Development of an Educational Patient Decision Aid (Treatments in Advanced Cancer - Decision Aid, TA-DA) to Promote Shared Decision Making for Third-line or Beyond Palliative Systemic Therapy

NCT07009886 | Recruiting DMC

• 2 other identifiers: 2025-0480NCI-2025-03797
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

Brief Summary

To develop an educational patient decision aid for advanced cancer patients to prepare them to have conversations with their clinicians about treatment options (Treatments in Advanced cancer - Decision Aid, TA-DA).

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year

Study Arms (2)

TA-DA

EXPERIMENTAL

Patient and caregiver participants are presented with a prototype version of TA-DA and participate in interviews over 90 minutes to further refine the tool.

Other: Communication

EUC

EXPERIMENTAL

Patient and caregiver participants are presented with a prototype version of TA-DA and participate in interviews over 90 minutes to further refine the tool.

Other: Communication

Interventions

Communication OTHER

Participants meet with clinician

EUC; TA-DA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinicians (Part I/II/III):
• MD Anderson medical oncologists and APPs who provide care to patients with advanced cancer
• Patients (Part I/II/III):
• Age 18 or over
• Diagnosis of advanced cancer (i.e., metastatic, relapsed, and/or incurable disease as defined by the treating oncologist) who has received at least 2 lines of palliative systemic therapy\*
• Patient-rated ECOG performance status of 1-3 for Part I/II and 2-3 for Part III
• Able to make treatment decisions based on the clinical judgement of the oncology team
• English speaking
• patient has started, is receiving, and/or has completed second-line palliative systemic therapy or beyond
• Caregivers (Part I/II/III):
• Age 18 or older
• Currently a primary caregiver to a patient who satisfies the patient eligibility criteria listed above
• For the study purposes, a primary caregiver is defined as:
• someone who provides physical, emotional, decisional and/or logistical assistance to the patient regularly (e.g. daily, weekly);
• can be a family member, friend, or other individual in a close relationship with the patient;

You may not qualify if:

• Any patient who meets any of the following criteria will be excluded from participation in this study:
• (Part I/II/III): Diagnosis of cognitive impairment or dementia requiring a surrogate decision maker as determined by the clinical team
• (Part III only): Participants in Part I and II

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

Study Officials

• David Hui, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Hui, MD

CONTACT

(713) 792-6258; dhui@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 8, 2025
• Study Start: July 10, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2030
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

US (1)