Head and Neck Cancer, Lymphedema
Conditions
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.
Interventions
BEHAVIORALHome-based Lymphedema Care Program
Undergo HBLCP
Sponsors
National Cancer Institute (NCI)
Vanderbilt Office of Clinical and Translational Scientist Development
Vanderbilt-Ingram Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in severity rate of head and neck lymphedema | Baseline to up to 3 months | Compared to baseline, head and neck cancer survivors with lymphedema who participates in the HBLCP will have improved outcome (e.g., decreased lymphedema severity) through measures of CTCAE, External HNLE-Fibrosis Grading Criteria, and Foldi's Scale at the study follow-ups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in rating of severity symptom burden | Baseline to up to 3 months | Compared to baseline, head and neck cancer survivors with lymphedema who participates in the HBLCP will have improved outcome (e.g., decreased symptom burden) through measures of VHNSS and LSIDS-H&N at the study follow-ups |
| Change in rating of jaw, neck, and shoulder range of motion | Baseline to up to 3 months | Compared to baseline, head and neck cancer survivors with lymphedema who participates in the HBLCP will have improved functional outcome measures in jaw, neck, and shoulder range of motion at the study follow-ups |
Other
| Measure | Time frame | Description |
|---|---|---|
| Assessment of feasibility of the HBLCP for head and neck cancer survivors with lymphedema | Baseline to up to 3 months | The major measures include to: 1) determine barriers to recruitment; and 2) evaluate implementation fidelity (i.e., competence and compliance) and barriers to implementation fidelity through feasibility questionnaires. |
| Recruitment estimates through number of patients recruited | Up to 3 months | Recruitment Log will be used to document recruitment information |
Countries
United States
Outcome results
None listed