Clinical trial NCT04984551: Impact of Project ECHO on Improving the Quality of Palliative Care in Patients With Advanced Cancer and Their Caregivers in Underserved Areas of Kenya, Nigeria, Ghana, South Africa, India, and Ethiopia
Official title: ECHO Telementoring to Improve Quality Palliative Care in Underserved Areas of Kenya, Nigeria, Ghana, South Africa, India, and Ethiopia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Advanced Malignant Solid Neoplasm
Hematopoietic and Lymphoid Cell Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 312
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This trial investigates the experience and satisfaction of care in patients with cancer that has spread to other places in the body (advanced) and their caregivers living in underserved areas of Kenya, Nigeria, Ghana, South Africa, India and Ethiopia as part of Project Extension for Community Healthcare Outcomes (ECHO). Project ECHO is a model of medical education and care management that empowers clinicians to provide better care to more people where they live. Understanding the experiences and satisfaction of patients and caregivers may help improve healthcare workforce capacity and increase access to specialty care for the world's rural and underserved populations.

Detailed description: PRIMARY OBJECTIVE:

I. 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-General \[G\]) in seriously ill patients of providers receiving ECHO model-based comprehensive educational and telementoring intervention (ECHO-Palliative Care, or ECHO-PCT).

SECONDARY/EXPLORATORY OBJECTIVES:

I. To examine the effects of ECHO-PCT on patients' symptom distress as assessed by the Edmonton Symptom Assessment Scale (ESAS), Symptom Distress Scores (SDS), as well as patient and caregiver experience and satisfaction as assessed by the FAMCARE-P 16-item (16)-patient and FAMCARE-caregiver questionnaires.

II. 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 as assessed by Palliative Care Participant Initial Survey, Palliative Care Participant Follow Up Survey, and Feedback Survey.

IIa. Increase patient access to quality palliative care in these regions (morphine consumption).

IIb. Increase patient access to quality palliative care in these regions (morphine consumption).

IIc. Increased patient access to palliative care (PC) measured by the number of patient visits (new and follow-ups).

IId. Provider turnover. IIe. Adherence, measured by the number of ECHO sessions held, the number of ECHO participants at each session, and the number of cases reviewed.

IIf. Comfort with the ECHO platform and ability to learn/engage via distance technology, assessed by the Palliative Care Participant Initial Survey and Palliative Care Participant Follow Up Survey.

OUTLINE: Participants are assigned to 1 of 3 arms.

ARM I (ECHO PARTICIPANTS): Participants participate in online ECHO clinics over 1 hour twice monthly for 12 months and in-country workshops twice per year. Participants complete 5 online surveys between baseline through end of year 2 for up to a total of 26 minutes .Participants complete a 15-minute interview in person or phone about their experience in the ECHO project.

ARM II (PATIENTS): Patients complete 3 in-person or phone questionnaires over a total of 20 minutes every 3 months for 2 years about their symptoms, emotional and physical well-being, and their experience and satisfaction with outpatient oncology care. Patients' medical charts are reviewed for data collection. Patients complete a 15-minute interview in person or phone about their care received by their physician at baseline, end of month 4 and month 12.

ARM III (CAREGIVERS): Caregivers complete an in-person or phone questionnaire over 5 minutes up to 8 times about their experience and satisfaction with the cancer care their family member has received. Caregivers complete a 15 minute interview in person or by phone about the care their family member received by their physician.

Eligibility criteria: Inclusion Criteria:

* PATIENT: Scheduled to receive treatment at participating primary care practice for advanced cancer
* PATIENT: 18 years or older
* PATIENT: Willing to be accessible to the research team for follow-up by telephone or in person
* PATIENT: Prognosis of at least 1 year as ascertained by the treating physician
* PATIENT: Able to read and understand English as assessed by the treating physician
* CAREGIVER: Identified or self-identified as primary caregiver of the patient
* CAREGIVER: Willing to be accessible to the research team for follow-up by telephone or in person
* CAREGIVER: 18 years or older
* CAREGIVER: Able to read and understand English as assessed by the treating physician
* ECHO PARTICIPANT: Participant must be a health care provider interested to participate in the study for 2 years and understand the protocol and provide consent
* ECHO PARTICIPANT: Able to read and understand English as assessed by principal investigator (PI)

Exclusion Criteria:

* Unable to understand and sign consent

Primary outcomes:
measure: Change in patients' quality of life
timeFrame: Baseline up to 12 months
Secondary outcomes:
measure: Change in patients' symptom distress
timeFrame: Baseline up to 2 years
measure: Patients' satisfaction of care
timeFrame: Baseline up to 2 years.
measure: Caregivers' satisfaction of care
timeFrame: Baseline up to 2 years
measure: Providers' efficacy in knowledge of delivering palliative care
timeFrame: Baseline
measure: Providers' efficacy in knowledge of delivering palliative care
timeFrame: Up to 2 years
measure: Providers' competence to deliver palliative care
timeFrame: Baseline up to 2 years
measure: Providers' Satisfaction and feedback
timeFrame: Baseline up to 2 years
measure: Burnout among ECHO participant
timeFrame: Baseline up to 2 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Sriram Yennu
role: PRINCIPAL_INVESTIGATOR
References: