NCT02170272

Home-Based Lymphedema Care Program (HBLCP) in Improving Lymphedema Self-Care in Head and Neck Cancer Survivors

Development and Pilot Testing of a Home-Based Program for Head and Neck Cancer Survivors With Lymphedema

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Head and Neck Cancer
• Lymphedema

Interventions

Type	Name	Description
BEHAVIORAL	Home-based Lymphedema Care Program	Undergo HBLCP

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-03-01
• Completion: 2017-10-01
• First posted: 2014-06-23
• Last updated: 2018-01-25

Locations

1 site across 1 country: United States