Head and Neck Cancer Clinical Trial
Official title:
Development and Pilot Testing of a Home-Based Program for Head and Neck Cancer Survivors With Lymphedema
This pilot clinical trial studies a home-based lymphedema care program in improving lymphedema self-care in head and neck cancer survivors. A home-based lymphedema care program may help head and neck cancer survivors manage their lymphedema and improve their well-being and quality of life.
PRIMARY OBJECTIVES:
I. To develop a home-based lymphedema care program (HBLCP) focusing on self-care of head and
neck lymphedema in head and neck cancer (HNC) patients who have received lymphedema therapy.
(Stage 1) II. To assess feasibility of the HBLCP for HNC patients with lymphedema to: 1)
obtain recruitment estimates and determine barriers to recruitment; 2) evaluate
implementation fidelity (i.e., competence and compliance) and barriers to implementation
fidelity; 3) assess safety; and 4) evaluate satisfaction. (Stage 2) III. To obtain
preliminary efficacy data of the HBLCP via the following indicators: 1) head and neck
lymphedema; 2) symptom burden; and 3) functional status. (Stage 2)
OUTLINE:
INTERVENTION DEVELOPMENT: A team of experts complete the development of a patient self-care
video, an educational manual, a therapist training video, and a protocol. Lymphedema
therapists test the therapist training video and protocol. Patients then undergo a training
session with the study therapy and test the patient video and educational manual.
PILOT HBLCP TESTING: Participants undergo one training session with a lymphedema therapist.
Participants also receive a self-care video and educational manual to review at home.
After completion of training session, participants are followed up at 1, 2, and 3 months.
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