Decision Aid for Lung Cancer

Not currently recruiting at 1 trial location

Age: Any Age

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)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 4-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a decision aid, a tool designed to assist people with non-small cell lung cancer in making informed treatment choices. The researchers aim to determine if this tool improves communication with doctors and enhances patients' understanding, satisfaction, and quality of life. Participants will either use the decision aid or receive usual care, allowing researchers to compare the effectiveness of each approach. The trial seeks individuals who have completed treatment for any stage of non-small cell lung cancer or are undergoing tests for it, and who can speak English. As an unphased trial, this study offers participants the chance to contribute to research that could improve 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. It focuses on decision-making for lung cancer treatment, so it's best to discuss your medications with the trial team.

What prior data suggests that this decision aid is safe for patients with non-small cell lung cancer?

Research shows that decision aids, used in lung cancer care, are generally well-received. They help patients understand their treatment options without causing harm. Studies have found that these tools increase patients' knowledge about lung cancer and assist them in making better decisions about their care. No reports indicate negative effects from using decision aids. As they are meant to help, not treat, they don't carry physical risks like some medical treatments might. Overall, decision aids are considered safe and helpful for patients wanting to make informed choices about their lung cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Decision Aid for Lung Cancer trial because it aims to enhance patient understanding and decision-making regarding their treatment options. Unlike traditional approaches that rely heavily on physician-led discussions, this decision aid involves a conversation tool designed to empower patients by providing clear, accessible information. This innovation can lead to more personalized care and ensure patients feel informed and confident in their treatment choices. Additionally, by improving communication and understanding, the decision aid has the potential to increase patient satisfaction and adherence to treatment plans.

What evidence suggests that this decision aid is effective for improving decision-making in non-small cell lung cancer patients?

Research has shown that decision aids can greatly assist patients with non-small cell lung cancer. In this trial, one group of participants will receive a conversation tool as a decision aid, while another group will receive usual care. These tools simplify understanding of the condition and treatment expectations. They also reduce uncertainty and stress, leading to improved conversations with doctors. Furthermore, decision aids are associated with higher satisfaction in healthcare choices and an enhanced quality of life. This evidence suggests that using a decision aid can significantly improve the decision-making process for patients dealing with lung cancer. ^{1 2 3 5 6}

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 English-speaking individuals with a life expectancy over 6 months who have completed treatment or are undergoing diagnostic work-up for suspected or confirmed stage I-IV non-small cell lung cancer. They must also be cognitively able to participate, as indicated by a score above 3 on a specific cognitive screener.

Inclusion Criteria

I am being tested for suspected lung cancer at any stage.

You are expected to live for at least 6 more months.

I have completed treatment for early or advanced non-small cell lung cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either the conversation tool or usual care

4-8 weeks

1 visit (in-person) at baseline

Follow-up

Participants are monitored for outcomes such as anxiety, decisional conflict, and shared decision-making quality

4-8 weeks

1 visit (in-person or virtual) for follow-up questionnaire

What Are the Treatments Tested in This Trial?

Interventions

• Decision Aid

Trial Overview

The study tests the effectiveness of a decision aid designed to improve decision-making in patients with non-small cell lung cancer. It aims to see if this tool helps patients understand their condition better and make more informed choices about their care alongside their doctors.

How Is the Trial Designed?

Group I: Arm I (conversation tool) Experimental Treatment 2 Interventions

Patients receive the conversation tool.

Group II: Arm II (usual care) Active Control 2 Interventions

Patients receive usual care.

Who Is Running the Clinical Trial?

OHSU Knight Cancer Institute

Lead Sponsor

Trials

239

Recruited

2,089,000+

Hildegard Lamfrom Endowment

Collaborator

Trials

1

Recruited

100+

Medical Research Foundation, Oregon

Collaborator

Trials

14

Recruited

1,100+

ATS Foundation

Collaborator

Trials

1

Recruited

100+

Oregon Health and Science University

Collaborator

Trials

1,024

Recruited

7,420,000+

Published Research Related to This Trial

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]

The web-based decision aid significantly increased participants' knowledge about lung cancer risks and screening options, leading to improved understanding and reduced decisional conflict regarding screening choices.

After using the decision aid, participants showed better alignment with U.S. Preventive Services Task Force recommendations for lung cancer screening, indicating that the tool effectively supports informed decision-making for current and former smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Personalized, Web-Based Decision Aid for Lung Cancer Screening. Lau, YK., Caverly, TJ., Cao, P., et al.[2018]

A single-page, paper-based encounter decision aid (EDA) used during shared decision-making visits for lung cancer screening significantly reduced patient decisional conflict, as indicated by a drop in the Decisional Conflict Scale score from 35.0 to 0.2 (p < 0.001).

While 28% of patients understood the mortality benefit of lung cancer screening after the visit, a much higher percentage (82%) grasped the frequency of abnormal screening results, highlighting the need for improved patient education on the mortality benefits of screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Study of an Encounter Decision Aid for Lung Cancer Screening. Ito Fukunaga, M., Balwan, A., Janis, JA., 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]

A computer-based decision aid for lung cancer screening was found to be feasible and acceptable for use in a clinical setting, with participants reporting low decisional conflict and high intentions to undergo screening.

The use of the decision aid facilitated shared decision-making discussions that averaged nearly 6 minutes, suggesting it effectively engages patients and healthcare providers in the screening process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and testing of "Is Lung Cancer Screening for You?" A computer-based decision aid. Owens, OL., McDonnell, KK., Newsome, BR., 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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12401189/

The quality of patient decision aids for lung cancer screening

Only 10 of the remaining decision aids met quality criteria from the International Patient Decision Aid Standards. These aids emphasized that ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39825419/

Rationale and design of a randomized clinical trial ... - PubMed

In a two parallel-arm randomized controlled trial, we are assessing an innovative eHealth delivery model that integrates PrEP with MOUD.

3.

formative.jmir.org

formative.jmir.org/2025/1/e69044/PDF

Previsit Preparation for Shared Decision-Making in Lung

Objective: We piloted previsit preparation comparing 2 strategies: a paper decision aid (DA; DA group) and an enhanced comparator strategy ...

4.

pcori.org

pcori.org/research-results/2013/patient-decision-aid-help-heavy-smokers-make-decisions-about-lung-cancer-screening

A Patient Decision Aid to Help Heavy Smokers Make ...

A decision aid delivered through tobacco quitlines effectively reaches a screening-eligible population and results in informed decisions about lung cancer ...

5.

ascpjournal.biomedcentral.com

ascpjournal.biomedcentral.com/articles/10.1186/s13722-024-00534-x

Rationale and design of a randomized clinical trial of ...

In a two parallel-arm randomized controlled trial, we are assessing an innovative eHealth delivery model that integrates PrEP with MOUD and is tailored to meet ...

6.

ldi.upenn.edu

ldi.upenn.edu/our-work/research-updates/an-interactive-web-tool-boosts-use-of-lung-cancer-screening/

An Interactive Web Tool Boosts Use of Lung Cancer Screening

Participants who used the decision aid scored higher on a survey about lung cancer screening knowledge than those in the control group.