| CTRI Number |
CTRI/2014/03/004477 [Registered on: 18/03/2014] Trial Registered Retrospectively |
| Last Modified On: |
13/03/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A survey to see how effective the supportive treatment given at the patients home by our home care team is.(for patients whose disease can no longer be cured) |
|
Scientific Title of Study
|
A survey on effectiveness of palliative home care services provided by Malabar Cancer Center |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M S Biji |
| Designation |
Assistant Professor |
| Affiliation |
Malabar Cancer Center |
| Address |
GOPAL
Pullambil Road
P.O.Chirakara
Thalassery
Kannur
P.O.Moozhikara
Thalassery
Kannur District
Kannur
KERALA
670103
India |
| Phone |
9496048807 |
| Fax |
04902355880 |
| Email |
bijims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
N R Sindhu |
| Designation |
GNM Nurse |
| Affiliation |
Malabar Cancer Center |
| Address |
Department of Cancer Palliative Medicine
P.O.Moozhikara
Thalassery
Kannur District
Kannur
KERALA
670103
India |
| Phone |
9496048807 |
| Fax |
04902355880 |
| Email |
nrsindhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M S Biji |
| Designation |
Assistant Professor |
| Affiliation |
Malabar Cancer Center |
| Address |
GOPAL
Pullambil Road
P.O.Chirakara
Thalassery
Kannur
P.O.Moozhikara
Thalassery
Kannur District
Kannur
KERALA
670103
India |
| Phone |
9496048807 |
| Fax |
04902355880 |
| Email |
bijims@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
MALABAR CANCER CENTER |
| Address |
MALABAR CANCER CENTER,
THALASSERY
KERALA 670103 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Biji MS |
Malabar Cancer Center |
Department of Cancer Palliative Medicine ,Malabar Cancer Center,P.O.Moozhikara
Thalassery
Kannur
Kannur
KERALA |
9496048807
04902355880
bijims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients with advanced malignancies on palliative care. |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients who are on home care services at Malabar cancer Center |
|
| ExclusionCriteria |
| Details |
All patients living beyond 35 km from the center. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Satisfaction with homecare services measured using patient outcome scale |
measured every 2 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in symptoms |
measured every 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Introduction:Palliative homecare offers a number of added psychological benefits to the terminal patient as the physical home environment enhances the patient’s independence,and quality of life, as the home is the place of familarity and comfort.Also studies report that 60 -70% of people would, given the chance,and the possibility of good care,prefer to remain at home under the family doctor. Aim:To find out the effectiveness of homecare service provided for the needy patients coming to the Cancer Palliative Medicine department of Malabar Cancer Center. Materials and Method:All the patients who received homecare during the period from February 2012 to August 2013, in the department of Cancer Palliative Medicine of Malabar Cancer Center will be included in the study.A total of 112 patients will be included in the study.Using the Patient outcome scale(POS) pain, other symptoms and psychological well being will be assessed (on a likert scale)and the overall satisfaction and the extend of warmth and care the patient felt with the homecare team will be assessed on a 0-10 scale(where 0 stands for not at all satisfied and 10 stands for highly satisfied.The assessment will be done in the first visit and thereafter in the subsequent visits every 2 weeks, Results:The results will be analysed using GLM repeated measure analysis . |