Decision Aid for Lung Cancer

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

98 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a tool that helps lung cancer patients understand their treatment options and make decisions with their doctors. It aims to improve patient knowledge, reduce uncertainty, and enhance communication. The study evaluates the tool's effectiveness.

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.

Is the Decision Aid treatment safe for humans?

The Decision Aid treatment, used to help patients make informed choices about their lung cancer treatment options, has been tested in a small group of patients and was found to increase awareness of treatment options and reduce concerns about costs and decision-making uncertainty. However, more studies are needed to fully understand its safety and effectiveness in clinical care. ^{1 2 3 4 5}

How does the decision aid treatment for lung cancer differ from other treatments?

The decision aid for lung cancer is unique because it focuses on helping patients make informed choices about their treatment options by providing personalized information and supporting shared decision-making with their doctors. Unlike traditional treatments that focus solely on medical interventions, this aid empowers patients to weigh the benefits and risks of different treatments, especially in non-curative settings where quality of life and potential side effects are significant considerations. ^{6 7 8 9 10}

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

Research shows that using decision aids for lung cancer treatment helps patients better understand their treatment options and reduces their uncertainty about making decisions. In a pilot study, patients using a decision aid expressed clear treatment preferences and had less concern about treatment costs. ^{1 2 4 6 11}

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]

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]

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]

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]

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]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

Pilot Study of an Encounter Decision Aid for Lung Cancer Screening. [2023]

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

Decision support systems for incurable non-small cell lung cancer: a systematic review. [2023]

4. Ireland pubmed.ncbi.nlm.nih.gov

Challenges for designing and implementing decision aids. [2007]

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

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

6. England pubmed.ncbi.nlm.nih.gov

Development and validation of a web-based patient decision aid for immunotherapy for patients with metastatic melanoma: study protocol for a multicenter randomized trial. [2021]

7. 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]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of a Personalized, Web-Based Decision Aid for Lung Cancer Screening. [2018]

9. England pubmed.ncbi.nlm.nih.gov

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

10. England pubmed.ncbi.nlm.nih.gov

The development of a decision aid to support Hodgkin lymphoma survivors considering lung cancer screening. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Development and testing of "Is Lung Cancer Screening for You?" A computer-based decision aid. [2023]