Cancer Palliative Care
Conditions
Brief summary
The goal of this pragmatic clinical trial is to test and evaluate a home-based palliative care intervention for utilizing community health workers to facilitate the delivery of palliative care to cancer patients in rural India. The study builds upon use of the World Health Organization-endorsed Palliative Care Toolkit, which provides a comprehensive suite of evidence-based materials for delivering palliative care in limited resource settings. For the intervention, two specific aims will be addressed to evaluate: 1) implementation of the intervention within the context of the RE-AIM Framework and 2) outcomes of this intervention to determine its relative effects compared to a standard control group on patients' palliative care needs, symptom burden, quality of life (QOL) and experience with care.
Detailed description
This pragmatic clinical trial is a collaboration between the Medical University of South Carolina (MUSC)and Tata Medical Center (TMC), a cancer center in Kolkata, India. The study has two parts: a) Implementation of a Pal-Care intervention as compared to control/no intervention b) Qualitative post-intervention evaluation. The part a) of the study is conducted at Tata Medical Center (TMC) in Kolkata, India, under the supervision of the site PI, Dr. Gaurav Kumar. All participants will be recruited from among the TMC patients who are referred to cancer palliative care and will be grouped to the Control or Pal-Care intervention groups. This part of the study will compare an intervention group of patients who will receive home-based palliative services (Pal-Care)from community health workers (CHWs) vs. a control group of patients who will receive cancer-center based palliative services. This intervention implementation part of the study is approved by TMC Ethics Board and Indian Council of Medical Research (ICMR), approval letter on file with MUSC IRB. MUSC relies on TMC IRB for this part and the ICF document is approved by the TMC Ethics Board in India. The part b) of the study (under purview of MUSC IRB) involves post-intervention qualitative interviews. MUSC research team will evaluate the implementation and effect of the Pal-Care intervention to deliver CHW navigated home-based palliative care for rural cancer patients in India. The participants of this part of the study will also be from India and include stakeholders, representing all Pal-Care clinical team members and CHWs and patients/caregivers who participated in the Pal-Care intervention. This part has a waiver of signed consent. The RE-AIM framework guides our evaluation plan to measure the reach, effectiveness, adoption, implementation and maintenance of the Pal-Care intervention. Diverse data sources will be used to evaluate the intervention within the REAIM Framework.
Interventions
BEHAVIORALPal-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.
BEHAVIORALControl-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.
Sponsors
National Cancer Institute (NCI)
Tata Medical Center
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults ages 18 years and over, any cancer type, late state cancer, residence in 24 Parganas Region, West Bengal, India, physician documentation in medical record that patient is to receive palliative care, patient willingness to participate in data collection.
Exclusion criteria
* Prisoner; diagnoses of substance addiction (illicit drugs), Mentally unstable or having moderate to severe mental health issue or incapable of decision making, Unable to speak or communicate with ease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Palliative Care Outcomes (POS Total Scores) | 6-month | 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. |
| Average Score for Quality of Life (QOL) Physical Domain | Baseline to Week 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. |
| Average Score for Quality of Life (QOL) Psychological Domain | Baseline to Week 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. |
| Total Score for Quality of Life (QOL) Social Domain | 6 months | 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. |
| Total Score for Quality of Life (QOL) Environment Domain | 6 Months | 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. |
Countries
India
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 43 |
| 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. | 43 |
| 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. | 22 |
| Total | 108 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death due to disease progression, lost to follow-up, consent withdrawal | 37 | 37 | 0 |
Baseline characteristics
| Characteristic | Pal-Care | Control | Total | Post-Intervention Interviews |
|---|---|---|---|---|
| Age, Continuous | 60.4 years STANDARD_DEVIATION 15.9 | 59.8 years STANDARD_DEVIATION 12.8 | 60.1 years STANDARD_DEVIATION 14.3 | — |
| Body weight (kg) | 57.8 kg STANDARD_DEVIATION 12.9 | 57.8 kg STANDARD_DEVIATION 13.6 | 57.8 kg STANDARD_DEVIATION 13.2 | — |
| Comfortable using Computers | 2 Participants | 7 Participants | 9 Participants | — |
| Comfortable using iPad/tablet | 2 Participants | 2 Participants | 4 Participants | — |
| Comfortable using None | 3 Participants | 1 Participants | 4 Participants | — |
| Comfortable using Smartphone | 36 Participants | 33 Participants | 69 Participants | — |
| Diagnosis based on system Breast | 5 Participants | 4 Participants | 9 Participants | — |
| Diagnosis based on system Cancer of Unknown Primary (CUP) | 1 Participants | 1 Participants | 2 Participants | — |
| Diagnosis based on system Genitourinary | 2 Participants | 2 Participants | 4 Participants | — |
| Diagnosis based on system GI Cancers | 13 Participants | 19 Participants | 32 Participants | — |
| Diagnosis based on system Gynecological | 8 Participants | 6 Participants | 14 Participants | — |
| Diagnosis based on system Head & Neck | 4 Participants | 6 Participants | 10 Participants | — |
| Diagnosis based on system Skin | 0 Participants | 1 Participants | 1 Participants | — |
| Diagnosis based on system Thoracic | 10 Participants | 4 Participants | 14 Participants | — |
| Discussion of non-escalation No | 25 Participants | 22 Participants | 47 Participants | — |
| Discussion of non-escalation Yes | 18 Participants | 21 Participants | 39 Participants | — |
| ECOG status Active - able to do light work | 14 Participants | 11 Participants | 25 Participants | — |
| ECOG status Bedridden >50% of the day | 5 Participants | 11 Participants | 16 Participants | — |
| ECOG status Self-caring - but unable to work | 22 Participants | 19 Participants | 41 Participants | — |
| ECOG status Well | 2 Participants | 2 Participants | 4 Participants | — |
| Employment status Disabled, not able to work | 11 Participants | 12 Participants | 23 Participants | — |
| Employment status Employed with an organization | 1 Participants | 0 Participants | 1 Participants | — |
| Employment status Not employed, looking for work | 0 Participants | 1 Participants | 1 Participants | — |
| Employment status Not employed, NOT looking for work | 13 Participants | 16 Participants | 29 Participants | — |
| Employment status Prefer not to answer | 1 Participants | 0 Participants | 1 Participants | — |
| Employment status Retired | 13 Participants | 10 Participants | 23 Participants | — |
| Employment status Self-Employed | 4 Participants | 4 Participants | 8 Participants | — |
| Has health insurance or funds No | 28 Participants | 23 Participants | 51 Participants | — |
| Has health insurance or funds Yes | 15 Participants | 20 Participants | 35 Participants | — |
| Has reliable internet access No | 3 Participants | 0 Participants | 3 Participants | — |
| Has reliable internet access Yes | 40 Participants | 43 Participants | 83 Participants | — |
| Health insurance Governmental insurance | 5 Participants | 4 Participants | 9 Participants | — |
| Health insurance Private insurance | 10 Participants | 16 Participants | 26 Participants | — |
| Health insurance Self-pay | 28 Participants | 23 Participants | 51 Participants | — |
| Highest level of education completed Bachelor degree (B.S, B.A, B.Com etc.) | 16 Participants | 17 Participants | 33 Participants | — |
| Highest level of education completed High school degree | 18 Participants | 16 Participants | 34 Participants | — |
| Highest level of education completed Less than high school degree | 7 Participants | 5 Participants | 12 Participants | — |
| Highest level of education completed Master's degree or above | 1 Participants | 4 Participants | 5 Participants | — |
| Highest level of education completed Prefer not to answer | 1 Participants | 0 Participants | 1 Participants | — |
| Highest level of education completed Some college but no degree | 0 Participants | 1 Participants | 1 Participants | — |
| Income INR100, 000 (1 lacs) or more | 7 Participants | 2 Participants | 9 Participants | — |
| Income INR 25,000 to INR 49,999 | 9 Participants | 12 Participants | 21 Participants | — |
| Income INR 50,000 to INR 99,999 | 4 Participants | 7 Participants | 11 Participants | — |
| Income INR 5,000 to INR 24,999 | 17 Participants | 17 Participants | 34 Participants | — |
| Income Less than INR 5,000 | 3 Participants | 0 Participants | 3 Participants | — |
| Income Prefer not to answer | 3 Participants | 5 Participants | 8 Participants | — |
| Living location Rural village | 12 Participants | 10 Participants | 22 Participants | — |
| Living location Suburban town | 10 Participants | 11 Participants | 21 Participants | — |
| Living location Urban city | 21 Participants | 22 Participants | 43 Participants | — |
| Marital Status Married | 29 Participants | 36 Participants | 65 Participants | — |
| Marital Status Single | 2 Participants | 0 Participants | 2 Participants | — |
| Marital Status Widowed | 12 Participants | 7 Participants | 19 Participants | — |
| Members in household (including self) | 4.5 Members in household (including self) STANDARD_DEVIATION 2.8 | 4.8 Members in household (including self) STANDARD_DEVIATION 2.4 | 4.7 Members in household (including self) STANDARD_DEVIATION 2.6 | — |
| Number of dependents in family | 2.7 Number of dependents in family STANDARD_DEVIATION 2.3 | 2.8 Number of dependents in family STANDARD_DEVIATION 1.6 | 2.7 Number of dependents in family STANDARD_DEVIATION 1.95 | — |
| Problems at identified at enrollment Emotional issues | 34 Participants | 30 Participants | 64 Participants | — |
| Problems at identified at enrollment Social issues | 30 Participants | 32 Participants | 62 Participants | — |
| Problems at identified at enrollment Spiritual issues | 16 Participants | 18 Participants | 34 Participants | — |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 43 Participants | 43 Participants | 86 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment India | 43 Participants | 43 Participants | 86 Participants | 0 Participants |
| Relationship with primary caregiver Other | 22 Participants | 18 Participants | 40 Participants | — |
| Relationship with primary caregiver Parent | 2 Participants | 0 Participants | 2 Participants | — |
| Relationship with primary caregiver Sibling | 1 Participants | 0 Participants | 1 Participants | — |
| Relationship with primary caregiver Spouse | 18 Participants | 25 Participants | 43 Participants | — |
| Religion Christian | 0 Participants | 2 Participants | 2 Participants | — |
| Religion Hindu | 35 Participants | 36 Participants | 71 Participants | — |
| Religion Muslim | 8 Participants | 5 Participants | 13 Participants | — |
| Sex: Female, Male Female | 19 Participants | 20 Participants | 39 Participants | 0 Participants |
| Sex: Female, Male Male | 24 Participants | 23 Participants | 47 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 17 / 43 | 18 / 43 | 0 / 0 |
| other Total, other adverse events | 0 / 43 | 0 / 43 | 0 / 0 |
| serious Total, serious adverse events | 19 / 43 | 24 / 43 | 0 / 0 |
Outcome results
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.
Time frame: Week 24
Population: Outcome surveys/data collection were not conducted on Post-intervention interview participants.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Average Score for Quality of Life (QOL) Physical Domain | 59.7 score on a scale |
| Pal-Care | Average Score for Quality of Life (QOL) Physical Domain | 62.9 score on a scale |
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.
Time frame: Baseline to Week 4
Population: Outcome surveys/data collection were not conducted on Post-intervention interview participants.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Average Score for Quality of Life (QOL) Physical Domain | 55.6 score on a scale |
| Pal-Care | Average Score for Quality of Life (QOL) Physical Domain | 56.1 score on a scale |
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.
Time frame: Week 4
Population: Outcome surveys/data collection were not conducted on Post-intervention interview participants.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Average Score for Quality of Life (QOL) Physical Domain | 51.3 score on a scale |
| Pal-Care | Average Score for Quality of Life (QOL) Physical Domain | 52.8 score on a scale |
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.
Time frame: Baseline to Week 12
Population: Outcome surveys/data collection were not conducted on Post-intervention interview participants.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Average Score for Quality of Life (QOL) Physical Domain | 59.1 score on a scale |
| Pal-Care | Average Score for Quality of Life (QOL) Physical Domain | 57.4 score on a scale |
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.
Time frame: Week 12
Population: Outcome surveys/data collection were not conducted on Post-intervention interview participants.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Average Score for Quality of Life (QOL) Physical Domain | 55.6 score on a scale |
| Pal-Care | Average Score for Quality of Life (QOL) Physical Domain | 52.8 score on a scale |
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.
Time frame: Baseline to Week 24
Population: Outcome surveys/data collection were not conducted on Post-intervention interview participants.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Average Score for Quality of Life (QOL) Physical Domain | 69.4 score on a scale |
| Pal-Care | Average Score for Quality of Life (QOL) Physical Domain | 60.2 score on a scale |
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.
Time frame: Baseline to Week 24
Population: Outcome surveys/data collection were not conducted on Post-intervention interview participants.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Average Score for Quality of Life (QOL) Psychological Domain | 76.6 score on a scale |
| Pal-Care | Average Score for Quality of Life (QOL) Psychological Domain | 59.9 score on a scale |
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.
Time frame: Baseline to Week 4
Population: Outcome surveys/data collection were not conducted on Post-intervention interview participants.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Average Score for Quality of Life (QOL) Psychological Domain | 63.3 score on a scale |
| Pal-Care | Average Score for Quality of Life (QOL) Psychological Domain | 58.3 score on a scale |
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.
Time frame: Week 4
Population: Outcome surveys/data collection were not conducted on Post-intervention interview participants.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Average Score for Quality of Life (QOL) Psychological Domain | 58.2 score on a scale |
| Pal-Care | Average Score for Quality of Life (QOL) Psychological Domain | 53.7 score on a scale |
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.
Time frame: Baseline to Week 12
Population: Outcome surveys/data collection were not conducted on Post-intervention interview participants.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Average Score for Quality of Life (QOL) Psychological Domain | 67.3 score on a scale |
| Pal-Care | Average Score for Quality of Life (QOL) Psychological Domain | 60.9 score on a scale |
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.
Time frame: Week 12
Population: Outcome surveys/data collection were not conducted on Post-intervention interview participants.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Average Score for Quality of Life (QOL) Psychological Domain | 59.6 score on a scale |
| Pal-Care | Average Score for Quality of Life (QOL) Psychological Domain | 55.8 score on a scale |
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.
Time frame: Week 24
Population: Outcome surveys/data collection were not conducted on Post-intervention interview participants.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Average Score for Quality of Life (QOL) Psychological Domain | 62.0 score on a scale |
| Pal-Care | Average Score for Quality of Life (QOL) Psychological Domain | 62.5 score on a scale |
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.
Time frame: 6-month
Population: Outcome surveys/data collection were not conducted on Post-intervention interview participants.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Control | Palliative Care Outcomes (POS Total Scores) | Baseline | 23.5 score on a scale |
| Control | Palliative Care Outcomes (POS Total Scores) | Week 4 | 22.2 score on a scale |
| Control | Palliative Care Outcomes (POS Total Scores) | Week 12 | 22.1 score on a scale |
| Control | Palliative Care Outcomes (POS Total Scores) | Week 24 | 21.3 score on a scale |
| Pal-Care | Palliative Care Outcomes (POS Total Scores) | Week 24 | 19.4 score on a scale |
| Pal-Care | Palliative Care Outcomes (POS Total Scores) | Baseline | 22.9 score on a scale |
| Pal-Care | Palliative Care Outcomes (POS Total Scores) | Week 12 | 20.8 score on a scale |
| Pal-Care | Palliative Care Outcomes (POS Total Scores) | Week 4 | 22.1 score on a scale |
Comparison: Baseline control vs. intervention
Comparison: Week 4 control vs. intervention
Comparison: Week 12, control vs. intervention
Comparison: Week 24, control vs. intervention
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.
Time frame: 6 Months
Population: Outcome surveys/data collection were not conducted on Post-intervention interview participants
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Control | Total Score for Quality of Life (QOL) Environment Domain | Baseline | 68.6 score on a scale |
| Control | Total Score for Quality of Life (QOL) Environment Domain | Week 4 | 65.8 score on a scale |
| Control | Total Score for Quality of Life (QOL) Environment Domain | Week 12 | 67.1 score on a scale |
| Control | Total Score for Quality of Life (QOL) Environment Domain | Week 24 | 72.7 score on a scale |
| Pal-Care | Total Score for Quality of Life (QOL) Environment Domain | Week 24 | 71.9 score on a scale |
| Pal-Care | Total Score for Quality of Life (QOL) Environment Domain | Baseline | 66.4 score on a scale |
| Pal-Care | Total Score for Quality of Life (QOL) Environment Domain | Week 12 | 66.1 score on a scale |
| Pal-Care | Total Score for Quality of Life (QOL) Environment Domain | Week 4 | 66.4 score on a scale |
Comparison: Baseline, control vs. intervention
Comparison: Week 4, control vs. intervention
Comparison: Week 12, control vs. intervention
Comparison: Week 24, control vs. intervention
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.
Time frame: 6 months
Population: Outcome surveys/data collection were not conducted on Post-intervention interview participants.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Control | Total Score for Quality of Life (QOL) Social Domain | Baseline | 81.1 score on a scale |
| Control | Total Score for Quality of Life (QOL) Social Domain | Week 4 | 73.3 score on a scale |
| Control | Total Score for Quality of Life (QOL) Social Domain | Week 12 | 77.9 score on a scale |
| Control | Total Score for Quality of Life (QOL) Social Domain | Week 24 | 80.2 score on a scale |
| Pal-Care | Total Score for Quality of Life (QOL) Social Domain | Week 24 | 82.8 score on a scale |
| Pal-Care | Total Score for Quality of Life (QOL) Social Domain | Baseline | 81.5 score on a scale |
| Pal-Care | Total Score for Quality of Life (QOL) Social Domain | Week 12 | 78.8 score on a scale |
| Pal-Care | Total Score for Quality of Life (QOL) Social Domain | Week 4 | 78.7 score on a scale |
Comparison: Baseline, control vs. intervention
Comparison: Week 4, control vs. intervention
Comparison: Week 12, control vs. intervention
Comparison: Week 24, control vs. intervention