 except for that by Belmonte et al. (67.8, SD = 11.3 years).⁴⁴

Tsai et al. obtained worse scores for compression garments than for taping, and for bandage than for compression garments, on the emotional subscale of the European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30).⁹ King et al. found that patients who received complex physical therapy, including multilayer low-stretch bandage, showed worse scores on the Disabilities of the Arm, Shoulder, and Hand scale than those who received the same therapy but with compression garment.¹⁰ The results obtained by these authors are similar to those obtained in this study, where the device with the highest score, and therefore worst satisfaction, was the multilayer low-stretch bandage (55.9), followed by the compression garment (41.2), and finally by the Kinesio taping (35.9).

Future multicentre validation studies should be carried out in samples with different sociodemographic characteristics. Selecting samples among a younger, actively working population would potentially allow the validation of items referring to sexual satisfaction, work, and driving of vehicles.

Limitations

It was not possible to include items on sexual satisfaction, paid work, or driving, which are very important to assess quality of life more adequately. Other types of devices, such as Circaid^® Juxtafit^®, or JoViPak^®, were not evaluated, and compression garments were not discriminated according to shape, material, and level of compression, so studying the psychometric properties of this questionnaire would be of interest to differentiate among more subtypes of devices. This questionnaire could also not be compared with others about textile devices since none could be found that was validated at the moment this trial was conducted. In addition, the potential effect that the lymphedema severity grade can have on the responses was not evaluated, which can be of interest in future research. This questionnaire was tested on a specific urban Spanish population, so validating it through multicenter studies with more diverse populations and in different languages is desirable.

Conclusion

These results support the appropriateness of the self-administered questionnaire SQ-TTD-BCRL in this population. Future multicenter studies, with larger sample sizes, populations of different sociodemographic characteristics, assessing the effect of the lymphedema severity, including other textile devices, and in different languages would be necessary to confirm these findings. This questionnaire could be useful for health professionals to assess the satisfaction of each patient with the type of therapeutic textile device used in a standardized manner. Assessing which textile device is most suitable for each patient depending on their degree of satisfaction with it can also be useful.

Footnotes

Acknowledgments

The authors would like to thank the rehabilitation service and especially Dr. De Carlos Iriarte, for her valuable contribution to the project during the recruitment phase. This study was possible thanks to the i + 12 Research Institute for having awarded V. Pajero Otero in the Fourth Call for Contracts for the Intensification of the Research Activity for Nursing Staff of the University Hospital 12 de Octubre.

Author Disclosure Statement

No competing financial interests exist.

Funding Information

This study has been possible thanks to the Research Institute imas12 for having awarded the main author V. Pajero Otero through the Fourth Call for Contracts for the Intensification of the Research Activity for Nursing Staff of the University Hospital 12 de Octubre. The prize consisted of being able to dedicate 6 months of his annual working time to the execution of two related research projects. One of them is the development of the Satisfaction Questionnaire About Therapeutic Textile Devices Used For Breast Cancer-Related Lymphedema.

Supplementary Material

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