Clinical trial NCT04972630: R21 India Pal-Care Evaluation
Official title: Implementation of Home-Based Palliative Care in Limited Resource Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Palliative Care
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Tata Medical Center
First posted: 2021-07-22
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Palliative Care Outcomes (POS Total Scores)
timeFrame: 6-month
measure: Average Score for Quality of Life (QOL) Physical Domain
timeFrame: Baseline to Week 4
measure: Average Score for Quality of Life (QOL) Physical Domain
timeFrame: Week 4
measure: Average Score for Quality of Life (QOL) Physical Domain
timeFrame: Baseline to Week 12
measure: Average Score for Quality of Life (QOL) Physical Domain
timeFrame: Week 12
measure: Average Score for Quality of Life (QOL) Physical Domain
timeFrame: Baseline to Week 24
measure: Average Score for Quality of Life (QOL) Physical Domain
timeFrame: Week 24
measure: Average Score for Quality of Life (QOL) Psychological Domain
timeFrame: Baseline to Week 4
measure: Average Score for Quality of Life (QOL) Psychological Domain
timeFrame: Week 4
measure: Average Score for Quality of Life (QOL) Psychological Domain
timeFrame: Baseline to Week 12
measure: Average Score for Quality of Life (QOL) Psychological Domain
timeFrame: Week 12
measure: Average Score for Quality of Life (QOL) Psychological Domain
timeFrame: Baseline to Week 24
measure: Average Score for Quality of Life (QOL) Psychological Domain
timeFrame: Week 24
measure: Total Score for Quality of Life (QOL) Social Domain
timeFrame: 6 months
measure: Total Score for Quality of Life (QOL) Environment Domain
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Kolkata
country: India
facility: Tata Medical Center
state: West Bengal
Study officials:
affiliation: Associate Professor
name: Suparna Qanungo, PhD
role: PRINCIPAL_INVESTIGATOR
References: