Decision-Making Support Tool for Lung Cancer
(iDECIDE Trial)
Recruiting in Palo Alto (17 mi)
+3 other locations
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.
12345Is 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.
12678How 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.
19101112Eligibility 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
+4 more
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (decision aid)Experimental Treatment2 Interventions
Patients review decision aid.
Group II: Group II (standard of care)Active Control2 Interventions
Patients receive standard of care.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
OHSU Knight Cancer InstitutePortland, OR
Portland VA Medical CenterPortland, OR
Hillsboro Medical CenterHillsboro, OR
Adventist Health PortlandPortland, OR
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Who Is Running the Clinical Trial?
OHSU Knight Cancer InstituteLead Sponsor
American Cancer Society, Inc.Collaborator
Oregon Health and Science UniversityCollaborator
References
Show me the roads and give me a road map: Development of a patient conversation tool to improve lung cancer treatment decision-making. [2023]Evidence-based decision support resources do not exist for persons with lung cancer. We sought to develop and refine a treatment decision support, or conversation tool, to improve shared decision-making (SDM).
Engaging Patients with Late-Stage Non-Small Cell Lung Cancer in Shared Decision Making about Treatment. [2021]Few treatment decision support interventions (DSIs) are available to engage patients diagnosed with late-stage non-small cell lung cancer (NSCLC) in treatment shared decision making (SDM). We designed a novel DSI that includes care plan cards and a companion patient preference clarification tool to assist in shared decision making. The cards answer common patient questions about treatment options (chemotherapy, chemotherapy plus immunotherapy, targeted therapy, immunotherapy, clinical trial participation, and supportive care). The form elicits patient treatment preference. We then conducted interviews with clinicians and patients to obtain feedback on the DSI. We also trained oncology nurse educators to implement the prototype. Finally, we pilot tested the DSI among five patients with NSCLC at the beginning of an office visit scheduled to discuss treatment with an oncologist. Analyses of pilot study baseline and exit survey data showed that DSI use was associated with increased patient awareness of the alternatives' treatment options and benefits/risks. In contrast, patient concern about treatment costs and uncertainty in treatment decision making decreased. All patients expressed a treatment preference. Future randomized controlled trials are needed to assess DSI implementation feasibility and efficacy in clinical care.
Evidence-based patient choice: a prostate cancer decision aid in plain language. [2018]Decision aids (DA) to assist patients in evaluating treatment options and sharing in decision making have proliferated in recent years. Most require high literacy and do not use plain language principles. We describe one of the first attempts to design a decision aid using principles from reading research and document design. The plain language DA prototype addressed treatment decisions for localized prostate cancer. Evaluation assessed impact on knowledge, decisions, and discussions with doctors in men newly diagnosed with prostate cancer.
Effectiveness of a Patient Education Class to Enhance Knowledge about Lung Cancer Screening: a Quality Improvement Evaluation. [2021]Best practices to facilitate high-quality shared decision-making for lung cancer screening (LCS) are not well established. In our LCS program, patients are first referred to attend a free group education class on LCS, taught by designated clinician specialists, before a personal shared decision-making visit is scheduled. We conducted an evaluation on the effectiveness of this class to enhance patient knowledge and shared decision-making about LCS. For quality improvement purposes, participants were asked to complete one-page surveys immediately before and after class to assess knowledge and decision-making capacity regarding LCS. To evaluate knowledge gained, we tabulated the distributions of correct, incorrect, unsure, and missing responses to eight true-false statements included on both pre- and post-class surveys and assessed pre-post differences in the number of correct responses. To evaluate decision-making capacity, we tabulated the distributions of post-class responses to items on decision uncertainty. From June 2017 to August 2018, 680 participants completed both pre- and post-class surveys. Participants had generally poor baseline knowledge about LCS. The proportion who responded correctly to each knowledge-related statement increased pre- to post-class, with a mean difference of 0.9 (paired t test, p
Decision making in oncology: a review of patient decision aids to support patient participation. [2022]Although cancer management is becoming more structured with disease-specific guidelines and clinical pathways, many decisions remain complex. Contributing to this complexity is the need to make value tradeoffs between benefits and harms across cancer treatment and/or screening options. Since there is no "best" option for everyone, decisions are defined as being of higher quality when informed with the latest scientific evidence and based on patients' informed values associated with outcomes of options. However, clinicians are not good judges of patients' values, and patients often have inadequate knowledge, unrealistic expectations, and decisional conflict that interfere with their involvement in decision making. Effective approaches to support patient involvement into clinical decisions include clinicians trained in shared decision making, question prompt sheets, patient decision aids, and decision coaching by nurses and other allied health professionals. Based on systematic review of 23 randomized trials of cancer patient decision aids, patients exposed to decision aids are more likely to participate in decision making and achieve higher-quality decisions. This review highlights key historical changes leading to patient involvement in decision making, summarizes evidence on effective interventions to support shared decision making, explores strategies to implement these interventions in oncology practices, and identifies future directions.
Adolescents' understanding of chemotherapy-related adverse events: a concept elicitation study. [2022]to document adolescents' understanding of chemotherapy-related core adverse events from the Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events and thus begin the validation process of this tool's items with Brazilian adolescents.
Low literacy impairs comprehension of prescription drug warning labels. [2022]Adverse events resulting from medication error are a serious concern. Patients' literacy and their ability to understand medication information are increasingly seen as a safety issue.
Development of a Plain Language Decision Support Tool for Cancer Clinical Trials: Blending Health Literacy, Academic Research, and Minority Patient Perspectives. [2022]Despite the promise of clinical trials for improving cancer care, less than 5% of all cancer patients participate. Racial/ethnic minorities continue to be underrepresented in cancer clinical trials (CCTs). To address this gap, we developed a plain language, web-based decision support tool (CHOICES DST) in English and Spanish to support decision-making about CCTs among Blacks and Hispanics. In phase 1 (information collection), we conducted qualitative interviews with 45 cancer patients, completed a thorough literature review, and reviewed results from a telephone survey of 1100 cancer patients. In phase 2 (content generation), we created the first iteration of the CHOICES DST. In phase 3 (usability testing), we gathered user experience and acceptability data from a small sample of cancer survivors (n = 9). The Knowledge, Empowerment, and Values Clarification (KEV) model of decision-making was developed based on data from phase 1. The KEV model and other phase 1 data allowed us to create the CHOICES DST platform. Usability testing of the CHOICES DST showed highly favorable responses from users, satisfaction with content, ease of navigation, and a desire to use the tool. Qualitative results identified addressable points that would benefit from content and navigation-related alterations. The final version of the CHOICES DST was well received and understood by Black and Hispanic participants, and adheres to the mandates for plain language communication. This research provides preliminary data that CHOICES DST holds promise for improving knowledge of CCTs and potentially improving informed decision-making about participation in trials.
Decision Support Tools for Low-Dose CT Lung Cancer Screening: A Scoping Review of Information Content, Format, and Presentation Methods. [2023]Several countries mandate informed or shared decision-making for low-dose CT (LDCT) lung cancer screening, but knowledge is limited about the type of information and presentation techniques used to support decision-making in practice. This review aimed to characterize the content, format, mode, and presentation methods of decision support tools (DSTs) for LDCT lung cancer screening. DSTs reported within peer-reviewed articles (January 2000-April 2021) were identified systematically from PubMed, PsycInfo, EMBASE, and CINAHL Plus. Inclusion criteria revolved around the development or evaluation of a resource or tool intended to support individual or shared decision-making for LDCT lung cancer screening. The data-charting and extraction framework was based on the International Patient Decision Aids Standards instrument and Template for Intervention Description and Reporting. Extracted data were organized within two categories: (1) study characteristics and context, format, and mode of DST use and (2) DST content and presentation methods. This review identified 22 DSTs in paper, video, or electronic formats across 26 articles. Most DSTs (n = 13) focused on knowledge exchange, whereas seven used interactive techniques to support values clarification (eg, Likert scales) and nine DSTs guided deliberation (eg, suggested discussion topics). The DSTs addressed similar topics, but the detail, quantification of probability, and presentation methods varied considerably. None described all the potential screening harms and results. The heterogeneity in DST design may affect the quality of decision-making, particularly for participants with lower literacy and numeracy. Evidence-based consensus guidelines for DST content and presentation methods should be developed collaboratively with screening-eligible adults.
Interactive Health Literacy and Symptom Self-management in Patients With Lung Cancer: A Critical Realist Analysis. [2023]Patients with lung cancer experience multiple symptoms requiring self-management. Little is known about how self-management is influenced by interactive health literacy, defined as communicating with healthcare providers to obtain and process information.
HELP - Heidelberg decision aid for lung cancer patients: a randomized controlled clinical trial. [2023]Shared decision-making (SDM), which increases the patient's well-being, adherence, and success of treatment, is becoming increasingly important in medicine and especially in oncology. To empower patients to participate more actively in consultations with their physicians decision aids have been developed. In non-curative settings, such as the treatment of advanced lung cancer, decisions differ substantially from the curative setting, as uncertain gains in terms of survival outcomes and quality of life have to be weighed against the severe side effects of treatment regimens. There is still a lack of tools developed and implemented for such specific settings in cancer therapy that support shared decision-making. The aim of our study is to evaluate the effectiveness of the HELP decision aid.
Aiding shared decision making in lung cancer screening: two decision tools. [2021]Shared decision making (SDM) preceding lung cancer screening is important for populations that are underrepresented in lung cancer screening trials. Current evidence-based guidelines; however, do not address personal risk and outcomes in underrepresented populations. This study compared two SDM decision aids (Option Grids and Shouldiscreen.com) for SDM efficacy, decision regret and knowledge.