Psychosocial Burden and Quality of Life in Caretakers of Hepatobiliary Cancer Patients

Psychosocial Burden and Quality of Life in Caretakers of Hepatobiliary Cancer Patients: A Survey-Based Analysis

Assess caregiver psychosocial burden, including Quality of Life, health, interpersonal relationship, access to support, and explore associated sociodemographic and contextual factors.

Study Overview

• Status: Recruiting
• Conditions: Psychosocial Problem

Detailed Description

While literature suggests significant psychosocial burden among hepatobiliary cancer caregivers, quantitative data specific to this population remain sparse, particularly regarding their Quality of Life, health, interpersonal relationship, and access to support. This investigation will fill a critical research gap by candidly assessing these dimensions and laying groundwork for future interventions tailored to improve caregiver well-being.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Crystee Cooper, DHEd; Phone Number: 214-947-1280; Email: ClinicalResearch@mhd.com
• Study Contact Backup: Name: Kavya Mankulangara; Phone Number: 214-947-4604; Email: ClinicalResearch@mhd.com

Study Locations

• United States
  • Texas
    • Richardson, Texas, United States, 75082
      • Recruiting
      • Methodist Richardson Medical Center- Clinical Research Institute
      • Contact: Colette Ngo Ndjom; Phone Number: 214-947-1289; Email: ClinicalResearch@mhd.com
      • Principal Investigator: Rohan Jeyarajah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Systemic assessment of caregiver needs and outcomes remains limited, and support services are inconsistently utilized or inadequately tailored to this population. Addressing this gap is critical, as caregiver well-being has downstream effects on patient outcomes, care continuity, and family resilience. By quantitatively characterizing the psychosocial burden, unmet needs, and support utilization among caregivers of patients with pancreatic and other major cancer types, this study aims to capture a more comprehensive understanding of the caregiving experience across the cancer continuum. The findings will provide an essential evidence base to inform targeted interventions aimed at improving both caregiver and patient Quality of Life.

Description

Inclusion Criteria:

Caretakers must be aged 18 years or older at the time of the survey Participants must be a family member or caretaker of an individual who is diagnosed with hepatobiliary cancer and is receiving care at the Methodist Cancer Center in Richardson, Texas. Diagnosis should be made within 2 years and is non-recurrent in nature. Participants must be an English speaker.

Exclusion Criteria:

This study is intended to assess the burden and well-being of unpaid caretakers of hepatobiliary cancer patients. Thus, paid caretakers, such as home health aides, will be excluded from the survey.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life score	Quality of Life score from the World Health Organization Quality of Life Survey	1 year

Collaborators and Investigators

• Sponsor: Methodist Health System

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: June 8, 2026
• First Submitted That Met QC Criteria: June 8, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 039.HPB.2025.R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The results of this research will be disseminated through submission to peer-reviewed scientific journals and presentation at professional conferences within but not limited to the fields of General Surgery, Hepatobiliary Surgery, and Psychiatry. Findings may also be presented at academic meetings.

All study results will be reported in aggregate form. No individual participant will be identifiable in any publication, presentation, or report. If qualitative data are included, direct quotations will be de-identified and reviewed to ensure removal of potentially identifying information.

Participants will not receive individual results, as the study does not involve clinical testing or diagnostic evaluation. A general summary of study findings may be made available to participants upon request.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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