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

Not Applicable

Not yet recruiting

• Conditions: Advanced Cancer

• Registration Number: NCT07009886
• Lead Sponsor: M.D. Anderson Cancer Center

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).

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-30
• Study First Submitted QC: 2025-05-30
• Last Update Submitted: 2025-05-30
• Study First Posted: 2025-06-08
• Last Update Posted: 2025-06-08
• Study Start: 2025-11-01
• Primary Completion: 2028-07-31
• Study Completion: 2030-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 155

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 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

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety and Adverse Events (AEs)	Through study completion; an average of 1 year	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Trial Locations

Locations (1)

The University of Texas M. D. Anderson Cancer Center; 🇺🇸 Houston, Texas, United States