Keywords
chemotherapy-induced alopecia - distress - distress scale - quality of life
Introduction
Chemotherapy-induced alopecia (CIA) casts a strong and definitely negative impact
on body image in terms of perception of aging, depression, loss of interest, and confidence.
Alopecia enhances vulnerability in the patient's mind with a constant reminder of
illness and the doom of cancer.[1]
Although transient and mostly reversible, CIA is devastating consequence of systemic
anticancer therapy for many patients especially females with significant psychological
and social impact.[2]
[3] Associated emotional trauma may lead to refusal or delay in the anticancer treatment.[4] Usually, distress with CIA (CAD) is not considered worthy enough reporting and,
when it is reported, it demonstrates reduced quality of life.[5] CAD scales are available in Italian and Chinese version.[3]
[6]
[7] Therefore, handling CAD is the need of the hour.
Methodology
This study deals with translation and validation of chemotherapy-induced alopecia
distress scale (CADS)[3] into Hindi and Marathi (stage I); the translated versions can be used to assess
distress level in larger population (stage II) at our tertiary cancer center.
The secondary objectives were to assess CAD in different malignant conditions, different
regimens and to compare association between socioeconomic, clinical, and demographic
data of patients with CAD in larger population.
This study was conducted in two stages. In stage I, nonexperimental descriptive research
design was used and in stage II cross-sectional survey research design was used for
the study. A non-probability convenient sampling technique was used. Sample size was
30 for stage I and 300 for stage II. The Clinical Trial Registry of India registration
number was CTR/2020/02/02335.
Stage I
Content Validity
-
Part A: Permission from concerned organization was taken before using CADS for the study.
Also, permission was obtained for translating CADS into Hindi and Marathi.
-
Part B: The tool was validated from nine experts including medical oncologists, nurses, and
psychologist. Few modifications were made after the suggestion of experts and content
validity was established.
Reliability
Data was summarized using mean and standard deviation and median and interquartile
range for normal and non-normally distributed data for all separate domains. Construct
validity was assessed by discriminant and convergent validity, and was explored by
use of psychometric techniques of analysis of scaling, using correlations between
items and scales (item–Scale), and correlation between scales (scale to scale) respectively.
For convergent validity, the 42 items within a scale were to be moderately or highly
correlated (>0.40) with their own scale. For discriminant validity, to indicate that
the two scales were different in construct, scale to scale correlation coefficient
of less than 0.70 was required. The Kaiser-Meyer-Olkin was the measure of sampling
adequacy, which varied between 0 and 1. Construct validity was established by exploratory
factor analysis using varimax method and principal component analysis for extraction.
The analyses were performed by using the criteria of Eigen value 1 and the screen-plot
method. Internal consistency of the multi-item questionnaire was assessed by use of
Cronbach's α coefficient, which was used to indicate scale of reliability.
Data Collection
Data collection was done by using CADS. CADS was first translated in Marathi and Hindi
language. CADS consisted of 25 items based on five domains: physical,[2] emotional,[8] daily activity,[8] relationship,[5] and treatment.[2] A four-point Likert scale on each statement scoring degree of distress on CADS was
as follows: 1 = not at all, 2 = a little, 3 = quite a bit, 4 = very much. Total scores
were calculated by summing responses for all items; higher scores meant more distress
due to CIA. In addition to CADS, tool also included demographics, socioeconomic, and
clinical characteristics—age, sex, marital status, education, Kuppuswamy socioeconomic
scale, data related to disease and chemotherapy, and measures undertaken by patient
for alopecia management are also included in the tool.
Association between severity of CIA with age, gender, marital status, socioeconomic
status, and diagnosis was analyzed using chi-squared test. A p-value less than 0.05 in a two-tailed test was considered statistically significant.
Then CADS was administered to 30 participants. Construct validity was assessed by
discriminant and convergent validity. Convergent validity was performed by using Spearman's
rank correlation. Reliability was checked by Cronbach's α coefficient.
Stage II
Stage II was conducted with 300 samples at Tata Memorial Hospital, Mumbai. Data was
gathered and analyzed by using descriptive and inferential statistics.
Results
In our study, approximately 40% of the patients were under the age of 40 years and
majority (71.3%) were females, 75.7% of patients were married, around 47.0% of patients
belonged to lower middle class, most patients (35.3%) involved in the study had breast
cancer ([Fig. 1]), most patients (65.3%) noticed alopecia after first cycle of chemotherapy, majority
of the patients (67.7%) received chemotherapy once in 3 weeks, and the majority (78.0%)
used a scarf to cover the head ([Supplementary Table S1] [available in the online version]). The median time to develop alopecia was 25.3
days.
Fig. 1 Distribution of chemotherapy-induced alopecia distress scale (CADS) with diagnosis.
Convergent validity: All the items have a correlation more than 0.4 except the physical domain. ([Table 1] and [Supplementary Table S2] [available in the online version]).
Table 1
Construct validity and internal consistency of scores for CADS scale
|
Cronbach's α
|
Inter-item correlation
|
Inter-item correlation significance value
|
Scale-scale DV validity
|
|
Items (1–2) Physical
|
0.264
|
0.152
|
0.512
|
−0.186–0.416
|
|
Items (3-10) Emotional
|
0.87
|
0.137–0.765
|
<0.001
|
−0.352–0.358
|
|
Items (11–16, 18, 20) Activity
|
0.832
|
0.178–0.718
|
<0.001
|
−0.186–0.287
|
|
Items (17,19,21–23) Relationship
|
0.232
|
0.443–0.719
|
<0.001
|
−0.233–0.336
|
|
Items (24-25) Treatment
|
0.559
|
0.396
|
0.029
|
−0.328–0.366
|
|
Overall reliability
|
0.882
|
|
|
|
Abbreviations: CADS, chemotherapy-induced alopecia distress scale.
Construct validity internal consistency: Internal consistency of the multi-item questionnaire was assessed by use of Cronbach's
α coefficient. For the physical domain, Cronbach's α was calculated as 0.264, Cronbach's
α was 0.87 for the emotional domain, and 0.832 for the activity domain. The overall
reliability for the 25 items was 0.882. Hence, the questionnaire proved to be a reliable
tool ([Table 1]).
The level of distress associated with CIA was measured in terms of mild, moderate,
and severe distress. The majority of the patients (58.66%) experienced severe distress
due to CIA ([Table 2]).
Table 2
Distress levels
|
Scores
|
CADS Score
|
Frequency
|
Percentage
|
|
Mild
|
0–33
|
2
|
1.0
|
|
Moderate
|
34–67
|
122
|
40.66
|
|
Severe
|
68–100
|
176
|
58.66
|
Abbreviations: CADS, chemotherapy-induced alopecia distress scale.
Higher the age, more was the severity of CIA distress (p-value <0.022). Females had severe CIA distress than males (p-value <0.001). Married patients had more severe distress than unmarried and widow
patients (p-value < 0.011). Most of the patients experienced severe CIA distress after first
cycle of chemotherapy administration (p-value <0.041).
There was no significant association between socioeconomic status, number of chemotherapy
cycles received, frequency of chemotherapy administration and CIA distress.
Discussion
Our study revealed that majority of the patients (58.66 %) had severe CAD and breast
cancer patients had severe (65.09%) CAD. Münstedt et al in his longitudinal study
on ovarian cancer assessed patients who had complete alopecia, in which 73.3% had
lack of confidence due to alopecia.[8] Machado et al also identified chemo-induced permanent alopecia after hematopoietic
stem cell transplantation[9] affecting the overall quality of life of these patients. Indian women especially
those who were married with higher age group cancer patients were affected more due
to CIA. This might also reflect the impact on the body image on married women than
unmarried young women.
Since the CAD was higher even after first cycle and was not affected by the number
of cycles or frequency of the cycles, the thought of alopecia even before it developed
would put these women through severe CAD. These findings may be useful especially
when it comes to developing coping strategies for the CIA. The treatment or prevention
of CIA should be preceded with the counseling and support provided by the chemotherapy
nurses, to bring down the severity of CAD.
The CAD is severe irrespective of socioeconomic status of the patients adding an important
perspective to the coping strategies. Since this study includes patients with various
solid and hematolymphoid malignancies, it broadens the thought process required to
deal with the CAD.
There are certain limitations to our study. A larger sample size is required to assess
its generalization across all the malignancies. The use of coping strategies in a
randomized trial is the need of the hour. Our study was a prospective nonrandomized
single-center noninterventional study.
Conclusion
CADS is valid and predictive of the presence of severe distress in our patients receiving
chemotherapy. This scale can be used for assessment in clinical areas and the more
sensitive area of alopecia can be addressed at the earliest by the caring nurses and
physicians.
