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CTRI Number  CTRI/2025/12/098576 [Registered on: 05/12/2025] Trial Registered Prospectively
Last Modified On: 05/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   Role of the support group to improve life for women after cancer 
Scientific Title of Study   Effectiveness of social support groups on the quality of life among female cancer survivors An interventional 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 Niharika T J 
Designation  PG Student 
Affiliation  School of Public Health, JSS Medical College, JSS AHER 
Address  Room no 2, Basement floor, School of Public Health, JSS Medical College, JSS AHER M G Road, Agrahara, Mysuru

Mysore
KARNATAKA
570004
India 
Phone  9164396346  
Fax    
Email  niharikathylur@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anil S Bilimale 
Designation  Associate Professor 
Affiliation  School of Public Health, JSS Medical College, JSS AHER 
Address  Associate Professor, HOD Cabin, Basement floor, School of Public Health, JSS Medical College, JSS AHER M G Road, Agrahara, Mysuru

Mysore
KARNATAKA
570004
India 
Phone  9880709226  
Fax    
Email  anilbilimale@jssuni.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Anil S Bilimale 
Designation  Associate Professor 
Affiliation  School of Public Health, JSS Medical College, JSS AHER 
Address  Associate Professor, HOD Cabin, Basement floor, School of Public Health, JSS Medical College, JSS AHER M G Road, Agrahara, Mysuru

Mysore
KARNATAKA
570004
India 
Phone  9880709226  
Fax    
Email  anilbilimale@jssuni.edu.in  
 
Source of Monetary or Material Support  
Bharath Hospital and Institute of Oncology, Mysuru, Karnataka, India Pin code: 570017 
JSS Hospital, M G Road, Agrahara, Mysuru, Karnataka, India Pin code: 570004 
 
Primary Sponsor  
Name  Dr Niharika T J 
Address  School of Public Health, JSS Medical College, JSS AHER, M G Road, Agrahara, Mysuru, Karnataka, India Pin Code: 570004 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Niharika T J  Bharath Hospital and Institute of Oncology  #438, Outer Ring Road, Hebbal, Mysuru
Mysore
KARNATAKA 		 9164396346

niharikathylur@gmail.com 
Dr Niharika T J  JSS Hospital  M G Road, Agrahara, Mysuru 570004
Mysore
KARNATAKA 		 9164396346

niharikathylur@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee, JSSMC   Approved 
Institutional Ethics Committee, JSSMC   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  social support groups and the activities in it  Interventions will be given for female cancer survivors diagnosed with breast or cervical cancers. Will be provided through structured group sessions, with three to four sessions conducted for each group over three months, once a month for each group on Thursday pr Tuesday of the week. First sessions will be of introduction of survivors with an ice-breaking session where the activities will be there, which include passing the thread, one word story, and if I could tell someone newly diagnosed, I would rather. After these activities, the survivors will be asked about their problems, and an awareness session will be given on treatment facilities, facilitation services, and available government schemes. We will train them about the photovoice technique in the same session. Ice-breaking and networking will help build trust among cancer survivors. Survivors will be encouraged to share their experiences and coping mechanisms during the second session, like the strength behind my smile, light in the tunnel, meaning in a memory, timeline walk, open mic/story circle, peer interviews, and survivors’ bingo. The third session will be on sexual health, and the purpose of the life and gratitude chain activity will be discussed. Each session will last for 45 minutes to 1 hour 
Comparator Agent  Without support group intervention  Female cancer survivors who are not willing to be a part of a support group but will be getting normal counselling, and the treatment 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  Female Cancer survivors with breast or cervical cancer who completed 6 months of treatment, up to 24 months after diagnosis, regardless of stage and type of therapy.
Female Survivors who have undergone surgery.
Female Cancer survivors who give consent to participate.
 
 
ExclusionCriteria 
Details  Female Cancer survivors who are immobile and bedridden.
Female Cancer survivors diagnosed with cognitive and neurological impairments. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improved quality of life among female cancer survivors through the social support group intervention  first point of recruitment, 3 months post recruitment, 5 months post recruitment 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="230"
Sample Size from India="230" 
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   Phase 2 
Date of First Enrollment (India)   16/12/2025 
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   Diagnosis of cancer is one of the most stressful events that happens in ones lifetime. This often leads to longterm psychosocial effects. Stress is a common factor among cancer survivors. Anxiety and depression in cancer patients are mainly due to stress. The support group role is important in managing the disability, anxiety, pain, and financial burden of a person. It ultimately reflects on cancer survivors various domains of quality of life. It has been proven that active social support and social interaction can improve quality of life in all domains. When they are socially active and can share their feelings, fears, and worries, it helps them mentally relieve themselves. It can also have a positive impact on their physical health. Survivors, when they lack social contacts, are affected in their well being and health. Factors such as lack of socialization, social isolation, and loneliness are important predictors of increased mortality. Social support can improve their quality of life. Creating a social support group and giving them the interventions to improve their quality of life could be a great opportunity. Assessing their quality of life before the support group intervention and after intervention has proved a significant improvement in physical health, mental health, and social functioning. This can be summarised as improved quality of life among cancer survivors. Providing simple interventions like sharing the experience of cancer, coping strategies, treatment, and the healing process, facing societal stigma could help in the improvement of the quality of life of cancer survivors. Hence the improved quality of life among female cancer survivors will the major goal of the study.

·        Female Cancer survivors who completed 6 months of treatment, up to 24 months after diagnosis, regardless of stage and type of therapy, female Cancer survivors who give consent to participate are included in the study and Female Cancer survivors who are immobile and bedridden, Cancer survivors diagnosed with cognitive and neurological impairments are excluded. The study will be conducted for a year at  tertiary care hospitals in Mysuru.

       Null hypothesis: There is no significant improvement in the quality of life of cancer survivors after the social support group intervention. Alternative hypothesis: There is a significant improvement in the quality of life of cancer survivors after the social support group intervention.

Matching will be performed for each case based on gender, age, and stage of cancer to minimise control bias. Interventions will be given through structured group sessions, with three to four sessions conducted for each group over a period of three months. The first sessions will be an introduction to survivors, followed by an ice-breaking session with activities that include passing a thread, telling a one-word story, and if I could tell someone newly diagnosed, I would rather. After these activities, the survivors will be asked about their problems, and an awareness session will be given on treatment facilities, facilitation services, and available government schemes. We will teach them about the photovoice technique in the same session. Ice-breaking and networking will help build trust among cancer survivors. Survivors will be encouraged to share their experiences and coping mechanisms during the second session, like the strength behind my smile, light in the tunnel, meaning in a memory, timeline walk, open mic/story circle, peer interviews, and survivors’ bingo. The third session will be on sexual health, and the purpose of the life and gratitude chain activity will be discussed. After all the interventions, their quality of life will be assessed, and a pre-post comparison will be done to analyse the effectiveness of the intervention among survivors. After the interventions, once the effect is proven, the quality of life of the cancer survivors is improved from a mean score of 40 to above 60. The same interventions will be given to the control group.




 
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