| CTRI Number |
CTRI/2022/02/039951 [Registered on: 02/02/2022] Trial Registered Prospectively |
| Last Modified On: |
28/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Project ECHO (Extension for Community Healthcare Outcomes) online lecture series to improve the quality of Palliative care services in lower middle income countries- Kenya, Nigeria, Ghana, South Africa, and India |
|
Scientific Title of Study
|
ECHO Telementoring to Improve Quality Palliative Care in Underserved Areas of Zambia, Kenya, Nigeria, Ghana, South Africa, and India. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT04984551 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jayita Deodhar |
| Designation |
Professor |
| Affiliation |
Tata Memorial Centre |
| Address |
Room no 75,Main Building-Ground floor,Tata Memorial Centre,Earnest Borges Road,Parel, Mumbai.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
24177000 |
| Fax |
|
| Email |
jukd2000@yahoo.co.uk |
|
Details of Contact Person
Scientific Query
|
| Name |
Jayita Deodhar |
| Designation |
Professor |
| Affiliation |
Tata Memorial Centre |
| Address |
Room No 75,Main Building-Ground floor,Tata Memorial Centre,Earnest Borges Road,Parel, Mumbai.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
24177000 |
| Fax |
|
| Email |
jukd2000@yahoo.co.uk |
|
Details of Contact Person
Public Query
|
| Name |
Jayita Deodhar |
| Designation |
Professor |
| Affiliation |
Tata Memorial Centre |
| Address |
Room No 75-Main Building- Ground floor,Tata Memorial Centre,Earnest Borges Road,Parel, Mumbai.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
24177000 |
| Fax |
|
| Email |
jukd2000@yahoo.co.uk |
|
|
Source of Monetary or Material Support
|
| M D Anderson Cancer Centre |
|
|
Primary Sponsor
|
| Name |
M D Anderson Cancer Centre |
| Address |
1515 Holcombe Blvd, Houston, Texas,77030, United States |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Ghana
India
Nigeria
South Africa
Zambia
Kenya |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jayita Deodhar |
Tata Memorial Centre , Mumbai |
Palliative Care OPD-Room number 75(Main Building), Ground floor
Tata Memorial Centre, Parel.
Mumbai 400012
Mumbai
MAHARASHTRA |
24177000
jukd2000@yahoo.co.uk |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Comitee-TMC Mumbai |
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 |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patient:
1) Scheduled to receive treatment at participating primary care practice for advanced cancer.
2) 18 years or older
3) Willing to be accessible to the research team for follow-up by telephone or in person
4)Prognosis of at least 1 year as ascertained by the treating physician
5)Able to read and understand English as assessed by the treating physician.
Caregiver:
1)Identified or self-identified as primary caregiver of the patient
2) Willing to be accessible to the research team for follow-up by telephone or in person
3) 18 years or older
4) Able to read and understand English as assessed by the treating physician.
ECHO Participant:
1) Participant must be a health care provider interested to participate in the study for 2 years and understand the protocol and provide consent.
2) Able to read and understand English as assessed by PI |
|
| ExclusionCriteria |
| Details |
1) Unable to understand and sign consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effects of Project ECHO on patient-reported quality of life [QOL] (as assessed by the change in Functional Assessment of Cancer Illness Therapy FACT-G) in seriously ill patients of providers receiving ECHO Model-Based comprehensive educational and telementoring intervention (ECHO-Palliative Care, or ECHO-PCT). |
0 months, 4 months, 8 months, 12 months, 16 months, 20 months, 24months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To examine the effects of ECHO-PCT on patients’ symptom distress as well as patient and caregiver experience and satisfaction.
2. To explore the effects of ECHO-PCT on providers’ efficacy in, knowledge of, and competence to deliver Palliative Care to Patients with serious life limiting illness, as well as their satisfaction with providing Palliative Care services ; (ii) increase patient access to quality palliative care in these regions (morphine consumption); and (iii) increase in the number of palliative care procedures performed by the ECHO participants (subcutaneous hydration, opioid rotation). iv) increased patient access to PC measured by the number of patient visits (new and follow-ups); v) provider turnover; vi) adherence, measured by the number of ECHO sessions held, the number of ECHO participants at each session, and the number of cases reviewed; and vii) comfort with the ECHO platform and ability to learn/engage via distance technology, |
0 months, 4 months, 8 months, 12 months, 16 months, 20 months, 24months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="50"
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)
|
10/02/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/08/2020 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="2"
Days="20" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Yes-Extension for Community Healthcare Outcomes-Palliative Care in Africa Program: Improving Access to Quality Palliative Care
Yennurajalingam et al
Jounal of Global Oncology |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients with advanced cancer suffer from devastating symptoms due to the disease and its treatment which impacts their quality of life and overall survival. In patients receiving palliative treatment,the intensity and severity of symptoms increase ,and they have increased financial and spiritual concerns and functional decline. The countries like Zambia, Kenya, Nigeria, Ghana, South Africa, and India remain ill-equipped to take care of the palliative care needs of cancer patients in advanced stages.To assist with training physicians, nurses, volunteers helping the patients with life limiting illnesses with skills required to provision of quality palliative care, we are proposing a collaborative project using Project ECHO. The primary objective is to evaluate the effects of Project ECHO on patient-reported quality of life [QOL] in seriously ill patients of providers receiving ECHO Model-Based comprehensive educational and telementoring intervention .The secondary objective is to examine the effects of tele mentoring on patients’ symptom distress ,and to explore the effects on providers’ efficacy in, knowledge of, and competence to deliver Palliative Care to Patients with serious life limiting illness, as well as their satisfaction with providing Palliative Care services. The two provider centers/organizations for Tata Memorial Hospital(TMH) in India are- Department of Palliative Care in HBCH and MPMMMC, Varanasi and Department of Palliative Medicine TMH Mumbai, in collaboration with Palcare India, Mumbai (patient will be recruited in TMH only). We will be recruiting 50 patients in each center and they will be followed up every 4 months till a period of 2 years. This is a prospective observational study. All project data will be collected using REDCap (Research Electronic Data Capture) electronic data capture tools hosted at MD Anderson (http://www.project-redcap.org). The data will be summarized by descriptive statistics at baseline, year 1 and 2 of ECHO-PCT. Through constant engagement, this project will enrich the research collaborations and educational partnerships between MD Anderson and our Sister Institution Network colleagues in Lower Middle Income Countries |