Clinical trial NCT02170272: Home-Based Lymphedema Care Program (HBLCP) in Improving Lymphedema Self-Care in Head and Neck Cancer Survivors
Official title: Development and Pilot Testing of a Home-Based Program for Head and Neck Cancer Survivors With Lymphedema
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Head and Neck Cancer
Lymphedema
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Vanderbilt Office of Clinical and Translational Scientist Development
First posted: 2014-06-23
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in severity rate of head and neck lymphedema
timeFrame: Baseline to up to 3 months
Secondary outcomes:
measure: Change in rating of severity symptom burden
timeFrame: Baseline to up to 3 months
measure: Change in rating of jaw, neck, and shoulder range of motion
timeFrame: Baseline to up to 3 months
Other outcomes:
measure: Assessment of feasibility of the HBLCP for head and neck cancer survivors with lymphedema
timeFrame: Baseline to up to 3 months
measure: Recruitment estimates through number of patients recruited
timeFrame: Up to 3 months
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Jie Deng
role: PRINCIPAL_INVESTIGATOR
References: