Web-Based Application for Acute Leukemia

Overseen By Erin Gallagher

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Cognitive impairment, Minors, Prisoners, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study aims to test the Tools for Reducing Inequity in Acute Leukemia (TRIAL) web-based application that is designed to support participants with acute leukemia by providing information and resources about leukemia and clinical trial participation.

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 safety data exists for the Web-Based Application for Acute Leukemia treatment?

The web-based medical safety reporting system has been used in a large clinical trial to improve the efficiency and accuracy of reporting serious adverse events, which helps in monitoring safety. This system was successfully implemented in a trial for a different condition, showing its potential to enhance safety reporting in clinical trials. ^{1 2 3 4 5}

How does the Web-Based Application for Acute Leukemia treatment differ from other treatments?

The Web-Based Application for Acute Leukemia is unique because it uses electronic technologies to streamline the management of clinical trials, allowing for real-time data oversight and improved collaboration. This approach focuses on integrating digital tools to enhance the efficiency and effectiveness of trial operations, which is different from traditional methods that may not utilize such advanced technology. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment TRIAL Web-Based Application for acute leukemia?

The use of patient-reported outcomes (PROs) in leukemia, including acute leukemia, has been shown to provide valuable information for evaluating treatment effectiveness and improving patient care. Studies have demonstrated that electronic PROs can enhance communication with healthcare providers and improve the quality of patient assessments. ^{11 12 13 14 15}

Who Is on the Research Team?

Andrew Hantel, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 who are suspected of having acute leukemia and admitted to a DFCI-affiliated inpatient unit. They must understand and sign consent. Excluded are those unable to do in-person testing, previous alpha-testers, cognitively impaired individuals, non-consenting adults, minors, and prisoners.

Inclusion Criteria

English speaking

Ability to understand and willingness to sign written informed consent

Admitted to DFCI-affiliated inpatient unit

Exclusion Criteria

Inability to participate in in-person application testing

Patients who participated in alpha-testing through protocol 23-404 (Appendix A)

I am mentally capable of participating in a study according to my care team.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline and Application Access

Participants complete baseline visit and questionnaires, and access the web application over the course of 14 days

2 weeks

1 visit (in-person), continuous access to web application

End of Study

Participants complete end of study questionnaires and some participate in semi-structured interviews

1-2 weeks

1 visit (in-person or virtual)

Follow-up

Participants are monitored for retention and usability outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TRIAL Web-Based Application

Trial Overview The TRIAL study is evaluating a web-based application designed to help people with acute leukemia by providing educational resources and support about their condition and clinical trials.

How Is the Trial Designed?

Group I: TRIAL Web-Based Application Experimental Treatment 1 Intervention

Enrolled participants will complete: * Baseline visit and questionnaires * Access to web application over the course of 14 days. * End of study questionnaires * 12 participants will take part in semi-structured interviews with study staff which will be audio recorded.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

American Society of Clinical Oncology

Collaborator

Trials

40

Recruited

148,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A smartphone application was developed for prostate cancer patients to electronically report their health outcomes, which was evaluated by 21 patients and 10 specialists, showing a high user satisfaction score of 5.95 out of 7.

The application aims to enhance communication between patients and healthcare providers, improve quality of care, and facilitate timely data collection, potentially reducing unnecessary treatment visits and side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic patient-reported outcome (ePRO) application for patients with prostate cancer. Mohseni, M., Ayatollahi, H., Arefpour, AM.[2023]

In a study involving 398 patients with acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL), 64% responded to patient-reported outcomes (PRO) six months after diagnosis, revealing significant differences in quality of life between the two groups, with ALL patients experiencing more challenges.

18% of patients reported symptoms of depression, with one-third of those prescribed antidepressants, highlighting the need for improved psychological support in leukemia care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introducing patient-reported outcome in the acute leukemia quality registries in Sweden. Lennmyr, EB., Karlsson, K., Abrahamsson, M., et al.[2021]

Adverse event (AE) reporting in pediatric acute myeloid leukemia trials often underestimates the actual rates, with sensitivity for many AEs being less than 50%, indicating a need for improved reporting methods.

Using external electronic data sources, like Pediatric Health Information System (PHIS) billing and microbiology data, significantly enhances the accuracy of AE detection, particularly for specific toxicities such as viridans group streptococcal bacteremia, which showed high sensitivity and positive predictive value.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of Adverse Event Ascertainment in Clinical Trials for Pediatric Acute Myeloid Leukemia. Miller, TP., Li, Y., Kavcic, M., et al.[2020]

The ExtractEHR automated package effectively identified and graded laboratory adverse events in a cohort of 1,077 children with acute myeloid leukaemia and acute lymphoblastic leukaemia, demonstrating its scalability and accuracy in capturing adverse event rates.

The study found that ExtractEHR reported significantly higher rates of laboratory adverse events compared to those manually reported in clinical trials, suggesting that automated systems can enhance the understanding of chemotherapy risks in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rates of laboratory adverse events by course in paediatric leukaemia ascertained with automated electronic health record extraction: a retrospective cohort study from the Children's Oncology Group. Miller, TP., Getz, KD., Li, Y., et al.[2023]

The study highlights the importance of accurately reporting infectious adverse events (AEs) in children with acute lymphoblastic leukemia (ALL) to better manage safety and toxicity during clinical trials.

Key processes implemented in two phase III trials included targeted toxicity identification, specific case report forms for infections, and real-time physician review, which have shown preliminary improvements in the reporting of infectious AEs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving infectious adverse event reporting for children and adolescents enrolled in clinical trials for acute lymphoblastic leukemia: A report from the Children's Oncology Group. Elgarten, CW., Thompson, JC., Angiolillo, A., et al.[2023]

The electronic safety reporting (ESR) module significantly improved the efficiency and consistency of reporting serious adverse events in a large multicenter clinical trial, processing 397 reports and submitting 33 FDA MedWatch reports.

By integrating safety and efficacy data within the same database, the ESR module streamlined the reporting process, reducing redundant data entry and enhancing the overall management of clinical trial data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A web-based medical safety reporting system for a large multicenter clinical trial: the ALIAS experience. Zhao, W., Waldman, BD., Dillon, C., et al.[2021]

The Chemo Assist for Children (CAC) mHealth application was developed to help parents manage chemotherapy-related symptoms in children with acute lymphoblastic leukemia (ALL), based on a thorough needs assessment and usability testing.

Usability evaluations showed that the CAC application is valid and accessible, effectively enabling parents to identify and manage symptoms, thereby improving communication with healthcare providers and enhancing the independence of symptom management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemo assist for children mobile health application to manage chemotherapy-related symptoms in acute leukemia in Indonesia: a user-centered design approach. Novrianda, D., Herini, ES., Haryanti, F., et al.[2023]

A scoping review identified 14 articles detailing nine Internet-based health technologies designed to help children undergoing chemotherapy report their health problems, highlighting the growing importance of digital tools in pediatric oncology.

Successful health applications for children, such as SPARK and Empower Stars!, are developed using theoretical foundations and rigorous testing, ensuring they meet user needs and enhance patient engagement during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Evaluation of Internet-based Health Technology in Pediatric Oncology: A Scoping Review. Novrianda, D., Haryanti, F., Supriyadi, E., et al.[2022]

Citations

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

Electronic patient-reported outcome (ePRO) application for patients with prostate cancer. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

A new internet-based tool for reporting and analysing patient-reported outcomes and the feasibility of repeated data collection from patients with myeloproliferative neoplasms. [2018]

3. Ireland pubmed.ncbi.nlm.nih.gov

Patient-facing cancer mobile apps that enable patient reported outcome data to be collected: A systematic review of content, functionality, quality, and ability to integrate with electronic health records. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Introducing patient-reported outcome in the acute leukemia quality registries in Sweden. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Health-related quality of life and symptom assessment in randomized controlled trials of patients with leukemia and myelodysplastic syndromes: What have we learned? [2022]

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

Accuracy of Adverse Event Ascertainment in Clinical Trials for Pediatric Acute Myeloid Leukemia. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Rates of laboratory adverse events by course in paediatric leukaemia ascertained with automated electronic health record extraction: a retrospective cohort study from the Children's Oncology Group. [2023]

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

Improving infectious adverse event reporting for children and adolescents enrolled in clinical trials for acute lymphoblastic leukemia: A report from the Children's Oncology Group. [2023]

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

A web-based medical safety reporting system for a large multicenter clinical trial: the ALIAS experience. [2021]

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Adverse event reporting in publications compared with sponsor database for cancer clinical trials. [2007]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Streamlined Operational Approaches and Use of e-Technologies in Clinical Trials: Beat Acute Myeloid Leukemia Master Trial. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Chemo assist for children mobile health application to manage chemotherapy-related symptoms in acute leukemia in Indonesia: a user-centered design approach. [2023]

13. Thailand pubmed.ncbi.nlm.nih.gov

Development and Evaluation of Internet-based Health Technology in Pediatric Oncology: A Scoping Review. [2022]

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

Internet for clinical trials: past, present, and future. [2019]

15. England pubmed.ncbi.nlm.nih.gov

Implementing a low-cost web-based clinical trial management system for community studies: a case study. [2015]