R21 India Pal-Care Evaluation

Medical University of South Carolina (MUSC)

Status: Enrolling

Conditions: Cancer Palliative Care

Treatments: Behavioral: Control-Usual Care; Behavioral: Pal-Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04972630

00089815

2019-3793 (Other Identifier)

1R21CA252850-01 (U.S. NIH Grant/Contract)

2019/GOVT/25/IRB8 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

Control

Active Comparator group

Description:

Control group participants will be recruited from the cancer patients in need of palliative care at Tata Medical Center (TMC), Kolkata, India. Participants will be recruited and consented by TMC researchers. There will be random allocation to the "control" or "Pal-Care" group. The control group (n=45) 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.

Treatment:

Behavioral: Control-Usual Care

Pal-Care

Experimental group

Description:

Intervention group participants will be recruited from cancer patients in need of palliative care at Tata Medical Center (TMC), Kolkata, India. Pal-Care will be delivered over a 6-month period. At baseline visit, the patient and their caregiver will meet with their community health worker (CHW) and clinical team and an individualized care plan will be created. Patients will be assigned to the CHW living nearest to their home. The CHW will make home visits to patients 1+ times weekly, depending on patient need. At each visit, the CHW will use resources from the WHO Palliative Care Toolkit to: 1)monitor patient condition, 2) provide basic palliative care (medication administration, wound care, catheter care), 3) deliver prescribed morphine, 4) teach caregivers to deliver care,5) monitor pain and symptom control, and 6) assist patients to access their oncologists and other resources. Timely communication between CHW and clinical team will be maintained using a tele-health platform.

Treatment:

Behavioral: Pal-Care

Post-Intervention Interviews

No Intervention group

Description:

Semi-structured interviews of stakeholder groups will be conducted by MUSC researchers who are well-trained and speak the local language, to evaluate the Pal-Care intervention. We will conduct 20 key informant interviews/KIIs (or until saturation is reached), representing Pal-Care clinical team members, CHWs and patients/caregivers, who participated in the intervention at TMC, India. Clinicians will include social workers, oncology nurses, cancer center administrators, counselors, and palliative care oncologists. Patients/ caregivers will be purposefully selected to represent experiences across different cancers, clinical problems and assigned CHWs. Interviews will be performed in-person or over a telehealth platform, as needed. Interviews will query barriers, facilitators, optimal strategies, experiences, needs and expectations for palliative care delivery. Interviews will be digitally recorded, transcribed and analyzed.