NeoplasmsNCT05538481
Study to Identify and Measure the Values and Palliative Care Pref. of Hindu Patients and Their Caregivers
An observational study of Neoplasms, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Historically, palliative care in the US has been rooted in the cultural values of a Caucasian, Christian middle class. Greater understanding of how culture influences the delivery of palliative care to minority patients is needed to achieve health equity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Semi-structured interview, Developed survey completion and Systems of Belief Inventory (SBI-15R)
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2023to Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cancer ≥18 years of age and self-identified Hindus who received the majority of their cancer care in Charlotte and surrounding areas within the past 5 years will be identified by the investigators and Community Advisory Group members. Or Caregivers ≥18 years of age and self-identified Hindus who are caring for an eligible Hindu patient or cared for an eligible Hindu patient who died ≤ 5 years will be identified by the investigators and Community Advisory Group members.
Who may be able to join
- Verbal informed consent by the patient or caregiver
- Age ≥ 18 years at the time of consent
- Participants must be a cancer patient or caregiver and/or:
- Self-identified Hindu
- Cancer patients must have received most of their cancer care in Charlotte and surrounding areas within the past 5 years from enrollment
- Caregivers must be caring for a patient who meets the above criteria and is too ill to participate or cared for a cancer patient who met the above criteria but died within the past 5 years from enrollment
- Ability to read, speak, and understand English
- As determined by the enrolling investigator, the ability of the participant to understand and comply with study procedures for the entire length of the study
Who cannot join
- 1. Lack of access to the technology required to attend virtual meetings and complete study surveys electronically (e.g., internet in home setting)
Trial locations and contacts
1 site in 1 country.
United States1 site
Levine Cancer Institute
Charlotte, North Carolina, 28204
About this study
Official title: A Prospective Study to Identify and Measure the Cultural Values and Palliative Care Preferences of Hindu Patients With Cancer and Their Caregivers
Historically, palliative care in the US has been rooted in the cultural values of a Caucasian, Christian middle class. Greater understanding of how culture influences the delivery of palliative care to minority patients is needed to achieve health equity.
The purpose of this study is to learn more about the cultural values (Hindu customs and beliefs) and palliative care (specialized care for people living with a serious illness) preferences of the Hindu community. To the study team's knowledge, there has not been another study that has used a research approach to help better understand and measure the cultural values and palliative care preferences of Hindu participants with cancer and their caregivers.
Read the detailed description
This is a cross-sectional study of Hindu patients with cancer in Charlotte and surrounding areas and their Hindu caregivers. This study will use the methods and principles of Community-based participatory research (CBPR).
Before enrollment of participants, a Community Advisory Group (CAG) will be formed, which represents the Hindu community's perspective in the research project and facilitates interactions with Hindu patients with cancer and caregivers. The CAG will be composed of 8-10 members, including healthcare professionals, leaders, patients with cancer, and their caregivers - identified by members from three Hindu institutions, Bochasanwasi Shri Akshar Purushottam Swaminarayan Sanstha (BAPS), Hindu Center of Charlotte, and Trimurti Temple Devasthanam, in Charlotte and surrounding areas. Charlotte is one of the two areas in NC with the fastest growing Indian population. The role of the CAG is to provide input throughout both parts of the study.
There will be two cohorts of patients with cancer/caregivers: 1) focus group cohort and 2) cognitive interview cohort. Data about cultural values and palliative care preferences collected from focus group participants (Cohort 1) will be analyzed using an inductive thematic analysis approach and will be used for survey development. The survey will be validated with cognitive interviews (Cohort 2). After any needed modifications, the final survey will be created and presented to all study participants. All of the study participants will also have the opportunity to review the survey to ensure that the questions reflect their real-world experiences. The investigators hypothesize that this final survey will be an effective tool to measure the cultural values and palliative care preferences of Hindu patients and their caregivers.
Participants will be enrolled over approximately 12 months.
- Conditions
- Neoplasms
- Being tested
- Semi-structured interview, Developed survey completion, Systems of Belief Inventory (SBI-15R)
- Keywords
- Palliative Care, Hindu Culture, Community-based Participatory Research
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured interviewOther
A collection of individual cultural values and palliative care preferences within the focus group meetings
Developed survey completionOther
A collection of individual responses to a survey created after focus group completion and analysis
Systems of Belief Inventory (SBI-15R)Other
A 15-item questionnaire designed to measure religious and spiritual beliefs and practices and the social support derived from a community sharing those beliefs.
| Study group | Role | What they receive |
|---|---|---|
| Focus Group | A total of 16 participants, including patients and caregivers, will be enrolled for 2 focus groups (group of 8 patients with cancer and group of 8 caregivers). Receives: Other: Semi-structured interview; Other: Systems of Belief Inventory (SBI-15R) | |
| Cognitive Interviews Group | A total of up to 30 participants will be enrolled in this cohort, and up to 3 rounds of cognitive interviews will be conducted. This cohort of participants will be enrolled after survey development based on the themes identified from the focus group analyses. Receives: Other: Developed survey completion; Other: Systems of Belief Inventory (SBI-15R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify the cultural values and palliative care preferences of Hindu patients with cancer and caregivers in Charlotte and surrounding areas.
Qualitative analysis will occur on collected sociodemographic data and responses to Systems of Belief Investigator (SBI-15R). Using MAXQDA Analytics Pro software, themes will be identified for coding based on the repetition of specific words, phrases, and opinions, use of language and general thought patterns, as well as specific topics that dominated the focus group discussion. A theme will be defined as an issue raised or discussed by ≥2 members in that focus group. This phase of the study will conclude when new themes no longer emerge, i.e., thematic saturation is reached.
Measured: approx. 12 months
To develop and validate the content of a survey of Hindu cultural values and palliative care preferences to measure their prevalence in a larger cohort.
Qualitative analysis will be performed based on Cognitive interviews utilizing created survey. Items that have <3 instances of being identified by participants as being problematic will be retained and will not be retested in any subsequent cognitive interview rounds. If any aspect of the measure has ≥3 instances of being identified by the participant as being problematic in the final round, that aspect will be removed from the final survey.
Measured: approx. 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study startJun 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionJun 2024 (estimated)
Why it stopped: Sponsor Investigator transferred from institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Rushil Patel, MD, Principal investigator, Atrium Health Levine Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538481
- Sponsor's protocol ID
- IRB00085986
- Other IDs
- LCI-SUPP-NOS-HCV-001
- Status last verified
- Jul 2023
- First submitted
- 5 Sep 2022
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Identify and Measure the Cultural Values and Palliative Care Preferences of Hindu Patients With Cancer and Their Caregivers
- ClinicalTrials.gov ID
- NCT05538481
- Acronym / sponsor ID
- IRB00085986
- Conditions
- Neoplasms
- Keywords
- Palliative Care, Hindu Culture, Community-based Participatory Research
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor Investigator transferred from institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute
- Study start
- Jun 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 13 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Historically, palliative care in the US has been rooted in the cultural values of a Caucasian, Christian middle class. Greater understanding of how culture influences the delivery of palliative care to minority patients is needed to achieve health equity.
The purpose of this study is to learn more about the cultural values (Hindu customs and beliefs) and palliative care (specialized care for people living with a serious illness) preferences of the Hindu community. To the study team's knowledge, there has not been another study that has used a research approach to help better understand and measure the cultural values and palliative care preferences of Hindu participants with cancer and their caregivers.
Detailed description
This is a cross-sectional study of Hindu patients with cancer in Charlotte and surrounding areas and their Hindu caregivers. This study will use the methods and principles of Community-based participatory research (CBPR).
Before enrollment of participants, a Community Advisory Group (CAG) will be formed, which represents the Hindu community's perspective in the research project and facilitates interactions with Hindu patients with cancer and caregivers. The CAG will be composed of 8-10 members, including healthcare professionals, leaders, patients with cancer, and their caregivers - identified by members from three Hindu institutions, Bochasanwasi Shri Akshar Purushottam Swaminarayan Sanstha (BAPS), Hindu Center of Charlotte, and Trimurti Temple Devasthanam, in Charlotte and surrounding areas. Charlotte is one of the two areas in NC with the fastest growing Indian population. The role of the CAG is to provide input throughout both parts of the study.
There will be two cohorts of patients with cancer/caregivers: 1) focus group cohort and 2) cognitive interview cohort. Data about cultural values and palliative care preferences collected from focus group participants (Cohort 1) will be analyzed using an inductive thematic analysis approach and will be used for survey development. The survey will be validated with cognitive interviews (Cohort 2). After any needed modifications, the final survey will be created and presented to all study participants. All of the study participants will also have the opportunity to review the survey to ensure that the questions reflect their real-world experiences. The investigators hypothesize that this final survey will be an effective tool to measure the cultural values and palliative care preferences of Hindu patients and their caregivers.
Participants will be enrolled over approximately 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Focus Group | – | Other: Semi-structured interview, Other: Systems of Belief Inventory (SBI-15R)A total of 16 participants, including patients and caregivers, will be enrolled for 2 focus groups (group of 8 patients with cancer and group of 8 caregivers). |
| Cognitive Interviews Group | – | Other: Developed survey completion, Other: Systems of Belief Inventory (SBI-15R)A total of up to 30 participants will be enrolled in this cohort, and up to 3 rounds of cognitive interviews will be conducted. This cohort of participants will be enrolled after survey development based on the themes identified from the focus group analyses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cancer ≥18 years of age and self-identified Hindus who received the majority of their cancer care in Charlotte and surrounding areas within the past 5 years will be identified by the investigators and Community Advisory Group members. Or Caregivers ≥18 years of age and self-identified Hindus who are caring for an eligible Hindu patient or cared for an eligible Hindu patient who died ≤ 5 years will be identified by the investigators and Community Advisory Group members.
Key inclusion criteria (8 listed)
- Verbal informed consent by the patient or caregiver
- Age ≥ 18 years at the time of consent
- Participants must be a cancer patient or caregiver and/or:
- Ability to read, speak, and understand English
- As determined by the enrolling investigator, the ability of the participant to understand and comply with study procedures for the entire length of the study
Key exclusion criteria (1 listed)
- 1. Lack of access to the technology required to attend virtual meetings and complete study surveys electronically (e.g., internet in home setting)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semi-structured interviewA collection of individual cultural values and palliative care preferences within the focus group meetings | Other | Focus Group |
| Developed survey completionA collection of individual responses to a survey created after focus group completion and analysis | Other | Cognitive Interviews Group |
| Systems of Belief Inventory (SBI-15R)A 15-item questionnaire designed to measure religious and spiritual beliefs and practices and the social support derived from a community sharing those beliefs. | Other | Cognitive Interviews Group, Focus Group |
Primary outcome
To identify the cultural values and palliative care preferences of Hindu patients with cancer and caregivers in Charlotte and surrounding areas.
Time frame: approx. 12 months
Qualitative analysis will occur on collected sociodemographic data and responses to Systems of Belief Investigator (SBI-15R). Using MAXQDA Analytics Pro software, themes will be identified for coding based on the repetition of specific words, phrases, and opinions, use of language and general thought patterns, as well as specific topics that dominated the focus group discussion. A theme will be defined as an issue raised or discussed by ≥2 members in that focus group. This phase of the study will conclude when new themes no longer emerge, i.e., thematic saturation is reached.
To develop and validate the content of a survey of Hindu cultural values and palliative care preferences to measure their prevalence in a larger cohort.
Time frame: approx. 12 months
Qualitative analysis will be performed based on Cognitive interviews utilizing created survey. Items that have <3 instances of being identified by participants as being problematic will be retained and will not be retested in any subsequent cognitive interview rounds. If any aspect of the measure has ≥3 instances of being identified by the participant as being problematic in the final round, that aspect will be removed from the final survey.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rushil Patel, MD principal investigator
Atrium Health Levine Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify the cultural values and palliative care preferences of Hindu patients with cancer and caregivers in Charlotte and surrounding areas. (time frame: approx. 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.