| CTRI Number |
CTRI/2022/09/046026 [Registered on: 29/09/2022] Trial Registered Prospectively |
| Last Modified On: |
28/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Mixed |
| Study Design |
Other |
|
Public Title of Study
|
"Health and illness Experiences of Patients with Acute Myeloid Leukemia". |
|
Scientific Title of Study
|
“Analyzing selected health-related parameters and illness experiences of patients with Acute Myeloid Leukemia and their caretakersâ€.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R Shankar Shanmugam |
| Designation |
Associate Professor/Reader |
| Affiliation |
|
| Address |
College of Nursing
Madras Medical college
Chennai-3
Chennai
TAMIL NADU
600003
India |
| Phone |
9884020914 |
| Fax |
|
| Email |
shankarshaki@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Shankar Shanmugam |
| Designation |
Associate Professor/Reader |
| Affiliation |
|
| Address |
College of Nursing
Madras Medical college
Chennai-3
Chennai
TAMIL NADU
600003
India |
| Phone |
9884020914 |
| Fax |
|
| Email |
shankarshaki@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Shankar Shanmugam |
| Designation |
Associate Professor/Reader |
| Affiliation |
|
| Address |
College of Nursing
Madras Medical college
Chennai-3
Chennai
TAMIL NADU
600003
India |
| Phone |
9884020914 |
| Fax |
|
| Email |
shankarshaki@yahoo.com |
|
|
Source of Monetary or Material Support
|
| College of Nursing, Madras Medical College, Chennai |
|
|
Primary Sponsor
|
| Name |
Dr R Shankar Shanmugam |
| Address |
College of Nursing
Madras Medical College
Chennai-3 |
| 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 |
| Dr R Shankar Shanmugam |
Madras Medical College |
R.No 4,6th floor, Tower block -II, Hematology Dept
Madras Medical College
Chennai-3
Chennai
TAMIL NADU |
9884020914
shankarshaki@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee.Madras Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C920||Acute myeloblastic leukemia, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults diagnosed with Leukemia and on treatment
for more than six months
2. Able to understand & speak Tamil.
3. Leukemia adults who are stable
|
|
| ExclusionCriteria |
| Details |
 Not able to speak Tamil
 Not willing to participate
 With complications
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| we can able get information about sleeplessness, drug adherence ,functional ability, stress, resilience and social support status of Acute myeloid Leukemic patients and illness experience of their Care takers. |
only baseline information will be collected at a single time point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary outcome will be
about Financial burden,Self Efficacy,Quality of life and the Illness experience of the Acute Myeloid leukemia patients. |
Baseline(Single time point) |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will be started from 01-10-2022 |