Self-care for head and neck cancer survivors with lymphedema and fibrosis: A pilot randomized clinical trial.

6094 Background: Lymphedema and fibrosis (LEF) are debilitating late effects in head and neck cancer survivors (HNCS). Initial therapy is usually directed by therapists following which patients undertake a LEF self-care program (SCP). No evidence based LEF-SCP are available. We report on the feasibility and preliminary efficacy data of a multifaceted LEF-SCP. Methods: 59 HNCS with LEF were randomized to: Usual care (n = 20), usual care + LEF-SCP (n = 20), and usual care + LEF-SCP + routine follow-up with a lymphedema therapist (n = 19). Assessments were conducted at baseline, 3-, 6-, 9-, and 12-months. Outcome measures include feasibility and preliminary efficacy (LEF progression, symptom burden, and jaw range of motion [ROM]). Multivariate covariance pattern model analysis was used to test for difference between arms. Results: 1) Feasibility: LEF-SCP training sessions - 80% completion rate; 90% satisfaction with the LEF-SCP; self-care adherence was similar between arms; no adverse event. 2) Preliminary Efficacy: Compared to usual care, participants randomized to LEF-SCP (+/- follow-up) showed a decrease in LEF severity (p < 0.05), reduction in symptom burden (p < 0.05), without significant improvement in jaw ROM. No significant differences were noted between the patients +/- follow-up with a lymphedema therapist. There was a trend to improved self-efficacy in patients participating in the LEF-SCP. Conclusions: The LEF-SCP is feasible and potentially efficacious for HNCS. Further testing is warranted. Clinical trial information: NCT03030859.