FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/06/019519 [Registered on: 04/06/2019] Trial Registered Retrospectively
Last Modified On: 02/06/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to assess the effectiveness of patient information booklet in preventing Hand foot syndrome in cancer patients recieving fluorouracil and capecitabine 
Scientific Title of Study   A study to assess the effectiveness of information booklet on prevention of hand foot syndrome in breast cancer patients receiving fluorouracil and capecitabine 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ng Saniiru lanah 
Designation  Msc nursing student 
Affiliation  All India Institute of Medical Sciences New Delhi 
Address  College of Nursing AIIMS New Delhi

South West
DELHI
110048
India 
Phone  8447312807  
Fax    
Email  lanahsaniiru77@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rachel Andrews 
Designation  Lecturer College of nursing AIIMS 
Affiliation  College of Nursing AIIMS New Delhi 
Address  Lecturer college of nursing AIIMS Ansari Nagar New Dehi

South West
DELHI
110029
India 
Phone  9953224917  
Fax    
Email  gaddamrachel@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rachel Andrews 
Designation  Lecturer College of nursing AIIMS 
Affiliation  College of Nursing AIIMS New Delhi 
Address  Lecturer college of nursing AIIMS Ansari Nagar New Dehi

South West
DELHI
110029
India 
Phone  9953224917  
Fax    
Email  gaddamrachel@gmail.com  
 
Source of Monetary or Material Support  
No monetary/ facilities support. Information booklet was prepared and printed and given to patients by investigator and the cost bear by them 
 
Primary Sponsor  
Name  No sponser 
Address  No sponser 
Type of Sponsor  Other [No sponser] 
 
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 
Ng Saniiru Lanah  AIIMs Day care centre, Dr BRAIRCH, New Delhi  AIIMS Ansari Nagar New Delhi
South West
DELHI 
8447312807

lanahsaniiru77@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L988||Other specified disorders of the skin and subcutaneous tissue, Prevention of Hand foot syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Provision of information booklet on Hand foot syndrome prevention  Patients receiving 5FU and capecitabine were randomly allocated to experimental and control group with sequentially sealed opaque envelops prepared with the help of computer generated random number table. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Adult male or female diagnosed with cancer and were recieving 5FU or capecitabine
Who could read Hindi or english. 
 
ExclusionCriteria 
Details  Who were not willing to participate in the study.
Who cannot read Hindi or English.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prevention of Hand foot syndrome
Increase in knowledge 
3 weeks after intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Association of knowledge with hand foot syndrome  at baseline and 21 days after intervention 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "81"
Final Enrollment numbers achieved (India)="81" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/06/2014 
Date of Study Completion (India) 31/12/2014 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Aim of the study: To assess the effectiveness of information booklet on improving knowledge and prevention of hand and foot syndrome in Cancer patients receiving fluorouracil and Capecitabine.

Materials and methods: This prospective randomized control trial included 81 patients from Day care unit and outpatient department, IRCH AIIMS, New Delhi during the period of June to December 2014.  All the patients meeting inclusion criteria were randomly assigned to experimental group (n=40) and control group (n=41). The demographic and clinical profile of patients were collected from both the groups. The pre –test was done before intervention with knowledge questionnaire to assess knowledge and checklist to assess the sign and symptoms of Hand foot syndrome. Patients in experimental group received information booklet along with short discussion on the content of the Booklet. Control group received standard routine care. Post-test was collected on 22nd day using the same tools for both the groups. Data was analyzed using STATA 12.1. All the patients recruited in the study were analyzed at the end and intention to treat analysis was done. Parametric test were applied for the test.

Results: A total of 81 patients participated in the study with 40 patients in experimental and 41 in the control group and 31patients from each group completed the study. The two groups were comparable at baseline regarding demographic variables and clinical profile except in duration of treatment which was >6 months in control group as compared to experimental group. Most of the subjects (59.3%) had poor knowledge regarding Hand foot syndrome at baseline (pre-test). There was statistically significant increase in knowledge from pre-test to post-test in both the groups but knowledge gain in experimental group  was higher as compared to control group at (p<0.001). Hand foot syndrome grades (grade 0, 1) in experimental and control group were comparable at baseline. Majority of patients 95% in experimental and 92% in control group hand foot syndrome grades remained unchanged from pre-test to post-test and both the groups were comparable at p>0.05. There was no statistically significant association between knowledge with selected demographic and clinical variables. However, there was statistically significant association of knowledge with hand foot syndrome grades. Patients with grade 1 hand foot syndrome had higher knowledge as compared to those without symptoms (grade 0) at (p=0.003).

Conclusion: Administration of Information booklet significantly increase the knowledge regarding HFS whereas there was no change with regard to prevention of Hand foot syndrome in cancer patients receiving fluorouracil and capecitabine. However, effectiveness of information booklet in prevention of hand foot syndrome can to be tested on larger sample size with repeated follow up.

 
Close