Minimize Cancer Treatment’s Debilitating Side Effects

NCI has announced several funding opportunities that align with the Cancer Moonshot.

Cancer patients often experience unpleasant side effects that contribute to lower quality of life, lead to costly emergency visits to the hospital, and can cause treatment delays or non-adherence to a therapy.

Poorly controlled symptoms increase risks for cancer recurrence, poor outcomes, and the likelihood of a patient not being able to return to work. Also, patients from racial/ethnic minority groups, older age groups, and underserved populations often experience worse side effects, have significant delays in or stop adhering to treatment, and have less access to symptom management approaches.

Improving patients’ quality of life and the likelihood that they will adhere to treatments that are effective, rather than abandoning them because of intolerable side effects, will require systematically gathering patient-reported outcomes data and evidence-based symptom management data for patients from diverse populations.

This recommendation supports research to accelerate the implementation of guidelines for routine monitoring and management of patient-reported symptoms in all populations. This research includes the development of symptom management systems and databases of patient-reported symptoms that will be used to determine the best approaches for symptom control and supportive care. Since patients at different points on the cancer continuum have different needs, the research will be applicable to patients from diagnosis through to survivorship or end-of-life.

The ultimate goal of this symptom management research is to reduce harmful symptoms experienced by cancer patients and decrease cancer care costs related to poorly controlled symptoms.

NCI currently has awarded funding opportunities that align with the recommendation to address treatment side effects:

Analyzing and Interpreting Clinician and Patient Adverse Event Data to Better Understand Tolerability

NCI has created a network of multidisciplinary teams that is developing new methods for collecting and analyzing patient-reported outcomes in the setting of cancer clinical trials, including the Patient-Reported Outcomes version of the CTCAE (PRO-CTCAE), as well as other patient reported outcome (PRO) data, such as health related quality of life data. This information will help researchers, clinicians, and patients understand the symptomatic side effects of cancer treatments. The multidisciplinary teams include data scientists, clinical researchers, and experts in patient-reported data. The teams are addressing the current limitations of clinician-reported side effects, including a lack of data about the trajectory of symptomatic side effects of treatment and the under-reporting of the onset and severity of these symptomatic side effects.

Projects in the network are leveraging patient reported data from existing trials and will seek to establish proof-of-principle for a range of methodologies for analyzing and interpreting PRO-CTCAE data. Findings from this project will shed light on the degree to which patients tolerate different cancer treatments.

Improving the Management of symPtoms during and following Cancer Treatment (IMPACT)

This collaborative research consortium is evaluating and the implementation of systematic symptom management in cancer care delivery to guide efforts on the improvement of symptom control for cancer patients during and following treatment. Research centers within this network are deploying integrated symptom monitoring and management systems in a group of clinical practices and testing the effects of those systems on patient outcomes, cancer treatment delivery, and healthcare utilization using randomized designs. The consortium is specifically focused on accelerating the adoption of systems that collect patient-reported symptom data and use these data to trigger a clinical response consistent with evidence-based guidelines. The goals of IMPACT are determining the best models for implementing symptom management approaches, understanding the utility of using systems to reduce the harmful effects of poorly controlled symptoms in cancer patients, and building a foundation for the development of effective symptom management tools in routine clinical care.

Graft-Versus-Host Disease (GVHD) Symptom Management

Chronic graft-versus-host disease (GVHD) is a major complication that can occur after a transplant of stem cells from the blood, which is often used to treat blood cancers. In GVHD, the stem cells from a donor (or the graft), attack the healthy tissues of the recipient patient (or host). Pediatric cancer patients can develop GVHD. However, there currently is no pediatric patient reported outcome measure of GVHD symptoms. Researchers with NCI’s Center for Cancer Research are developing a pediatric chronic symptom scale (PCSS) for GVHD to improve the way that GVHD symptoms are understood and managed. These studies are providing new tools and insights that can be used to accelerate research for reducing and preventing pediatric GVHD.

Projects Awarded Cancer Moonshot Funding to Address Symptom Management

Awarded Projects

ENLARGE

Funding Opportunity	Project Title	Institution	Principal Investigator(s)
Analyzing and Interpreting Clinician and Patient Adverse Event Data to Better Understand Tolerability (U01)	Analyzing and Interpreting PRO-CTCAE with CTCAE and Other Clinical Data to Characterize Drug Tolerability	University of North Carolina at Chapel Hill	Basch, Ethan M; Dueck, Amylou C
	Analysis of ECOG-ACRIN Adverse Event Data to Optimize Strategies for the Longitudinal Assessment of Tolerability in the Context of Evolving Cancer Treatment Paradigms (EVOLV)	Dana-Farber Cancer Institute	Gray, Robert J; Wagner, Lynne I
	Understanding Treatment Tolerability in Older Patients with Cancer	University of Rochester	Mohile, Supriya G
	Advancing Analysis and Interpretation of Adverse Events and PROs in Cancer Clinical Trials	Cedars-Sinai Medical Center	Rogatko, Andre; Ganz, Patricia A
Research Centers for Improving Management of Symptoms Across Cancer Treatments (IMPACT) (UM1)/td>	Implementation and Evaluation of an Expanded Bilingual Electronic Symptom Management Program across a Multi-site, Fully-integrated Comprehensive Cancer Center	Northwestern University	Cella, David
	Enhanced, EHR-facilitated Cancer Symptom Control (E2C2) Pragmatic Clinical Trial	Mayo Clinic Rochester	Chebille, Andrea Lynne
	SIMPRO Research Center: Integration and Implementation of PROs for Symptom Management in Oncology Practice	Dana-Farber Cancer Institute	Schrag, Deborah; Osarogiagbon, Raymond U; Wong, Sandra L
Coordinating Center for Improving Management of Symptoms Across Cancer Treatments (IMPACT) (U24)	Coordinating Center for Research Centers for Improving Management of Symptoms During and Following Cancer Treatment	Research Triangle Institute	Kroner, Barbara L