R21 India Pal-Care Evaluation

Last updated: November 18, 2024
Sponsor: Medical University of South Carolina
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Control-Usual Care

Pal-Care

Clinical Study ID

NCT04972630
00089815
2019-3793
1R21CA252850-01
2019/GOVT/25/IRB8
  • Ages 18-85
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults ages 18 years and over, any cancer type, late state cancer, residence in 24Parganas Region, West Bengal, India, physician documentation in medical record thatpatient is to receive palliative care, patient willingness to participate in datacollection.

Exclusion

Exclusion Criteria:

  • Prisoner; diagnoses of substance addiction (illicit drugs), Mentally unstable orhaving moderate to severe mental health issue or incapable of decision making,Unable to speak or communicate with ease

Study Design

Total Participants: 112
Treatment Group(s): 2
Primary Treatment: Control-Usual Care
Phase:
Study Start date:
November 01, 2021
Estimated Completion Date:
July 31, 2023

Study Description

This pragmatic clinical trial is a collaboration between the Medical University of South Carolina (MUSC)and Tata Medical Center (TMC), a cancer center in Kolkata, India. The study has two parts: a) Implementation of a Pal-Care intervention as compared to control/no intervention b) Qualitative post-intervention evaluation.

The part a) of the study is conducted at Tata Medical Center (TMC) in Kolkata, India, under the supervision of the site PI, Dr. Gaurav Kumar. All participants will be recruited from among the TMC patients who are referred to cancer palliative care and will be grouped to the "Control" or "Pal-Care" intervention groups. This part of the study will compare an intervention group of patients who will receive home-based palliative services (Pal-Care)from community health workers (CHWs) vs. a control group of patients who will receive cancer-center based palliative services. This intervention implementation part of the study is approved by TMC Ethics Board and Indian Council of Medical Research (ICMR), approval letter on file with MUSC IRB. MUSC relies on TMC IRB for this part and the ICF document is approved by the TMC Ethics Board in India.

The part b) of the study (under purview of MUSC IRB) involves post-intervention qualitative interviews. MUSC research team will evaluate the implementation and effect of the Pal-Care intervention to deliver CHW navigated home-based palliative care for rural cancer patients in India. The participants of this part of the study will also be from India and include stakeholders, representing all Pal-Care clinical team members and CHWs and patients/caregivers who participated in the Pal-Care intervention. This part has a waiver of signed consent.

The RE-AIM framework guides our evaluation plan to measure the reach, effectiveness, adoption, implementation and maintenance of the Pal-Care intervention. Diverse data sources will be used to evaluate the intervention within the REAIM Framework.

Connect with a study center

  • Tata Medical Center

    Kolkata, West Bengal 700160
    India

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.