| CTRI Number |
CTRI/2024/07/071112 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Sexual health of female breast cancer survivors aged between 25years and 60 years after one year of breast cancer surgery. |
|
Scientific Title of Study
|
Sexual health of female breast cancer survivors aged between 25years and 60 years after one year of breast surgery for breast cancer : a cross sectional comparative 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 |
Dr Gutta Anuhya |
| Designation |
Post graduate |
| Affiliation |
All India Institute of Medical Sciences, Patna |
| Address |
Department of General Surgery, OPD AIIMS Patna, Phulwarisharif, Patna
Patna
BIHAR
801507
India |
| Phone |
7032161877 |
| Fax |
|
| Email |
docanuhya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashant Kumar Singh |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, Patna |
| Address |
Department of General Surgery ,OPD AIIMS Patna, Phulwarisharif , Patna
Patna
BIHAR
801507
India |
| Phone |
8809645678 |
| Fax |
|
| Email |
drprashantks@aiimspatna.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prashant Kumar Singh |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, Patna |
| Address |
Department of General Surgery ,OPD AIIMS Patna, Phulwarisharif , Patna
BIHAR
801507
India |
| Phone |
8809645678 |
| Fax |
|
| Email |
drprashantks@aiimspatna.org |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery, 3rd floor opd building, AIIMS Patna PIN code 801507 |
|
|
Primary Sponsor
|
| Name |
All India institute of medical sciences |
| Address |
Department of General Surgery, 3rd floor OPD building, AIIMS PATNA,
Bihar
India
Pin- 801507 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Gutta Anuhya |
All India institute of medical sciences, Patna |
Department of General Surgery , 3rd floor opd building
, AIIMS Patna
Patna
BIHAR |
7032161877
docanuhya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS PATNA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Y836||Removal of other organ (partial) (total) as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Not applicable |
| Intervention |
NIL |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Women attending follow up clinic 1 year after undergoing surgery for breast cancer
Age between 25years and 60 years
Married or Ina relationship
|
|
| ExclusionCriteria |
| Details |
Patients with recurrence
Revision Breast surgery for recurrence
Patients with diagnosed psychiatric illness
Not willing to participate
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Identify and quantify sexual quality of life in female breast cancer survivors after more than a year of surgery |
1 year post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparision of quality of sexual health in female breast cancer survivors between patients who underwent Breast conservation and mastectomy after more than a year of surgery |
1 year after surgery |
|
|
Target Sample Size
|
Total Sample Size="151"
Sample Size from India="151"
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)
|
05/08/2024 |
| 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="1"
Months="0"
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
|
Breast cancer is prevalent among women globally, and advancements in treatment have led to an increasing number of survivors facing challenges related to Female Sexual Dysfunction (FSD) post-treatment. This study seeks to address the gap in understanding sexual health issues among breast cancer survivors in eastern India, where such research has not done till date.
The primary aim is to assess the Quality of Sexual Health (QOSH) in female breast cancer survivors one year following breast surgery, using Female Sexual Function Index (FSFI) scoring system, which comprehensively evaluates various dimensions of sexual function. The study also aims to compare QOSH outcomes across different surgical interventions.
The anticipated outcome is psycho-sexual challenges faced by breast cancer survivors in the region. These findings are expected to provide psychological support/ therapy aimed at enhancing sexual health among at-risk women.
By addressing these research questions and hypotheses, the study aims to establish a foundation for future interventions and guidelines tailored to improve QOSH outcomes among breast cancer survivors in eastern India. This research is important in filling the existing knowledge gap. |