| 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
|
|
|
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
|
|
|
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. |