CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 112 enrolled
Drug / intervention
Pal-Care +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04972630
NCT04972630N/ACompleted

Implementation of Home-Based Palliative Care in Limited Resource Settings

Medical University of South Carolina·interventional·Posted Jul 22, 2021·Updated Nov 27, 2024

In Brief

A clinical study evaluating Pal-Care and Control-Usual Care for Cancer Palliative Care. Completed, enrolled 112 participants across 1 site.

Detailed Summary

The goal of this pragmatic clinical trial is to test and evaluate a home-based palliative care intervention for utilizing community health workers to facilitate the delivery of palliative care to cancer patients in rural India. The study builds upon use of the World Health Organization-endorsed "Palliative Care Toolkit," which provides a comprehensive suite of evidence-based materials for delivering palliative care in limited resource settings. For the intervention, two specific aims will be addressed to evaluate: 1) implementation of the intervention within the context of the RE-AIM Framework and 2) outcomes of this intervention to determine its relative effects compared to a standard control group on patients' palliative care needs, symptom burden, quality of life (QOL) and experience with care.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndia

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJul 22, 2021
Enrollment StartNov 1, 2021
Primary CompletionJul 31, 2023
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 4.9 years ago

Interventions

Pal-Carebehavioral

Pal-Care intervention participants will receive a 6-month intervention based upon the WHO toolkit and it will be delivered by the community health workers (CHWs). The goal of this pragmatic clinical trial is to test and evaluate a home-based palliative care intervention for utilizing community health workers to facilitate the delivery of palliative care to cancer patients in rural India. More details provided in the "intervention" arms section. After the intervention, clinicians, CHWs and a purposefully selected set of patients/caregivers, who were involved in the Pal-Care will be interviewed to understand their experiences, needs, expectations, barriers, facilitators and strategies.

Control-Usual Carebehavioral

The control group will receive "usual care" palliative services in which the patient or caregiver (by proxy) must visit the Tata Medical Center (TMC) cancer center for care. TMC services include consultation with a multi-disciplinary team (oncologist, nurse, psychologist), a 21-day morphine supply at reduced cost (as morphine is regulated in use),basic training on medication usage, catheter and wound care, other topics as relevant,and psychological counseling. Patients (or their proxy) must return to the cancer center as needed for follow up care and they are provided a 24/7 hotline to call in case of emergency.