| CTRI Number |
CTRI/2024/01/061356 [Registered on: 11/01/2024] Trial Registered Prospectively |
| Last Modified On: |
08/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Educational] |
| Study Design |
Other |
|
Public Title of Study
|
To assess the effectiveness of an intervention package on the care of children undergoing chemotherapy on the knowledge, quality of life, and caregiver burden among the parents of children diagnosed with cancer. |
|
Scientific Title of Study
|
A study to assess the effectiveness of an intervention package on the care of children undergoing chemotherapy on the knowledge, quality of life and caregiver burden among the parents of children diagnosed with cancer in selected hospital of Udupi district, Karnataka. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaishnavi A |
| Designation |
Student |
| Affiliation |
|
| Address |
Dept. of Child Health (Paediatric) Nursing
Manipal College of Nursing
MAHE, Manipal
Karnataka - 576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
8086044240 |
| Fax |
|
| Email |
vaishnaviashok88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vaishnavi A |
| Designation |
Student |
| Affiliation |
Manipal College of Nursing |
| Address |
Manipal College of Nursing
MAHE, Manipal
Karnataka - 576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
8086044240 |
| Fax |
|
| Email |
vaishnaviashok88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vaishnavi A |
| Designation |
Student |
| Affiliation |
|
| Address |
Dept. of Child Health (paediatric) Nursing
Manipal College of Nursing
MAHE, Manipal
Karnataka - 576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
8086044240 |
| Fax |
|
| Email |
vaishnaviashok88@gmail.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support: Pediatric Hematology and Oncology wards, Kasturba Hospital, Manipal |
| Nil |
|
|
Primary Sponsor
|
| Name |
Vaishnavi A |
| Address |
Manipal College of Nursing
MAHE, Manipal
Karnataka - 576104
India |
| Type of Sponsor |
Other [Self ] |
|
|
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 Anjalin DSouza |
Kasturba Hospital |
Pediatric Hematology Oncology Wards
Kasturba Hospital
Madhav Nagar
Manipal, Karnataka
576104
Udupi
KARNATAKA |
9845378098
anjeline.d@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Parents of children undergoing chemotherapy for cancer
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Information booklet on care of children undergoing chemotherapy and session on coping strategies for parents of children diagnosed with cancer |
Information booklet on care of children undergoing chemotherapy and session on coping strategies for parents of children diagnosed with cancer for 2 days |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Parents of children diagnosed with cancer and undergoing chemotherapy
2. Parents who are available during data collection
3. Parents who are able to read and write Kannada or English
|
|
| ExclusionCriteria |
| Details |
1. Parents of children who are having other co-morbidities with cancer |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| knowledge |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life and care giver burden |
Day 1 - Day 16 |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
18/01/2024 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 conducted after obtaining permission from the Department of Pediatric Hematology
and Oncology of Kasturba Hospital, Manipal. The participants will be explained
about the study and their participation in the research. Samples will be
selected using a convenient sampling technique. The researcher has adopted a pre-experimental
one-group pretest-posttest research design. Parents of children undergoing
chemotherapy for cancer are the participants in the study. Data will be
collected from parents while their children are admitted. The data on
demographic variables will be collected by administering demographic proforma.
During the pretest caregivers will be given a structured knowledge
questionnaire to assess their knowledge on the care of children undergoing
chemotherapy, WHO-QOL BREF 26 to assess the quality of life, and a structured
burden assessment scale for parents of children diagnosed with cancer. On the
same day, an information booklet on the care of children undergoing
chemotherapy will be given to the parents. A session on coping strategies for
parents of children diagnosed with cancer will be conducted on day 1 and day 2.
The post-test will be conducted on day 16. The post-test will be conducted to
assess the knowledge on the care of children undergoing chemotherapy, quality
of life, and caregiver burden using the same data collection instruments. |