1.6-4.8% in the form of invasive, expensive and

1.6-4.8% of
all the cancers in India are diagnosed in children below 15 years of age with
an overall incidence of 38 to 124 per million and the rate is increasing
according to population based cancer registry survey 2009-20112, 6. Compared
with population norms, parents of children with cancer have reported poorer
physical and psychosocial quality of life in all psychological domains5.
These parents face the psychological effects of cancer indirectly in the form
of invasive, expensive and long chemotherapy treatment given to their child
which causes a large number of distressing, unavoidable side effects8.
Depression is one of the leading causes of ill health and disability worldwide
and caring for a child with cancer has been associated with increased odds of
clinically relevant depressive symptoms in the parents3, 1.
Furthermore, parents of children newly diagnosed or in active cancer therapy have
also reported higher levels of anxiety than parents of children off active
cancer therapy9. They have reported significant worsening of their
own health due to poorer diet and nutrition, less physical activity and less
time spent engaged in enjoyable activities4. Few studies have been
done to find the association of various variables with the levels on anxiety
and depression of parents with children undergoing chemotherapy, especially in
India. Depression is one of the biggest hidden issues plaguing the Indian
society due to the stigma that comes associated with it. Hence, this study is
designed to bring to light these levels and their association with the
socio-demographic and clinical factors.

Objective:

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1.    To assess the level of anxiety and
depression among parents of children with cancer currently undergoing
chemotherapy.

2.    To identify the association of
anxiety and depression levels among the parents of children with cancer
currently on chemotherapy with the socio-demographic factors and clinical
characteristics of the child.

Methodology:

The study
will be conducted in the Department of Medical Oncology, Jawaharlal Institute
of Postgraduate Medical Education and Research (JIPMER), Puducherry.

a)   
Type of study – This will be a cross sectional
observational study

b)  
Study Period – The study will be conducted for 4
months (April-July) with 3 months for collection of data, 1 month for analysis
of collected data and preparation of report.

c)   
Study Participants- Humans

d)  
Sample Size –138 (Sample size is estimated using
the statistical formula for estimating a single proportion. It is estimated
with an expectation that 90% of the parents with children with cancer currently
on chemotherapy will have moderate level of anxiety and depression and the
sample size is estimated at 5% level of significance and 5% absolute precision.

e)  
Inclusion Criteria – Biological parents or step parents involved
in the care of children 0-18 years
of age currently undergoing chemotherapy in JIPMER will be considered. Written
consent will be taken from them.

f)    
Exclusion Criteria – Parents with the following
characteristics will be excluded from study.

·       clinical depression

·       significant family death in the past
6 months

·       chronic illnesses and malignancies

The cases diagnosed in
the past 2 months will also be excluded from the study (?)

g)   
Sampling

·       Population – Parents
of pediatric cancer patients undergoing chemotherapy at Regional Cancer Centre,
JIPMER.

·       Sampling Method – Convenient sampling

 

h)  
Brief Procedure

 

The demographic details (sex, age, marriage status, income, location,
time of travel, religion, education, occupation, etc.) and the clinical details
(patient’s age at diagnosis, cancer diagnosis, stage of cancer, time since
diagnosis) will be collected. Anxiety and depression will be measured by using
HAM-A and HAM-D rating scales. The anxiety and depression scales will be
administered once during the chemotherapy. The Tamil version of HAM-A and HAM-D
scale is available and will be used. For participants who do not know how to
read and write, the questions will be explained in their mother tongue and
response will be noted on interview basis.

 

Hamilton Depression Scale (HAM-D), is a multiple item questionnaire used
to provide an indication of depression, and the questionnaire is designed for
adults and is used to rate the severity of their depression by probing mood,
feelings of guilt, insomnia, agitation or retardation, anxiety, weight loss and
somatic symptoms. Although HAM-D form lists 21 items, the scoring is based on
first 17. Eight items are scored on a 5 point scale, ranging from 0 = not
present to 4 = severe. Nine are scored from 0-2.

 

Hamilton Anxiety Rating Scale (HAM-A),
is a psychological
questionnaire used by clinicians to rate the severity of a patients anxiety.
The scale consists of 14 items designed to assess the severity of a patient’s
anxiety. Each of the 14 items contains
a number of symptoms, and each group of symptoms is rated on a scale of zero to
four, with four being the most severe. All these scores are used to compute an
overarching score that indicates a person’s anxiety severity. Following the
item number, the item itself is listed along with a brief description of the
criterion. The description is in the form of a short phrase that elaborates on
the item and provides specificity to the clinician regarding the appropriate
evaluation. Adjacent to each item is a five point scale, displaying numerals 0
to 4 outlined by a square.

 

Statistical Tests to be used for Data
Analysis

The data on categorical variables on clinical and socio-demographic
characteristics of child and parent, clinical characteristics of the child,
treatment history, etc. will be expressed as frequency and percentages. The
continuous data such as age, level of anxiety, level of depression, etc. will
be expressed as mean with standard deviation or median with range. The
comparison of level of anxiety and depression between the categorical variables
mentioned above will be carried out by using independent student’s t-test/Mann
Whitney U-test or one way analysis of variance/Kruskal Wallis whichever is
appropriate based on number of groups and distribution of data. The independent
factors associated with the level of anxiety and depression will be explored by
using linear regression analysis or structural analysis will be carried out at 5%
level of significance and p-value