FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/03/051169 [Registered on: 29/03/2023] Trial Registered Prospectively
Last Modified On: 04/04/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   prospective observational study 
Study Design  Other 
Public Title of Study   To assess sexual relationships of female cancer survivors  
Scientific Title of Study   To assess sexual relationships of female cancer survivors aged 20 to 60 yrs with their spouse post cancer treatment : A prospective observational study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kamaljeet S Randhe 
Designation  Counsellor 
Affiliation  HCG NCHRI CANCER HOSPITAL ,NAGPUR 
Address  HCG CANCER CENTRE automotive square Kalamna Ring Road Nagpur 440026
KGN SOCIETY KATOL ROAD, NAGPUR
Nagpur
MAHARASHTRA
440026
India 
Phone  8625096696  
Fax    
Email  kamaljeet.k@hcgel.com  
 
Details of Contact Person
Scientific Query  
Name  DR Kamaljeet S Randhe 
Designation  Counsellor 
Affiliation  HCG NCHRI CANCER HOSPITAL ,NAGPUR 
Address  HCG CANCER CENTRE automotive square Kalamna Ring Road Nagpur 440026
KGN SOCIETY KATOL ROAD, NAGPUR
Nagpur
MAHARASHTRA
440026
India 
Phone  8625096696  
Fax    
Email  kamaljeet.k@hcgel.com  
 
Details of Contact Person
Public Query  
Name  DR Kamaljeet S Randhe 
Designation  Counsellor 
Affiliation  HCG NCHRI CANCER HOSPITAL ,NAGPUR 
Address  HCG CANCER CENTRE automotive square bande nawaz nagar Kalamna Ring Road Nagpur 440026
KGN SOCIETY KATOL ROAD, NAGPUR 440013
Nagpur
MAHARASHTRA
440026
India 
Phone  8625096696  
Fax    
Email  kamaljeet.k@hcgel.com  
 
Source of Monetary or Material Support  
HCG NCHRI Cancer Centre, Nagpur 
 
Primary Sponsor  
Name  HCG CANCER CENTRE NAGPUR 
Address  Automotive square kalamna ring road Nagpur- 440026 
Type of Sponsor  Other [Corporate ] 
 
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 Kamaljeet Randhe  HCG NCHRI Cancer centre nagpur  Khasra No.50,51, Mouja Wanjri Bande Nawaz Nagar,Near Automotive Square Kalmana Ring Road, Nagpur
Nagpur
MAHARASHTRA 		 8625096696

kamaljeet.k@hcgel.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
HCG NCHRI Cancer Center Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  female cancer survivors age group 20 years to 60 years  
 
ExclusionCriteria 
Details  suffering from any severe psychiatric illness
those who are not sexually active 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
sexual assessments   1 year after completion of cancer treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  Not applicable 
 
Target Sample Size   Total Sample Size="82"
Sample Size from India="82" 
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)   01/04/2023 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Introduction:

Now Cancer is considered as a chronic disease. [1]Undergoing cancer treatment is likely to cause some level of sexual dysfunction at some point during diagnosis, treatment, and/or long-term survival. Dysfunction may be due to the disease process, short- and long-term treatment-related side effects, problems with co-morbidities/their treatments, psychosocial issues including problems with relationships, psychological conditions, or concerns, or a combination of any of these factors. These problems can lead to  various sexual issues , non intimate relationships and other discomfortness, loss of interest towards sexual pleasure etc. [2]

Talking with patients about their sexual health is laden with many fears and concerns.

The need for a comprehensive and problem specific asessment of patients for sexual issues associated with post treatment is felt by many reserachers.[2] In Indian scenario with cultural and ethical boundaries, talking about sex or sex related problems is still a taboo and so are not freely discussed.[3]

 

Very few studies have been conducted so far hence the idea to conduct a study was conceptualised. 

 

Objectives

To assess sexual relationships of female cancer survivors aged 20 to 60 yrs with their spouse post cancer treatment.

 

 Ethics Committee Approval and CTRI registration:

The institutional ethics committee approval will be obtained before starting the study. CTRI registration will be done.

 

Materials and Methods:

Study design: Single-center, prospective observational study

 

Setting and participants:

Female cancer survivors with any type of cancer.

 

Subjects: Sample size:  82

Sampling method: A convenience sample

 

Inclusion and Exclusion criteria:

 

Inclusion criteria

Exclusion Criteria

Female Cancer survivors

Suffering from any severe psychiatric illness

Age group 20years – 60 years

Those who are not sexually active

 

 

 

Informed written concent will be obtained from the eligible Cancer Survivors who are willing to participate in the study. The concept of the study will be explained to the cancer survivors by audio visual method. The patients’ responses will be recorded by the interview technique by a Counsellor.  

 

Measures:

The following questionnaires will be used for collecting the data.

· Demographic details of the Cancer Survivors: Psycho Assessment Form

· A questionnaire for structured interview: A questionnaire of 18 questions was prepared. Each question has responses ranging from 1 to 5, where 1=Not at all , 2=little bit, 3=Some what, 4=Very Much, and 5=Dont Know. The questionnaire was validated for its content by a panel of experts including a sexologist, a psychiatrist, a gynaecologist, a medical oncologist and an oncosurgeon.

 

 

Duration of the study: Approximately 6 months

 

Data Analysis:

Data will be analyzed using appropriate software and tests.

 

Results: The results will be evaluated and interpreted and conclusions will be drawn.

 

References:

1. Phillips JL, Currow DC. Cancer as a chronic disease. Collegian. 2010 Jul 1;17(2):47-50.

2. Krebs LU. Sexual assessment in cancer care: concepts, methods, and strategies for success. InSeminars in oncology nursing 2008 May 1 (Vol. 24, No. 2, pp. 80-90). WB Saunders.

 

3. Shankar A, Prasad N, Roy S, Chakraborty A, Biswas AS, Patil J, Rath GK. Sexual dysfunction in females after cancer treatment: an unresolved issue. Asian Pacific journal of cancer prevention: APJCP. 2017;18(5):1177.

 

 
Close