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CTRI Number  CTRI/2023/12/060857 [Registered on: 27/12/2023] Trial Registered Prospectively
Last Modified On: 02/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of video assisted health education program on self efficacy and wellbeing of patients undergoing chemotherapy  
Scientific Title of Study   Effectiveness of video assisted health education program on self efficacy and wellbeing of patients undergoing chemotherapy at Tertiary cancer center 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shany Thomas 
Designation  Professor 
Affiliation  Bhaikaka University 
Address  Institute of Nursing Sciences Bhaikaka University Karamsad

Anand
GUJARAT
388325
India 
Phone  09925025023  
Fax    
Email  shanyt@charutarhealth.org  
 
Details of Contact Person
Scientific Query  
Name  Shany Thomas 
Designation  Professor 
Affiliation  Bhaikaka University 
Address  Institute of Nursing Sciences Bhaikaka University Karamsad

Anand
GUJARAT
388325
India 
Phone  09925025023  
Fax    
Email  shanyt@charutarhealth.org  
 
Details of Contact Person
Public Query  
Name  Ansu Varghese 
Designation  PG Student 
Affiliation  Bhaikaka University 
Address  Institute of Nursing Sciences Bhaikaka University Karamsad

Anand
GUJARAT
388325
India 
Phone  09925025023  
Fax    
Email  ansushaan24@gmail.com  
 
Source of Monetary or Material Support  
M S Ptel Cancer Centre, Shree Krishna Hospital, Karamsad 
 
Primary Sponsor  
Name  Shany Thomas 
Address  Institute of Nursing Sciences Bhaikaka University Karamsad 
Type of Sponsor  Other [Self] 
 
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 Nirav Asarwala  MS Patel Cancer Centre  Shree Krishna Hospital, Karamsad
Anand
GUJARAT 		 9825744593

niravna@charutarhealth.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-2, HM Patel Centre for Medical Care and Education  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C508||Malignant neoplasm of overlappingsites of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Behavioral intervention-Video assisted Health education.   The health education video will include multidimensional approaches to improve self-efficacy and wellbeing of patient receiving chemotherapy which will be administered to participants in the interventional group. 
Comparator Agent  No intervention  The control group will receive routine information regarding chemotherapy as per the hospital policy.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patient diagnosed with cancer and undergoing a standard chemotherapy regimen for the first time.
2. Patients diagnosed with cancer and undergoing Chemotherapy
3. Patient who could communicate English/Gujarati/Hindi. 
 
ExclusionCriteria 
Details  1.Patient who already completed the course of chemotherapy previously.
2. Patients who are totally dependent on caregivers for activities of daily living, who have psychiatric problems, or chronically ill 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Patients who receive video assisted health education will have enhanced self efficacy as measured by Symptom-Management Self-Efficacy Scale-Breast Cancer and wellbeing as measured by The Functional Assessment of Cancer Therapy – General (FACT-G).
 		 Baseline data will be assessed before administering the intervention and the outcome will be measured 21 days after the intervention.
 
 
Secondary Outcome  
Outcome  TimePoints 
Association between self efficacy and selected demographic variable  21 days after receiving the intervention 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 3 
Date of First Enrollment (India)   01/01/2024 
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="3"
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    A diagnosis of cancer is frightening to most people, though reactions might vary depending on the specific diagnosis, location, stage, therapy, impact on bodily functioning, and prognosis. Anxiety and depression are severe co-morbidities that cancer patients regularly endure, and they may reduce survival time. Even though each patient may have unique information preferences and coping processes, giving patients information and social support may enhance their psychological well-being. Information-seeking behaviors must be taken into consideration when presenting information because the majority of cancer patients want as much information as possible. There is increasing evidence to suggest that patients with cancer require more information about their disease and its consequences than they receive. In an attempt to address these needs, a variety of methods have been used to facilitate the passage of information from health professionals and other cancer information sources to cancer patients and their families. In this study, a systematically designed health education video that will focus on the multidimensional approaches to improve self-efficacy and well-being in patients receiving chemotherapy will be developed by the investigator and validated by experts before being administered to the patient. 
The health education video will be developed based on available data on chemotherapy that had previously been identified in the same setting by the investigator. The video will include a multidimensional approach to improve wellbeing & self-efficacy consisting of Physical, Social, Emotional/ Spiritual and Functional aspects of self-care of the patient receiving chemotherapy and prior to the development of the video, the content of the video will be validated by a minimum of 5 subject experts. The video will be developed with the support of Arena Animation training center and a copy will be submitted to IEC for review. A sampling frame will be created by the investigator prior to the data collection, and the sample will be selected through a simple random method and assigned to the experimental group & control group randomly. The investigator will give the participants a brief explanation of the necessity and goal of the study before they sign the consent form. Pretests will be conducted from the experimental & control group, after the experimental group will be explained the content of the health education video by the investigator and the participant’s queries will be addressed during the initial session. A copy of the health education video will also be shared with the participants of the experimental group while the control group will receive information as routine, and then the post-test will be conducted when participants come for the next cycle of chemotherapy after 21 days. The data will be gathered using the Symptom-Management Self-Efficacy Scale-Breast Cancer (SMSES-BC) 13, a standardized instrument, and The Functional Assessment of Cancer Therapy – General (FACT-G).
 
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