An interventional study of Pal-Care and Control-Usual Care in Cancer Palliative Care, sponsored by Medical University of South Carolina. Completed at 1 site in India. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-27.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Supportive care
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.
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.
Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.
Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.
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Exclusion Criteria:
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
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
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.
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.
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.
Palliative Care Outcomes (POS Total Scores)
Multidimensional palliative care outcomes will be measured with Palliative Care Outcomes (POS) Scale that measures physical and psychological symptoms; spiritual, practical and emotional concerns; and psychosocial needs of patient/family. The overall POS scale included 10 items, it is a 5-point Likert scale, scored from 0 to 4, with a total summed score ranging from 0-40. A score of 0 indicates that the particular issue is not a problem at all and a score of 4 indicates that the issue is an overwhelming burden/concern for the patient. The higher the total score, the worser the palliative care outcomes are.
Time frame: 6-month
Average Score for Quality of Life (QOL) Physical Domain
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Physical Domain scale included 7 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 7 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for physical QOL and a score of 4 indicates that the highest level of physical QOL for the patient. Higher total score indicates better physical QOL for the patient.
Time frame: Baseline to Week 4
Average Score for Quality of Life (QOL) Physical Domain
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Physical Domain scale included 7 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 7 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for physical QOL and a score of 4 indicates that the highest level of physical QOL for the patient. Higher total score indicates better physical QOL for the patient.
Time frame: Week 4
Average Score for Quality of Life (QOL) Physical Domain
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Physical Domain scale included 7 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 7 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for physical QOL and a score of 4 indicates that the highest level of physical QOL for the patient. Higher total score indicates better physical QOL for the patient.
Time frame: Baseline to Week 12
Average Score for Quality of Life (QOL) Physical Domain
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Physical Domain scale included 7 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 7 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for physical QOL and a score of 4 indicates that the highest level of physical QOL for the patient. Higher total score indicates better physical QOL for the patient.
Time frame: Week 12
Average Score for Quality of Life (QOL) Physical Domain
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Physical Domain scale included 7 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 7 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for physical QOL and a score of 4 indicates that the highest level of physical QOL for the patient. Higher total score indicates better physical QOL for the patient.
Time frame: Baseline to Week 24
Average Score for Quality of Life (QOL) Physical Domain
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Physical Domain scale included 7 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 7 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for physical QOL and a score of 4 indicates that the highest level of physical QOL for the patient. Higher total score indicates better physical QOL for the patient.
Time frame: Week 24
Average Score for Quality of Life (QOL) Psychological Domain
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Psychological Domain scale included 6 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 6 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for psychological QOL and a score of 4 indicates that the highest level of psychological QOL for the patient. Higher total score indicates better psychological QOL for the patient.
Time frame: Baseline to Week 4
Average Score for Quality of Life (QOL) Psychological Domain
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Psychological Domain scale included 6 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 6 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for psychological QOL and a score of 4 indicates that the highest level of psychological QOL for the patient. Higher total score indicates better psychological QOL for the patient.
Time frame: Week 4
Average Score for Quality of Life (QOL) Psychological Domain
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Psychological Domain scale included 6 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 6 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for psychological QOL and a score of 4 indicates that the highest level of psychological QOL for the patient. Higher total score indicates better psychological QOL for the patient.
Time frame: Baseline to Week 12
Average Score for Quality of Life (QOL) Psychological Domain
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Psychological Domain scale included 6 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 6 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for psychological QOL and a score of 4 indicates that the highest level of psychological QOL for the patient. Higher total score indicates better psychological QOL for the patient.
Time frame: Week 12
Average Score for Quality of Life (QOL) Psychological Domain
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Psychological Domain scale included 6 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 6 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for psychological QOL and a score of 4 indicates that the highest level of psychological QOL for the patient. Higher total score indicates better psychological QOL for the patient.
Time frame: Baseline to Week 24
Average Score for Quality of Life (QOL) Psychological Domain
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Psychological Domain scale included 6 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 6 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for psychological QOL and a score of 4 indicates that the highest level of psychological QOL for the patient. Higher total score indicates better psychological QOL for the patient.
Time frame: Week 24
Total Score for Quality of Life (QOL) Social Domain
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Social Domain scale included 3 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 3 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for social QOL and a score of 4 indicates that the highest level of social QOL for the patient. Higher total score indicates better social QOL for the patient.
Time frame: 6 months
Total Score for Quality of Life (QOL) Environment Domain
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Environmental Domain scale included 8 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 8 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for environmental QOL and a score of 4 indicates that the highest level of environmental QOL for the patient. Higher total score indicates better environmental QOL for the patient.
Time frame: 6 Months
| Milestone | Control | Pal-Care | Post-Intervention Interviews |
|---|---|---|---|
| Started | 45 | 45 | 22 |
| Completed | 8 | 8 | 22 |
| Not completed | 37 | 37 | 0 |
| Withdrew: Death due to disease progression, lost to follow-up, consent withdrawal | 37 | 37 | 0 |
Multidimensional palliative care outcomes will be measured with Palliative Care Outcomes (POS) Scale that measures physical and psychological symptoms; spiritual, practical and emotional concerns; and psychosocial needs of patient/family. The overall POS scale included 10 items, it is a 5-point Likert scale, scored from 0 to 4, with a total summed score ranging from 0-40. A score of 0 indicates that the particular issue is not a problem at all and a score of 4 indicates that the issue is an overwhelming burden/concern for the patient. The higher the total score, the worser the palliative care outcomes are.
| score on a scale | Control | Pal-Care | Post-Intervention Interviews |
|---|---|---|---|
| Baseline | 23.5 (18.7 to 28.3) | 22.9 (18.1 to 27.7) | — |
| Week 4 | 22.2 (16.9 to 27.5) | 22.1 (15.9 to 28.3) | — |
| Week 12 | 22.1 (16.9 to 27.3) | 20.8 (15 to 26.6) | — |
| Week 24 | 21.3 (15.1 to 27.5) | 19.4 (12.4 to 26.4) | — |
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Physical Domain scale included 7 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 7 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for physical QOL and a score of 4 indicates that the highest level of physical QOL for the patient. Higher total score indicates better physical QOL for the patient.
| score on a scale | Control | Pal-Care | Post-Intervention Interviews |
|---|---|---|---|
| Average Score for Quality of Life (QOL) Physical Domain | 55.6 (35.7 to 75.5) | 56.1 (43.1 to 69.1) | — |
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Physical Domain scale included 7 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 7 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for physical QOL and a score of 4 indicates that the highest level of physical QOL for the patient. Higher total score indicates better physical QOL for the patient.
| score on a scale | Control | Pal-Care | Post-Intervention Interviews |
|---|---|---|---|
| Average Score for Quality of Life (QOL) Physical Domain | 51.3 (30.4 to 72.2) | 52.8 (32.1 to 73.5) | — |
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Physical Domain scale included 7 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 7 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for physical QOL and a score of 4 indicates that the highest level of physical QOL for the patient. Higher total score indicates better physical QOL for the patient.
| score on a scale | Control | Pal-Care | Post-Intervention Interviews |
|---|---|---|---|
| Average Score for Quality of Life (QOL) Physical Domain | 59.1 (42 to 76.2) | 57.4 (44.3 to 70.5) | — |
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Physical Domain scale included 7 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 7 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for physical QOL and a score of 4 indicates that the highest level of physical QOL for the patient. Higher total score indicates better physical QOL for the patient.
| score on a scale | Control | Pal-Care | Post-Intervention Interviews |
|---|---|---|---|
| Average Score for Quality of Life (QOL) Physical Domain | 55.6 (33.1 to 78.1) | 52.8 (34.5 to 71.1) | — |
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Physical Domain scale included 7 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 7 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for physical QOL and a score of 4 indicates that the highest level of physical QOL for the patient. Higher total score indicates better physical QOL for the patient.
| score on a scale | Control | Pal-Care | Post-Intervention Interviews |
|---|---|---|---|
| Average Score for Quality of Life (QOL) Physical Domain | 69.4 (58.4 to 80.4) | 60.2 (52.1 to 68.3) | — |
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Physical Domain scale included 7 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 7 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for physical QOL and a score of 4 indicates that the highest level of physical QOL for the patient. Higher total score indicates better physical QOL for the patient.
| score on a scale | Control | Pal-Care | Post-Intervention Interviews |
|---|---|---|---|
| Average Score for Quality of Life (QOL) Physical Domain | 59.7 (33.4 to 86) | 62.9 (40.1 to 85.7) | — |
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Psychological Domain scale included 6 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 6 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for psychological QOL and a score of 4 indicates that the highest level of psychological QOL for the patient. Higher total score indicates better psychological QOL for the patient.
| score on a scale | Control | Pal-Care | Post-Intervention Interviews |
|---|---|---|---|
| Average Score for Quality of Life (QOL) Psychological Domain | 63.3 (44.8 to 81.8) | 58.3 (42.2 to 74.4) | — |
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Psychological Domain scale included 6 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 6 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for psychological QOL and a score of 4 indicates that the highest level of psychological QOL for the patient. Higher total score indicates better psychological QOL for the patient.
| score on a scale | Control | Pal-Care | Post-Intervention Interviews |
|---|---|---|---|
| Average Score for Quality of Life (QOL) Psychological Domain | 58.2 (42.2 to 74.2) | 53.7 (30.3 to 77.1) | — |
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Psychological Domain scale included 6 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 6 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for psychological QOL and a score of 4 indicates that the highest level of psychological QOL for the patient. Higher total score indicates better psychological QOL for the patient.
| score on a scale | Control | Pal-Care | Post-Intervention Interviews |
|---|---|---|---|
| Average Score for Quality of Life (QOL) Psychological Domain | 67.3 (50.4 to 84.2) | 60.9 (45 to 76.8) | — |
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Psychological Domain scale included 6 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 6 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for psychological QOL and a score of 4 indicates that the highest level of psychological QOL for the patient. Higher total score indicates better psychological QOL for the patient.
| score on a scale | Control | Pal-Care | Post-Intervention Interviews |
|---|---|---|---|
| Average Score for Quality of Life (QOL) Psychological Domain | 59.6 (38.6 to 80.6) | 55.8 (39.6 to 72) | — |
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Psychological Domain scale included 6 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 6 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for psychological QOL and a score of 4 indicates that the highest level of psychological QOL for the patient. Higher total score indicates better psychological QOL for the patient.
| score on a scale | Control | Pal-Care | Post-Intervention Interviews |
|---|---|---|---|
| Average Score for Quality of Life (QOL) Psychological Domain | 76.6 (60 to 93.2) | 59.9 (47.7 to 72.1) | — |
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Psychological Domain scale included 6 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 6 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for psychological QOL and a score of 4 indicates that the highest level of psychological QOL for the patient. Higher total score indicates better psychological QOL for the patient.
| score on a scale | Control | Pal-Care | Post-Intervention Interviews |
|---|---|---|---|
| Average Score for Quality of Life (QOL) Psychological Domain | 62.0 (39.4 to 84.6) | 62.5 (39.2 to 85.8) | — |
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Social Domain scale included 3 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 3 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for social QOL and a score of 4 indicates that the highest level of social QOL for the patient. Higher total score indicates better social QOL for the patient.
| score on a scale | Control | Pal-Care | Post-Intervention Interviews |
|---|---|---|---|
| Baseline | 81.1 (61.7 to 100.5) | 81.5 (64.4 to 98.6) | — |
| Week 4 | 73.3 (50.1 to 96.5) | 78.7 (59.8 to 97.6) | — |
| Week 12 | 77.9 (52.4 to 103.4) | 78.8 (61.6 to 96) | — |
| Week 24 | 80.2 (58.5 to 101.9) | 82.8 (65.2 to 100.4) | — |
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Environmental Domain scale included 8 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 8 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for environmental QOL and a score of 4 indicates that the highest level of environmental QOL for the patient. Higher total score indicates better environmental QOL for the patient.
| score on a scale | Control | Pal-Care | Post-Intervention Interviews |
|---|---|---|---|
| Baseline | 68.6 (55.1 to 82.1) | 66.4 (53.1 to 79.7) | — |
| Week 4 | 65.8 (53.5 to 78.1) | 66.4 (49.7 to 83.1) | — |
| Week 12 | 67.1 (53.3 to 80.9) | 66.1 (51.7 to 80.5) | — |
| Week 24 | 72.7 (59.5 to 85.9) | 71.9 (52.2 to 91.6) | — |
Collected over Up to 24 Weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 17/43 (39.5%) | 19/43 (44.2%) | 0/43 (0%) |
| Pal-Care | 18/43 (41.9%) | 24/43 (55.8%) | 0/43 (0%) |
| Post-Intervention Interviews | — | — | — |
| Event | Control | Pal-Care | Post-Intervention Interviews |
|---|---|---|---|
| Patient Expired at HomeGeneral disorders | 16/43 | 14/43 | — |
| Patient Expired at Local HospitalGeneral disorders | 1/43 | 4/43 | — |
| Progression of DiseaseGeneral disorders | 2/43 | 0/43 | — |
| Consumption of a liquid mosquito repellentInjury, poisoning and procedural complications | 0/43 | 1/43 | — |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 0/43 | 1/43 | — |
| Progression of DiseaseRespiratory, thoracic and mediastinal disorders | 0/43 | 1/43 | — |
| Progression of DiseaseRespiratory, thoracic and mediastinal disorders | 0/43 | 1/43 | — |
| Progression of DiseaseRespiratory, thoracic and mediastinal disorders | 0/43 | 1/43 | — |
| Progression of DiseaseRespiratory, thoracic and mediastinal disorders | 0/43 | 1/43 | — |
| Progression of DiseaseRespiratory, thoracic and mediastinal disorders | 0/43 | 1/43 | — |
Baseline data was only meant to be collected for control and intervention participants. For the post-intervention interviews, the participants were people who had in some way engaged in the Pal-Care intervention as a provider, community health worker or patient. Hence for the research purpose, we are not double counting as the outcome data is only reflective of control and intervention groups and not impacted by the qualitative interviews.
| Age, Continuous(years) | Control | Pal-Care | Post-Intervention Interviews | Total |
|---|---|---|---|---|
| Mean | 59.8 ± 12.8 | 60.4 ± 15.9 | — | 60.1 ± 14.3 |
| Sex: Female, Male(Participants) | Control | Pal-Care | Post-Intervention Interviews | Total |
|---|---|---|---|---|
| Female | 20 | 19 | 0 | 39 |
| Male | 23 | 24 | 0 | 47 |
| Race (NIH/OMB)(Participants) | Control | Pal-Care | Post-Intervention Interviews | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 43 | 43 | 0 | 86 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Control | Pal-Care | Post-Intervention Interviews | Total |
|---|---|---|---|---|
| India | 43 | 43 | 0 | 86 |
| Marital Status(Participants) | Control | Pal-Care | Post-Intervention Interviews | Total |
|---|---|---|---|---|
| Single | 0 | 2 | — | 2 |
| Married | 36 | 29 | — | 65 |
| Widowed | 7 | 12 | — | 19 |
| Religion(Participants) | Control | Pal-Care | Post-Intervention Interviews | Total |
|---|---|---|---|---|
| Hindu | 36 | 35 | — | 71 |
| Muslim | 5 | 8 | — | 13 |
| Christian | 2 | 0 | — | 2 |
| Highest level of education completed(Participants) | Control | Pal-Care | Post-Intervention Interviews | Total |
|---|---|---|---|---|
| Less than high school degree | 5 | 7 | — | 12 |
| High school degree | 16 | 18 | — | 34 |
| Some college but no degree | 1 | 0 | — | 1 |
| Bachelor degree (B.S, B.A, B.Com etc.) | 17 | 16 | — | 33 |
| Master's degree or above | 4 | 1 | — | 5 |
| Prefer not to answer | 0 | 1 | — | 1 |
| Employment status(Participants) | Control | Pal-Care | Post-Intervention Interviews | Total |
|---|---|---|---|---|
| Employed with an organization | 0 | 1 | — | 1 |
| Self-Employed | 4 | 4 | — | 8 |
| Not employed, looking for work | 1 | 0 | — | 1 |
| Not employed, NOT looking for work | 16 | 13 | — | 29 |
| Retired | 10 | 13 | — | 23 |
| Disabled, not able to work | 12 | 11 | — | 23 |
| Prefer not to answer | 0 | 1 | — | 1 |
14 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — MUSC researchers have access to ONLY de-identified data. All source documents and identifiers are with Dr. Gaurav Kumar, Site PI at TATA Medical Centre, Rajarhat, Kolkata, India
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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