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CTRI Number  CTRI/2024/02/063368 [Registered on: 29/02/2024] Trial Registered Prospectively
Last Modified On: 23/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Sexual Concerns in Breast Cancer Survivors 
Scientific Title of Study   Concerns in Breast Cancer Survivors with respect to Sexual Function,Sexual Satisfaction and Distress: A Sequential Explanatory 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  Jisha Abraham 
Designation  Lecturer Psycho-Oncology 
Affiliation  Malabar Cancer Centre 
Address  Room no 21, Division of Psycho-Oncology Malabar Cancer Centre Kodiyeri, Muzhikkara - MCC Rd, Illathaazha, Thalassery

Kannur
KERALA
670103
India 
Phone  8086767706  
Fax    
Email  jishasarah@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jisha Abraham 
Designation  Lecturer Psycho-Oncology 
Affiliation  Malabar Cancer Centre 
Address  Room no 21, Division of Psycho-Oncology Malabar Cancer Centre Kodiyeri, Muzhikkara - MCC Rd, Illathaazha, Thalassery


KERALA
670103
India 
Phone  8086767706  
Fax    
Email  jishasarah@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sangeetha U M 
Designation  Fellow in Oncology Social Work 
Affiliation  Malabar Cancer Centre 
Address  Room no 21, Division of Psycho-Oncology Malabar Cancer Centre Kodiyeri, Muzhikkara - MCC Rd, Illathaazha, Thalassery

Kannur
KERALA
670103
India 
Phone  9902864810  
Fax    
Email  sangeethaudayakumar28@gmail.com  
 
Source of Monetary or Material Support  
Malabar Cancer Centre 
 
Primary Sponsor  
Name  Malabar Cancer Centred 
Address  Kodiyeri, Muzhikkara - MCC Rd, Illathaazha, Thalassery, Kerala 670103  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Adarsh D  Malabar Cancer Centre  Room no 8, Division of Gynaec-Oncology Department of Surgical Oncology Malabar Cancer Centre Kodiyeri, Muzhikkara - MCC Rd, Illathaazha, Thalassery
Kannur
KERALA 		 9947616776

dradarshdharmarajan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Malabar Cancer Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Breast Cancer Survivors 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Inclusion Criteria for quantitative study:
1-Married/live-in women, living with Partner for the last 2 months
2-Completed at least 6 months after curative intent treatment for breast cancer (Stage I,
II, III)
3-Should have been sexually active before diagnosis
4-Can read, speak, and understand either English or Malayalam


Eligibility of survivor to include in Qualitative study:
1-FSFI score less than 55
2-Partner present during the study
3-Living with this Partner for the last two months

Eligibility of partner to include in the qualitative study:
1-Partner of the participant included in the qualitative study
2-Partner Can read, speak, and understand either English or Malayalam

Eligibility of Oncologist to include in the qualitative study:

1-Consultant Surgical Oncologists, Gynaec-Oncologists, Medical Oncologists, Radiation
Oncologists.
2-Experience of treating breast cancer patients.
3-minimum 2 years of experience at Cancer Centre 
 
ExclusionCriteria 
Details  Exclusion Criteria for quantitative study:
● Participants with history of psychiatric illness or neurological disorder.
● Participants with a relapse, recurrence, or second primary, metachronous Bilateral
Breast Cancer 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessing the Sexual Function and Sexual Satisfaction and distress of Breast Cancer Survivors and understanding their sexual concerns from the
perspective of the survivors, their partners and the oncologists. 		 Minimum of 6 months after curative intent treatment 
 
Secondary Outcome  
Outcome  TimePoints 
To find the relationship between Sexual Function and Sexual Satisfaction and Distress among Breast Cancer Survivors  Minimum of 6 months after curative intent treatment 
 
Target Sample Size   Total Sample Size="115"
Sample Size from India="115" 
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)   06/03/2024 
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="0"
Months="5"
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  
This study aims to identify the level of sexual function and sexual distress among Breast
cancer Survivors and to better understand their individualistic sexual concerns from the
perspective of the survivor, their partner. The study will also provide an insight into the
sexual concerns of Breast cancer Survivors from the perspective of oncologists. 
   
The primary objectives of the study are to assess the Sexual Function, Sexual Satisfaction and
Distress among Breast Cancer Survivors and to better understand the sexual concerns of
Breast Cancer Survivors from the perspective of the survivors, their partners, and the
oncologists. The study is a mixed method study using Sequential Explanatory method - both
Quantitative and Qualitative research methods in a sequential manner. The sample size for the
descriptive study is 115 Breast Cancer Survivors belonging to the age group of 21-65 years
and have completed curative intent treatment for Breast Cancer in Malabar Cancer Centre.
The data for the qualitative part of the study will be conducted until data saturation. The tools
Female Sexual Function Index (FSFI) and Sexual Satisfaction Scale (SSS) will be used for

the quantitative part of the study. The qualitative data will be collected using a semi
structured interview.
The inclusion criteria for the quantitative study are Married/live-in women, living with
Partner for the last 2 months, Completed at least 6 months after curative intent treatmentfor
breast cancer (Stage I, II, III), Should have been sexually active before diagnosis, Can read,
speak, and understand either English or Malayalam. Those with known history of psychiatric
illness or neurological disorder, relapse, recurrence, or second primary, metachronous
Bilateral Breast Cancer will be excluded. The survivors who secured a score less than 55 in
FSFI is eligible for qualitative study. Partners of the participant included in the qualitative
study who can read, speak, and understand either English or Malayalam will be eligible.
Consultant Surgical Oncologists, Gynaec-Oncologists, Medical Oncologists,Radiation
Oncologists with an experience of treating breast cancer patients and a minimum 2 years of
experience at Cancer Centers will be eligible for qualitative study.
Descriptive Statistical techniques such as the Mean, Standard deviation, Correlation
coefficient and one way analysis of variance (ANOVA) will be used to analyse the
quantitative data. The descriptive data collected from the participants through in-depth
interview will be analysed using, thematic analysis.
 
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