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

Not yet recruiting

• Conditions: Health Options; Strategic Care Planning

• Registration Number: NCT06722846
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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

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 Timeline

• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2024-12-03
• Study First Posted: 2024-12-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-20
• Study Start: 2025-06-30
• Primary Completion: 2026-08-31
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Through study completion; an average of 1 year.	Progression Free Survival (PFS)

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States