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

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Advanced Cancer

Treatments: Other: Communication

Study type: Interventional

Funder types: Other

Identifiers

NCT07009886

2025-0480

NCI-2025-03797 (Other Identifier)

Details and patient eligibility

About

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).

Full 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).

Enrollment: 155 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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155 participants in 2 patient groups

TA-DA

Experimental group

Description:

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.

Treatment:

Other: Communication

EUC

Experimental group

Description:

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.

Treatment:

Other: Communication