| CTRI Number |
CTRI/2024/12/078293 [Registered on: 18/12/2024] Trial Registered Prospectively |
| Last Modified On: |
11/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [multimodal interventions] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of selected nurse led care on physical and psychological wellbeing among patients with breast cancer surgery |
|
Scientific Title of Study
|
Effect of a nurse led multimodal intervention on perceived wellness quotient and symptom burden of breast cancer surgery patients in selected hospitals at Bangalore A mixed method study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
EVANGELENE G |
| Designation |
PhD Scholar |
| Affiliation |
St Johns College of Nursing |
| Address |
St Johns Medical college Hospital Bangalore
Oncology department
Surgical oncology division
Room no C2-001
Bangalore
KARNATAKA
560034
India |
| Phone |
9741027226 |
| Fax |
|
| Email |
eva.arun1986@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bindhu Mathew |
| Designation |
Professor & Principal |
| Affiliation |
St Johns College of Nursing |
| Address |
St Johns College of Nursing
Department of Nursing
Medical and Surgical Nursing division
Room number 1
Bangalore
KARNATAKA
560034
India |
| Phone |
9886731355 |
| Fax |
|
| Email |
bindhu.m@stjohns.in |
|
Details of Contact Person
Public Query
|
| Name |
Evangelene G |
| Designation |
PhD Scholar |
| Affiliation |
St Johns college of Nursing |
| Address |
St Johns College of Nursing
Department of Nursing
Medical and Surgical Nursing division
Room number 7
Bangalore
KARNATAKA
560034
India |
| Phone |
9741027226 |
| Fax |
|
| Email |
eva.arun1986@gmail.com |
|
|
Source of Monetary or Material Support
|
| St Johns Medical College Hospital Bangalore 560034 Karnataka
India
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL (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 Rakesh S Ramesh |
St Johns Medical College Hospital Bangalore |
Oncology division
Department of Surgical oncology
Room no C2-001
Bangalore
KARNATAKA |
9980007455
srakesh99@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| St Johns Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nurse led multimodal intervention |
Exercises in group of 10 patients 1 session for 30 minutes with telephonic reinforcement to do exercises at home
Cognitive behavioral therapy & counseling One to one basis, 30-45 minutes for 2 sessions
Group therapy 10 patients per group
45-60 minutes for 2 sessions
Cosmetic education program in group of 10 patients 1 session for 30 minutes
|
| Comparator Agent |
Standard routine care |
Exercises 1 session for 15-20 minutes |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Breast cancer surgery patients with or without adjuvant therapy and are on follow up |
|
| ExclusionCriteria |
| Details |
patients with metastasis
patients with documented psychiatric illness |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The findings of the study will
Reveal the effectiveness of nurse-led multimodal intervention on perceived wellness quotient and symptom burden, which will serve as a basis to implement evidence based intervention in the oncology setting.
|
3 time points
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Development of specific modules related to multimodal intervention package, which later can be utilized to train nurses |
3 time points |
|
|
Target Sample Size
|
Total Sample Size="216"
Sample Size from India="216"
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)
|
01/04/2025 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Selection & recruitment of study subjects: Breast cancer surgery patients on regular follow up care attending surgical oncology department at St Johns medical college hospital will be recruited for the study based on inclusion & exclusion criteria with the consultation of Co-guide Dr Rakesh surgical oncologist in oncology department. A total of 216 patients with 108 in each experimental and control group will be recruited for the study.
|