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

NCT05538481 | Withdrawn DMC

• 2 other identifiers: IRB00085986LCI-SUPP-NOS-HCV-001
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Neoplasms

Keywords

Palliative Care; Hindu Culture; Community-based Participatory Research

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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; 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.

Other: Developed survey completion; Other: Systems of Belief Inventory (SBI-15R)

Interventions

Semi-structured interview OTHER

A collection of individual cultural values and palliative care preferences within the focus group meetings

Focus Group

Developed survey completion OTHER

A collection of individual responses to a survey created after focus group completion and analysis

Cognitive Interviews Group

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.

Cognitive Interviews Group; Focus Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Atrium Health Levine Cancer Institute: collaborator

Study Sites (1)

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Rushil Patel, MD

  Atrium Health Levine Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: September 13, 2022
• Study Start: June 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: July 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)