Decision Support Tool for Blood Cancers
(DISCOVERY Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: UNC Lineberger Comprehensive Cancer Center
Disqualifiers: Dementia, Psychiatric condition, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?The purpose of this study is to evaluate whether a novel decision support tool called PRIME (Preference Reporting to Improve Management and Experience), which combines values-elicitation with tailored feedback to patients and providers, improves patient-reported values-concordance of initial treatment decisions compared to usual care.
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's best to discuss this with the study team or your doctor.
What data supports the effectiveness of the PRIME Decision Support Tool for blood cancers?
Research shows that decision support tools can help patients make better-informed decisions about their cancer treatment, leading to higher-quality decisions and improved patient involvement. While specific data on the PRIME tool is not available, similar tools have been shown to enhance patient participation and decision-making in cancer care.
12345Is the Decision Support Tool for Blood Cancers safe for humans?
The available research does not provide specific safety data for the Decision Support Tool for Blood Cancers or its related names. The studies focus on patient preferences and adverse event reporting in clinical trials, but do not directly address the safety of this tool in humans.
56789How does the Decision Support Tool for Blood Cancers treatment differ from other treatments?
The Decision Support Tool for Blood Cancers is unique because it focuses on aligning chemotherapy choices with patient preferences, using tools like discrete choice experiments and best-worst scaling to quantify what outcomes patients value most. This approach emphasizes shared decision-making, which is not typically a focus of standard treatments.
810111213Eligibility Criteria
This trial is for adults aged 60 or older who are new to the hematology/oncology clinic and need treatment decisions for conditions like lymphoma, leukemia, or multiple myeloma. Participants must be able to understand the study and give consent.Inclusion Criteria
Written or verbal informed consent obtained to participate in the study and HIPAA authorization for the release of personal health information
I am 60 years old or older.
I am a new patient at the clinic for blood cancers or bone marrow transplant.
+1 more
Exclusion Criteria
Dementia, altered mental status, or psychiatric condition that would prohibit the understanding or rendering of informed consent or participation in the intervention
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Intervention
Participants are randomized to receive decision support with PRIME or usual care prior to their first visit with their oncologist
Up to 24 months
Follow-up
Participants are monitored for the effectiveness of the PRIME tool in improving values-concordance of treatment decisions
Up to 24 months
Participant Groups
The DISCOVERY trial is testing PRIME, a decision support tool designed to help patients with blood cancers make treatment choices that align with their personal values by providing feedback to both patients and doctors.
2Treatment groups
Experimental Treatment
Active Control
Group I: PRIME interventionExperimental Treatment1 Intervention
Receive the PRIME intervention.
Group II: Usual CareActive Control1 Intervention
Receive usual care.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Lineberger Comphrehensive Cancer Center at University of North CarolinaChapel Hill, NC
Loading ...
Who Is Running the Clinical Trial?
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Exploration of oncologists' attitudes toward and perceived value of patient-reported outcomes. [2021]To understand oncologists' attitudes toward patient-reported outcome (PRO) measures and to learn how PRO data influence their clinical decision-making.
The effects of cancer clinical decision support systems on patient-reported outcomes: A systematic review. [2023]The implementation of high-quality decision-making support are integral to ensuring the delivery of quality cancer care and subsequently achieving positive patient outcomes. Decision Support Systems (DSS) are increasingly used, however it is not known what the effects are beyond supporting the decision-making process. We aimed to identify and synthesize the available literature regarding the effects of DSS on patient-reported outcomes both during and after cancer treatment.
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.
Survival After Implementation of a Decision Support Tool to Facilitate Evidence-Based Cancer Treatment. [2023]Decision support tools (DSTs) to facilitate evidence-based cancer treatment are increasingly common in care delivery organizations. Implementation of these tools may improve process outcomes, but little is known about effects on patient outcomes such as survival. We aimed to evaluate the effect of implementing a DST for cancer treatment on overall survival (OS) among patients with breast, colorectal, and lung cancer.
Developing an instrument to assess patient preferences for benefits and risks of treating acute myeloid leukemia to promote patient-focused drug development. [2022]Objective Acute myeloid leukemia (AML) is a progressive blood cancer with few effective treatment options. As part of a patient-focused drug development (PFDD) initiative led by the Leukemia and Lymphoma Society (LLS), this study sought to use a community-centered approach to develop and pilot an instrument to measure patient preferences for the benefits and risks of treating AML. Methods Instrument development was informed by a literature review, engagement with expert stakeholders (n = 12), engagement with community stakeholders, and pre-testing. A discrete-choice experiment (DCE), in which participants made choices between 16 pairs of hypothetical treatments, was developed with five attributes: event-free survival, complete remission, time in hospital, short-term side-effects, and long-term side-effects. A pilot test was conducted and analyzed using conditional logistic regression. Results are presented using relative attribute importance (RAI) scores. Results Patients with AML and caregivers were engaged in developing (n = 15), pre-testing (n = 13), and pilot testing (n = 26) the instrument. The pilot included patients with AML (n = 18) and caregivers of living or deceased patients with AML (n = 8). Participants had a mean age of 50 years (range =24-81), and were mostly college educated (n = 22), privately insured (n = 21), and employed (n = 13). Based on the DCE, complete remission was identified as the most important attribute (RAI =10), followed by event-free survival (3.7), time in hospital (2.8), long-term side-effects (2.3), and short-term side-effects (2.1). Conclusion The mixed-methods approach to PFDD was welcomed by all stakeholders and there was strong endorsement to implement this DCE as part of a national survey. Key points for decision makers The Leukemia and Lymphoma Society (LLS) initiated an independent effort to promote patient-focused drug development (PFDD). This study presents the development and piloting of a preference study as a first step in this initiative. Results of this pilot study were used to guide a PFDD meeting to discuss the lived experience of patients and caregivers affected by AML. Productive engagement by all patients, caregivers, and stakeholders throughout the process resulted in strong endorsement of the project's approach and recognition of the need to conduct a national study.
Evolution of Hematology Clinical Trial Adverse Event Reporting to Improve Care Delivery. [2021]Reporting of adverse events on hematology clinical trials is crucial to understanding the safety of standard treatments and novel agents. However, despite the importance of understanding toxicities, challenges in capturing and reporting accurate adverse event data exist.
Variation in Toxicity Reporting Methods for Early Phase Lung Cancer Treatment Trials at Oncology Conferences. [2021]Phase I and II trials provide the initial human safety and tolerability data for new drugs. Nevertheless, the methods for presenting toxicity data are not standardized. Clinicians often first encounter these data at professional conferences. We sought to characterize how the burden of adverse events (AEs) is reported at the largest professional conference in clinical oncology.
Development of a Patient-Centered Preference Tool for Patients With Hematologic Malignancies: Protocol for a Mixed Methods Study. [2022]The approval of novel therapies for patients diagnosed with hematologic malignancies have improved survival outcomes but increased the challenge of aligning chemotherapy choices with patient preferences. We previously developed paper versions of a discrete choice experiment (DCE) and a best-worst scaling (BWS) instrument to quantify the treatment outcome preferences of patients with hematologic malignancies to inform shared decision making.
Development and implementation of a risk assessment tool for chemotherapy-induced neutropenia. [2019]To evaluate a tool developed and implemented to help practitioners assess the risk of chemotherapy-induced neutropenia (CIN) and its complications in patients with nonleukemia cancer types.
Provider and patient insights into the cancer care journey. [2022]To assess provider and patient preferences for an oncologist selection tool, value-based care, involvement in cancer care, and end-of-life planning.
Goals, preferences, and concerns of patients with acute myeloid leukemia at time of treatment decision. [2023]Current cancer value-based models require documentation of patient goals of care and an evidence-based treatment course commensurate with patient goals. This feasibility study assessed the utility of an electronic tablet-based questionnaire to elicit patient goals, preferences, and concerns at a treatment decision making time point in patients with acute myeloid leukemia.
Hematology oncology practice in the Asia-Pacific APHCON survey results from the 6th international hematologic malignancies conference: bridging the gap 2015, Beijing, China. [2023]This report serves as a snapshot of the state-of-knowledge in the Asia Pacific (APAC) Hematology Oncology community, and establishes a baseline for longitudinal investigations to follow changes in best practices over time. The objective of this study was to understand the approach to hematologic diseases, common standards of care and best practices, issues that remain controversial or debated, and educational or resource gaps that warrant attention. We used mobile application to disseminate and distribute questionnaires to delegates during the 6th international hematologic malignancies conference hosted by the APAC Hematology Consortium at Beijing, China. User responses were collected in an anonymous fashion. We report survey results in two ways: the overall responses, and responses as stratified between Chinese physicians and "Other" represented nationalities. Overall geographical concordance in survey responses was positive and strong. Perhaps more interesting than instances of absolute agreement, these data provide a unique opportunity to identify topics in which physician knowledge or opinions diverge. We assigned questions from all modules to broad categories of: patient information; diagnosis; treatment preference; transplantation; and general knowledge/opinion. On average, we observed a geographic difference of 15% for any particular answer choice, and this was fairly constant across survey modules. These results reveal utility and need for widespread and ongoing initiatives to assess knowledge and provide evidence-based education in real time. The data will be made more valuable by longitudinal participation, such that we can monitor changes in the state of the art over time.
Humanistic burden of living with anaplastic lymphoma kinase-positive non-small-cell lung cancer: findings from the ALKConnect patient insight network and research platform. [2022]Evaluate real-world patient preferences, experiences and outcomes (health-related quality of life [HRQoL]) from patients with anaplastic lymphoma kinase-positive (ALK+) non-small-cell lung cancer (NSCLC) utilizing the ALKConnect Patient Insight Network.