Psychosocial ProblemNCT07644091
Psychosocial Burden and Quality of Life in Caretakers of Hepatobiliary Cancer Patients
An observational study of Psychosocial Problem, run by Methodist Health System at 1 site in United States.
Trial summary
Assess caregiver psychosocial burden, including Quality of Life, health, interpersonal relationship, access to support, and explore associated sociodemographic and contextual factors. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychosocial Problem
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2026to May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Methodist Richardson Medical Center- Clinical Research Institute
Richardson, Texas, 75082
Colette Ngo Ndjom, 214-947-1289, ClinicalResearch@mhd.com
Rohan Jeyarajah
About this study
Official title: 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.
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.
- Conditions
- Psychosocial Problem
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life score
Quality of Life score from the World Health Organization Quality of Life Survey
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start26 May 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychosocial ProblemStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07644091
- Sponsor's protocol ID
- 039.HPB.2025.R
- Status last verified
- Apr 2026
- First submitted
- 8 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Burden and Quality of Life in Caretakers of Hepatobiliary Cancer Patients: A Survey-Based Analysis
- ClinicalTrials.gov ID
- NCT07644091
- Acronym / sponsor ID
- 039.HPB.2025.R
- Conditions
- Psychosocial Problem
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 26 May 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 12 Jun 2026 (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.
Assess caregiver psychosocial burden, including Quality of Life, health, interpersonal relationship, access to support, and explore associated sociodemographic and contextual factors.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of Life score
Time frame: 1 year
Quality of Life score from the World Health Organization Quality of Life Survey
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: 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.
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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.
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 Psychosocial Problem, run by Methodist Health System 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 1 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: looking for participants now, as of the sponsor's last update on 12 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Crystee Cooper, DHEd (214-947-1280, ClinicalResearch@mhd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life score (time frame: 1 year). 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 12 Jun 2026.