| CTRI Number |
CTRI/2021/01/030757 [Registered on: 27/01/2021] Trial Registered Prospectively |
| Last Modified On: |
20/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of knowledge, attitude and practices about cancer and its treatment and prferences about cancer treatment in urological cancer patients seeking treatment at Tata Memorial Hospital |
|
Scientific Title of Study
|
Prospective study to assess the impact of patients’ Knowledge, Attitude and Practices about cancer on the Stage At Presentation for seeking cancer treatment at the hospital, among patients registered with the Out Patient Department of the Uro-oncology Disease Management Group at Tata Memorial Hospital (KAP-SAP study) |
| Trial Acronym |
KAP-SAP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 3627 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ganesh Bakshi |
| Designation |
Professor, Dept of Surgical Oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
OPD 224, HBB, Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai
Dr E Borges Marg, Parel, Mumbai
Postal code: 400012
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
02224176228 |
| Fax |
|
| Email |
gkbakshi73uro@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ganesh Bakshi |
| Designation |
Professor, Dept of Surgical Oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
OPD 224, HBB, Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai
Dr E Borges Marg, Parel, Mumbai
Postal code: 400012
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
02224176228 |
| Fax |
|
| Email |
gkbakshi73uro@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ganesh Bakshi |
| Designation |
Professor, Dept of Surgical Oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
OPD 224, HBB, Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai
Dr E Borges Marg, Parel, Mumbai
Postal code: 400012
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
02224176228 |
| Fax |
|
| Email |
gkbakshi73uro@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai, Postal Code: 400012 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Ganesh Bakshi |
Tata Memorial Hospital |
HBB OPD 222-225, GJB OPD 501-503, Uro-oncology DMG, Tata Memorial Hospital, Dr E Borges Marg, PArel, Mumbai 400012
Mumbai (Suburban)
MAHARASHTRA |
02224176228
gkbakshi73uro@hotmail.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: C67||Malignant neoplasm of bladder, (2) ICD-10 Condition: C64||Malignant neoplasm of kidney, except renal pelvis, (3) ICD-10 Condition: C68||Malignant neoplasm of other and unspecified urinary organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. New registered patients presenting to Uro-oncology DMG.
2. All adult patients
3. Patients with atleast one consenting adult accompanying person
4. The any consenting accompanying person must necessarily be an adult. The consenting adult accompanying person must necessarily be a literate in cases where patient is illiterate.
5. Patients who are willing to give the informed consent.
|
|
| ExclusionCriteria |
| Details |
1. The consenting adult accompanying person is an not an adult or is an illiterate in cases where the patient is illiterate.
2. The consenting adult accompanying refuses to assist the patient, in cases where the patient is illiterate.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the association of patients’ knowledge, attitude and practices (KAP) of cancer and cancer management, at initial hospital visit, on their cancer stage at presentation at theUro-oncology DMG, Tata Memorial Hospital to seek cancer treatment. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the association of patients’ cancer related KAP at initial hospital visit, with the compliance to first definitive treatment. [Compliance to advised treatment may be anyone of the following: undergoing the treatment procedure or taking the treatment as prescribed (doses and time)]
|
6 months |
To determine the socio-economic and demographic factors influencing the knowledge, attitude and practices among the patients presenting at the Urooncology DMG, Tata Memorial Hospital.
|
6 months |
To determine the socio-economic and demographic factors influencing the treatment related preferences among the patients presenting at the Urooncology DMG, Tata Memorial Hospital.
|
6 months |
To determine patients’ cancer treatment related preferences, at two different time points, first at the first visit at Tata Memorial hospital and for the second time after first treatment planning consultation with the doctor.
|
6 months |
| To evaluate the impact of doctors’ consultation on the treatment preferences of the patient. This will be done by comparing the patients’ treatment preferences at both the time points |
6 months |
| To compare the association of the patients’ cancer treatment related preferences at both the time points with the patient’s compliance to the first definitive treatment |
6 months |
| To evaluate the association of patient’s knowledge, attitude and practices (KAP) of cancer and cancer management, at initial hospital visit, on the patient’s cancer stage at presentation at the Uro-oncology DMG, Tata Memorial Hospital to seek cancer treatment |
6 months |
|
|
Target Sample Size
|
Total Sample Size="256"
Sample Size from India="256"
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)
|
27/01/2021 |
| 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
|
No publications yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cancer is a growing concern worldwide. There has been an increasing trend in the cancer cases, with nearly 50% of the new cases and a little more
than 50% of cancer deaths being reported from Asia. According to WHO,
approximately 70% of deaths from cancer occur in low-and middle-income
countries, and around one third of deaths from cancer are due to modifiable
behavioral and dietary risks.
There is a varied pattern of awareness about cancer in the Indian population
and this is affected by the socio-demographic characteristics as well. Overall,
the awareness about cancer, its risk factors, symptoms, treatment measures,
preventive measures has been low. Early detection of cancer facilitates better
outcomes, improved survival, less morbidity and less expensive treatment. A
study in Puducherry, South India found that there was a low level of
awareness of common cancers among adults. General awareness of cancer
and also about its curability, preventability and screening methods is poor
among the Indian population. KAP of the patient and
family members knowledge, attitudes and practices (KAP) about cancer and
its treatment play an important role in influencing the healthcare seeking
behavior among cancer patients and the patient’s compliance to diagnosis
and treatment.
The studies to asses cancer related KAP have largely been conducted in the
communities. There are very few hospital-based studies on this subject. To
the best of our knowledge there are no studies conducted to assess the KAP
of Urological cancers.
We hypothesize that the cancer related knowledge, attitude, and practices
(KAP) influences the patient’s cancer care seeking behaviour. |