Shared Decision-Making Aid for Lung Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Dementia, Severe hearing or visual impairment

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial compares the use of a shared decision-making communication tool during a clinical encounter to standard care for improving the quality of the shared decision-making process among patients with non-small cell lung cancer. Lung cancer patients are faced with many decisions about their treatment options. Studies have found that patients are most satisfied if they perceive an effort by their physician to share decision making and are afforded sufficient time to make their decision. Shared decision-making tools can help physicians guide the conversation, offer tailored estimates of the potential benefits, harms, and practical inconveniences of the available options, and support deliberations that take into account patient biological and biographical circumstances, goals, and priorities. Incorporating a shared decision-making communication tool into standard clinical encounters may improve the shared-decision making process as well as patient satisfaction with their treatment choice.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Shared Decision-Making Aid for Lung Cancer treatment?

Research shows that shared decision-making tools, like decision aids, can improve patient well-being and treatment success by helping patients actively participate in their healthcare decisions, especially in complex cases like advanced lung cancer. ^{1 2 3 4 5}

Is the Shared Decision-Making Aid for Lung Cancer safe for humans?

The research does not provide specific safety data for the Shared Decision-Making Aid, but it suggests that these tools are designed to improve patient understanding and decision-making, which can enhance patient safety by helping them make informed treatment choices. ^{3 4 5 6 7}

How does this treatment differ from other lung cancer treatments?

This treatment is unique because it focuses on shared decision-making, which involves the patient actively participating in choosing their treatment options. Unlike traditional approaches, this method uses decision aids to help patients understand their choices and align them with their personal values and preferences, especially in complex cases like advanced lung cancer. ^{2 3 4 5 6}

Research Team

Konstantinos Leventakos

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

This trial is for adult patients (18+) with non-small cell lung cancer stage >1B who are eligible for adjuvant treatment and can give informed consent. It's open to those at Mayo Clinic in Rochester, including various clinicians. Patients with dementia or severe hearing/vision impairments cannot participate.

Inclusion Criteria

Appointments at Mayo Clinic in Rochester

My lung cancer is stage 2 or higher.

Eligible by their oncologist for adjuvant treatment

Exclusion Criteria

Exclude patient with major barriers to provide written informed consent or to participate in shared decision-making (i.e., dementia, severe hearing or visual impairment)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Patients attend a standard of care visit with or without the shared decision-making conversation tool

1 day

1 visit (in-person)

Follow-up

Participants are monitored for decisional conflict and satisfaction with the intervention

6 weeks

2 visits (in-person)

Treatment Details

Interventions

• Shared Decision-making Communication Tool

Trial Overview The study tests a shared decision-making tool used during clinical visits against standard care, aiming to improve the quality of decisions made by lung cancer patients regarding their treatment options.

Participant Groups

Group I: Arm II (standard of care, conversation aid) Experimental Treatment 6 Interventions

Patients attend a standard of care visit with the use of the shared decision-making conversation tool by the clinician on study.

Group II: Arm I (standard of care) Active Control 5 Interventions

Patients attend a standard of care visit with their clinician on study.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

Introducing Shared Decision Making (SDM) and a Patient Decision Aid (PtDA) in lung cancer diagnostics significantly improved patient-reported outcomes, with a notable reduction in decisional conflict and decision regret scores compared to usual clinical practice.

Patients in the SDM group reported higher satisfaction with the decision-making process, as evidenced by a greater percentage achieving maximum scores on the CollaboRATE scale, suggesting that SDM enhances patient engagement and satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective cohort study of shared decision making in lung cancer diagnostics: Impact of using a patient decision aid. Søndergaard, SR., Madsen, PH., Hilberg, O., et al.[2020]

The review emphasizes the importance of shared decision-making for patients with high-risk, operable stage I lung cancer, highlighting the need for effective patient decision aids to facilitate this process.

It outlines the development of a specific education and decision support tool for patients choosing between radiation therapy and surgical resection, while also addressing the challenges faced in implementing and evaluating such tools in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing an Educational and Decision Support Tool for Stage I Lung Cancer Using Decision Science. Housten, AJ., Kozower, BD., Engelhardt, KE., et al.[2023]

A study involving 12 patients, 7 relatives, 12 nurses, and 18 doctors highlighted significant challenges in decision-making for advanced lung cancer treatment, including the need for strong clinician-patient relationships and better information exchange.

Participants expressed a desire for decision aids that could help navigate the complexities and uncertainties of treatment options, but clinicians were concerned that these tools might complicate consultations rather than enhance them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"The challenge is the complexity" - A qualitative study about decision-making in advanced lung cancer treatment. Orstad, S., Fløtten, Ø., Madebo, T., et al.[2023]

A new conversation tool designed for patients with non-small cell lung cancer (NSCLC) was developed to enhance shared decision-making in treatment, showing promise in helping patients clarify their values and communicate better with doctors.

In a study with 27 participants, those with prior cancer experiences felt more prepared for decision-making, and all agreed the tool could empower them to take an active role in their treatment choices, indicating its potential effectiveness for improving patient engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Show me the roads and give me a road map: Development of a patient conversation tool to improve lung cancer treatment decision-making. Golden, SE., Disher, N., Dieckmann, NF., et al.[2023]

The HELP decision aid aims to enhance shared decision-making for patients with advanced lung cancer by providing clarity on personal attitudes towards treatment options, which is crucial given the complex trade-offs between potential benefits and severe side effects.

This study is a randomized controlled trial designed to evaluate the effectiveness of the HELP decision aid in improving patient engagement and decision-making clarity, with the primary outcome measured by the Decisional Conflict Scale after a decision coaching session.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HELP - Heidelberg decision aid for lung cancer patients: a randomized controlled clinical trial. Deis, N., Unsöld, L., Siegle, A., et al.[2023]

Shared decision making is an important process in healthcare that helps patients with high-risk conditions, like clinical stage I non-small cell lung cancer, choose between treatment options such as segmentectomy or stereotactic body radiation therapy.

The study emphasizes the use of clinical tools to facilitate this decision-making process, ensuring that patient preferences and values are considered for a more personalized treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared Decision Making and Effective Risk Communication in the High-Risk Patient With Operable Stage I Non-Small Cell Lung Cancer. Samson, P., Waters, EA., Meyers, B., et al.[2017]

Informatics tools can significantly enhance patient safety by supporting shared decision-making and risk communication, helping patients understand their treatment options and associated risks and benefits.

Key features of these tools include interactive tutorials for better risk comprehension, personalized presentation modes, individual risk calculations, and automatic updates of evidence, all aimed at improving treatment choices and patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient safety through informatics tools for shared decision making and risk communication. Ruland, CM.[2004]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

A prospective cohort study of shared decision making in lung cancer diagnostics: Impact of using a patient decision aid. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Developing an Educational and Decision Support Tool for Stage I Lung Cancer Using Decision Science. [2023]

3. Ireland pubmed.ncbi.nlm.nih.gov

"The challenge is the complexity" - A qualitative study about decision-making in advanced lung cancer treatment. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Show me the roads and give me a road map: Development of a patient conversation tool to improve lung cancer treatment decision-making. [2023]

5. England pubmed.ncbi.nlm.nih.gov

HELP - Heidelberg decision aid for lung cancer patients: a randomized controlled clinical trial. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Shared Decision Making and Effective Risk Communication in the High-Risk Patient With Operable Stage I Non-Small Cell Lung Cancer. [2017]

7. Ireland pubmed.ncbi.nlm.nih.gov

Improving patient safety through informatics tools for shared decision making and risk communication. [2004]