In recent years, research on the experiences of people with cancer during and after treatment has expanded. Clinical trials don’t just study whether a treatment is effective against a disease, but they also report on patients’ experience of side effects and their quality of life while in treatment. These outcomes are considered when researchers look at whether a trial is successful and whether a drug should move forward to further trials or approval.
In clinical trials in childhood cancers, researchers often collect data about the effects of an experimental drug on the cancer and on other organs in the body. Measuring and reporting on the child’s quality of life and other aspects of their experience has not been routinely documented.
A new study published in the journal Cancer addresses this issue. It provides evidence that it is both feasible and beneficial to incorporate children’s descriptions of their experiences into clinical trial results.
Considering children’s experiences in clinical trials
Researchers at Children’s National Health System in Washington, DC, conducted interviews with children and adolescents with cancer ranging in age from 8 to 18 who were already participating in early-stage clinical trials. They asked these children questions about their symptoms and experiences with cancer, treatment and side effects, as well as questions about their experience of being part of a clinical trial and the impact of participating in the trial on their lives.
Most of the children reported that participating in a trial was a generally positive experience. But they also reported that side effects of treatments, interruptions to their usual schedules, and having to spend time away from their families and friends to be at the hospital negatively affected their lives.
While the study only had a small number of participants, the researchers were able to show that asking children directly about their experiences was a feasible and reliable way to collect quality of life information. Researchers could add questions about quality of life to children’s trials to help doctors learn more how children are affected by the treatments they are receiving.
Incorporate children’s experiences to improve quality of life
Doctors can only take steps to manage symptoms and side effects or address quality of life issues when they know what their patients are experiencing. It has not been common practice in clinical trials to formerly ask children directly about their experiences, side effects and quality of life and track their responses during the study. Yet, this information can be very important in deciding whether a new drug should be approved for treatment.
This new study gives children a voice during the clinical trial experience. It shows that children and adolescents can reliably tell their health care providers about their experiences during a trial. By knowing their experiences, doctors can address the issues the children are experiencing and improve their quality of life during a challenging time for both the children and their families.
Eileen Hoftyzer, BSc and Carolyn Goard, PhD