Feasibility and preliminary efficacy of a lymphedema and fibrosis self-management program for head and neck cancer survivors: a pilot randomized controlled trial

Survivors of head and neck cancer (HNC) are at high risk for developing lymphedema and fibrosis (LEF). Once diagnosed with LEF, survivors must engage in a lifelong program of self-care to minimize long-term adverse effects. However, evidence-based LEF self-management (SM) programs are lacking. To fill this void, we developed and pilot-tested a LEF-SM program for HNC survivors. The LEF-SM Program was developed using the Information-Motivation-Behavioral Skills model of health behavior change as a framework. The program was pilot tested in a three-group randomized controlled trial evaluating feasibility and preliminary efficacy. Fifty-nine participants were randomized to: Usual care (n = 20), usual care plus LEF-SM Program (n = 20), and usual care plus LEF-SM Program plus lymphedema therapist follow-up (n = 19). Assessments were conducted at baseline, 3-, 6-, 9-, and 12-month. Outcomes included feasibility and preliminary efficacy (LEF progression, symptom burden, and jaw range of motion). Multivariate covariance pattern model analysis was used to test differences between groups. 1) Feasibility: 97.4% of the participants completed three of three planned LEF self-management skill training sessions, 92.1% completed at least two of three planned motivational interviewing sessions, and 82.3% completed at least two of three planned lymphedema therapist follow-up sessions. Participant satisfaction with the LEF-SM Program was high. No adverse events were reported. 2) Preliminary Efficacy: Compared to usual care, LEF-SM Program (± follow-up) showed a decrease in LEF severity and symptom burden (p < 0.05). The LEF-SM Program is feasible and potentially efficacious. Further testing is warranted for this novel program addressing an unmet need for HNC survivors. This study was registered on January 22, 2017, at ClinicalTrials.gov, a service of the US National Institute of Health (NCT03030859). The URL of the trial registry record:https://www. gov/study/NCT03030859.