A peer navigation model that addresses barriers in diverse participation and aims to boost enrollment in childhood cancer therapeutic clinical trials is underway, and one of the study researchers presented on the model at the 66th American Society of Hematology Annual Meeting & Exposition, held recently in San Diego, CA.1
Informed consent is essential for clinical trials, as it ensures that participants understand the potential risks and benefits of participating in a therapeutic study. For parents of children with cancer, however, the process can be daunting, and this is particularly true in populations where low health literacy and language barriers can hinder participants’ ability to properly understand and fill out informed consent documents.
Studies have shown that Hispanic patients whose primary language is not English particularly struggle to fully understand the information provided by informed consent documents. One study conducted at Rady Children's Hospital San Diego showed that many Spanish-speaking parents felt clinical trial participation information is overly complex and that they needed more time to process the details before signing consent forms. Parents whose children have cancer and whose primary language is not English have noted that, although interpreters are often available, the process can feel rushed and does not provide enough opportunity for them to ask questions or seek clarification.
In response to these challenges, Paula Aristizabal, MD, MAS, a pediatric hematologist/oncologist at Rady Children’s Hospital-San Diego/associate professor at the University of California San Diego, and her research team developed a peer navigation intervention known as the Childhood Malignancy Peer Research Navigation (Comprendo) program. This program pairs trained parent navigators—individuals who have experienced similar challenges with their own children’s cancer care—with parents who are newer to the experience, with the intention to guide these families through the informed consent process for childhood cancer clinical trials.
Aristizabal noted that, in addition to helping the parents who are newer to clinical trial experience overcome barriers like health literacy, language, and cultural barriers, the peer navigators serve as trusted guides for families, helping them understand the complex language of clinical trials and offering much needed emotional support during this stressful time. The intervention trains the navigators in motivational interviewing techniques, ensuring that navigators are equipped to engage families in a way that fosters decision-making and understanding of complex medical concepts.
The pilot study enrolled more than 140 parents and their children across several healthcare settings and randomly assigned them to the intervention or usual care. Findings from the study have been promising, Aristizabal noted, with parents in the intervention demonstrating higher comprehension of documents compared with those who were in the standard-of-care group. Parent satisfaction with the intervention was high, especially among Hispanic families, with many parents praising the peer navigators for their ability to break down complex concepts and provide reassurance.
The intervention also had a positive impact on the clinical staff, with healthcare providers noting the parents who participated in the Comprendo intervention were better prepared for the informed consent discussion, leading to more efficient and productive interactions.
“Everyone was on board with the intervention, and importantly, they felt that there was a new alliance between navigators and clinicians,” Aristizabal said during the session. “The parents perceived that they had a lot of guidance and support from the navigators that they didn’t have in the past.”
Building on the success of the pilot study, the Comprendo intervention is now being expanded into a multisite randomized controlled trial at 4 hospitals across the United States. The Comprendo team, which includes researchers from institutions such as UCSF Benioff Children’s Hospital in San Francisco, Dana-Farber Cancer Institute in Boston, and the University of Alabama, is working to enroll about 400 parents of Hispanic children and refine the intervention to ensure that it is accessible and beneficial to a broader population.
According to the study’s description, “A mixed methods (surveys, individual interviews) implementation evaluation will examine implementation factors that can inform the use of peer navigation in clinical practice, integrating data from clinicians, navigators, administrators, and parents before and after the randomized control trial.” The study aimed to assess the feasibility, acceptability, and impact of the intervention, with a particular focus on Hispanic families who face additional challenges related to language and health literacy.
Aristizabal closed her presentation by stating that strategies to encourage clinical trial participation be tailored to specific settings—because navigators practice in different hospitals—and that these strategies should also address structural barriers identified in the study design.
“Training focused on patient-provider communication is extremely important, and the development of cultural, linguistic, and concordant tools, and having a staff that also is bilingual at the patient level, can help build trust,” she said.
Reference
- Aristizabal P. Achieving equity and inclusion in clinical trial enrollment: challenges and opportunities. Presented at: 66th ASH Annual Meeting & Exposition. December 7-10, 2024; San Diego, CA.