Communication Tool for Advanced Cancer

Overseen By David Hui, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Cognitive impairment, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

155 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to create a tool for patients with advanced cancer to discuss treatment options with their doctors. Patients and their caregivers will test a new decision aid called TA-DA, a communication tool, and provide feedback for its improvement. The trial is open to patients with advanced cancer who have undergone at least two rounds of treatment focused on comfort and quality of life. Caregivers actively involved in providing support can also participate. As an unphased trial, this study offers patients the opportunity to contribute to developing a tool that could enhance communication and decision-making in cancer care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on communication and decision-making rather than changing treatments.

What prior data suggests that this communication tool is safe for advanced cancer patients?

In a previous study, researchers examined how communication tools can assist patients in discussing cancer treatment options with their doctors. These tools aim to enhance conversations about critical decisions. Research has shown that using these tools can make patients feel more informed and less likely to avoid important health information.

The TA-DA tool serves as a communication aid for cancer patients, designed to facilitate meaningful discussions between patients, caregivers, and healthcare providers. No evidence suggests any health risks from using tools like TA-DA, as they support discussions rather than directly impact physical health.

Regarding safety, the TA-DA tool poses very low risk. It focuses on improving communication and decision-making, not on medical treatment itself. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Communication Tool for Advanced Cancer, known as TA-DA, because it aims to enhance communication between patients and caregivers in a way that current options don't address. Unlike traditional treatments that focus solely on medical interventions, TA-DA is a digital tool designed to improve the quality of conversations about care preferences and decisions. By involving both patients and caregivers in the development process through interviews, the tool is tailored to meet real-world needs, potentially leading to more personalized and effective communication strategies in advanced cancer care.

What evidence suggests that this communication tool is effective for advanced cancer patients?

Research has shown that tools like TA-DA, which facilitate communication between patients and healthcare teams, can be very effective. In this trial, participants will use a prototype version of TA-DA to further refine the tool. Studies have found that such tools improve discussions between patients and doctors about treatment options and simplify conversations about care plans. For example, digital tools have successfully engaged patients in planning future medical decisions, leading to better preparation. Communication strategies focusing on both patients and doctors have also made medical consultations clearer and more effective. Overall, these tools help patients feel more informed and confident in their healthcare decisions. ^{6 7 8 9 10}

Who Is on the Research Team?

David Hui, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for advanced cancer patients who are considering third-line or beyond palliative systemic therapy. It aims to help them understand their treatment options better.

Inclusion Criteria

Patients: Age 18 or over, Diagnosis of advanced cancer who has received at least 2 lines of palliative systemic therapy, 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

Clinicians: MD Anderson medical oncologists and APPs who provide care to patients with advanced cancer

I am over 18, caring for a patient in the study, can consent, and speak English.

Exclusion Criteria

Participants in Part I and II

My condition requires someone else to make decisions for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Qualitative Exploration

Using qualitative methods to explore decision-making needs of patients, caregivers, and clinicians

4-6 weeks

Interviews and focus groups

Development and Acceptability Testing

Develop and measure the acceptability of the educational patient decision aid

8-12 weeks

Multiple sessions for feedback and refinement

Pilot RCT

Conduct a pilot randomized controlled trial to estimate the effect of the decision aid on patient knowledge

12 weeks

Regular assessments and follow-ups

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TA-DA

Trial Overview The trial is testing an educational tool called TA-DA, designed to aid in shared decision-making between patients and clinicians regarding late-stage cancer treatments.

How Is the Trial Designed?

Group I: TA-DA Experimental Treatment 1 Intervention

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 II: EUC Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9411882/

Feasibility and effectiveness of tools that support ... Our aim was to provide an overview of the feasibility and effectiveness of tools that support communication between healthcare professionals and patients.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11652780/

Feasibility of implementing a decision aid for advanced cancer ... This study focuses on perspectives of oncologists and other healthcare providers on the hindering and facilitating factors for implementing a customizable DA.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2820603

Clinician- and Patient-Directed Communication Strategies ... This cluster randomized trial tests the independent and combined effects of clinician and patient behavioral economic implementation ...

4. researchgate.net researchgate.net/publication/393919002_Effectiveness_of_Digital_Tools_in_Promoting_Advance_Care_Planning_A_Systematic_Review_Protocol

Effectiveness of Digital Tools in Promoting Advance Care ... Primary outcomes include ACP engagement rates, advance directive completion, and quality of ACP discussions. Two independent reviewers will ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2059702922002575

Effects of a communication training for oncologists on early ... Findings indicate that the compact communication skills training PALLI-COM increases oncologists' competencies in early addressing PC/EoL-related issues from ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8131252/

How technology impacts communication between cancer ... The purpose of this literature review is to explore and demonstrate how various health information technologies impact doctor-patient communication in oncology ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0738399124000971

Linking patient-centered communication with cancer ... The results demonstrated that patient-centered communication is directly associated with reduced cancer information avoidance, especially among cancer patients.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35901043/

Development of an advance directive 'communication tool ... This article shows the complex task of developing an advance directive suitable for cancer patients from six European countries.

9. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0271919

Development of an advance directive 'communication tool ... This article shows the complex task of developing an advance directive suitable for cancer patients from six European countries.

10. bmcpalliatcare.biomedcentral.com bmcpalliatcare.biomedcentral.com/articles/10.1186/s12904-021-00794-3

Video decision support tool promoting values conversations in ... This study will evaluate the potential utility of a video decision support tool (VDST) that models values-based ACP discussions between cancer patients and ...