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A Multi-site Prospective Study to Determine Household Out-of-Pocket Expenditure Incurred by Families of Children Newly Diagnosed with Cancer in India

Active, not recruiting
Conditions
Hodgkin lymphoma,
Registration Number
CTRI/2016/11/007492
Lead Sponsor
Cankids
Brief Summary

**Objectives:** A diagnosis of cancer in childhood places a considerable economic burden on families, although these burdens remain unknown in India. The objectives of this prospective study are t 

1. Identify the costs incurred and resource utilized by families leading up to the start of treatment

2. Identify the costs incurred and resource utilized by families for the duration of treatment

3. Assess the variability of these costs by demographic, disease-related, treatment-related and centre-related factors

4. Assess the contribution of the assistance provided by governmental and non-governmental sectors in meeting these costs

5. Explore the psychological and socio-economic impact of these costs on the family

6. Measure events (abandonment rates, mortality, progression/relapse) and assess correlation with costs incurred.

**Methods**: A prospective cost of illness design will be conducted from a family household perspective. The sample will consist of 540 children from 15 study sites in 4 cities. At recruitment, a baseline family information questionnaire will be completed. For the duration of the child’s treatment, a social worker will contact parents to record their costs and resource utilization, beginning with the initial study enrolment, and repeated every week. A questionnaire tool administered to the parents at the end of treatment will be used to assess the psychological and socio-economic impact of the treatment. Occurrence of any event (abandonment, mortality, progression/relapse) will be confirmed by hospital records and/or contacting the parents. Descriptive analyses will be used to categorize the type and value of costs (medical and non medical) expressed in 2017 Indian Rupee (INR) and Purchasing Power Parity (PPP).

**Significance**: The proposed study will determine the costs incurred by families of children newly diagnosed with cancer in a resource poor (middle-income) country and how these costs vary depending on demographic, disease-related, treatment-related and centre-related factors. With systematically collected cost data, our goal is to understand the nature of these costs, the impact on the families, its correlation with outcomes (specifically abandonment of treatment) and the role of the assistance provided by governmental and non-governmental sectors. This information will be useful to clinicians, researchers, funding bodies, patient/parent support groups, health planners and hospital administrators with the ultimate goal of assisting the families with these costs and hence mitigating their financial impact.

Detailed Description

Not available

Recruitment & Eligibility

Status
Closed to Recruitment of Participants
Sex
All
Target Recruitment
540
Inclusion Criteria

Newly diagnosed with cancer who have been registered at the participating centres Following diagnosis, the child may have commenced treatment, but the duration of treatment has to be less than 2 weeks.

Exclusion Criteria

Children not from India Children > 18 years of age at time of diagnosis Children who receive therapy only for palliation of symptoms and signs Children with relapsed/recurrent cancer Parents/care-givers who refuse consent.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Out-of-pocket expenditure expressed in Indian Rupee (INR) and Purchasing Power Parity (PPP)At end of treatment
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (8)

ADYAR CANCER INSTITUTE (WIA)

🇮🇳

Chennai, TAMIL NADU, India

Apollo Speciality Cancer Hospital

🇮🇳

Chennai, TAMIL NADU, India

Asian Institute of Oncology

🇮🇳

Mumbai, MAHARASHTRA, India

Dr. B. R. A. Institute Rotary Cancer Hospital

🇮🇳

South, DELHI, India

Lokmanya Tilak Medical College and Hospital

🇮🇳

Mumbai, MAHARASHTRA, India

Max Super-Speciality Hospital

🇮🇳

South, DELHI, India

Saroj Gupta Cancer Centre & Research Institute

🇮🇳

Kolkata, WEST BENGAL, India

Tata Memorial Hospital

🇮🇳

Mumbai, MAHARASHTRA, India

ADYAR CANCER INSTITUTE (WIA)
🇮🇳Chennai, TAMIL NADU, India
Venkatraman Radhakrishnan
Principal investigator
9498082771
venkymd@gmail.com

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