- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06722846
Communicating Health Options to Inform Care and Empower Strategic Care Planning (CHOICES): A Multi-layer Randomized Case Vignette Study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Primary Objectives • To examine how provision of medical information (risks, benefits, time toxicity, prognosis, oncologists' recommendation, and costs) affects preference for palliative systemic therapy in participants with advanced cancer.
Secondary Objective
• To examine how different options of medical information (risks/benefits, time toxicity, prognosis, oncologists' recommendation, and costs) affect preference for palliative systemic therapy in participants with advanced cancer.
Exploratory Objective
- To examine how the order of presentation of medical information affects preference for palliative systemic therapy in participants with advanced cancer.
- To examine the association between intrinsic participants characteristics (such as participants demographics, symptoms, anxiety, depression, illness understanding, acceptance, coping strategies, religious coping, hope, decision making style, trust in oncologist, financial distress) and preference for palliative systemic therapy in participants with advanced cancer.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: David Hui, MD
- Phone Number: 713-792-6258
- Email: dhui@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- MD Anderson Cancer Center
-
Contact:
- David Hui, MD
- Phone Number: 713-792-6258
- Email: dhui@mdanderson.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Diagnosis of advanced solid tumor (i.e. metastatic, relapsed, and/or incurable disease) or aggressive lymphoma.
- Age 18 or greater
- Seen at MD Anderson Cancer Center Thoracic and Lymphoma Oncology Clinics for a follow-up visit
- Been treated with at least 2 lines of palliative systemic cancer therapies
Exclusion Criteria:
- Diagnosis of cognitive impairment or dementia requiring a surrogate decision maker
- Non-English speaking
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Randomized Case Vignette Study
If participants agree to take part in this study, participants will complete about 16 questionnaires that will have questions about participants quality of life, anxiety, health, and case scenarios that are not real or based on your actual health situation. It should take a bit more than an hour to complete all the questionnaires. If participants find that any of these questions are difficult to read, understand, or otherwise complete; or if they cause distress, participants may ask the study team for clarification, skip the question, or even stop the study at any time. Additionally, information will be collected from participants medical record about participants health and treatment, as well as participants demographic information (age, race, sex, and so on). Investigators may also ask participants for additional demographic information not found in your medical record. |
Particpants will complete about 16 questionnaires that will have questions about particpants quality of life, anxiety, health, andcase scenarios that are not real or based on particpants actual health situation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Survival (OS)
Time Frame: Through study completion; an average of 1 year.
|
Progression Free Survival (PFS)
|
Through study completion; an average of 1 year.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Hui, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2024-0531
- NCI-2024-10042 (Other Identifier: NCI-CTRP Clinical Registry)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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