A collaborative virtual clinical trial will study the effectiveness of two digital therapeutics. Both digital therapeutics are anticipated to have an impact on mental and physical health when used adjunctively with multidisciplinary oncology care regimens.
The goal of the joint trial is to maximize recruitment efforts with patients experiencing cancer-related distress and who may benefit from a fully virtual trial, including home-based subjects who can’t or wouldn’t want to travel to a trial site. This will allow access to patient populations that have been underrepresented in traditional site-based clinical studies. The decentralized clinical trial (DCT) model ensures more diverse studies because unique populations – which typically are underrepresented in clinical trials – can be included, regardless of location.
The DCT platform will be used to recruit participants, screen, consent, and then help guide them through the reporting and activities required for the study. 353 patients are being recruited for the fully remote trial, which will begin in early March. The data from this trial is expected to support future regulatory submissions to the U.S. Food and Drug Administration.
About Cancer-Related Distress
There are about 18 million cancer patients and survivors in the United States today. Nearly half of all cancer patients experience psychosocial distress, anxiety, or depression. If left untreated, these feelings can lower a cancer survivor’s quality of life and may negatively affect survival. The National Comprehensive Cancer Network (NCCN) has established guidelines for the delivery of mental health care services in oncology, which include screening patients for signs of distress and implementing a treatment plan to address these needs with a mental health care specialist. Unfortunately, fewer than half of patients who experience cancer-related distress, which can be defined as any unpleasant feeling, emotion, or experience that affects a patient’s quality of life or ability to cope with cancer diagnosis and treatment, are referred to mental health care specialists. Prescription digital therapeutics designed to treat cancer-related distress can help close this cancer treatment gap.
Reprint Courtesy of PRNewswire
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