| CTRI Number |
CTRI/2019/03/018096 [Registered on: 15/03/2019] Trial Registered Prospectively |
| Last Modified On: |
23/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
"A study to determine the effectiveness of teaching programme regarding cancer pain medications and adherence to the pain medications in patients who are suffering from cancer pain |
|
Scientific Title of Study
|
"A study to assess the effectiveness of patient teaching programme on knowledge of analgesic and its compliance among patients who are attending pain clinic in Dr. BRA IRCH, AIIIMS, New Delhi" |
| Trial Acronym |
RCT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aparna |
| Designation |
M.Sc nursing (oncology) student |
| Affiliation |
AIIMS, DELHI |
| Address |
College of nursing, AIIMS, NEW DELHI
South
DELHI
110029
India |
| Phone |
9717717729 |
| Fax |
|
| Email |
aparnasnj61@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr L Gopichandran |
| Designation |
Lecture |
| Affiliation |
AIIMS, DELHI |
| Address |
College of nursing, AIIMS, NEW DELHI
South
DELHI
110029
India |
| Phone |
8130930287 |
| Fax |
|
| Email |
pravigopi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aparna |
| Designation |
M.Sc nursing (oncology) student |
| Affiliation |
AIIMS, DELHI |
| Address |
College of nursing, AIIMS, NEW DELHI
South
DELHI
110029
India |
| Phone |
9717717729 |
| Fax |
|
| Email |
aparnasnj61@gmail.com |
|
|
Source of Monetary or Material Support
|
| aparna
college of nursing AIIMS new delhi |
|
|
Primary Sponsor
|
| Name |
Aparna |
| Address |
college of nursing, AIIMS, New delhi 110029 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Aparna |
AIIMS, New Delhi |
pain clinic, Dr. BRA IRCH
South
DELHI |
9717717729
aparnasnj61@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: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Patient teaching programme |
One to one teaching programme with the help of pamphlets, as developed by the researcher for cancer patients, for the purpose of the study
Teaching programme will be done in pain clinic, IRCH, AIIMS.
Time duration is 5-10 minutes
Content includes the analgesic, types of analgesic use, its benefits and side effects, how to manage the side effects, and how to administer various types of analgesic. |
| Comparator Agent |
Usual care |
It involves treatment and advice by palliative care specialist for the management of cancer pain. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients (>18years) diagnosed with cancer and receiving analgesic management for cancer pain
Patients who have had at least 2 consecutive follow-up visits
Patient who are willing to participate in the study.
Patients who can read either Hindi or English. |
|
| ExclusionCriteria |
| Details |
Patients who can not have follow up at IRCH, AIIMS.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of patient teaching programme on knowledge regarding analgesic and analgesic compliance among patients attending pain clinic |
Effectiveness of patient teaching programme on knowledge regarding analgesic and analgesic compliance among patients attending pain clinic will be done after 2 and 4 weeks after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| there will be positive correlation between knowledge regarding analgesic and analgesic compliance |
correlation between knowledge regarding analgesic and analgesic compliance will be assessed after 2 and 4 weeks of intervention |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2019 |
| Date of Study Completion (India) |
20/12/2019 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The primary purpose of the protocol is to assess the effectiveness of patient teaching programme on knowledge regarding analgesic and analgesic compliance among patients attending pain clinic at Dr. BRA IRCH, AIIMS, New Delhi. The hypothesis is Knowledge regarding analgesic will be better in patients attending teaching programme as compared to usual care patient with a p-value less than 0.05 and Analgesic compliance will be better in patients attending teaching programme as compared to usual care patient with a p-value less than 0.05 |