RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2025-07-10

Study Completion:2030-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07009886

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Clinicians (Part I/II/III): 2. Patients (Part I/II/III): * 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 2 or greater * 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	* (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

Inclusion Criteria

Exclusion Criteria

1. Clinicians (Part I/II/III):
2. Patients (Part I/II/III):
* 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 2 or greater
* 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

* (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

Contacts and Locations

Study Contact

David Hui, MD

CONTACT

(713) 792-6258

dhui@mdanderson.org

Principal Investigator

David Hui, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

David Hui, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-10

Study Completion Date2030-07-31

Study Record Updates

Study Start Date2025-07-10

Study Completion Date2030-07-31

Terms related to this study

Additional Relevant MeSH Terms

Advanced Cancer