NCT04984551

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
312

participants targeted

Target at P75+ for phase_2

Timeline
6mo left

Started Aug 2020

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Aug 2020Dec 2026

Study Start

First participant enrolled

August 24, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2020

Completed
11 months until next milestone

First Posted

Study publicly available on registry

July 30, 2021

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

6.4 years

First QC Date

August 27, 2020

Last Update Submit

March 3, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in patients' quality of life

    Measured by Functional Assessment of Cancer Illness Therapy FACT-General (FACT-G). A 27-item compilation of general questions divided into four primary domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Each question is assessed using a Likert scale ranging from 0 to 4. The FACT-G total score is the sum of the domain scores..

    Baseline up to 12 months

Secondary Outcomes (8)

  • Change in patients' symptom distress

    Baseline up to 2 years

  • Patients' satisfaction of care

    Baseline up to 2 years.

  • Caregivers' satisfaction of care

    Baseline up to 2 years

  • Providers' efficacy in knowledge of delivering palliative care

    Baseline

  • Providers' efficacy in knowledge of delivering palliative care

    Up to 2 years

  • +3 more secondary outcomes

Study Arms (3)

Arm I: ECHO Participants (ECHO clinics, workshop, education)

EXPERIMENTAL

Participants participate in online ECHO clinics over 1 hour twice monthly for 12 months and in-country workshops twice per year. Participants also receive 5 core lectures through an internet-based professional education curriculum.

Other: Extension of Community Health (ECHO) Telementoring ClinicOther: In-Country WorkshopsOther: Professional Oncology Educations Programs

Arm II: Patients (questionnaire, medical chart review)

EXPERIMENTAL

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 the care they received by their physician at baseline, end of month 4 and month 12.

Other: Medical Chart ReviewOther: Questionnaire Administration

Arm III: Caregivers (questionnaire)

EXPERIMENTAL

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 their family member received by their physician.

Other: Questionnaire Administration

Interventions

Participate in ECHO clinics presenting cases for guidance and feedback

Arm I: ECHO Participants (ECHO clinics, workshop, education)

In-Country Workshops Participate in hands-on training and workshops

Arm I: ECHO Participants (ECHO clinics, workshop, education)

Receive 5 core online lectures

Arm I: ECHO Participants (ECHO clinics, workshop, education)

Medical charts are reviewed for data collection

Also known as: Chart Review
Arm II: Patients (questionnaire, medical chart review)

Complete questionnaire(s)

Arm II: Patients (questionnaire, medical chart review)Arm III: Caregivers (questionnaire)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Unable to understand and sign consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Sriram Yennu

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2020

First Posted

July 30, 2021

Study Start

August 24, 2020

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 5, 2026

Record last verified: 2026-03

Locations