| CTRI Number |
CTRI/2025/01/078891 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the effect of two educational methods to improve cervical cancer screening uptake in women who care for cancer patients. |
|
Scientific Title of Study
|
Comparison of the effect of educational interventions on the uptake of
cervical cancer screening among women caregivers of cancer patients in two tertiary care
hospitals in coastal Karnataka |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anusree Prabhakaran |
| Designation |
PhD Scholar |
| Affiliation |
Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Global Public Health Policy and Governance, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8281839551 |
| Fax |
|
| Email |
anusree1.psphmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arathi P Rao |
| Designation |
Associate Professor and Head of the Department |
| Affiliation |
Prasanna School of Public Health |
| Address |
Department of Global Public Health Policy and Governance, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9008418848 |
| Fax |
|
| Email |
arathi.anil@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arathi P Rao |
| Designation |
Associate Professor and Head of the Department |
| Affiliation |
Prasanna School of Public Health |
| Address |
Department of Global Public Health Policy and Governance, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9008418848 |
| Fax |
|
| Email |
arathi.anil@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India. Pin: 576104 |
|
|
Primary Sponsor
|
| Name |
Prasanna School of Public Health |
| Address |
Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India. Pin: 576104 |
| Type of Sponsor |
Other [Public Health School and Research Organization] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shirley Lewis Salins |
Kasturba Medical College (KMC) Manipal |
Department of Radiotherapy Oncology, Kasturba Medical College (KMC) Manipal, Manipal, Udupi, Karnataka, India
Pin: 576104
Udupi
KARNATAKA |
9969557231
shirley.salins@manipal.edu |
| Dr M S Athiyamaan |
Kasturba Medical College Hospital (KMCH) Attavar |
Department of Radiation Oncology, Kasturba Medical College Hospital (KMCH), Attavar, Mangalore, Dakshina Kannada, Karnataka, Pin: 575001
Dakshina Kannada
KARNATAKA |
8892118848
athiyamaan.ms@manipal.edu |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College, Mangalore |
Approved |
| 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 |
Women who take care of cancer patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
mHealth intervention - mobile application |
A mobile application which delivers educational information related to cervical cancer and cervical cancer screening, including informational videos, quizzes, motivational quotes to undergo screening, audio recordings, FAQs etc. Intervention will be delivered for 6 months |
| Comparator Agent |
Pamphlet |
Pamphlet with information related to cervical cancer and cervical cancer screening. Intervention will be given for 6 months |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
a.) A women providing informal care to a cancer patient who is undergoing treatment for at least one month or completed treatment within the last 2 years and is on follow up.
b.) Between the age of 30-65 years
c.) Must have a smart phone
d.) Able to communicate in Kannada/Malayalam/English
|
|
| ExclusionCriteria |
| Details |
a.) Undergoing or completed cervical cancer treatment
b.) Undergone hysterectomy
c.) Not willing to take part in the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A significant difference in the percentage of uptake of cervical cancer screening between the women caregivers of cancer patients who recieved the pamphlet and the mHealth intervention |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| A significant difference in the percentage of awareness and willingness to undergo cervical cancer screening between the women caregivers of cancer patients who recieved the pamphlet and the mHealth intervention |
6 months |
|
|
Target Sample Size
|
Total Sample Size="230"
Sample Size from India="230"
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)
|
28/01/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This is an interventional study, aiming to compare the effectiveness of an mHealth intervention (mobile application) delivering educational and motivational contents related to cervical cancer screening with a traditional pamphlet with educational information in improving the uptake of cervical cancer screening among women caregivers of cancer patients. A survey using a content-validated questionnaire will be used to assess the awareness, accessibility, and willingness of the participants to undergo cervical cancer screening, and an in-depth interview will be conducted to explore the barriers and challenges of the participants to undergo cervical cancer screening. Based on the findings of the quantitative and qualitative research, the contents and features of the intervention will be developed. A pre-test post-test questionnaire will be used to assess the change in awareness, willingness, and uptake of cervical cancer screening among the participants before and after the intervention. The study will ultimately compare the effectiveness of both interventions in the uptake of cervical cancer screening in the study population. The findings aim to provide valuable insights into designing targeted interventions to improve cervical cancer screening uptake in this unique population, ultimately contributing to better preventive healthcare strategies. |