What type of study is this?

This is a RCT study (also classified as: Phase 2).

August 17, 2025Open Access

CTLT-02 Effect of Early Integrated Neuropsychological Care in Patients With Brain Metastases – A Phase 2 Randomized Controlled Trial (Athena Trial)

Puntos clave

Deterioration of quality-of-life at 3 months was not different between the intervention and control groups, suggesting integrated care may not enhance benefits.
Cognitive decline incidence did not show significant differences between arms at both 3 months (24.1% vs. 27.3%) and 6 months (50.0% vs. 43.8%).
This study utilized a randomized controlled trial approach to explore the effects of a certified neuropsychologist on brain metastases patients receiving radiotherapy.
These results indicate that early integrated neuropsychological care may not significantly improve quality-of-life or cognitive function following treatment.

Resumen

Abstract Radiation advancements including hippocampal avoidance whole brain radiotherapy (HA-WBRT) and stereotactic radiosurgery (SRS) can better preserve quality-of-life (QOL) and mitigate the risk of cognitive decline, but many patients experience reductions in these areas. This Phase 2 Randomized Controlled Trial (NCT05503251) aimed to evaluate the impact of a neuropsychological evaluation and intervention with a certified neuropsychologist on QOL and cognitive function for brain metastases patients treated with RT. Patients with brain metastases were randomized 1:1 to either neuropsychology evaluation and intervention plus brain RT or brain RT alone. The intervention arm included five appointments with the neuropsychology team for testing, evaluation, and counseling over a three-month period starting before initiation of RT. The primary endpoint was deterioration of QOL at 3 months as measured by Functional Assessment of Cancer Therapy-Brain (FACT-Br). Cognition was measured by Hopkins Verbal Learning Test-Revised, Controlled Oral Word Association Test, and Trail Making Test A/B, with cognitive decline defined as decline on at least one assessment using reliable change index. Between August 2022 and June 2024, 110 patients were randomized. The median overall survival or time to last follow-up was 8.5 months. Deterioration of QOL at 3 months was not different between the control and intervention arms (p = 0.93). Cognitive decline incidence between the control and intervention arms was not significant at 3 months (24.1% vs. 27.3%) or 6 months (50.0% vs. 43.8%, p = 0.46). Additionally, there were no differences at 3 or 6 months with verbal fluency, executive function, immediate recall, delayed recall, or delayed recognition between arms. This study did not meet its primary endpoint, better preserved QOL at 3 months, for patients receiving early integrated neuropsychological care. Further evaluation of the delayed impact ( 6 months) of neuropsychology intervention on QOL and cognitive function will be reported when data are available.

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