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CTRI Number  CTRI/2019/07/020057 [Registered on: 05/07/2019] Trial Registered Prospectively
Last Modified On: 04/07/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) 
Study Design  Other 
Public Title of Study   A study to assess effectiveness of social support group among cervical cancer patients and their caregivers.  
Scientific Title of Study   A study to develop and assess the effectiveness of support group approach for cervical cancer patients and their caregivers with an intention to improve selected outcome variables attending Radiotherapy OPD,PGIMER,Chandigarh,2018-20. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ankita Thakur 
Designation  M.Sc. Nursing Student 
Affiliation  PGIMER Chandigarh 
Address  New OPD 3rd floor,Department of Radiotherapy
PGIMER Chandigarh
Chandigarh
CHANDIGARH
160014
India 
Phone  7560060331  
Fax    
Email  ankita.palwal12@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Meenakshi Aganihotri 
Designation  Tutor 
Affiliation  PGIMER Chandigarh 
Address  New OPD 3rd floor,Department of Radiotherapy
PGIMER Chandigarh
Chandigarh
CHANDIGARH
160014
India 
Phone  9872885336  
Fax    
Email  smrishima@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Ankita Thakur 
Designation  M.Sc. Nursing Student 
Affiliation  PGIMER 
Address  New OPD 3rd floor,Department of Radiotherapy
PGIMER Chandigarh
Chandigarh
CHANDIGARH
160014
India 
Phone  7560060331  
Fax    
Email  ankita.palwal12@gmail.com  
 
Source of Monetary or Material Support  
Self 
 
Primary Sponsor  
Name  PGIMERChandigrah 
Address  National Institute of Nursing Education, PGIMER Chandigrah 
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 
Ankita Thakur  PGIMER,Chandigarh  Radiotherapy department
Chandigarh
CHANDIGARH 		 7560060331

ankita.palwal12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Postgraduate Institute of Medical Education And Research, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  development of social support group  Develop social support group and assess the effectiveness of social support group among cervical cancer patient on their physical symptoms and psychological symptoms 
Comparator Agent  Social support group  to assess effectiveness of social support group among cervical cancer patinets 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Cervical cancer patients undergoing chemotherapy and radiotherapy treatment attending Radiotherapy OPD, PGIMER, Chandigarh.
Patients of cervical cancer patients who are willing to participate in study.
Caregivers who are willing to participate in study. 
 
ExclusionCriteria 
Details  Cervical cancer patients and their caregivers who are seeking psychiatric consultation.
Cervical cancer patients who are terminally ill.
Caregivers who are seeking psychiatric consultation. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
-Level of Pain
-Level of Fatigue
-Level of bleeding and discharge
-Sleep Disturbance


Outcome Variables (for caregivers)
-Psychological Distress
-Social support
 		 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Psychological
-Level of Anxiety
-Level of depression
-Level of Stress
-Self esteem
-Quality of life
Outcome Variables (for caregivers)
-Psychological Distress
-Social support 		 3 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 1 
Date of First Enrollment (India)   15/07/2019 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Cancer as a life-threatening illness affects individual health status. Although the cancer is the disease of geriatrics but it can also occur in young ages now a days. Receiving the news of diagnosis of cervical cancer for female is shocking. The diagnosis of cancer is associated with a high level of psychological stress, and is a crisis for patients and their families due to its resulting emotional, physical and social issues. The symptoms and side-effects of treatment of cancer decreases patient’s physical well being and quality of life (QOL). There are numerous side effects of chemotherapy and radiotherapy such as alopecia, fatigue, nausea, mucositis, vomiting, anemia etc. Cancer support group offers a blend of emotional social and educational support to guide those going through cancer treatments as well through phases of cancer. Many studies have showed that support group can improve quality of life for people dealing with cancer diagnosis.

 
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