| CTRI Number |
CTRI/2025/03/082908 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
31/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [ effectiveness of a nurse-led program] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Nurse-Led Family Caregiver Intervention on Cancer Patients Caregivers in Bangalore |
|
Scientific Title of Study
|
The impact of a nurse-led family caregiver program among cancer patients at selected hospital in Bangalore |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr. James Raj K |
| Designation |
PhD Scholar Department of Nursing |
| Affiliation |
KLE University, Belagavi |
| Address |
Room No. 2
KLE University, College of Nursing
Dr. Prabhakar Kore Basic Medical Sciences Building
Near KLE Hospital & Medical Research Centre
Belagavi - 590010, Karnataka, India
Belgaum
KARNATAKA
590010
India |
| Phone |
9500482944 |
| Fax |
|
| Email |
jamj36668@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Preeti Bhupali |
| Designation |
Vice principal |
| Affiliation |
KLE University, Belagavi |
| Address |
Room No; 4
KLE University, College of Nursing Science.
Dr. Prabhakar Kore Basic Medical Sciences Building
Near KLE Hospital & Medical Research Centre
Belagavi - 590010, Karnataka, India
Belgaum
KARNATAKA
590010
India |
| Phone |
9448526697 |
| Fax |
|
| Email |
preetirb7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr. James Raj K |
| Designation |
PhD Scholar Department of Nursing |
| Affiliation |
KLE University, Belagavi |
| Address |
Room No. 2
KLE University, College of Nursing
Dr. Prabhakar Kore Basic Medical Sciences Building
Near KLE Hospital & Medical Research Centre
Belagavi - 590010, Karnataka, India
Belgaum
KARNATAKA
590010
India |
| Phone |
9500482944 |
| Fax |
|
| Email |
jamj36668@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Dr.Chandramma Dayananda Sagar Institute of medical Education and Research, The institute provides infrastructural support, including access to patient records, caregiver participants, and clinical facilities. Official Address: Deverakaggalahalli, Kanakapura Road,Bengaluru South District,
Karnataka - 562 112 |
|
|
Primary Sponsor
|
| Name |
MR JAMES RAJ K |
| Address |
KLE University, College of Nursing
Dr.Prabhakar Kore Basic Medical Sciences Building,
Near KLE Hospital & Medical Research Centre,
Belagavi - 590010,
Karnataka, India |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| JAMES RAJ K |
CDSIMER (Dr.Chandramma Dayananda Sagar Institute of medical Education and Research) |
Deverakaggalahalli, Kanakapura Road,Bengaluru South District, Karnataka - 562 112
Bangalore Rural
KARNATAKA |
9500482944
jamj36668@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Dr. Chandramma Dayananda Sagar Institute of Medical and Research (CDSIMER) |
Approved |
| KAHER Ethics Committee on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable (Single Arm Study) |
Not Applicable (Single Arm Study) |
| Intervention |
Nurse-led Family Caregiver Program |
The Nurse-led Family Caregiver Program aims to reduce caregiver burden, enhance the quality of life, and manage stress levels in caregivers of cancer patients through structured counseling, support, and training,Frequency: Weekly sessions
Duration: 12 weeks (with a post-test immediately after the intervention and another post-test after 12 weeks) |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adults (18 years and older) diagnosed with various types of cancer currently receiving treatment chemotherapy radiation surgery immunotherapy
Patients family members providing regular care to the cancer patients Willing to participate in the caregiver program Participants who have given the consent |
|
| ExclusionCriteria |
| Details |
patients with cognitive impairments, who have previously participated in a similar caregiver program, caregivers with severe physical or mental health conditions. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Caregiver burden (measured using the Zarit Burden Interview), quality of life (measured using WHOQOL-100), and stress levels (measured using DASS-21) in cancer patients and caregivers. |
Pre-intervention, post-intervention, and 3 months follow-up. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Caregiver Satisfaction: Improvement in satisfaction with caregiver support.
Tool: Structured feedback questionnaire
Time Frame: Post-intervention
Adherence to Caregiving Practices: Increased adherence to recommended caregiving practices.
Tool: Self-reported checklist
Time Frame: Post-intervention
Psychological Well-being of Caregivers: Improvement in stress levels.
Tool: DASS-21
Time Frame: Pre- and post-intervention
Hospital Readmission Rates: Reduction in patient readmissions due to improved care.
Tool: Hospital records
Time Frame: Follow-up |
Pre-intervention, post-intervention, and 3 months follow-up. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
01/09/2025 |
| 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="1"
Months="10"
Days="29" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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
Modification(s)
|
The study received Institutional Ethical Committee approval in June 2025. Participant recruitment for the pilot phase commenced in mid-November 2025 at the selected study site. Therefore, the recruitment status has been updated from ‘Not Yet Recruiting’ to ‘Open to Recruitment’ |