Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R21CA252850-01 | U.S. NIH Grant/Contract | View source | |
| 2019/GOVT/25/IRB8 | Other Identifier | Tata Medical Center, Kolkata, India | |
| 2019-3793 | Other Identifier | Indian Council of Medical Research (ICMR), India |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Tata Medical Center | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | 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. |
|
| Pal-Care | Experimental | 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. |
|
| Post-Intervention Interviews |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pal-Care | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Week 4 |
| Average Score for Quality of Life (QOL) Physical Domain |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Suparna Qanungo, PhD | Associate Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tata Medical Center | Kolkata | West Bengal | 700160 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37658397 | Derived | Qanungo S, Cartmell KB, Mueller M, Butcher M, Sarkar S, Carlson TG, Madisetti M, Kumar G. Comparison of home-based palliative care delivered by community health workers versus usual care: research protocol for a pilot randomized controlled trial. BMC Palliat Care. 2023 Sep 2;22(1):125. doi: 10.1186/s12904-023-01235-z. |
| Label | URL |
|---|---|
| Comparison of home-based palliative care delivered by community health workers versus usual care: research protocol for a pilot randomized controlled trial (PMID 37658397) | View source |
Not provided
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
Not provided
Not provided
Not provided
Not provided
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 only needed to know if they had engaged in the intervention and NO additional demographics/OUTCOME DATA were counted twice for research.
All participants were informed through a statement of research (waiver of signed consent in place) and verbally consented prior to conducting interviews.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Control | 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. |
| FG001 | Pal-Care | 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. |
| FG002 | 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. The patients were a part of the intervention group. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Outcome surveys/data collection were not conducted on Post-intervention interview participants. | Posted | Mean | 95% Confidence Interval | score on a scale | 6-month |
|
Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients)
All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Consumption of a liquid mosquito repellent | Injury, poisoning and procedural complications | Non-systematic Assessment | Consumption of a liquid mosquito repellent. Volume not specified. C/o mild SOB. No other complain. |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Suparna Qanungo | Medical University of South Carolina | (843) 876-1125 | qanungo@musc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 4, 2019 | Aug 23, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 22, 2020 | Oct 10, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 4, 2019 | Mar 2, 2023 | ICF_002.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
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. |
|
| Control-Usual Care | Behavioral | 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. |
|
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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 6 Months |
| BG001 | Pal-Care | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants. | Count of Participants | Participants |
|
| Region of Enrollment | Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants. | Count of Participants | Participants |
|
| Marital Status | Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants. | Count of Participants | Participants |
|
| Religion | Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants. | Count of Participants | Participants |
|
| Highest level of education completed | Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants. | Count of Participants | Participants |
|
| Employment status | Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants. | Count of Participants | Participants |
|
| Income | Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants. | Count of Participants | Participants |
|
| Living location | Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants. | Count of Participants | Participants |
|
| Members in household (including self) | Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants. | Mean | Standard Deviation | Members in household (including self) |
|
| Number of dependents in family | Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants. | Mean | Standard Deviation | Number of dependents in family |
|
| Relationship with primary caregiver | Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants. | Count of Participants | Participants |
|
| Has health insurance or funds | Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants. | Count of Participants | Participants |
|
| Health insurance | Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants. | Count of Participants | Participants |
|
| Diagnosis based on system | Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants. | Count of Participants | Participants |
|
| Body weight (kg) | One patient in the "control" group could not be mobilized at the point of time, hence weight could not be taken. Additionally, baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants. | Mean | Standard Deviation | kg |
|
| Has reliable internet access | Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants. | Count of Participants | Participants |
|
| Comfortable using | Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants. | Count of Participants | Participants |
|
| ECOG status | Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants. | Count of Participants | Participants |
|
| Problems at identified at enrollment | Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants. | Count of Participants | Participants |
|
| Discussion of non-escalation | Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants. | Count of Participants | Participants |
|
| OG001 | Pal-Care | 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. |
| OG002 | 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. |
|
|
|
| Primary | 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. | Outcome surveys/data collection were not conducted on Post-intervention interview participants. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to Week 4 |
|
|
|
|
| Primary | 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. | Outcome surveys/data collection were not conducted on Post-intervention interview participants. | Posted | Mean | 95% Confidence Interval | score on a scale | Week 4 |
|
|
|
|
| Primary | 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. | Outcome surveys/data collection were not conducted on Post-intervention interview participants. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to Week 12 |
|
|
|
|
| Primary | 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. | Outcome surveys/data collection were not conducted on Post-intervention interview participants. | Posted | Mean | 95% Confidence Interval | score on a scale | Week 12 |
|
|
|
|
| Primary | 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. | Outcome surveys/data collection were not conducted on Post-intervention interview participants. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to Week 24 |
|
|
|
|
| Primary | 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. | Outcome surveys/data collection were not conducted on Post-intervention interview participants. | Posted | Mean | 95% Confidence Interval | score on a scale | Week 24 |
|
|
|
|
| Primary | 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. | Outcome surveys/data collection were not conducted on Post-intervention interview participants. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to Week 4 |
|
|
|
|
| Primary | 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. | Outcome surveys/data collection were not conducted on Post-intervention interview participants. | Posted | Mean | 95% Confidence Interval | score on a scale | Week 4 |
|
|
|
|
| Primary | 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. | Outcome surveys/data collection were not conducted on Post-intervention interview participants. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to Week 12 |
|
|
|
|
| Primary | 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. | Outcome surveys/data collection were not conducted on Post-intervention interview participants. | Posted | Mean | 95% Confidence Interval | score on a scale | Week 12 |
|
|
|
|
| Primary | 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. | Outcome surveys/data collection were not conducted on Post-intervention interview participants. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to Week 24 |
|
|
|
|
| Primary | 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. | Outcome surveys/data collection were not conducted on Post-intervention interview participants. | Posted | Mean | 95% Confidence Interval | score on a scale | Week 24 |
|
|
|
|
| Primary | 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. | Outcome surveys/data collection were not conducted on Post-intervention interview participants. | Posted | Mean | 95% Confidence Interval | score on a scale | 6 months |
|
|
|
|
| Primary | 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. | Outcome surveys/data collection were not conducted on Post-intervention interview participants | Posted | Mean | 95% Confidence Interval | score on a scale | 6 Months |
|
|
|
|
| 17 |
| 43 |
| 19 |
| 43 |
| 0 |
| 43 |
| EG001 | Pal-Care | 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. | 18 | 43 | 24 | 43 | 0 | 43 |
| EG002 | 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. The patients were a part of the intervention group. 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. | 0 | 0 | 0 | 0 | 0 | 0 |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Shortness of breath. |
|
| Progression of Disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Breathlessness, cold, reduced intake of food. |
|
| Progression of Disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Breathlessness, Urinary retention. |
|
| Progression of Disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Respiratory distress. |
|
| Progression of Disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Shortness of breath, chest pain, disorientation. |
|
| Progression of Disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Constipation, nausea, abdominal distension and pain, vomiting. |
|
| Progression of Disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Shortness of breath |
|
| Progression of Disease | Metabolism and nutrition disorders | Non-systematic Assessment | Anorexia, not able to eat or drink, high colored urine, yellowish discoloration, generalized itching. |
|
| Progression of Disease | General disorders | Non-systematic Assessment | Both leg pedal edema, abdominal distension, generalized weakness. |
|
| Progression of Disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Shortness of breath. |
|
| Dyselectrolytemia and Sepsis | Blood and lymphatic system disorders | Non-systematic Assessment | Drowsiness and disorientation with vomiting. |
|
| Gastritis | Gastrointestinal disorders | Non-systematic Assessment | Epigastric pain, petechial lesion in the right forearm. |
|
| Progression of Disease | General disorders | Non-systematic Assessment | Abdominal distention, Shortness of breath, seizures, senselessness, fever and coffee colored stool. |
|
| Subacute intestinal obstruction. | Gastrointestinal disorders | Non-systematic Assessment | Abdominal pain, abdominal tightness, bloating, dyspepsia, anorexia, generalized weakness, vomiting (brownish color). |
|
| Subacute intestinal obstruction. | Gastrointestinal disorders | Non-systematic Assessment | Abdominal pain. |
|
| Progression of disease and Dyselectrolytemia | General disorders | Non-systematic Assessment | Abdominal discomfort and pain, decreased urine output and irrelevant talks |
|
| Infection and Dyselectrolytemia | General disorders | Non-systematic Assessment | Abdominal distension, Weakness ,Vomiting. |
|
| Disorientation and Reduced intake of Food | Metabolism and nutrition disorders | Non-systematic Assessment | Bleeding from lower lip, disorientation on and off, reduced intake of food, generalized weakness. |
|
| Progression of Disease | General disorders | Non-systematic Assessment | Breathlessness on exertion, Anasarca |
|
| Ulcer proliferative Lesion | General disorders | Non-systematic Assessment | Bleeding and headache. On examination he was found to have a large ulcer proliferative lesion in his left cheek and angle of mouth. The lesion was bleeding and pus was draining which was foul-smelling. |
|
| Hypertension, Dehydrated, Cachectic, and Tense Ascites | General disorders | Non-systematic Assessment | Drowsiness, generalized weakness and abdominal distension. Hypotension with a BP of 70/40mmHg and dehydrated and cachectic and also had tense ascites. |
|
| Sepsis | Blood and lymphatic system disorders | Non-systematic Assessment | Dysphagia, anorexia, generalized weakness. |
|
| Sepsis and Anemia | Blood and lymphatic system disorders | Non-systematic Assessment | Generalized weakness, loose stool, constipation, generalized body pain, appetite loss. |
|
| Sepsis | Blood and lymphatic system disorders | Non-systematic Assessment | Generalized weakness, Insomnia and Anxiety. |
|
| Sepsis | Blood and lymphatic system disorders | Non-systematic Assessment | Generalized weakness, Black stools |
|
| Fluctuating BP and blood sugar | General disorders | Non-systematic Assessment | Generalized weakness, fluctuating BP and blood sugar, occasional bleeding from tumor site, dehydration. |
|
| Sepsis, Diabetic Ketoacidosis and Dyselectrolytemia | Blood and lymphatic system disorders | Non-systematic Assessment | Generalized weakness, decreased intake of food |
|
| Low hemoglobin | Blood and lymphatic system disorders | Non-systematic Assessment | Bleeding per rectum and vagina. |
|
| Sepsis | Blood and lymphatic system disorders | Non-systematic Assessment | Breathlessness intermittently, Bleeding PV, Recto-vaginal fistula, Feverish. |
|
| Hypercalcemia | Blood and lymphatic system disorders | Non-systematic Assessment | Constipation, anorexia and weakness. |
|
| Dyselectrolytemia and Sepsis | Blood and lymphatic system disorders | Non-systematic Assessment | Drowsiness and constipation, decreased intake of food. |
|
| Progression of Disease and Sepsis | Blood and lymphatic system disorders | Non-systematic Assessment | Drowsiness, No urine. |
|
| Progression of Disease | General disorders | Non-systematic Assessment | Unresponsive. |
|
| Sepsis | Blood and lymphatic system disorders | Non-systematic Assessment | Vomiting, generalized weakness and abdominal pain. |
|
| Chest Infection | Cardiac disorders | Non-systematic Assessment | Shortness of breath, hypotension. |
|
| Deep Vein Thrombosis, Dyselectrolytemia, and Suspected Sepsis | Blood and lymphatic system disorders | Non-systematic Assessment | Swelling of right upper limbs, generalized weakness and tremors ,deep vein thrombosis, Dyselectrolytemia and suspected sepsis |
|
| Progression Of Disease With Pneumonia | General disorders | Non-systematic Assessment | Vomiting, Dizziness, Blurring of vision, Headache, Cough and Back pain. |
|
| Dyselectrolytemia and Sepsis | Blood and lymphatic system disorders | Non-systematic Assessment | Shortness of breath, generalized weakness. |
|
| Hypoproteinemia, Anemia and Sepsis | Blood and lymphatic system disorders | Non-systematic Assessment | Dysuria, scrotal swelling in genital area and whole body edema, hypotensive |
|
| Chickenpox | Infections and infestations | Non-systematic Assessment | Fever with rash. |
|
| Cerebral metastases | Nervous system disorders | Non-systematic Assessment | Involuntary facial muscle twitching, restlessness, drowsiness, back pain, seizures. |
|
| Electrolyte disturbance. | Metabolism and nutrition disorders | Non-systematic Assessment | Mild facial deviation. Face deviated toward one side for 5 sec, and there was dribbling of water from angle of mouth. |
|
| Dyselectrolytemia and Sepsis | Blood and lymphatic system disorders | Non-systematic Assessment | Reduced appetite, unable to swallow, Imbalance in gait, Urinary incontinence, Drowsy, Loose stools. |
|
| ICD Block | Cardiac disorders | Non-systematic Assessment | No output from ICD. |
|
| Sepsis and Hypoglycemia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Respiratory distress, slurring of speech. |
|
| Sepsis | Blood and lymphatic system disorders | Non-systematic Assessment | Drowsiness. |
|
| Infection and UTI | Infections and infestations | Non-systematic Assessment | Fever and weakness. |
|
| Upper GI bleeding | Gastrointestinal disorders | Non-systematic Assessment | Hematemesis |
|
| Progression of Disease | Gastrointestinal disorders | Non-systematic Assessment | Pain in abdomen & vomiting. |
|
| Hypogastric plexus and Block | Gastrointestinal disorders | Non-systematic Assessment | Pain in lower abdomen and left leg. |
|
| Cancer Pain | General disorders | Non-systematic Assessment | Pain, cough, low grade fever. |
|
| PR Bleeding and Generalized weakness | Blood and lymphatic system disorders | Non-systematic Assessment | PR Bleeding, Leading to anemia, Malena, Generalized weakness. |
|
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Severe respiratory distress, tachycardia, hyperglycemia. |
|
| severe anemia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Shortness of breath |
|
| Progression of Disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Shortness of breath, Hemoptysis, Melena, Upper abdomen pain, Vomiting, jaundice |
|
| Progression of Disease | Blood and lymphatic system disorders | Non-systematic Assessment | Tumor site bleeding, Shortness of breath. |
|
| Patient Expired at Home | General disorders | Non-systematic Assessment | Family informed that patient expired at home. |
|
| Patient Expired at Local Hospital | General disorders | Non-systematic Assessment | Family informed that patient expired at local Hospital. |
|
| Progression of Disease | General disorders | Non-systematic Assessment | Patient came in emergency with c/o twitching of right side face, pain in right side chest, edema |
|
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Week 4 |
|
|
| Week 12 |
|
|
| Week 24 |
|
|
| Mean Difference (Final Values) |
| 5.5 |
| 2-Sided |
| 95 |
| Other |
Comparison via 95% confidence interval |
| Week 12, control vs. intervention | Mean Difference (Final Values) | 0.9 | 2-Sided | 95 | Other | Comparison via 95% confidence interval |
| Week 24, control vs. intervention | Mean Difference (Final Values) | 2.6 | 2-Sided | 95 | Other | Comparison via 95% confidence interval |
| Week 4 |
|
|
| Week 12 |
|
|
| Week 24 |
|
|
| Mean Difference (Final Values) |
| 0.5 |
| 2-Sided |
| 95 |
| Other |
Comparison via 95% confidence interval |
| Week 12, control vs. intervention | Mean Difference (Final Values) | -0.9 | 2-Sided | 95 | Other | Comparison via 95% confidence interval |
| Week 24, control vs. intervention | Mean Difference (Final Values) | -0.8 | 2-Sided | 95 | Other | Comparison via 95% confidence interval |