Study protocol for a multi-site randomized clinical trial of an intervention program to promote self-management among head and neck cancer survivors with lymphedema and fibrosis [PROMISE trial].

BACKGROUND: Lymphedema and fibrosis (LEF) secondary to head and neck cancer (HNC) treatment is a chronic process and a lifelong commitment to self-care. Although prospective data is lacking, a program of self-management may reduce LEF progression and minimize associated functional impairments and symptom burden. Barriers to long-term LEF self-care include lack of standardized self-care protocols as well as lack of LEF-related knowledge, skills, self-efficacy and adherence among HNC survivors. The objective of this study is to evaluate the effectiveness of a standardized lymphedema and fibrosis self-management program (LEF-SMP) in reducing LEF-associated symptom burden and functional deficits, thereby improving quality of life (QOL). METHODS: We will conduct a 3-year, multi-site, 3-arm parallel-group, randomized clinical trial (N = 204). The targeted population consists of adult HNC survivors. Eligible participants will be randomized to one of the following groups: Group 1, usual care; Group 2, in-person LEF-SMP; and Group 3, telehealth LEF-SMP. Recruitment, data collection, and study intervention will be conducted at two comprehensive medical centers including University of Pennsylvania Health System (Penn Medicine) and Vanderbilt-Ingram Cancer Center (VICC). Primary study endpoint is LEF severity; and secondary study endpoints include LEF-related symptom burden, functional impairments, QOL, LEF-related knowledge, skills, self-efficacy, and self-care adherence. All above-mentioned primary and secondary endpoints will be measured at the baseline (pre-intervention), and 3-, 6-, and 9-month post-intervention. DISCUSSION: This study will test whether the standardized lymphedema and fibrosis self-management program (LEF-SMP) has the ability to decrease the burden of LEF and its impact on HNC survivors. We anticipate that the intervention will improve LEF self-management, reduce LEF-associated symptom burden and functional impairments, and enhance QOL as well as LEF-related knowledge and skills in HNC survivors. TRIAL REGISTRATION: This study was registered on November 01, 2023, at ClinicalTrials.gov, a service of the US National Institute of Health (NCT06125743). The URL of the trial registry record: https://clinicaltrials.gov/study/NCT06125743 .