| CTRI Number |
CTRI/2022/03/040924 [Registered on: 09/03/2022] Trial Registered Prospectively |
| Last Modified On: |
09/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening
Process of Care Changes
Other (Specify) [NURSING] |
| Study Design |
Other |
|
Public Title of Study
|
Assessing the effect of a training program on problems and difficulties faced by the caregivers of breast cancer patients. |
|
Scientific Title of Study
|
Effectiveness of multimodal intervention on Caregiver Burden, Stress, Quality of Life and Coping Strategies among caregivers of breast cancer patients in selected oncology departments. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHAJI E J |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Amala Institute of Medical Sciences |
| Address |
Amala College of Nursing
Amala Institute of Medical Sciences, Amala Nagar, Thrissur
Kerala, India.
Amala Nagar, Thrissur, Kerala, India,680555
Thrissur
KERALA
680555
India |
| Phone |
9496244475 |
| Fax |
|
| Email |
jothishcsc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrNalini M |
| Designation |
H O D Department of Mental Health Nursing,, ASSOCIATE PROFESSOR |
| Affiliation |
Nitte Usha Institute of Nursing Sciences |
| Address |
Nitte Usha Institute of Nursing Sciences (NUINS)
Nitte (Deemed to be)University
Deralakatte
Mangalore -575018
Nitte Usha Institute of Nursing Sciences (NUINS)
Nitte (Deemed to be)University
Deralakatte
Mangalore -575018
Dakshina Kannada
KARNATAKA
680555
India |
| Phone |
8095679510 |
| Fax |
|
| Email |
nalini@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
SHAJI E J |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Amala Institute of Medical Sciences |
| Address |
Amala College of Nursing
Amala Institute of Medical Sciences, Amala Nagar Thrissur
Kerala, India.
Amala Nagar, Thrissur, Kerala, India
680555
Thrissur
KERALA
680555
India |
| Phone |
9496244475 |
| Fax |
|
| Email |
jothishcsc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amala Institute of Medical Sciences, Amala Nagar, Thrissur, Kerala,India |
|
|
Primary Sponsor
|
| Name |
SHAJI E J |
| Address |
Amala College of Nursing,
Amala Institute of Medical Sciences, Amala Nagar, Thrissur, Kerala,India
680555 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nitte Usha Institute of Nursing Sciences |
Nitte (Deemed to be)University Mangalore
Paneer,Kotekar Beeri Road, Deralakatte, Karnataka, India
575018
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| SHAJI E J |
Amala College of Nursing |
Amala Nagar,
Thrissur,
Kerala, India
680555
Thrissur
KERALA |
9496244475
jothishcsc@gmail.com |
| SHAJI E J |
Amala Institute of Medical Sciences |
Amala Nagar,
Thrissur, Kerala,India
Thrissur
KERALA |
9496244475
jothishcsc@gmail.com |
| Dr Nalini M |
Nitte Usha Institute of Nursing Sciences |
Nitte (Deemed to be)University Mangalore
Paneer,Kotekar Beeri Road, Deralakatte, Karnataka, India
575018
Dakshina Kannada
KARNATAKA |
8095679510
nalini@nitte.edu.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,Amala Institute of Medical Sciences |
Approved |
| Institutional research committee,Amala College of Nursing |
Approved |
| The Central Ethics Committee NITTE (Deemed to be University) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy primary caregivers of breast cancer patients receiving chemotherapy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MULTIMODAL INTERVENTION |
the following sessions will be provided only once after pre test:
1. skill training- post-mastectomy exercise (duration: 10 minutes)
2. teaching breathing exercises (duration: 10 minutes)
3. psychoeducational program (duration: 10 minutes)
4. counseling (duration : 15 minutes)
total duration : 45 minutes |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Primary caregivers of patients who had undergone mastectomy and receiving chemotherapy
Individuals who are able to give voluntary consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
Paid, professional, or formal caregivers
Deaf and dumb primary caregivers of chemotherapy patients
Caregivers who were diagnosed with any preexisting major psychiatric disorders based on ICD 10 |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improved Quality of Life |
The outcome is measured at 12th week after the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NOT APPLICABLE |
NOT APPLICABLE |
|
|
Target Sample Size
|
Total Sample Size="154"
Sample Size from India="154"
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)
|
15/03/2022 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a true experimental quantitative two group study to assess the effectiveness of a multimodal intervention on Caregiver Burden, Stress, Quality of Life, and Coping Strategies among caregivers of breast cancer patients receiving chemotherapy among 154 caregivers (77 in the control group and 77 in experimental group) which will be conducted in the oncology department of a private medical college in Kerala, India. The primary outcome is decreased Caregiver Burden as well as Stress, improved Quality of Life, and Coping Strategies which will be measured using Zarit Burden Interview Scale, Kingstone Caregiver Stress Scale, Modified Quality of life Family Version, Brief COPE Scale respectively after the 12th week of intervention. |