AUG 18, 2025 3:00 AM PDT

Symptom Monitoring Improves Quality of Life for Clinical Trial Participants

WRITTEN BY: Katie Kokolus

Quality of life (QOL), a measure of an individual's overall enjoyment of life, stands as an essential consideration for healthcare professionals conducting clinical trials.  When evaluating the benefits of investigational interventions, including new drugs and treatment strategies, it remains crucial for clinical trials to assess both efficacy and the impact on QOL.  The potential curative properties of anticancer medications are only as beneficial as a treated patient’s ability to enjoy living life as a cancer survivor. 

Patients with the ERBB2-positive subtype of metastatic breast cancer receive an antibody-drug conjugate therapy called trastuzumab deruxtecan (T-DXd), and this treatment causes adverse events in some patients, hindering their QOL.  Because of the anticancer benefits of this treatment modality, early detection of adverse side effects, allowing for management before QOL deteriorates, could help more patients stay on treatment. 

Electronic patient-reported outcomes (ePROs), systems that enable patients to track the onset of symptoms and vital signs easily, can improve QOL by prompting early interventions.  These systems are implemented by providing patients with a user-friendly interface to record their symptoms and vital signs.  To study whether ePROs could help patients receiving T-DXd treatments maintain a good QOL during treatment, a group of researchers compared outcomes in patients monitoring symptoms and vital signs to those receiving usual care.  The results of the study, recently published in JAMA Network Open, show a promising effect of ePRO implementation.

The study enrolled 111 women from 38 cancer treatment centers in Japan.  All patients had ERBB2-positive metastatic breast cancer and received T-DXd.  The researchers randomized 56 women to the monitoring group and 55 to the usual care group.  Patients randomized into the monitoring group recorded symptoms weekly and vital signs, including body temperature and oxygenation levels, daily.  The patient’s healthcare team played a crucial role in this process, receiving alerts when adverse events or vital signs reached a minimal threshold for intervention, highlighting the importance of their role in patient care. 

At baseline, patients in the monitoring and usual care groups had similar QOL scores.  However, 24 weeks after treatment initiation, the QOL score for women in the monitoring group exceeded that of the usual care group by an average of eight points.  Women in the monitoring group exhibited greater improvements in role, cognitive, and social functioning compared to the usual care group.  Also, women receiving usual care experienced more fatigue than those in the monitoring group. 

While symptom monitoring did not affect cancer outcomes, women reporting on daily changes to their vitals and weekly QOL scores exhibited a notable difference in QOL while undergoing T-DXd.  This study underscores the importance of balancing cancer control and QOL, showing that this approach can significantly improve survivorship.  Providing new strategies to limit the deterioration of QOL will have a positive overall impact on cancer treatment. 

 

Sources: Nat Med, JAMA Netw Open

About the Author
Doctorate (PhD)
I received a PhD in Tumor Immunology from SUNY Buffalo and BS and MS degrees from Duquesne University. I also completed a postdoc fellowship at the Penn State College of Medicine. I am interested in developing novel strategies to improve the efficacy of immunotherapies used to extend cancer survivorship.
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