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

Abstract

Objectives: 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.

Materials and methods: 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.

Results: 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).

Conclusion: The LEF-SM Program is feasible and potentially efficacious. Further testing is warranted for this novel program addressing an unmet need for HNC survivors.

Trial registration: 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.

Clinicaltrials: gov/study/NCT03030859.

Keywords: Fibrosis; Head and neck cancer; Lymphedema; Self-care; Self-management; Survivorship.