Decision-Making Support Tool for Lung Cancer

(iDECIDE Trial)

Recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: OHSU Knight Cancer Institute

Disqualifiers: Non-English speakers, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 4

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new conversation tool designed to help people with lung cancer make informed treatment decisions. Researchers aim to determine if this tool improves patients' understanding of their options and participation in decision-making, particularly for those with lower health literacy. Participants will either use the new tool or receive the usual care. Individuals who suspect they have lung cancer and are comfortable communicating in English might be suitable for this trial. As an unphased study, this trial offers a unique opportunity to contribute to research that could enhance decision-making tools for future patients.

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 prior data suggests that this conversation tool is safe for patients with lung cancer?

Research shows that the conversation tool aiding patients in lung cancer treatment decisions is easy to use and well-received. Studies have found it particularly helpful for those unfamiliar with medical terms. The tool enhances patients' understanding of their treatment options and encourages collaborative decision-making with their doctors.

Importantly, no reports have indicated any problems or safety issues from using this tool. As it is not a drug or medical procedure, it primarily enhances communication and understanding, making it generally considered safe to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it introduces a decision-making support tool specifically for lung cancer patients. Unlike standard care that primarily focuses on medical and surgical treatment options, this tool aims to empower patients by providing clear, personalized information to guide their treatment choices. The unique aspect of this approach is its emphasis on patient engagement and informed decision-making, potentially leading to better alignment between patient values and treatment plans. This could enhance patient satisfaction and improve overall treatment outcomes.

What evidence suggests that this conversation tool is effective for decision-making in lung cancer patients?

Research has shown that a conversation tool, available to participants in this trial, can assist lung cancer patients in making better treatment decisions. Studies indicate that this tool is particularly beneficial for patients who struggle to understand medical information. It enhances shared decision-making, enabling patients and doctors to collaborate more effectively on selecting the best treatment plan. Early results suggest that patients find the tool easy to use and helpful. Overall, this tool aims to clarify complex treatment decisions and focus on the patient's needs. ^{1 2 3 6 7}

Who Is on the Research Team?

Donald Sullivan

Principal Investigator

OHSU Knight Cancer Institute

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Conversation Tool

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

A group education class on lung cancer screening significantly improved participants' knowledge, with an average increase of 0.9 correct responses on a true-false quiz after the class, based on surveys from 680 participants.

Approximately 70% of participants felt they had enough information to make informed decisions about lung cancer screening after attending the class, indicating that this educational approach effectively enhances decision-making capacity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Patient Education Class to Enhance Knowledge about Lung Cancer Screening: a Quality Improvement Evaluation. Sakoda, LC., Meyer, MA., Chawla, N., et al.[2021]

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]

A study involving 17 Brazilian adolescents aged 13-18 undergoing chemotherapy showed that they can effectively describe and report their chemotherapy-related adverse events, highlighting the importance of their perspectives in treatment assessments.

The research indicates that using open-ended questions during interviews can facilitate better communication and understanding of adverse events among adolescent cancer patients, paving the way for improved assessment tools tailored to their needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adolescents' understanding of chemotherapy-related adverse events: a concept elicitation study. Silva-Rodrigues, FM., Hinds, PS., Nascimento, LC.[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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40098532/

Improving lung cancer decision-making using a ... In this study, we evaluate a low literacy lung cancer treatment conversation tool to enhance shared decision-making (SDM). The Improving Decision-Making ...

2. 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 acceptable ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05407168

Improving Decision-Making Encounters in Lung Cancer ... This clinical trial evaluates the effectiveness of a conversation tool on patient-centered health and decision-making outcomes in patients with lung cancer ...

4. journal.chestnet.org journal.chestnet.org/article/S0012-3692(23)03733-9/fulltext

IMPROVING DECISION-MAKING ENCOUNTERS IN LUNG ... Our conversation tool may improve patient-centered and decisional outcomes regarding NSCLC treatments and warrants further investigation through ...

5. research.va.gov research.va.gov/currents/1024-Conversation-tool-helps-Veterans-make-decisions-about-lung-cancer-treatment.cfm

Conversation tool helps Veterans make decisions about ... Conversation tool helps Veterans make decisions about lung cancer treatment. October 25, 2024. By Tristan Horrom VA Research Communications.

6. tandfonline.com tandfonline.com/doi/10.1080/14796694.2025.2475733

Improving lung cancer decision-making using a ... In this study, we evaluate a low literacy lung cancer treatment conversation tool to enhance shared decision-making (SDM).

7. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/346411

Improving Decision-Making Encounters in Lung Cancer ... This clinical trial evaluates the effectiveness of a conversation tool on patient-centered health and decision-making outcomes in patients ...