N/A
N=112
R21 India Pal-Care Evaluation
Cancer Palliative Care
Bottom Line
View on ClinicalTrials.gov: NCT04972630 ↗Enrolled (actual)
112
Serious AEs
50.0%
Results posted
Nov 2024
Primary outcome: Primary: Palliative Care Outcomes (POS Total Scores) — 23.5; 22.9; 22.2; 22.1 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pal-Care (Behavioral); Control-Usual Care (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Palliative Care Outcomes (POS Total Scores) |
23.5; 22.9; 22.2; 22.1; 22.1; 20.8 | — |
| PRIMARY Average Score for Quality of Life (QOL) Physical Domain |
59.7; 62.9 | — |
| PRIMARY Average Score for Quality of Life (QOL) Physical Domain |
59.7; 62.9 | — |
| PRIMARY Average Score for Quality of Life (QOL) Physical Domain |
59.7; 62.9 | — |
| PRIMARY Average Score for Quality of Life (QOL) Physical Domain |
59.7; 62.9 | — |
| PRIMARY Average Score for Quality of Life (QOL) Physical Domain |
59.7; 62.9 | — |
| PRIMARY Average Score for Quality of Life (QOL) Physical Domain |
59.7; 62.9 | — |
| PRIMARY Average Score for Quality of Life (QOL) Psychological Domain |
62.0; 62.5 | — |
| PRIMARY Average Score for Quality of Life (QOL) Psychological Domain |
62.0; 62.5 | — |
| PRIMARY Average Score for Quality of Life (QOL) Psychological Domain |
62.0; 62.5 | — |
| PRIMARY Average Score for Quality of Life (QOL) Psychological Domain |
62.0; 62.5 | — |
| PRIMARY Average Score for Quality of Life (QOL) Psychological Domain |
62.0; 62.5 | — |
| PRIMARY Average Score for Quality of Life (QOL) Psychological Domain |
62.0; 62.5 | — |
| PRIMARY Total Score for Quality of Life (QOL) Social Domain |
81.1; 81.5; 73.3; 78.7; 77.9; 78.8 | — |
| PRIMARY Total Score for Quality of Life (QOL) Environment Domain |
68.6; 66.4; 65.8; 66.4; 67.1; 66.1 | — |
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 Criteria
- Adults ages 18 years and over, any cancer type, late state cancer, residence in 24 Parganas Region, West Bengal, India, physician documentation in medical record that patient is to receive palliative care, patient willingness to participate in data collection.
Exclusion Criteria
- Prisoner; diagnoses of substance addiction (illicit drugs), Mentally unstable or having moderate to severe mental health issue or incapable of decision making, Unable to speak or communicate with ease
Data sourced from ClinicalTrials.gov (NCT04972630). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.