| CTRI Number |
CTRI/2026/03/105883 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
10/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [therapeutic] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Nurse led diary in improving self care |
|
Scientific Title of Study
|
A Randomised Control Trial (RCT) to assess the effectiveness of Breast Cancer Self- Care Chronicle (BCSCC) among Breast Cancer patients in improving Self-Care Management and recognition of Red-Flag Symptom after Breast Cancer Surgery in Surgical Oncology Ward at AIIMS Delhi. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Indu Dahiya |
| Designation |
M.Sc.Nursing |
| Affiliation |
College of Nursing, AIIMS Delhi |
| Address |
Room no. 4 Pota cabin, 2nd floor, College of Nursing, AIIMS Delhi
New Delhi
DELHI
110029
India |
| Phone |
08307242318 |
| Fax |
|
| Email |
indudahiya133@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Aditi Prashant Sinha |
| Designation |
Associate Professor |
| Affiliation |
College of Nursing, AIIMS Delhi |
| Address |
Room no.4, Pota Cabin, 2nd floor, College of Nursing, AIIMS Delhi
New Delhi
DELHI
110029
India |
| Phone |
09810784806 |
| Fax |
|
| Email |
aaditiprashant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Indu Dahiya |
| Designation |
MSc nursing |
| Affiliation |
College of Nursing, AIIMS Delhi |
| Address |
Room no. 4, Pota cabin, 2nd floor, College of Nursing, AIIMS Delhi
New Delhi
DELHI
110029
India |
| Phone |
8307242318 |
| Fax |
|
| Email |
indudahiya133@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
not applicable |
| Address |
not applicable |
| Type of Sponsor |
Other [] |
|
|
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 |
| Indu Dahiya MSc nursing student |
AIIMS New Delhi |
Surgical Oncology ward, BRAIRCH AIIMS New Delhi
New Delhi
DELHI |
08307242318
indudahiya133@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI 110029 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Breast Cancer Self- Care Chronicle (BCSCC) |
Printable, nurse-delivered patient education and monitoring tool provided postoperatively to breast cancer patients, consisting of structured daily log sections for tracking pain, wound status, drain output, arm exercises, and daily wellness activities, along with pictorial red-flag prompts and culturally appropriate illustrations verified by oncology nurses for accuracy, used over 4 weeks to support self-care management. |
| Comparator Agent |
Usual care |
At the time of discharge usual care and teaching is provided regarding postoperative breast self care. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
1. Women aged 18 years and above
2. Histologically confirmed breast cancer undergoing definitive surgery (Breast-Conserving Surgery or Modified Radical Mastectomy, with or without axillary procedure)
4. Able to read or understand Hindi/English or local language.
5. Possession of a mobile phone for telephonic follow-up.
6. Willingness to provide informed consent and participate throughout the study duration
|
|
| ExclusionCriteria |
| Details |
1. Patients undergoing immediate whole breast reconstruction (autologous or implant-based) -
2. Patients with known cognitive impairment, psychiatric illness, or communication barriers without a responsible caregiver
3. Patients undergoing palliative surgery or with advanced disease where long-term self-care goals are not applicable
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess the effectiveness of the Breast Cancer Self- Care Chronicle — in improving self-care management in experimental group and control group.
2. To assess the effectiveness of the Breast Cancer Self- Care Chronicle — in recognition of red- flag symptoms and early reporting in experimental group and control group.
|
4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
3. To assess the incidence of follow-up and re-admission due to red-flag symptoms among postoperative breast cancer patients in experimental group.
4. To assess the effectiveness of the Breast Cancer Self- Care Chronicle on psychosocial, sexual and impact on work among postoperative breast cancer patients in experimental group.
5. To assess the patient satisfaction with Breast Cancer Self- Care Chronicle in experimental group.
|
4 week |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/08/2026 |
| 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="3"
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
|
A randomised controlled trial will be conducted among 100 women undergoing breast conserving surgery or mastectomy with or without axillary procedure in surgical oncology ward BRAIRCH AIIMS New Delhi to evaluate the effectiveness of Breast Cancer Self Care Chronicle which is a printable nurse delivered self care chronicle used for 4 weeks postoperatively. The intervention includes daily logs for wound and drain care, arm exercises, sleep, diet, hygiene and pictorial red flag prompts to support self care management and early recognition of warning symptoms.
Primary objectives are to compare self -care management and recognition or early reporting of red flag symptoms between experiment and control groups. secondary objectives are to assess incidence of follow up or readmission due to red flag symptoms in intervention group, effects on eligible participants are women above 18 years with histologically confirmed breast cancer undergoing definitive surgery , able to understand hindi or english or local language, owning reconstruction, significant cognitive or psychiatric or communication issues without caregiver , and palliative surgery or advanced disease.
Simple randomization will allocate participants to intervention. BCSCC and usual care will be provided to intervention group while only usual care will be given to control group. Data collection tool are developed by researcher and are under expert validation.Ethical approval, informed consent, and anonymity will be ensured. Pilot study will be done on 10 patients. Data will be analyzed using descriptive and inferential statistics. |