1.6-4.8% given to their child which causes

1.6-4.8% ofall the cancers in India are diagnosed in children below 15 years of age withan overall incidence of 38 to 124 per million and the rate is increasingaccording to population based cancer registry survey 2009-20112, 6.

Comparedwith population norms, parents of children with cancer have reported poorerphysical and psychosocial quality of life in all psychological domains5.These parents face the psychological effects of cancer indirectly in the formof invasive, expensive and long chemotherapy treatment given to their childwhich causes a large number of distressing, unavoidable side effects8.Depression is one of the leading causes of ill health and disability worldwideand caring for a child with cancer has been associated with increased odds ofclinically relevant depressive symptoms in the parents3, 1.Furthermore, parents of children newly diagnosed or in active cancer therapy havealso reported higher levels of anxiety than parents of children off activecancer therapy9. They have reported significant worsening of theirown health due to poorer diet and nutrition, less physical activity and lesstime spent engaged in enjoyable activities4.

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Few studies have beendone to find the association of various variables with the levels on anxietyand depression of parents with children undergoing chemotherapy, especially inIndia. Depression is one of the biggest hidden issues plaguing the Indiansociety due to the stigma that comes associated with it. Hence, this study isdesigned to bring to light these levels and their association with thesocio-demographic and clinical factors.

Objective:1.    To assess the level of anxiety anddepression among parents of children with cancer currently undergoingchemotherapy.2.    To identify the association ofanxiety and depression levels among the parents of children with cancercurrently on chemotherapy with the socio-demographic factors and clinicalcharacteristics of the child.Methodology:The studywill be conducted in the Department of Medical Oncology, Jawaharlal Instituteof Postgraduate Medical Education and Research (JIPMER), Puducherry.a)   Type of study – This will be a cross sectionalobservational studyb)  Study Period – The study will be conducted for 4months (April-July) with 3 months for collection of data, 1 month for analysisof collected data and preparation of report.c)   Study Participants- Humansd)  Sample Size –138 (Sample size is estimated usingthe statistical formula for estimating a single proportion.

It is estimatedwith an expectation that 90% of the parents with children with cancer currentlyon chemotherapy will have moderate level of anxiety and depression and thesample size is estimated at 5% level of significance and 5% absolute precision. e)  Inclusion Criteria – Biological parents or step parents involvedin the care of children 0-18 yearsof age currently undergoing chemotherapy in JIPMER will be considered. Writtenconsent will be taken from them.f)    Exclusion Criteria – Parents with the followingcharacteristics will be excluded from study.·       clinical depression ·       significant family death in the past6 months·       chronic illnesses and malignancies The cases diagnosed inthe past 2 months will also be excluded from the study (?)g)   Sampling ·       Population – Parentsof 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 sincediagnosis) will be collected. Anxiety and depression will be measured by usingHAM-A and HAM-D rating scales. The anxiety and depression scales will beadministered once during the chemotherapy. The Tamil version of HAM-A and HAM-Dscale is available and will be used. For participants who do not know how toread and write, the questions will be explained in their mother tongue andresponse will be noted on interview basis. Hamilton Depression Scale (HAM-D), is a multiple item questionnaire usedto provide an indication of depression, and the questionnaire is designed foradults and is used to rate the severity of their depression by probing mood,feelings of guilt, insomnia, agitation or retardation, anxiety, weight loss andsomatic symptoms.

Although HAM-D form lists 21 items, the scoring is based onfirst 17. Eight items are scored on a 5 point scale, ranging from 0 = notpresent to 4 = severe. Nine are scored from 0-2. Hamilton Anxiety Rating Scale (HAM-A),is a psychologicalquestionnaire 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’sanxiety. Each of the 14 items containsa number of symptoms, and each group of symptoms is rated on a scale of zero tofour, with four being the most severe. All these scores are used to compute anoverarching score that indicates a person’s anxiety severity. Following theitem number, the item itself is listed along with a brief description of thecriterion. The description is in the form of a short phrase that elaborates onthe item and provides specificity to the clinician regarding the appropriateevaluation. Adjacent to each item is a five point scale, displaying numerals 0to 4 outlined by a square.

 Statistical Tests to be used for DataAnalysisThe data on categorical variables on clinical and socio-demographiccharacteristics of child and parent, clinical characteristics of the child,treatment history, etc. will be expressed as frequency and percentages. Thecontinuous data such as age, level of anxiety, level of depression, etc.

willbe expressed as mean with standard deviation or median with range. Thecomparison of level of anxiety and depression between the categorical variablesmentioned above will be carried out by using independent student’s t-test/MannWhitney U-test or one way analysis of variance/Kruskal Wallis whichever isappropriate based on number of groups and distribution of data. The independentfactors associated with the level of anxiety and depression will be explored byusing linear regression analysis or structural analysis will be carried out at 5%level of significance and p-value <0.05 will be considered as significant. Ethical ConsiderationsEthical approval will be obtained from IEC. Written informed consent willbe taken from the participants before the administration of questionnaire.

Thisstudy poses no risk to the participants. Confidentiality will be maintained andthe details of the participants will not be revealed under any circumstances.Data analysis will be done using de-identified information.  Implication: This study will help to identify the risk factors which can lead to increasedlevels of negative psychological feelings such as depression and anxiety in theparents of children currently on chemotherapy.

Understanding which factorsaffect psychological distress among parents may help to identify those parentsat risk for distress and inform the development of supportive services. Itcould also help to develop new screening tests in order to direct the limitedpsychological care and resources to the group that requires it more in order toattain maximum benefit.

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