| CTRI Number |
CTRI/2024/03/063922 [Registered on: 11/03/2024] Trial Registered Prospectively |
| Last Modified On: |
09/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
A study to evaluate the Psychological and Social impact of Breast Cancer treatment on patients. |
|
Scientific Title of Study
|
Ignoring the Needs of Breast Cancer Survivors: An Urgent Call to Action.
A Prospective study to assess incidence and severity of psychosocial problems in breast cancer survivors and impact of necessary intervention. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kanika Sharma |
| Designation |
Consultant (Medical Oncology) |
| Affiliation |
Max Super Speciality Hospital Mohali |
| Address |
Room No. 203 , Basement 2, Oncology Department
Max Super Speciality Hospital, Mohali(A Unit of Hometrail Buildtech Pvt. Ltd.)
Near Civil Hospital, Phase-6, Mohali
Rupnagar
PUNJAB
160055
India |
| Phone |
9971833003 |
| Fax |
|
| Email |
kanika.sharma@maxhealthcare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kanika Sharma |
| Designation |
Consultant (Medical Oncology) |
| Affiliation |
Max Super Speciality Hospital Mohali |
| Address |
Room No. 203 , Basement 2, Oncology Department
Max Super Speciality Hospital, Mohali(A Unit of Hometrail Buildtech Pvt. Ltd.)
Near Civil Hospital, Phase-6, Mohali
Rupnagar
PUNJAB
160055
India |
| Phone |
9971833003 |
| Fax |
|
| Email |
kanika.sharma@maxhealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kanika Sharma |
| Designation |
Consultant (Medical Oncology) |
| Affiliation |
Max Super Speciality Hospital Mohali |
| Address |
Room No. 203 , Basement 2, Oncology Department
Max Super Speciality Hospital, Mohali(A Unit of Hometrail Buildtech Pvt. Ltd.)
Near Civil Hospital, Phase-6, Mohali
Rupnagar
PUNJAB
160055
India |
| Phone |
9971833003 |
| Fax |
|
| Email |
kanika.sharma@maxhealthcare.com |
|
|
Source of Monetary or Material Support
|
| Max Super Speciality Hospital, Mohali(A Unit of Hometrail Buildtech Pvt. Ltd.)
Near Civil Hospital, Phase-6, Mohali, Punjab-160055, India
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Kanika Sharma |
Max Super Speciality Hospital, Mohali |
Room No. 203 , Basement 2, Oncology Department
Max Super Speciality Hospital, Mohali(A Unit of Hometrail Buildtech Pvt. Ltd.)
Near Civil Hospital, Phase-6, Mohali-160055
Rupnagar
PUNJAB |
9971833003
kanika.sharma@maxhealthcare.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Max Super Speciality Hospital, Mohali (A Unit of Hometrail Buildtech Pvt. Ltd.) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G||Mental Health, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
Women of more than 18 years of age, diagnosed case of non-metastatic breast cancer who have completed definitive treatment (surgery, chemotherapy, radiotherapy) and are on hormonal therapy/targeted therapy or regular follow-up in Oncology OPD |
|
| ExclusionCriteria |
| Details |
Women with metastatic disease, previous history of any other cancer prior to the diagnosis of breast cancer will be excluded from the study
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of women needing therapeutic psychiatric intervention and to assess treatment efficacy at 3 or 6 months. |
Baseline at 3 and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
18/03/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
It is a prospective observational study to assess the psychosocial impact of cancer diagnosis and treatment in breast cancer survivors who have completed their definitive treatment. It will be assessed by various scoring systems (DASS-21, BIS-10, MENQOL). Women with high risk scores will be assessed by psychologist and psychiatrist to assess the need of therapeutic psychiatric intervention in breast cancer survivors at baseline, 3 months and 6 months.
|