Decision-Making Support Tool for Lung Cancer

(iDECIDE Trial)

Recruiting at 3 trial locations

Overseen by Donald Sullivan

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: OHSU Knight Cancer Institute

Disqualifiers: Non-English speakers, Cognitive impairment, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a conversation tool designed to help lung cancer patients, particularly those who find medical information hard to understand, make better treatment decisions. The tool aims to improve how patients talk with their doctors and understand their options.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the Decision-Making Support Tool for Lung Cancer treatment?

The Decision-Making Support Tool for Lung Cancer, which includes the iDECIDE and Low-Literacy Conversation Tool, has shown promise in increasing patient awareness of treatment options and reducing uncertainty in decision-making for lung cancer patients. A pilot study indicated that patients using the tool were more informed about the benefits and risks of different treatments and expressed clear treatment preferences. ^{1 2 3 4 5}

Is the Decision-Making Support Tool for Lung Cancer safe for humans?

The research on decision-making support tools, including those for lung cancer, shows that they are generally well-received and help patients understand their treatment options better. There is no specific mention of safety concerns related to these tools in the studies provided. ^{1 2 6 7 8}

How does the Decision-Making Support Tool for Lung Cancer differ from other treatments for this condition?

This tool is unique because it focuses on improving shared decision-making between patients and healthcare providers, helping patients understand their treatment options and make informed choices, which is not typically the focus of standard lung cancer treatments. ^{1 9 10 11 12}

Research Team

Donald Sullivan

Principal Investigator

OHSU Knight Cancer Institute

Eligibility Criteria

This trial is for individuals with suspected lung cancer who are fluent in English, have a life expectancy of more than 6 months, and are currently making treatment decisions. It's aimed at those with lower health literacy to help them understand their options. Non-veterans are specifically included to ensure the study's findings apply broadly.

Inclusion Criteria

Non-Veterans will be recruited for this study. Non-Veterans are an important component to this project since they will provide outside perspective. In this way, results of this study will be more generalizable

Participation in Aim 1

Life expectancy of more than 6 months

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are randomized to either review a decision aid or receive standard care

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for decision-making outcomes and quality of life

6 months

3 visits (in-person or virtual) at 2 weeks, 3 months, and 6 months

Treatment Details

Interventions

• Conversation Tool (Behavioural Intervention)

Trial Overview The trial is testing a conversation tool designed to improve patient-centered outcomes by aiding decision-making in lung cancer treatments. The goal is to determine if this tool helps patients better understand and participate in choosing their treatment path.

Participant Groups

Group I: Group I (decision aid) Experimental Treatment 2 Interventions

Patients review decision aid.

Group II: Group II (standard of care) Active Control 2 Interventions

Patients receive standard of care.

Who Is Running the Clinical Trial?

OHSU Knight Cancer Institute

Lead Sponsor

Trials

239

Recruited

2,089,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Oregon Health and Science University

Collaborator

Trials

1,024

Recruited

7,420,000+

Findings from Research

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]

A novel decision support intervention (DSI) for patients with late-stage non-small cell lung cancer (NSCLC) was developed, which includes care plan cards and a patient preference tool to facilitate shared decision making about treatment options.

Pilot testing with five patients showed that using the DSI increased awareness of treatment options and their benefits/risks, while reducing concerns about treatment costs and decision-making uncertainty, indicating its potential effectiveness in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging Patients with Late-Stage Non-Small Cell Lung Cancer in Shared Decision Making about Treatment. Myers, RE., Advani, SM., Myers, P., et al.[2021]

A plain language decision aid (DA) for localized prostate cancer was developed and evaluated, showing that it effectively improved patient knowledge and facilitated discussions with doctors about treatment options among newly diagnosed patients (n = 60).

The DA was found to be clear and useful, leading to increased understanding of radiation therapy side effects, indicating its potential to enhance shared decision-making in a patient-friendly manner.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based patient choice: a prostate cancer decision aid in plain language. Holmes-Rovner, M., Stableford, S., Fagerlin, A., et al.[2018]

A systematic review of 23 randomized trials found that cancer patient decision aids significantly improve patient participation in decision making and lead to higher-quality decisions regarding treatment options.

Effective strategies to enhance shared decision making include training clinicians, using question prompt sheets, and providing decision coaching, which can help address patients' knowledge gaps and unrealistic expectations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision making in oncology: a review of patient decision aids to support patient participation. Stacey, D., Samant, R., Bennett, C.[2022]

About one-third of the 251 adult patients surveyed at a public hospital clinic had low literacy levels, which significantly impacted their ability to correctly interpret prescription medication warning labels.

Patients with low literacy were 3.4 times less likely to understand these labels correctly, highlighting the need for clearer, simpler warning labels that are easier for all patients to comprehend, especially those with lower literacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low literacy impairs comprehension of prescription drug warning labels. Davis, TC., Wolf, MS., Bass, PF., et al.[2022]

A web-based decision support tool (CHOICES DST) was developed to help Black and Hispanic cancer patients understand and make informed decisions about participating in cancer clinical trials, addressing the low participation rates of these groups.

Usability testing with cancer survivors showed that the CHOICES DST was well-received, with users expressing satisfaction with its content and navigation, indicating its potential to enhance knowledge and decision-making regarding clinical trial participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Plain Language Decision Support Tool for Cancer Clinical Trials: Blending Health Literacy, Academic Research, and Minority Patient Perspectives. Langford, AT., Hawley, ST., Stableford, S., et al.[2022]

A review of 22 decision support tools (DSTs) for low-dose CT lung cancer screening revealed that most tools focused on knowledge exchange, but there was significant variability in how information was presented and the depth of content provided.

None of the DSTs fully addressed all potential harms and outcomes of screening, which could lead to suboptimal decision-making, especially for individuals with lower literacy and numeracy skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision Support Tools for Low-Dose CT Lung Cancer Screening: A Scoping Review of Information Content, Format, and Presentation Methods. Jallow, M., Bonfield, S., Kurtidu, C., et al.[2023]

Patients with lung cancer reported an average of 14 symptoms causing moderate distress, and their ability to manage these symptoms was influenced by their level of interactive health literacy, which was found to be in the moderate range.

Higher interactive health literacy allowed patients to better engage with healthcare providers about symptom management strategies, suggesting that improving these skills could enhance patient confidence and effectiveness in self-management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive Health Literacy and Symptom Self-management in Patients With Lung Cancer: A Critical Realist Analysis. Campbell, JK., Erickson, JM.[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]

In a study involving 237 lung cancer screening patients, both Option Grids and Shouldiscreen.com were effective in facilitating shared decision making (SDM), but Option Grids led to lower decision regret and better understanding of potential complications compared to Shouldiscreen.com.

Patients using Shouldiscreen.com reported less knowledge about complications and had higher decision regret regarding their choice to pursue screening, highlighting the importance of the decision aid used in the SDM process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aiding shared decision making in lung cancer screening: two decision tools. Sferra, SR., Cheng, JS., Boynton, Z., et al.[2021]

References

1. 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]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Engaging Patients with Late-Stage Non-Small Cell Lung Cancer in Shared Decision Making about Treatment. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Evidence-based patient choice: a prostate cancer decision aid in plain language. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Effectiveness of a Patient Education Class to Enhance Knowledge about Lung Cancer Screening: a Quality Improvement Evaluation. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Decision making in oncology: a review of patient decision aids to support patient participation. [2022]

6. Brazil pubmed.ncbi.nlm.nih.gov

Adolescents' understanding of chemotherapy-related adverse events: a concept elicitation study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Low literacy impairs comprehension of prescription drug warning labels. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Development of a Plain Language Decision Support Tool for Cancer Clinical Trials: Blending Health Literacy, Academic Research, and Minority Patient Perspectives. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Decision Support Tools for Low-Dose CT Lung Cancer Screening: A Scoping Review of Information Content, Format, and Presentation Methods. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Interactive Health Literacy and Symptom Self-management in Patients With Lung Cancer: A Critical Realist Analysis. [2023]

11. England pubmed.ncbi.nlm.nih.gov

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

12. England pubmed.ncbi.nlm.nih.gov

Aiding shared decision making in lung cancer screening: two decision tools. [2021]