What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Group Self-Management Sessions, or Educational Materials Only. The registry lists allocation as randomized. The goal of this clinical trial is to learn if the newly designed group self-management program is feasible to conduct and improves mental and behavioral health outcomes compared to a control group in people diagnosed with brain cancer.
They plan to enroll about 64 people at 2 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.
Official title (unrewritten)
Pilot Study of the Living Well With Brain Cancer Intervention
Interventions: Group Self-Management Sessions, Educational Materials Only
Primary outcome (registry wording): Change from Baseline of Overall Score from the RAND 36-Item Short Form Survey Instrument (SF-36)