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• W4231519085 abstract "Abstract Background: Head and neck cancer (HNC) patients are at high risk for developing lymphedema and fibrosis (LEF) following cancer treatment. Once HNC patients develop LEF, they need to conduct life-long self-care to slow LEF progression and reduce associated symptom burden and functional deficits. Data demonstrate that inadequate LEF self-care may be a potentially remediable issue. The objective of this study is to explore the feasibility and preliminary efficacy of an Information-Motivation-Behavioral (IMB) Skills model driven self-care program (SCP) to improve LEF management and reduce LEF-related symptom burden and functional impairments. Methods/Design: This is a three-arm, prospective, randomized controlled clinical trial to compare: Group 1-Usual Care, Group 2-Usual Care Plus LEF-SCP, and Group 3 - Usual Care Plus LEF-SCP Plus Follow-Up. Participants will be HNC survivors aged > 18 years of age, who meet predefined inclusion and exclusion criteria. A sample size of 75 participants is targeted. Interventions will be provided by trained staff. The study assessments for all groups will take place at five points: study entry then 3-, 6-, 9-, and 12-month post-enrollment. Outcome measures include: 1) feasibility (barriers to implementation, safety, and satisfaction) of the proposed intervention; 2) self-efficacy and adherence to self-care; and 3) preliminary efficacy (LEF progression, symptom burden, and functional status) of the proposed intervention. Discussion: This will be the first study to evaluate the feasibility of a LEF-SCP in the HNC population and its impact on self-efficacy and adherence. Furthermore, it will evaluate the potential benefit of routine follow-up on adherence and fidelity to the self-care protocol. We expect that the trial will provide evidence supporting the feasibility of a LEF self-care program. In addition, we anticipate that preliminary data will support improved outcomes including increased adherence and fidelity, and decreased LEF associated symptoms. Trial registration: This study was registered on January 22, 2017 at Clinical Trial.gov, a service of the US National Institute of Health (NCT 03030859). The URL of the trail registry record: https://clinicaltrials.gov/ct2/show/NCT03030859?term=lymphedema+and+fibrosis&cond=Head+and+Neck+Cancer&cntry=US&rank=1 Keywords: Head and neck cancer, lymphedema, fibrosis, self-care, self-management, survivorship" @default.
• W4231519085 created "2022-05-12" @default.
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• W4231519085 date "2019-08-07" @default.
• W4231519085 modified "2023-10-16" @default.
• W4231519085 title "Self-Care for Head and Neck Cancer Survivors with Lymphedema and Fibrosis: Study Protocol for a Randomized Controlled Trial" @default.
• W4231519085 doi "https://doi.org/10.21203/rs.2.12485/v1" @default.
• W4231519085 hasPublicationYear "2019" @default.
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