Asian Patients Perspectives Regarding Outcomes Awareness Care & Health

STUDY PROTOCOL

PROTOCOL TITLE:

|ASIAN PATIENT PERSPECTIVES REGARDING OUTCOMES, AWARENESS, CARE & HEALTH (APPROACH II)

| |PROTOCOL NUMBER:

|INSERT PROTOCOL NUMBER HERE

| |PROTOCOL VERSION:

1

|PROTOCOL DATE:

27/10/2023

| |OVERALL PRINCIPAL INVESTIGATOR:

Eric Finkelstein, Director, Lien Centre for Palliative Care, Duke-NUS Medical School

| SITE PRINCIPAL INVESTIGATOR:

Dr Somnath Dey

MPMMCC/HBCH, Tata Memorial Centre

Varanasi

| | |  |  |  |

  Table of Contents

1.       BACKGROUND AND RATIONALE. 3

2.       HYPOTHESIS AND OBJECTIVES. 4

3.       EXPECTED RIKS AND BENEFITS. 6

4.       STUDY POPULATION.. 6

4.1.         List the number and nature of subjects to be enrolled. 6

4.2.         Criteria for Recruitment and Recruitment Process. 7

4.3.         Inclusion Criteria. 7

4.4.         Exclusion Criteria. 7

5.       STUDY DESIGN AND PROCEDURES/METHODOLOGY. 7

6.       SAFETY MEASUREMENTS. 8

6.1.         Safety Monitoring Plan. 8

6.2.         Complaint Handling. 8

7.       DATA ANALYSIS. 8

7.1.         Data Quality Assurance. 8

7.2.         Data Entry and Storage. 8

8.       SAMPLE SIZE AND STATISTICAL METHODS. 9

8.1.         Determination of Sample Size. 9

8.2.         Statistical and Analytical Plans. 9

9.       DIRECT ACCESS TO SOURCE DATA/DOCUMENTS. 9

10.     QUALITY CONTROL AND QUALITY ASSURANCE. 9

11.     ETHICAL CONSIDERATIONS. 9

11.1.      Informed Consent. 10

11.2.      Confidentiality of Data and Patient Records. 10

12.     PUBLICATIONS. 10

13.     RETENTION OF STUDY DOCUMENTS. 11

14.     FUNDING and INSURANCE. 11

 

**1.****BACKGROUND
AND RATIONALE**
Measuring
the quality of end-of-life (EOL) care from the patient and caregiver’s
perspective is a crucial step towards patient-centric healthcare management.
Yet, few efforts have focussed on systematically measuring how well various
entities and countries deliver EOL care.

Despite a lack of systematic reporting in most countries, there is overwhelming evidence that even high-functioning health systems often fail to deliver on aspects of end-of-life care that are important to patients with advanced illness and their caregivers. Most end-of-life patients, even in high income countries, die in pain and after experiencing serious health-related suffering, not at their place of choice, under severe psychological distress and prior to death, often express regret about how the last period of their life was spent. 1,2,3

 Many patients also routinely undergo expensive and marginal or non-beneficial treatments that may inadvertently worsen their EOL experience. 4 As a result, poor care, serious health-related suffering, medical bankruptcy and treatment regret are common in both more and less developed countries. Under an effort undertaken by the Lien Centre for Palliative Care, a Quality of Death and Dying Index (QODDI) 2021, was undertaken to systematically rank and grade countries on the quality of EOL care taking patient and caregiver preferences into account while developing the weighting criteria. An extensive scoping review was performed to identify the core domains of end-of-life care that matters most to patients and caregivers. 5

The scoping review systematically analysed 309 articles to identify 13 domains capturing key aspects of ‘quality of death’ that can guide EOL care reform. Based on this review a 15-item instrument called Quality of Care for Patients with Advance Illnesses (QCPAI) was developed for measuring EOL care.

 Although many studies on end-of-life care have been carried out in developed countries, reports on end-of-care needs in Asia are very few. This study can highlight the end-of-life care in India and it can also serve as a basic data for end-of-life care in Asia. It can also identify the barriers and areas in need which could call attention of health care system planners to augment the development of end-of-life care services in the country.

  |**2.**HYPOTHESIS AND OBJECTIVES  |The current study seeks to increase our understanding of patients’ perspectives regarding their quality of life and end of life care. To meet this aims, several specific research objectives outlined below will be examined.

 Domain 1: Prognostic beliefs

Aim 1: Assess patients’ prognostic beliefs and compare it with their perception of their physicians’ prognostic beliefs.

 Aim 2: Assess patients’ own prognostic beliefs and compare it with their perception of prognosis for a hypothetical patient with the same diagnosis.

 Aim 3: Assess association between prognostic beliefs and sense of suffering.

 Domain 2: Survival expectations, bias and hope in the face of advanced illness.

 Aim 1: Whether patients who have advanced illness in LMICs have similar survival expectations, and experience hope in the same way as patients who have advanced illness in high-income countries. Do patients in low-income countries carry high levels of hope.

 Aim 2: Assess survival expectations of patients with advanced illness in low and middle-income countries and whether patients display evidence of cognitive bias.

 Aim 3: Explore the relationship between hope and (1) survival predictions and (2) health seeking behaviours.

  Domain 3: Quality of Care in Patients with Advanced Illness (QCPAI)

Aim 1: Explore the extent to which responses on QCPAI vary based on observable characteristics of the health care institute and the individual (e.g., race, income, gender, hope).

 Aim 2: Through vignettes, explore whether or not differences in QCPAI scores are driven by reporting heterogeneity.

|**3.**EXPECTED RISKS AND BENEFITS  |Participants are not expected to benefit directly from participation in this study. However, this study will lead us to understand more about patients’ quality of life and quality of care, their prognostic belief and treatment preferences. This understanding will be the important step to identify the areas that need improvement and integrate optimal end-of-life care in current practice and health care policies surrounding end-of-life care.

 The study involves no foreseeable physical risk to participants. Participants may experience some emotional discomfort while responding to survey items. While they complete the survey form, they may deeply think of their actual situation and may feel less hopeful. Participants can withdraw from the survey any time they want.

   |**4.**STUDY POPULATION |4.1. List thenumber and nature of subjects to be enrolled.   |1)      Patients will be eligible to be recruited if they are diagnosed with (a) histology of any type of solid cancer in stage IV.  Site will recruit 200 patients diagnosed with advanced stage cancer and their family caregiver.

   |4.2. Criteria for Recruitment and Recruitment Process  |·         Treating physicians at participating sites will help to identify eligible patients. The workflow for recruitment of eligible patients will be determined in consultation with each collaborator at each site.

·         Research coordinator/ interviewer will obtain list from clinics where the physicians had given approval to recruit and identify patients who meet the eligibility criteria.

·         The eligible patients and their caregiver will then be approached by the research coordinator and the details of the study will be explained to them. Consent will be obtained.

  The site PIs will be responsible for recruitment and establishing a recruitment process. It will be made clear that decision to participate in this study is entirely voluntary and will not affect/influence the healthcare services they receive. Duke-NUS research team will not be involved in any interaction with participants.

  |4.3. Inclusion Criteria  |Patients must meet the criteria listed below in order to be able to participate:

2)      Citizen of their country

3)      Over 21 years of age

4)      Physically and mentally well enough to participate in the survey.

5)      Histology of any type of solid cancer in stage IV

6)      Patients should be aware of their diagnosis.

7)      Can understand and speak either English, Hindi.

8)      Agreeable to provide consent.

  |4.4. Exclusion Criteria  |Patients meeting any of the criteria listed below will be excluded from participation:

1)         Patients with impaired cognitive function

2)         Patients who are too sick to answer the survey.

3)         Patients who are not aware of their illness

4)         Patients who are not willing to provide consent to participate in the study.

 Inclusion criteria for caregivers:1)      At least 21 years of age

2)      Involved in providing care or ensuring provision of care or in making decisions regarding treatment/care of the patient.

3)      Patient they are caring for is enrolled in the study.

 Exclusion criteria for caregivers:

1)      Domestic workers/maids will be excluded from the study**.**

  |  |**5.**STUDY DESIGN AND PROCEDURES/METHODOLOGY  |This is a cross-sectional study. Patients with advanced cancer admitted to the inpatient and outpatient clinics at the hospital will be recruited to the study. All possible effort will be made to find a quiet place to conduct the consent and to administer the survey.

Participants will be asked to complete the survey through a tablet. The survey will not ask participants for any identifying information. Each participant will be assigned a unique code.

Validated versions of the instrument will be used whenever available. In instances where it is not available, instruments will be professionally translated in local languages before being used. The survey will be pilot tested before commencing the main survey and will be kept short to minimize patient burden. The survey was originally developed in English. All surveys for both patient and caregiver will be administered in his/her preferred language.

The survey will be tested extensively with at least 50 patients and 50 caregivers to test the readability of the survey and to assess whether certain items/questions are difficult to understand. Based on the feedback received such questions will be simplified/amended.

Patients who are recruited into the study will complete a survey that will be administered by a trained interviewer or research coordinator.  The survey is estimated to take at most 30-45 minutes to complete.

Assisted Personal Interviewing will be used to administer the survey through an electronic format. The interviewer will read the survey to the participants and record the answers. The survey will be completed electronically. The interviewer will ensure adequate privacy so that the participants will be comfortable answering the survey without concerns of privacy. The survey will be administered at a time that is convenient to the participants in order to ensure that they are free from intrusions. The survey will be conducted by a trained interviewer who will be able to converse with participants in their language of choice.

The surveys, identified by study codes for each participant and their caregiver, will be administered through survey tool-Qualtrics. The participant’s response to survey will be uploaded to an online Qualtrics account. This account will be username/password protected. Data will be stored for a period of ten years after the study in an online Qualtrics account.

| |**6.**SAFETY MEASUREMENTS |6.1. Safety Monitoring Plan  |The site Principal Investigator will monitor and report any adverse events to the IEC. The study involves minimal risk to participants. For this reason, this study is deemed to not be in need of a Data and Safety Monitoring Board and meetings will be scheduled as needed.

  |6.2. Complaint Handling   |Participants who wish to express and lodge their complaints may do so with the site Principal Investigator.

|**7.**DATA ANALYSIS |7.1. Data Quality Assurance  |Survey interviews will be monitored for quality control on a regular basis. The survey will be conducted by interviewers who will be trained extensively on administering the survey before being allowed to make contact with the participants. The interviewer will be provided a comprehensive guide detailing the protocol of administering the survey. There will be frequent re-training session conducted for the interviewer in order to ensure that the data obtained from this research is accurate, complete and reliable.

The site Principal Investigator will oversee data collection of participants.  The site Principal Investigator will be able to contact the Lien Centre for Palliative Care at Duke-NUS Medical School, Singapore for any guidance on data collection matters.

  |7.2. Data Entry and Storage  |Each participant will be identified by generated study code, such that the identity of the subject remains anonymous. The e-surveys, identified by study codes for each participant and their caregiver, will be administered through survey tool- Qualtrics. The participant’s response to survey will be uploaded to an online Qualtrics account. This account will be username/password protected. The surveys that are administered on hard copy format will be inputted into the Qualtrics account by the interviewer after completion of the survey.

De-identified information will be shared by participating sites with the Duke-NUS team for data analyses.

  |**8.**SAMPLE SIZE AND STATISTICAL METHODS |8.1. Determination of Sample Size   |As this study is not an RCT, the sample size is not based on testing a single endpoint. Rather, the goal is to enrol an appropriate number of subjects such that the study is feasible, while simultaneously ensuring a sample size large enough to conduct analyses and estimate models.

  |8.2. Statistical and Analytical Plans |Data will be processed and analyzed in STATA and will be described using percentage and relevant data displayed in tables and figures. The associations among study variables will be assessed by correlation coefficients analyses (bi-serial, parametric or non-parametric, whichever is appropriate) and regression analyses. Mixed modelling methods will be used to identify patient characteristics and disease/treatment factors associated with topics of interest (i.e., awareness and preferences for prognostic information, quality of life, quality of care).

|**9.**DIRECT ACCESS TO SOURCE DATA/DOCUMENTS The site Principal Investigator will be the only one who will have access to the files with identifiable data. The rest of the research team and the Duke-NUS research team will have access to the data with no identifiable information.

**10.**QUALITY CONTROL AND QUALITY ASSURANCE The Principal Investigator will be directly involved in overseeing recruitment and data collection.  The Principal Investigator will be mentored by the Lien Centre for Palliative Care, Duke-NUS and will have occasional meetings to ensure study quality.  More frequent meetings in the initial stages and monthly meetings in the later stages will be held to discuss and troubleshoot issues that may arise and maintain quality of protocol adherence.  The study investigators will also train and monitor closely other research staff (e.g., medical students, research assistant) involved in data collection.

**11.**ETHICAL CONSIDERATIONS This study will be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with the local regulatory requirements of India.

 This final study protocol, including the final version of the Patient Information and Informed Consent Form, must be approved in writing by the Institutional Review Board (IRB), prior to enrolment of any patient into the study.

 The site Principal Investigator is responsible for informing the IRB of any amendments to the protocol or other study-related documents, as per local requirement.

|11.1.         Informed Consent  |The consent process will take place before the participant answering any survey questions. Recruitment and consent will take place in the inpatient and outpatient settings. In the case of outpatient setting, in all cases every effort will be made to provide a private room in which the survey can be administered. The consent process will involve explaining the study and asking participants to check “ I agree to participate” box to the participants. The consent process will be conducted by trained interviewers.

  |11.2.         Confidentiality of Data and Patient Records  |The information collected from this research will be kept confidential. Participants will have their own ID code number for this study. Survey forms will be coded by ID number only. Electronic data in password-protected files can be accessed only by the principal investigator. All study findings will be reported in aggregate form and individual participants will not be identified in public reports or documents.

 Data Sharing

This study is part of a multi-country collaborative project managed by the Lien Centre for Palliative Care, Duke-NUS Medical School, Singapore. Original data collected in this current study will be kept and maintained at the Department of Palliative and Rehabilitation Medicine, Aster Hospital. To facilitate data analyses, electronic de-identified data will be sent to Duke-NUS using password-protected files.

| | |**12.**RETENTION OF STUDY DOCUMENTS |Data will be stored for a period of 10 years. The records will be accessible for inspection and copying by relevant authorities.

|

References

1.       FM Knaul, PE Farmer, EL Krakauer, et al. Alleviating the access abyss in palliative care and pain relief-an imperative of universal health coverage: The Lancet Commission report. Lance, 391 (2018)

2.       AE Singer, JR Giebel, YM Kim, et al. Populations and interventions for palliative care and end-of-life care: a systematic review. J Palliative Med, 19 (2016)

3.       D Clark, N Baur, D Clellan, et al. Mapping levels of palliative care development in 198 countries: the situation in 2017, J Pain Symptom Management, 59 (2020)

4.       M Cardona-Morell, JCH Kim, M Bradbrand, et al. What is inappropriate hospital use for elderly people near the end of life? A systematic review. Eur J Intern Med, 42 (2017)

5.       A Bhadelia, LE Oldfield, JL Cruz et al. Identifying the core domains to assess the ‘quality of death’: a scoping review. J Pain Symptom Management (2021)

 STUDY PROTOCOL

PROTOCOL TITLE:

|ASIAN PATIENT PERSPECTIVES REGARDING OUTCOMES, AWARENESS, CARE & HEALTH (APPROACH II)

| |PROTOCOL NUMBER:

|INSERT PROTOCOL NUMBER HERE

| |PROTOCOL VERSION:

1

|PROTOCOL DATE:

27/10/2023

| |OVERALL PRINCIPAL INVESTIGATOR:

Eric Finkelstein, Director, Lien Centre for Palliative Care, Duke-NUS Medical School

| SITE PRINCIPAL INVESTIGATOR:

Dr Somnath Dey

MPMMCC/HBCH, Tata Memorial Centre

Varanasi

| | |  |  |  |

  Table of Contents

1.       BACKGROUND AND RATIONALE. 3

2.       HYPOTHESIS AND OBJECTIVES. 4

3.       EXPECTED RIKS AND BENEFITS. 6

4.       STUDY POPULATION.. 6

4.1.         List the number and nature of subjects to be enrolled. 6

4.2.         Criteria for Recruitment and Recruitment Process. 7

4.3.         Inclusion Criteria. 7

4.4.         Exclusion Criteria. 7

5.       STUDY DESIGN AND PROCEDURES/METHODOLOGY. 7

6.       SAFETY MEASUREMENTS. 8

6.1.         Safety Monitoring Plan. 8

6.2.         Complaint Handling. 8

7.       DATA ANALYSIS. 8

7.1.         Data Quality Assurance. 8

7.2.         Data Entry and Storage. 8

8.       SAMPLE SIZE AND STATISTICAL METHODS. 9

8.1.         Determination of Sample Size. 9

8.2.         Statistical and Analytical Plans. 9

9.       DIRECT ACCESS TO SOURCE DATA/DOCUMENTS. 9

10.     QUALITY CONTROL AND QUALITY ASSURANCE. 9

11.     ETHICAL CONSIDERATIONS. 9

11.1.      Informed Consent. 10

11.2.      Confidentiality of Data and Patient Records. 10

12.     PUBLICATIONS. 10

13.     RETENTION OF STUDY DOCUMENTS. 11

14.     FUNDING and INSURANCE. 11

 

**1.****BACKGROUND
AND RATIONALE**
Measuring
the quality of end-of-life (EOL) care from the patient and caregiver’s
perspective is a crucial step towards patient-centric healthcare management.
Yet, few efforts have focussed on systematically measuring how well various
entities and countries deliver EOL care.

Despite a lack of systematic reporting in most countries, there is overwhelming evidence that even high-functioning health systems often fail to deliver on aspects of end-of-life care that are important to patients with advanced illness and their caregivers. Most end-of-life patients, even in high income countries, die in pain and after experiencing serious health-related suffering, not at their place of choice, under severe psychological distress and prior to death, often express regret about how the last period of their life was spent. 1,2,3

 Many patients also routinely undergo expensive and marginal or non-beneficial treatments that may inadvertently worsen their EOL experience. 4 As a result, poor care, serious health-related suffering, medical bankruptcy and treatment regret are common in both more and less developed countries. Under an effort undertaken by the Lien Centre for Palliative Care, a Quality of Death and Dying Index (QODDI) 2021, was undertaken to systematically rank and grade countries on the quality of EOL care taking patient and caregiver preferences into account while developing the weighting criteria. An extensive scoping review was performed to identify the core domains of end-of-life care that matters most to patients and caregivers. 5

The scoping review systematically analysed 309 articles to identify 13 domains capturing key aspects of ‘quality of death’ that can guide EOL care reform. Based on this review a 15-item instrument called Quality of Care for Patients with Advance Illnesses (QCPAI) was developed for measuring EOL care.

 Although many studies on end-of-life care have been carried out in developed countries, reports on end-of-care needs in Asia are very few. This study can highlight the end-of-life care in India and it can also serve as a basic data for end-of-life care in Asia. It can also identify the barriers and areas in need which could call attention of health care system planners to augment the development of end-of-life care services in the country.

  |**2.**HYPOTHESIS AND OBJECTIVES  |The current study seeks to increase our understanding of patients’ perspectives regarding their quality of life and end of life care. To meet this aims, several specific research objectives outlined below will be examined.

 Domain 1: Prognostic beliefs

Aim 1: Assess patients’ prognostic beliefs and compare it with their perception of their physicians’ prognostic beliefs.

 Aim 2: Assess patients’ own prognostic beliefs and compare it with their perception of prognosis for a hypothetical patient with the same diagnosis.

 Aim 3: Assess association between prognostic beliefs and sense of suffering.

 Domain 2: Survival expectations, bias and hope in the face of advanced illness.

 Aim 1: Whether patients who have advanced illness in LMICs have similar survival expectations, and experience hope in the same way as patients who have advanced illness in high-income countries. Do patients in low-income countries carry high levels of hope.

 Aim 2: Assess survival expectations of patients with advanced illness in low and middle-income countries and whether patients display evidence of cognitive bias.

 Aim 3: Explore the relationship between hope and (1) survival predictions and (2) health seeking behaviours.

  Domain 3: Quality of Care in Patients with Advanced Illness (QCPAI)

Aim 1: Explore the extent to which responses on QCPAI vary based on observable characteristics of the health care institute and the individual (e.g., race, income, gender, hope).

 Aim 2: Through vignettes, explore whether or not differences in QCPAI scores are driven by reporting heterogeneity.

|**3.**EXPECTED RISKS AND BENEFITS  |Participants are not expected to benefit directly from participation in this study. However, this study will lead us to understand more about patients’ quality of life and quality of care, their prognostic belief and treatment preferences. This understanding will be the important step to identify the areas that need improvement and integrate optimal end-of-life care in current practice and health care policies surrounding end-of-life care.

 The study involves no foreseeable physical risk to participants. Participants may experience some emotional discomfort while responding to survey items. While they complete the survey form, they may deeply think of their actual situation and may feel less hopeful. Participants can withdraw from the survey any time they want.

   |**4.**STUDY POPULATION |4.1. List thenumber and nature of subjects to be enrolled.   |1)      Patients will be eligible to be recruited if they are diagnosed with (a) histology of any type of solid cancer in stage IV.  Site will recruit 200 patients diagnosed with advanced stage cancer and their family caregiver.

   |4.2. Criteria for Recruitment and Recruitment Process  |·         Treating physicians at participating sites will help to identify eligible patients. The workflow for recruitment of eligible patients will be determined in consultation with each collaborator at each site.

·         Research coordinator/ interviewer will obtain list from clinics where the physicians had given approval to recruit and identify patients who meet the eligibility criteria.

·         The eligible patients and their caregiver will then be approached by the research coordinator and the details of the study will be explained to them. Consent will be obtained.

  The site PIs will be responsible for recruitment and establishing a recruitment process. It will be made clear that decision to participate in this study is entirely voluntary and will not affect/influence the healthcare services they receive. Duke-NUS research team will not be involved in any interaction with participants.

  |4.3. Inclusion Criteria  |Patients must meet the criteria listed below in order to be able to participate:

2)      Citizen of their country

3)      Over 21 years of age

4)      Physically and mentally well enough to participate in the survey.

5)      Histology of any type of solid cancer in stage IV

6)      Patients should be aware of their diagnosis.

7)      Can understand and speak either English, Hindi.

8)      Agreeable to provide consent.

  |4.4. Exclusion Criteria  |Patients meeting any of the criteria listed below will be excluded from participation:

1)         Patients with impaired cognitive function

2)         Patients who are too sick to answer the survey.

3)         Patients who are not aware of their illness

4)         Patients who are not willing to provide consent to participate in the study.

 Inclusion criteria for caregivers:1)      At least 21 years of age

2)      Involved in providing care or ensuring provision of care or in making decisions regarding treatment/care of the patient.

3)      Patient they are caring for is enrolled in the study.

 Exclusion criteria for caregivers:

1)      Domestic workers/maids will be excluded from the study**.**

  |  |**5.**STUDY DESIGN AND PROCEDURES/METHODOLOGY  |This is a cross-sectional study. Patients with advanced cancer admitted to the inpatient and outpatient clinics at the hospital will be recruited to the study. All possible effort will be made to find a quiet place to conduct the consent and to administer the survey.

Participants will be asked to complete the survey through a tablet. The survey will not ask participants for any identifying information. Each participant will be assigned a unique code.

Validated versions of the instrument will be used whenever available. In instances where it is not available, instruments will be professionally translated in local languages before being used. The survey will be pilot tested before commencing the main survey and will be kept short to minimize patient burden. The survey was originally developed in English. All surveys for both patient and caregiver will be administered in his/her preferred language.

The survey will be tested extensively with at least 50 patients and 50 caregivers to test the readability of the survey and to assess whether certain items/questions are difficult to understand. Based on the feedback received such questions will be simplified/amended.

Patients who are recruited into the study will complete a survey that will be administered by a trained interviewer or research coordinator.  The survey is estimated to take at most 30-45 minutes to complete.

Assisted Personal Interviewing will be used to administer the survey through an electronic format. The interviewer will read the survey to the participants and record the answers. The survey will be completed electronically. The interviewer will ensure adequate privacy so that the participants will be comfortable answering the survey without concerns of privacy. The survey will be administered at a time that is convenient to the participants in order to ensure that they are free from intrusions. The survey will be conducted by a trained interviewer who will be able to converse with participants in their language of choice.

The surveys, identified by study codes for each participant and their caregiver, will be administered through survey tool-Qualtrics. The participant’s response to survey will be uploaded to an online Qualtrics account. This account will be username/password protected. Data will be stored for a period of ten years after the study in an online Qualtrics account.

| |**6.**SAFETY MEASUREMENTS |6.1. Safety Monitoring Plan  |The site Principal Investigator will monitor and report any adverse events to the IEC. The study involves minimal risk to participants. For this reason, this study is deemed to not be in need of a Data and Safety Monitoring Board and meetings will be scheduled as needed.

  |6.2. Complaint Handling   |Participants who wish to express and lodge their complaints may do so with the site Principal Investigator.

|**7.**DATA ANALYSIS |7.1. Data Quality Assurance  |Survey interviews will be monitored for quality control on a regular basis. The survey will be conducted by interviewers who will be trained extensively on administering the survey before being allowed to make contact with the participants. The interviewer will be provided a comprehensive guide detailing the protocol of administering the survey. There will be frequent re-training session conducted for the interviewer in order to ensure that the data obtained from this research is accurate, complete and reliable.

The site Principal Investigator will oversee data collection of participants.  The site Principal Investigator will be able to contact the Lien Centre for Palliative Care at Duke-NUS Medical School, Singapore for any guidance on data collection matters.

  |7.2. Data Entry and Storage  |Each participant will be identified by generated study code, such that the identity of the subject remains anonymous. The e-surveys, identified by study codes for each participant and their caregiver, will be administered through survey tool- Qualtrics. The participant’s response to survey will be uploaded to an online Qualtrics account. This account will be username/password protected. The surveys that are administered on hard copy format will be inputted into the Qualtrics account by the interviewer after completion of the survey.

De-identified information will be shared by participating sites with the Duke-NUS team for data analyses.

  |**8.**SAMPLE SIZE AND STATISTICAL METHODS |8.1. Determination of Sample Size   |As this study is not an RCT, the sample size is not based on testing a single endpoint. Rather, the goal is to enrol an appropriate number of subjects such that the study is feasible, while simultaneously ensuring a sample size large enough to conduct analyses and estimate models.

  |8.2. Statistical and Analytical Plans |Data will be processed and analyzed in STATA and will be described using percentage and relevant data displayed in tables and figures. The associations among study variables will be assessed by correlation coefficients analyses (bi-serial, parametric or non-parametric, whichever is appropriate) and regression analyses. Mixed modelling methods will be used to identify patient characteristics and disease/treatment factors associated with topics of interest (i.e., awareness and preferences for prognostic information, quality of life, quality of care).

|**9.**DIRECT ACCESS TO SOURCE DATA/DOCUMENTS The site Principal Investigator will be the only one who will have access to the files with identifiable data. The rest of the research team and the Duke-NUS research team will have access to the data with no identifiable information.

**10.**QUALITY CONTROL AND QUALITY ASSURANCE The Principal Investigator will be directly involved in overseeing recruitment and data collection.  The Principal Investigator will be mentored by the Lien Centre for Palliative Care, Duke-NUS and will have occasional meetings to ensure study quality.  More frequent meetings in the initial stages and monthly meetings in the later stages will be held to discuss and troubleshoot issues that may arise and maintain quality of protocol adherence.  The study investigators will also train and monitor closely other research staff (e.g., medical students, research assistant) involved in data collection.

**11.**ETHICAL CONSIDERATIONS This study will be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with the local regulatory requirements of India.

 This final study protocol, including the final version of the Patient Information and Informed Consent Form, must be approved in writing by the Institutional Review Board (IRB), prior to enrolment of any patient into the study.

 The site Principal Investigator is responsible for informing the IRB of any amendments to the protocol or other study-related documents, as per local requirement.

|11.1.         Informed Consent  |The consent process will take place before the participant answering any survey questions. Recruitment and consent will take place in the inpatient and outpatient settings. In the case of outpatient setting, in all cases every effort will be made to provide a private room in which the survey can be administered. The consent process will involve explaining the study and asking participants to check “ I agree to participate” box to the participants. The consent process will be conducted by trained interviewers.

  |11.2.         Confidentiality of Data and Patient Records  |The information collected from this research will be kept confidential. Participants will have their own ID code number for this study. Survey forms will be coded by ID number only. Electronic data in password-protected files can be accessed only by the principal investigator. All study findings will be reported in aggregate form and individual participants will not be identified in public reports or documents.

 Data Sharing

This study is part of a multi-country collaborative project managed by the Lien Centre for Palliative Care, Duke-NUS Medical School, Singapore. Original data collected in this current study will be kept and maintained at the Department of Palliative and Rehabilitation Medicine, Aster Hospital. To facilitate data analyses, electronic de-identified data will be sent to Duke-NUS using password-protected files.

| | |**12.**RETENTION OF STUDY DOCUMENTS |Data will be stored for a period of 10 years. The records will be accessible for inspection and copying by relevant authorities.

|

References

1.       FM Knaul, PE Farmer, EL Krakauer, et al. Alleviating the access abyss in palliative care and pain relief-an imperative of universal health coverage: The Lancet Commission report. Lance, 391 (2018)

2.       AE Singer, JR Giebel, YM Kim, et al. Populations and interventions for palliative care and end-of-life care: a systematic review. J Palliative Med, 19 (2016)

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