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

NCT ID: NCT07009886

Last Updated: 2025-11-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-10
• Study Completion Date: 2030-07-31

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).

Detailed Description

Primary Objectives:

The study objective is to develop an educational patient DA (Treatments in Advanced cancer - Decision Aid, TA-DA) to assist patients, their caregivers, and clinicians to make an informed decision about third-line or beyond palliative systemic therapy for advanced cancer. To fulfill the study's objectives, we will complete 3 study parts:

Using qualitative methods, explore the decision-making needs of patients with advanced cancer, their caregivers, and clinicians, about third-line or beyond palliative systemic therapy; identify initial preferences and recommendations to inform the design of the educational patient DA in Part II.

Following a user-centered design approach, develop and measure the acceptability of an educational patient DA to promote shared decision making among patients with advanced cancer, their caregivers, and clinicians, about third-line or beyond palliative systemic therapy.

Conduct a pilot RCT to estimate the effect of the educational patient DA (TA-DA) on patient's knowledge of their treatment options.

Secondary Objectives:

Examine the impact of the educational patient DA (TA-DA) on patients' illness understanding (Prigerson's items), preparation for decision making (PrepDM Scale), decisional conflict (Decisional Conflict Scale [DCS]), quality of the shared decision-making process (SDM Process Scale), decisional regret (decisional regret scale), therapeutic alliance (The Human Connection Scale [THC]), anxiety (Generalized Anxiety Disorder 7 [GAD-7]), final treatment choice, and end-of-life care outcomes (e.g., systemic therapy use in last month of life).

Examine the impact of the educational patient DA (TA-DA) on caregivers' knowledge of the patient's treatment options, illness understanding (Prigerson's items), preparation for decision making (PrepDM Scale), decisional conflict (DCS), quality of the shared decision- making process (SDM Process Scale), therapeutic alliance (THC Scale), and anxiety (GAD-7).

Examine the acceptability (Ottawa Acceptability Scale) of the educational patient DA (TA-DA) among patients, caregivers, and oncologists in the educational patient DA group. Examine the acceptability (modified Acceptability of Intervention Measure [AIM]), appropriateness (Intervention Appropriateness Measure [IAM]), and feasibility (Feasibility of Intervention Measure [FIM]) of the educational patient DA (TA-DA) among clinicians in the educational patient DA group.

Exploratory Objective:

2.3.1. (Part III) Examine the impact of the educational patient DA (TA-DA) on the concordance between patient-caregiver dyads for knowledge of the patient's treatment options, illness understanding (Prigerson's items), preparation for decision making (PrepDM Scale), decisional conflict (DCS), quality of the shared decision-making process (SDM Process Scale), therapeutic alliance (THC Scale), and anxiety (GAD-7).

Conditions

Advanced Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Communication

Intervention Type: OTHER

Participants meet with clinician

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.

Group Type: EXPERIMENTAL

Communication

Intervention Type: OTHER

Participants meet with clinician

Interventions

Communication

Participants meet with clinician

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Hui, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

David Hui, MD

Role: CONTACT

Phone: (713) 792-6258

Email: dhui@mdanderson.org

Facility Contacts

David Hui, MD

Role: primary

Related Links

http://www.mdanderson.org

MD Anderson Cancer Center Website

Other Identifiers

NCI-2025-03797

Identifier Type: OTHER

Identifier Source: secondary_id

2025-0480

Identifier Type: -

Identifier Source: org_study_id