| CTRI Number |
CTRI/2021/01/030428 [Registered on: 13/01/2021] Trial Registered Prospectively |
| Last Modified On: |
12/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Quality of Life in Cancer Patients with Stoma. |
|
Scientific Title of Study
|
Quality of Life Outcome in Cancer Patients living with intestinal stoma :A Prospective Cross sectional Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr BIJI MS |
| Designation |
Assitant Professor |
| Affiliation |
Malabar Cancer Centre |
| Address |
DEPARTMENT OF CANCER PALLIATIVE MEDICINE
MALABAR CANCER CENTRE
MOOZHIKARA (P.O)
MOOZHIKARA (P.O)
Kannur
KERALA
670103
India |
| Phone |
09496048807 |
| Fax |
|
| Email |
bijims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr BIJI MS |
| Designation |
Assitant Professor |
| Affiliation |
Malabar Cancer Centre |
| Address |
DEPARTMENT OF CANCER PALLIATIVE MEDICNE
MALABAR CANCER CENTRE
MOOZHIKARA (P.O)
MOOZHIKARA (P.O)
Kannur
KERALA
670103
India |
| Phone |
09496048807 |
| Fax |
|
| Email |
bijims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr BIJI MS |
| Designation |
Assitant Professor |
| Affiliation |
Malabar Cancer Centre |
| Address |
DEPARTMENT OF CANCER PALLIATIVE MEDICINE
MALABAR CANCER CENTRE
MOOZHIKARA (P.O)
MOOZHIKARA (P.O)
Kannur
KERALA
670103
India |
| Phone |
09496048807 |
| Fax |
|
| Email |
bijims@gmail.com |
|
|
Source of Monetary or Material Support
|
| Malabar Cancer Center, Thalassery |
|
|
Primary Sponsor
|
| Name |
MALABAR CANCER CENTER |
| Address |
(P.O)MOOZHIKARA
THALASSERY
KANNUR DISTRICT
KERALA |
| 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 |
| Dr MS BIJI |
Malabar Cancer Center |
STOMA CLINIC
DEPARTMENT OF CANCER PALLIATIVE MEDICINE
MALABAR CANCER CENTRE
MOOZHIKARA (P.O)
Kannur
KERALA |
09496048807
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 |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients who are under follow up at Malabar cancer Centre and have undergone intestinal stoma at least 3 months prior to enrolling in the study.
|
|
| ExclusionCriteria |
| Details |
1. Those patients who have cognitive dysfunction that may preclude administration of questionnaire
2. Those who do not read and understand Malayalam.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Quality of life using Malayalam version of ‘City of Hope National medical center quality of life questionnaire(COHQOL-OQ) for patients with an ostomy’
|
ONE TIME ONLY AT BASELINE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To find the association between QOL and other demographic characteristics like age, gender, occupation, duration of stoma, availability of insurance coverage, diet changes, type of stoma
2. To determine the predictors of QoL in patients with ostomy’
|
one TIME ONLY AT BASELINE |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
18/01/2021 |
| 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 Applicable |
| 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
|
Research question
Do cancer patients who have undergone intestinal stoma
as a part of their cancer treatment have poor quality of life?
Hypothesis
Cancer
patients who have undergone intestinal stoma for treatment of their cancer have
poor quality of life.
Aim
To
study about quality of life in cancer patients who have undergone intestinal
stoma in treatment of their cancer and are following up with stoma clinic of
Malabar Cancer center.
Objective-
Among
the Cancer patients who have undergone intestinal stoma in treatment of their
cancer and are following up with stoma clinic of Malabar Cancer center, to
asses
Primary:
1.
Quality of life
using Malayalam version of ‘City of Hope National medical center quality of
life questionnaire(COHQOL-OQ) for patients with an ostomy’
Secondary
Objective:
1.
To find the association between QOL and other demographic
characteristics like age, gender, occupation, duration of stoma, availability
of insurance coverage, diet changes, type of stoma
2.
To determine the
predictors of QoL in patients with ostomy’ |