Communicating Health Options to Inform Care and Empower Strategic Care Planning (CHOICES): A Multi-layer Randomized Case Vignette Study.

NCT ID: NCT06722846

Last Updated: 2025-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-21

Study Completion Date

2028-08-31

Brief Summary

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To learn more about how the delivery of medical information affects therapy choices for participants with advanced forms of cancer.

Detailed Description

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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.

Conditions

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Health Options Strategic Care Planning

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Randomized Case Vignette Study

Intervention Type BEHAVIORAL

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.

Interventions

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Randomized Case Vignette Study

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Hui, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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David Hui, MD

Role: CONTACT

713-792-6258

Facility Contacts

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David Hui, MD

Role: primary

713-792-6258

Provided Documents

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Document Type: Informed Consent Form

View Document

Related Links

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http://www.mdanderson.org

MD Anderson Cancer Center

Other Identifiers

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NCI-2024-10042

Identifier Type: OTHER

Identifier Source: secondary_id

2024-0531

Identifier Type: -

Identifier Source: org_study_id

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