Recruiting

Decision Aid

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT07009886

Conditions

Advanced Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Communication

Study Details

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

Study ID

NCT07009886

Start date

Jul 10, 2025

Status verified date

Aug, 2026

Completion date

Jul 31, 2030

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Clinicians (Part I/II/III):

MD Anderson medical oncologists and APPs who provide care to patients with advanced cancer
2. 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
3. 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;
  • must be identified by the patient and self-identify as the primary person providing caregiving support to the patient
  • Able to provide informed consent and participate in the study
  • English speaking

Exclusion Criteria:

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

Study Design

Enrollment

155 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: TA-DA

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.

experimental: EUC

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.

Interventions

Communication

Participants meet with clinician

Primary outcome measure

  • Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts and Locations

Central contacts

Locations

The University of Texas M. D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

David Hui, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-08-12.