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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: CTRI
Last refreshed on: 24 November 2021
Main ID:  CTRI/2017/11/010481
Date of registration: 14-11-2017
Prospective Registration: No
Primary sponsor: Department of Atomic Energy Clinical Trials Centre
Public title: A multicenter survey of patients decision making preferences in patients with advanced cancers
Scientific title: Patients decisional control preferences in the Palliative Care setting: a multicenter survey
Date of first enrolment: 06-12-2014
Target sample size: 100
Recruitment status: Completed
URL:  http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=12188
Study type:  Observational
Study design:  Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
 
Phase:  N/A
Countries of recruitment
Argentina Brazil Chile India Jordan Philippines Singapore South Africa
Spain United States of America
Contacts
Name: Dr MaryAnn Muckaden   
Address:  Department of Palliative Medicine, Dr Ernest Borges Road, Parel, Mumbai Mumbai MAHARASHTRA 400012 India 400012 Mumbai, MAHARASHTRA India
Telephone: 02224177148
Email: muckadenma@tmc.gov.in
Affiliation:  Tata Memorial Hospital
Name: Dr MaryAnn Muckaden   
Address:  Department of Palliative Medicine, Dr Ernest Borges Road, Parel, Mumbai Mumbai MAHARASHTRA 400012 India 400012 Mumbai, MAHARASHTRA India
Telephone: 02224177148
Email: muckadenma@tmc.gov.in
Affiliation:  Tata Memorial Hospital
Key inclusion & exclusion criteria
Inclusion criteria: 1. Patient with advanced cancer (locally recurrent or metastatic).

2. Patient is 18 years of age or older (as the assessment tools used in this study have not been validated in the pediatric population).

3. Patient with normal cognitive status as determined by the interviewer and by her/his ability to understand the nature of the study and consent process.

4. Patient willing to participate in the study and sign informed consent.

5. Patient seen by the palliative care team consultation for atleast one visit.

6. Patient has resided in the study country for at least 5 years


Exclusion criteria: 1. Patient refusal to participate in the study.

Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Health Condition 1: C00-D49- Neoplasms
Intervention(s)
Intervention1: NIL: NIL
Primary Outcome(s)
To describe the proportions of passive decision making for individual countries throughout the world.Timepoint: at the time of outpatients consultation of patient in department of Palliative Medicine
Secondary Outcome(s)
To identify the factors that influence patient satisfaction with the decision-making process.Timepoint: at the time of outpatients consultation of patient in department of Palliative Medicine
To determine the agreement between patientsâ?? decisional control preferences and their self-reported actual decision-making experiences regarding cancer care.Timepoint: at the time of outpatients consultation of patient in department of Palliative Medicine
To compare the proportion of passive decision making in developed and developing countries.

Timepoint: at the time of outpatients consultation of patient in department of Palliative Medicine
To identify associations among patients decisional control preferences with their socio demographic and clinical characteristics.Timepoint: at the time of outpatients consultation of patient in department of Palliative Medicine
To determine patientsâ?? level of understanding of their illness and prognosis.Timepoint: at the time of outpatients consultation of patient in department of Palliative Medicine
Secondary ID(s)
1273 (Version 1.0 dated 06.03.2013)
Source(s) of Monetary Support
Department of Atomic Energy Clinical Trials Centre, Tata Memorial Centre, Dr E. Borges Road, Parel, Mumbai -400012
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 16/10/2014
Contact:
Institutional Ethics Committee
Results
Results available:
Date Posted:
Date Completed: 23/09/2016
URL:
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