Decision Support Tool for Blood Cancers

(DISCOVERY Trial)

Overseen By Mireille L Leone

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: Dementia, Psychiatric condition, 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: Unknown

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool called PRIME (Preference Reporting to Improve Management and Experience) to assist people with blood cancers in making better treatment decisions. The PRIME tool combines patients' priorities with personalized advice for both patients and doctors. Participants will either use this new tool or receive usual care to determine its impact on treatment choices. The study seeks individuals who are new patients at a clinic for blood cancers or bone marrow transplants and are 60 years or older. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance decision-making 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's best to discuss this with the study team or your doctor.

What prior data suggests that the PRIME Decision Support Tool is safe?

Research has shown that the PRIME tool (Preference Reporting to Improve Management and Experience) aids patients and doctors in making better decisions about blood cancer treatments. This tool emphasizes understanding what patients value most in their treatment options, using electronic methods to guide these decisions.

As a decision support tool rather than a medical treatment, PRIME poses no risk of physical side effects or adverse reactions. It aims to enhance communication and ensure that patients' treatment choices align with their preferences.

In summary, PRIME is safe because it doesn't involve medication or procedures. It simply facilitates more effective collaboration between patients and doctors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PRIME intervention for blood cancers because it focuses on improving patient management and experience through preference reporting. Unlike standard treatments that primarily focus on medical and clinical outcomes, PRIME emphasizes patient preferences and experiences, potentially leading to more personalized and satisfactory care. This approach could transform how care decisions are made, offering a more holistic strategy that integrates patients' voices directly into their treatment plans.

What evidence suggests that the PRIME Decision Support Tool is effective for blood cancers?

Research has shown that tools like the PRIME intervention, which participants in this trial may receive, are appreciated by many patients with blood cancers. These tools help patients feel more involved in choosing their treatments, ensuring decisions align with their personal values. For example, a review of studies found that decision aids increase patient involvement and satisfaction. Additionally, online tools have effectively provided personalized risk information, helping patients understand their choices better. This evidence suggests that PRIME could assist patients in making treatment decisions that align with their preferences and needs. ^{1 6 7 8 9}

Who Is on the Research Team?

Daniel R Richardson, MD, MA, MSc

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

Dementia, altered mental status, or psychiatric condition that would prohibit the understanding or rendering of informed consent or participation in the intervention

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Preference Reporting to Improve Management and Experience (PRIME)

Trial Overview

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.

How Is the Trial Designed?

Group I: PRIME intervention Experimental Treatment 1 Intervention

Receive the PRIME intervention.

Group II: Usual Care Active Control 1 Intervention

Receive usual care.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A study involving 26 participants (18 AML patients and 8 caregivers) developed a tool to measure patient preferences for AML treatment, highlighting that complete remission is the most valued outcome, followed by event-free survival.

The mixed-methods approach to patient-focused drug development (PFDD) was well-received, indicating strong support for implementing this preference study in a national survey to better understand patient and caregiver experiences with AML.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing an instrument to assess patient preferences for benefits and risks of treating acute myeloid leukemia to promote patient-focused drug development. Seo, J., Smith, BD., Estey, E., et al.[2022]

A systematic review of 15 studies found that Decision Support Systems (DSS) were effective in reducing worst and usual pain scores for cancer patients, indicating some benefit in symptom management during and after treatment.

However, DSS interventions showed mixed results for improving overall health-related outcomes like quality of life and depression, highlighting the need for better evaluation methods to understand their full impact on patient-reported outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of cancer clinical decision support systems on patient-reported outcomes: A systematic review. Pitt, E., Bradford, N., Robertson, E., et al.[2023]

Most oncologists lack experience with patient-reported outcome (PRO) measures but recognize their value in assessing patient symptoms and treatment responses, especially in advanced or incurable diseases and palliative care.

Challenges such as unfamiliarity with PRO measures, overwhelming data, unclear meaningful changes in scores, and lack of standardization hinder oncologists' ability to effectively use PRO data in clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploration of oncologists' attitudes toward and perceived value of patient-reported outcomes. Meldahl, ML., Acaster, S., Hayes, RP.[2021]

A survey of primary care providers and cancer patients revealed that most providers (79.2%) do not currently use an oncologist selection tool, but a majority (77.3%) are open to using one to help direct patients to high-quality oncologists.

Patients value referrals from their primary care providers (52.7% rated it as very important) and show interest in using oncologist selection tools, with 65.2% indicating it would be somewhat or very important for their decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Provider and patient insights into the cancer care journey. McLarty, S., Johnson, KA., Francis, EA., et al.[2022]

In a study of 104 patients with ALK+ non-small-cell lung cancer, those treated with ALK tyrosine kinase inhibitors (TKIs) reported better health-related quality of life (HRQoL) and were more likely to be employed, highlighting the importance of effective treatment in managing symptoms and maintaining daily activities.

Key patient concerns included the impact of symptoms like fatigue and disturbed sleep on their work and daily life, emphasizing the need for treatments that not only prolong survival but also improve overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Humanistic burden of living with anaplastic lymphoma kinase-positive non-small-cell lung cancer: findings from the ALKConnect patient insight network and research platform. Lin, HM., Pan, X., Biller, A., et al.[2022]

The study aims to develop an electronic health care tool (EHT) that utilizes discrete choice experiments (DCE) and best-worst scaling (BWS) to capture patient preferences in treatment decisions for hematologic malignancies, enhancing shared decision-making between patients and healthcare providers.

Through a mixed methods approach involving healthy volunteers and patient-caregiver pairs, the study evaluates the usability and cognitive workload of the EHT prototypes, which will ultimately inform the design of tools that better align treatment options with patient preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Patient-Centered Preference Tool for Patients With Hematologic Malignancies: Protocol for a Mixed Methods Study. Cole, A., Richardson, DR., Adapa, K., et al.[2022]

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]

The implementation of a decision support tool (DST) for cancer treatment showed little effect on overall survival (OS) among 1,059 patients with breast, colorectal, and lung cancer, indicating that process improvements may not lead to better patient outcomes.

Despite high adherence to evidence-based treatment recommendations (over 90% after DST implementation), the largest survival benefit observed was only 1.7 months for lung cancer patients, suggesting that existing treatment practices were already effective prior to the DST's introduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival After Implementation of a Decision Support Tool to Facilitate Evidence-Based Cancer Treatment. Ojha, RP., Lu, Y., Narra, K., et al.[2023]

Adverse event reporting in hematology clinical trials is currently done manually, leading to significant underreporting, especially in phase III trials, which can obscure the true safety profile of treatments for clinicians and patients.

Recent studies are exploring innovative methods, such as automated data extraction from electronic health records and alert systems, to improve the accuracy and comprehensiveness of adverse event reporting, enhancing our understanding of treatment toxicities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolution of Hematology Clinical Trial Adverse Event Reporting to Improve Care Delivery. Miller, TP., Aplenc, R.[2021]

The study involved 77 patients with acute myeloid leukemia who used an electronic tablet-based questionnaire to express their treatment goals and preferences before meeting with their physician, demonstrating that this method is feasible and efficient for gathering patient insights.

A significant majority of patients (97.4%) aimed to eliminate cancer and prioritize feeling better and living longer, highlighting the importance of understanding patient goals in tailoring treatment discussions and decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Goals, preferences, and concerns of patients with acute myeloid leukemia at time of treatment decision. Jamy, OH., Dudley, WN., Dudley, LS., et al.[2023]

A survey conducted at the 6th international hematologic malignancies conference in Beijing revealed strong geographical concordance in the approaches to hematologic diseases among physicians in the Asia Pacific region, indicating a shared understanding of best practices.

However, the study also identified a consistent 15% divergence in responses between Chinese physicians and those from other countries, highlighting the need for ongoing education and knowledge assessment to address these gaps and improve treatment standards.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hematology oncology practice in the Asia-Pacific APHCON survey results from the 6th international hematologic malignancies conference: bridging the gap 2015, Beijing, China. Huang, XJ., Liu, K., Ritchie, D., et al.[2023]

A review of 209 lung cancer phase I and II trials presented at the American Society for Clinical Oncology meetings from 2017 to 2019 revealed significant variability in how adverse events (AEs) were reported, with six different thresholds for reporting AEs of any grade.

Treatment-related AEs were reported twice as often as treatment-emergent AEs, and there was a lack of clear definitions for critical terms like dose-limiting toxicity and serious AEs, highlighting the need for standardized reporting methods to improve data comparability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variation in Toxicity Reporting Methods for Early Phase Lung Cancer Treatment Trials at Oncology Conferences. Simons, EA., Smith, DE., Gao, D., et al.[2021]

The implementation of a risk assessment tool for chemotherapy-induced neutropenia (CIN) in a community oncology practice significantly reduced the frequency of complications such as febrile neutropenia, IV antibiotic use, and hospitalizations among patients treated with chemotherapy.

Patients identified as high-risk for CIN were effectively managed with colony-stimulating factor (CSF) support from the first chemotherapy cycle, demonstrating the tool's efficacy in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and implementation of a risk assessment tool for chemotherapy-induced neutropenia. Donohue, R.[2019]

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