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

Trial Summary

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. ^{1 2 3 4 5}

Is 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. ^{5 6 7 8 9}

How 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. ^{8 10 11 12 13}

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.

Research Team

Daniel R Richardson, MD, MA, MSc

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Eligibility 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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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 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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Exploration of oncologists' attitudes toward and perceived value of patient-reported outcomes. [2021]

2. Scotland pubmed.ncbi.nlm.nih.gov

The effects of cancer clinical decision support systems on patient-reported outcomes: A systematic review. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Decision making in oncology: a review of patient decision aids to support patient participation. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Survival After Implementation of a Decision Support Tool to Facilitate Evidence-Based Cancer Treatment. [2023]

5. England 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Evolution of Hematology Clinical Trial Adverse Event Reporting to Improve Care Delivery. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Variation in Toxicity Reporting Methods for Early Phase Lung Cancer Treatment Trials at Oncology Conferences. [2021]

8. Canada pubmed.ncbi.nlm.nih.gov

Development of a Patient-Centered Preference Tool for Patients With Hematologic Malignancies: Protocol for a Mixed Methods Study. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

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

10. United States pubmed.ncbi.nlm.nih.gov

Provider and patient insights into the cancer care journey. [2022]

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

Goals, preferences, and concerns of patients with acute myeloid leukemia at time of treatment decision. [2023]

12. United States 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. [2023]

13. England 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. [2022]