| CTRI Number |
CTRI/2023/08/055968 [Registered on: 01/08/2023] Trial Registered Prospectively |
| Last Modified On: |
17/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Financial, Quality of life, Family Functioning, Burden among parents with children having cancer |
|
Scientific Title of Study
|
Psychosocial Problems in parents of children with Pediatric Cancer: An Cross-sectional study from a Tertiary Care Center |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sneha Sesha |
| Designation |
PG Student of Mphil PSW |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Psychiatry, Kasturba Medical College, Madhav Nagar, Manipal
Manipal Academy of Higher Education, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
08202922217 |
| Fax |
|
| Email |
sneha.sesha@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Soyuz John |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Room No: 33, OPD Building, Third Floor, Department of Psychiatry, Kasturba Medical College, Madhav Nagar, Manipal
Manipal Academy of Higher Education, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
08202922217 |
| Fax |
|
| Email |
soyuz.john@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Soyuz John |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Room No: 33, OPD Building, Third floor, Department of Psychiatry, Kasturba Medical College, Madhav Nagar, Manipal
Manipal Academy of Higher Education, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
08202922217 |
| Fax |
|
| Email |
soyuz.john@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Psychiatry, Kasturba Medical College, Manipal |
|
|
Primary Sponsor
|
| Name |
Department of Psychiatry |
| Address |
OPD No-33, Kasturba Medical College, Madhav Nagar, Manipal |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Soyuz John |
Kasturba Hospital |
Room No:33, Department of Psychiatry, OPD building, Third Floor, Kasturba Medical College, Manipal
Udupi
KARNATAKA |
08202922217
soyuz.john@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Internal ethics Committee Kasturba Medical College Kasturba Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Parents of Children with Cancer |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The age range is18-60 years,
Both mother and father
Their child is seeking treatment in the pediatric oncology department for solid tumors and Hematolymphoid
The child is in the treatment for at least a period of one month
|
|
| ExclusionCriteria |
| Details |
Parents who refuse to give consent
Parents of children who are in stage 4 of cancer
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
the psychological problems burden family functioning & the quality of life of the parents with children with cancer The outcome measures for this study will be the scores Sociodemographic &
Clinical Details Depression Anxiety & Stress Scale Family Functionality Scale Zarit Burden Scale & WHOQOLBREFF |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
none |
|
|
Target Sample Size
|
Total Sample Size="93"
Sample Size from India="93"
Final Enrollment numbers achieved (Total)= "93"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2023 |
| Date of Study Completion (India) |
31/10/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will be recruiting parents of children with cancer, who are willing to consent.
Inclusion criteria: •The age range is18-60 years, •Both mother and father •Their child is seeking treatment in the pediatric oncology department for solid tumors and Hematolymphoid •The child is in treatment for at least a period of one month
Exclusion: Parents who refuse to give consent and Parents of children who are in stage 4 of cancer Aim: The study aims to find the psychosocial problems in parents of children with cancer Objectives: 1.To find the psychological problems in parents 2.To understand the burden of the parents. 3.To understand the family functioning of the parents 4. To understand the quality of life of the parents. 93 Selected participants will be taken as a part of convenient sampling for the study and scales will be administered |