R21 India Pal-Care Evaluation

Sponsor

Medical University of South Carolina (Other)

Overall Status

Recruiting

CT.gov ID

NCT04972630

Collaborator

National Cancer Institute (NCI) (NIH), Tata Medical Center, Kolkata, India (Other)

Enrollment

Location

Arms

19.9

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Palliative Care	Behavioral: Pal-Care Behavioral: Control-Usual Care	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Implementation of Home-Based Palliative Care in Limited Resource Settings

Actual Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control 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.	Behavioral: Control-Usual Care 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.
Experimental: Pal-Care 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.	Behavioral: Pal-Care 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.
No Intervention: Post-Intervention Interviews 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.

Arm

Intervention/Treatment

Active Comparator: Control

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.

Behavioral: Control-Usual Care

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.

Experimental: Pal-Care

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.

Behavioral: Pal-Care

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.

No Intervention: Post-Intervention Interviews

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.

Outcome Measures

Primary Outcome Measures

Average score for Quality of Life (QOL) [6-month]
Quality of Life will be will be assessed with the 26-item WHO QOL-BREFF Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. Items are rated on a 5-point Likert scale (low score of 1 to high score of 5; higher score indicating higher QOL).
Palliative care outcomes [6-month]
Multidimensional palliative care outcomes will be measured with Palliative Care Outcomes (POS) Scale that that measures physical and psychological symptoms; spiritual, practical and emotional concerns; and psychosocial needs of patient/family on a 5-point likert scale (0-4, with a higher score indicating higher symptom burden or concern).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tata Medical Center	Kolkata	West Bengal	India	700160

Sponsors and Collaborators

Medical University of South Carolina
National Cancer Institute (NCI)
Tata Medical Center, Kolkata, India

Investigators

Principal Investigator: Suparna Qanungo, PhD, Associate Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Suparna Qanungo, Associate Professor, Medical University of South Carolina

ClinicalTrials.gov Identifier:

NCT04972630

Other Study ID Numbers:

00089815
1R21CA252850-01
2019/GOVT/25/IRB8
2019-3793

First Posted:

Jul 22, 2021

Last Update Posted:

Jul 26, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 26, 2022