| CTRI Number |
CTRI/2016/11/007492 [Registered on: 25/11/2016] Trial Registered Retrospectively |
| Last Modified On: |
18/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A Multi-site Prospective Study to Determine Household Out-of-Pocket Expenditure Incurred by Families of Children Newly Diagnosed with Cancer in India |
|
Scientific Title of Study
|
A Multi-site Prospective Study to Determine Household Out-of-Pocket Expenditure Incurred by Families of Children Newly Diagnosed with Cancer in India |
| Trial Acronym |
HOPE Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ramandeep Arora |
| Designation |
Pediatric oncologist |
| Affiliation |
Max Super Speciality hospital |
| Address |
1,2, Press Enclave Road, Saket, New Delhi
South
DELHI
110017
India |
| Phone |
8375017305 |
| Fax |
|
| Email |
childhoodcancer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ramandeep Arora |
| Designation |
Pediatric oncologist |
| Affiliation |
Max Super Speciality hospital |
| Address |
1,2, Press Enclave Road, Saket, New Delhi
South
DELHI
110017
India |
| Phone |
8375017305 |
| Fax |
|
| Email |
childhoodcancer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ramandeep Arora |
| Designation |
Pediatric oncologist |
| Affiliation |
Max Super Speciality hospital |
| Address |
1,2, Press Enclave Road, Saket, New Delhi
South
DELHI
110017
India |
| Phone |
8375017305 |
| Fax |
|
| Email |
childhoodcancer@gmail.com |
|
|
Source of Monetary or Material Support
|
| Cankids |
| Conquer Cancer Foundation |
|
|
Primary Sponsor
|
| Name |
Cankids |
| Address |
D- 7/7 Vasant Vihar, Delhi 110057 |
| Type of Sponsor |
Other [Not for profit Non Governmental Organisation] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Venkatraman Radhakrishnan |
ADYAR CANCER INSTITUTE (WIA) |
ADYAR CANCER INSTITUTE (WIA)
Department of Medical Oncology
No 1, East Canal Bank Road, Gandhi Nagar, Adyar, Chennai, Tamil Nadu 600020
Chennai
TAMIL NADU |
9498082771
venkymd@gmail.com |
| Revathi raj |
Apollo Speciality Cancer Hospital |
Apollo Speciality Cancer Hospital, Division of Hematology - Oncology
No. 320, Anna Salai,Teynampet,Nandanam, Chennai - 600035
Chennai
TAMIL NADU |
9841070249
revaraj@yahoo.com |
| Anupama Borker |
Asian Institute of Oncology |
Department of Medical and Pediatric Oncology,Asian Institute of Oncology
Off Easter Express Highway, Behind Everard Nagar, Somaiya Ayurvihar, Sion(East), Mumbai, Maharashtra 400022
Mumbai
MAHARASHTRA |
9869084466
dranupamasb@gmail.com |
| Sameer Bakhshi |
Dr. B. R. A. Institute Rotary Cancer Hospital |
Department of Medical Oncology
Dr. B. R. A. Institute
Rotary Cancer Hospital,All India Institute of
Medical Sciences
New Delhi-110029
South
DELHI |
9868398312
sambakh@hotmail.com |
| Mamta Manglani |
Lokmanya Tilak Medical College and Hospital |
Division of Hematology - Oncology
Lokmanya Tilak Medical College and Hospital
Dr. Babasaheb Ambedkar Road, Sion West, Mumbai, Maharashtra 400022
Mumbai
MAHARASHTRA |
9821322071
mmanglani@hotmail.com |
| Ramandeep Arora |
Max Super-Speciality Hospital |
Department of Medical Oncology, Max Cancer Centre
1,2, Press Enclave Road, Mandir Marg, Saket, New Delhi 110017
South
DELHI |
8375017305
childhoodcancer@gmail.com |
| RN Ghosh |
Saroj Gupta Cancer Centre & Research Institute |
Saroj Gupta Cancer Centre & Research Institute
Department of Haematology & Paediatric Oncology
Mahatma Gandhi Road, Thakurpukur, Kolkata, West Bengal 700063
Kolkata
WEST BENGAL |
9830042421
ghoshrn@yahoo.co.uk |
| Brijesh Arora |
Tata Memorial Hospital |
Department of Medical Oncology
Tata Memorial Hospital
Mumbai
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA |
9757222510
brijesh.aurora@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Apollo Chennai Institutional Ethics Committee - Clinical Studies |
Approved |
| Cancer Institute, Institutional Ethics Committee |
Approved |
| INSTITUTE ETHICS COMMITTEE ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
Approved |
| Institute Ethics Committee Madras Medical College |
Approved |
| Institute Ethics Committee VMMC and Safdarjung Hospital |
Approved |
| Institution Ethics Committee of Saroj gupta Cancer Centre and Research Institute |
Approved |
| KJ Somaiya Medical college and hospital IEC |
Approved |
| Lokrnanya Tilak Municipal Medical Collage and hospital IEC |
Approved |
| Max Super specialty Hospital Ethics committee |
Approved |
| TATA MEMORIAL CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Children (less than 18 years of age) with cancer, (1) ICD-10 Condition: C81||Hodgkin lymphoma, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Out-of-pocket expenditure expressed in Indian Rupee (INR) and Purchasing Power Parity (PPP) |
At end of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="540"
Sample Size from India="540"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/08/2016 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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 - Identify the costs incurred and resource utilized by families leading up to the start of treatment
- Identify the costs incurred and resource utilized by families for the duration of treatment
- Assess the variability of these costs by demographic, disease-related, treatment-related and centre-related factors
- Assess the contribution of the assistance provided by governmental and non-governmental sectors in meeting these costs
- Explore the psychological and socio-economic impact of these costs on the family
- 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. |