Study to Identify and Measure the Values and Palliative Care Pref. of Hindu Patients and Their Caregivers

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.

Study Overview

• Status: Withdrawn
• Conditions: Neoplasms
• Intervention / Treatment: Other: Semi-structured interview; Other: Systems of Belief Inventory (SBI-15R); Other: Developed survey completion

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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Levine Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

1. Verbal informed consent by the patient or caregiver
2. Age ≥ 18 years at the time of consent

3. 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
4. Ability to read, speak, and understand English
5. 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

Exclusion Criteria:

1. Lack of access to the technology required to attend virtual meetings and complete study surveys electronically (e.g., internet in home setting)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Other: Semi-structured interview; A collection of individual cultural values and palliative care preferences within the focus group meetings; Other: 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.
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.	Other: 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: Developed survey completion; A collection of individual responses to a survey created after focus group completion and analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	approx. 12 months

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Atrium Health Levine Cancer Institute
• Investigators: Principal Investigator: Rushil Patel, MD, Atrium Health Levine Cancer Institute

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: September 5, 2022
• First Submitted That Met QC Criteria: September 8, 2022
• First Posted (Actual): September 13, 2022

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 5, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Palliative Care; Community-based Participatory Research; Hindu Culture
• Other Study ID Numbers: IRB00085986; LCI-SUPP-NOS-HCV-001 (Other Identifier: Levine Cancer Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No