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

Vanderbilt University Medical Center

Status: Terminated

Conditions: Lymphedema; Head and Neck Cancer

Treatments: Behavioral: Home-based Lymphedema Care Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02170272

VICC HN 1431

P30CA068485 (U.S. NIH Grant/Contract)

NCI-2014-00867 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Home-based Lymphedema Care Program

Experimental group

Description:

Home-based Lymphedema Care Program (HBLCP): Participants will undergo one training session with a lymphedema therapist, and then receive a self-care video and educational manual to review at home. After completion of training session, follow-up measures occur at 1, 2, and 3 months.

Treatment:

Behavioral: Home-based Lymphedema Care Program