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

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.

Inclusion Criteria:

- STAGE 1:

- EXPERT PANEL:

- A convenience sample of 10-15 experts (at least three lymphedema therapists and a
varying number of HNC medical, radiation, and surgical oncologists, HNC nurse
practitioners, speech and language pathologists, and nursing and informatics
scientists) will be recruited to inform development of videos, protocol, and
educational manual

- Knowledgeable in either HNC or lymphedema management or informatics

- LYMPHEDEMA THERAPISTS:

- Subsequent to the development of the materials, five additional therapists will be
recruited to conduct an unbiased test of the therapists' training video and protocol

- Certified lymphedema therapists

- Knowledgeable in head and neck lymphedema management

- PATIENT PARTICIPANTS:

- A convenience sample of 10 HNC survivors will be recruited to undergo a training
session with the study therapist and test the patient video and educational manual

- Post HNC primary treatment

- No evidence of cancer (NED)

- Completion of lymphedema therapy for lymphedema of the head and neck

- Ability to understand English in order to complete questionnaires

- Able to complete the onsite training and home self-care activities for lymphedema
management

- Able to provide informed consent

- STAGE 2 PATIENT PARTICIPANTS:

- Using the same inclusion criteria as Stage 1 a convenience sample of 30 different HNC
survivors will be recruited

Exclusion Criteria:

- Patients with medical conditions (e.g., acute infection, congestive heart failure,
renal failure, cardiac or pulmonary edema, sensitive carotid sinus, severe carotid
blockage, and uncontrolled hypertension) that would prohibit the safe implementation
of home-based self-care of lymphedema will be excluded