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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a special communication tool can improve conversations between doctors and patients with non-small cell lung cancer during medical appointments. The Shared Decision-making Communication Tool aims to ensure patients understand their treatment options and feel more involved in deciding what’s best for them. Participants will either receive standard care or use the conversation tool during their visits. This study may suit someone diagnosed with non-small cell lung cancer, seeing a doctor at the Mayo Clinic, and eligible for additional treatment after surgery. As an unphased trial, this study offers a unique opportunity to enhance patient-doctor communication and empower patients in their treatment decisions.

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 prior data suggests that this shared decision-making communication tool is safe for use in clinical encounters?

Research has shown that shared decision-making tools are safe and well-liked in medical settings, including lung cancer care. Studies have found that these tools help doctors and patients communicate more effectively about treatment choices. They offer clear information on the pros and cons of treatments, making decision-making easier and more satisfying for patients. No reports indicate these tools cause harm, as they primarily aim to improve conversations and understanding between patients and doctors. Therefore, shared decision-making tools are considered low-risk and helpful in enhancing patient-doctor interactions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the shared decision-making communication tool for lung cancer because it enhances the way patients and doctors communicate during treatment planning. Unlike the traditional approach, which often involves clinicians making decisions without extensive patient involvement, this tool actively engages patients in discussions about their treatment options. This method aims to empower patients by ensuring their values and preferences are considered, potentially leading to more personalized and satisfactory care experiences. By fostering better communication, the tool could improve patient outcomes and satisfaction, marking a significant shift in how lung cancer care is delivered.

What evidence suggests that this shared decision-making communication tool is effective for improving the decision-making process in lung cancer patients?

Research has shown that tools for shared decision-making can enhance patient satisfaction with lung cancer care. In this trial, participants in Arm II will receive standard care plus a shared decision-making conversation tool. Studies have found that decision aids help patients make better-informed treatment choices. For example, a decision aid used in lung cancer screening helped people understand their options more clearly. Another study found that a conversation tool improved decision-making in lung cancer treatment. These tools guide discussions by providing clear information on the pros and cons of each choice, helping patients feel more involved in their care decisions. ^{1 3 5 6 7}

Who Is on the Research Team?

Konstantinos Leventakos

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9286651/

Availability and effectiveness of decision aids ... Shared decision making is not always commonplace in advanced colorectal or lung cancer care. Decision aids (DAs) might be helpful.

2. journal.chestnet.org journal.chestnet.org/article/S0012-3692(24)05126-2/fulltext

Decisions, Decisions - CHEST Journal Shared decision-making using a decision aid is required for lung cancer screening (LCS) reimbursement by the Centers for Medicare & Medicaid Services.

3. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.70008

The quality of patient decision aids for lung cancer screening ... Patient decision aids can be used to support shared decision making for lung cancer screening, but they need to meet quality standards to ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2759845

Effect of a Patient Decision Aid on Lung Cancer Screening ... In this study, a PDA delivered to clients of tobacco quit lines improved informed decision-making about lung cancer screening.

5. sciencedirect.com sciencedirect.com/science/article/pii/S294978922500011X

Improving Decision-Making Encounters in Lung Cancer ... We sought to determine if a low-literacy conversation tool (Improving Decision-Making Encounters in Lung Cancer Treatment [iDECIDE]) was feasible and ...

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2808933

Lung Cancer Screening Decision Aid Designed for a ... This patient decision aid designed for use in a primary care setting can inform future research to advance LCS shared decision-making interventions.

7. hsrd.research.va.gov hsrd.research.va.gov/publications/esp/sdm-lung-cancer-app.pdf

Shared Decision-Making for Lung Cancer Screening 8 exp People by smoking status/ or cigarette smoking/ or vaping/ or electronic cigarette/ or Smoking cessation/ or (e-cigarette? or ever-smoker? or ex-smoker?