| CTRI Number |
CTRI/2024/11/076423 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
26/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to understand patient and caregivers perspectives on chronic illness |
|
Scientific Title of Study
|
APPROACH II observational study on patient and caregivers perspective on chronic illness and cancer disease awareness, care and health: mixed methods study. |
| Trial Acronym |
APPROACH II |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Naveen Salins |
| Designation |
Associate Dean Research, Head of Department |
| Affiliation |
KMC, MAHE |
| Address |
Department of Palliative Medicine and Supportive Care, Shirdi Sai Baba Cancer Hospital And Research Centre, Kasturba Hospital, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9969683669 |
| Fax |
|
| Email |
naveen.salins@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naveen Salins |
| Designation |
Associate Dean Research, Head of Department |
| Affiliation |
KMC, MAHE |
| Address |
Department of Palliative Medicine and Supportive Care, Shirdi Sai Baba Cancer Hospital And Research Centre, Kasturba Hospital, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9969683669 |
| Fax |
|
| Email |
naveen.salins@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naveen Salins |
| Designation |
Associate Dean Research, Head of Department |
| Affiliation |
KMC, MAHE |
| Address |
Department of Palliative Medicine and Supportive Care, Shirdi Sai Baba Cancer Hospital And Research Centre, Kasturba Hospital, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9969683669 |
| Fax |
|
| Email |
naveen.salins@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Madhav Nagar, Manipal, Udupi
KARNATAKA
576104
India |
|
|
Primary Sponsor
|
| Name |
Dr Naveen Salins |
| Address |
Department of Palliative Medicine and Supportive Care, Shirdi Sai Baba Cancer Hospital and Research Centre, Kasturba Hospital, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka
Udupi
576104
India |
| Type of Sponsor |
Private medical college |
|
|
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 Naveen Salins |
Kasturba Hospital |
Department of Palliative Medicine and Supportive care, Room no 28, Faculty rooms, Near Tiger Circle, Madhav Nagar, Manipal 576104
Udupi
KARNATAKA |
9969683669
naveen.salins@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba osital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: Z518||Encounter for other specified aftercare, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL AS THIS IS AN OBSERVATIONAL STUDY |
| Comparator Agent |
NIL |
NIL AS THIS IS AN OBSERVATIONAL STUDY |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a. Inclusion criteria for patients
(1) Citizens of the country
(2) At least 21 years of age
(3) Physically and mentally well enough to participate in the survey.
(4) Histology of solid cancer in stage IV i.e. non-haematological malignancy
Patients diagnosed with heart failure NYHA 3 and 4 heart disease.
Patients diagnosed with chronic respiratory disease.
GOLD 1-mild: FEC1 GOLD 1 mild FEV1 greater than equal to 80% predicted.
GOLD 2 moderate: 50% less than FEV1 less than 80% predicted.
GOLD 3 severe30% lessthan FEV1 lessthan 50% predicted.
GOLD 4 very severe : FEV1 less than 30% predicted.
(5) Patients diagnosed with renal disease eGFRless than 15ml/min
(6) Patients should be aware of their diagnosis.
(7) Can understand and speak Kannada and or English.
(8) Agreeable to provide consent by checking I agree to participate in the study.
nclusion criteria for caregivers
(1) At least 21 years of age
(2) Involved in providing care or ensuring provision of care or in making decisions
regarding treatment care of the patient.
(3) Patient they are caring for is enrolled in the study.
|
|
| ExclusionCriteria |
| Details |
. Exclusion criteria for patients
(1) Patients with impaired cognitive function
(2) Patients who are below 21 years of age
(3) Patients who are too sick to answer the survey.
(4) Patients who are not aware of their illness.
(5) Patients who are not willing to consent to participate in the study.
Exclusion criteria for caregivers
(1) Foreign domestic workers/maid will be excluded from the study.
(2) Caregivers below the age of 21 will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study aims to measure (1) prognostic beliefs of patients (2) survival expectations, bias and hope in patients and (3) quality of care of patients with advanced illnesses. |
one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study seeks to increase the understanding of patients’ perspectives regarding their quality of life and end-of-life care. This study can highlight end-of-life care in India and serve as basic data for end-of-life care in Asia. It can also identify the barriers and areas in need, which could call the attention of healthcare system planners to augment the development of end-of-life care services in the country. |
two years |
|
|
Target Sample Size
|
Total Sample Size="800"
Sample Size from India="800"
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)
|
01/01/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Site PIs, treating physicians, interviewers, study coordinators will screen medical records to identify
eligible patients. Site PIs/ treating physicians/healthcare workers (e.g., Radiotherapists) will also refer
patients who meet the study’s inclusion criteria. |