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RecruitingNCT07644091Updated Jun 12, 2026

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

An observational study in Psychosocial Problem, sponsored by Methodist Health System. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by Methodist Health System · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

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Conditions studied

  • Psychosocial Problem
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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.

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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Quality of Life score

    Quality of Life score from the World Health Organization Quality of Life Survey

    Time frame: 1 year

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Study locations

1 of 1 sites recruiting
  • Methodist Richardson Medical Center- Clinical Research Institute
    Richardson, Texas 75082, United States
    Recruiting
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References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT07644091
Lead sponsor
Methodist Health System
Responsible party
Sponsor
First posted
Jun 12, 2026
Start date
May 26, 2026
Primary completion
May 2027 (estimated)
Completion
May 2028 (estimated)
Last update
Jun 12, 2026

Study contacts

Crystee Cooper, DHEd
Contact
ClinicalResearch@mhd.com
214-947-1280
Kavya Mankulangara
Contact
ClinicalResearch@mhd.com
214-947-4604

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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