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 Usual Care, In-Person LEF-SMP, or Telehealth LEF-SMP. The registry lists allocation as randomized. The goal of this study is to measure the effectiveness of a standardized lymphedema and fibrosis self-management program (LEF-SMP) to improve LEF self-management and reduce LEF-associated symptom burden, functional deficits, and improve quality of life in head and neck cancer (HNC) survivors.
They plan to enroll about 204 people at 2 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.
Official title (unrewritten)
Promoting Self-Management in Head and Neck Cancer Survivors With Lymphedema and Fibrosis [PROMISE Trial]
Interventions: Usual Care, In-Person LEF-SMP, Telehealth LEF-SMP
Primary outcome (registry wording): Changes in severity of lymphedema and fibrosis