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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02170272
• Other study ID #: VICC HN 1431
• Secondary ID: NCI-2014-00867P3
• Status: Terminated
• Phase: N/A
• First received: June 13, 2014
• Last updated: January 23, 2018
• Start date: June 2014
• Est. completion date: October 2017

Study information

• Verified date: January 2018
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: October 2017
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Lymphedema

Intervention

Behavioral:
• Home-based Lymphedema Care Program
Undergo HBLCP

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI), Vanderbilt Office of Clinical and Translational Scientist Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of feasibility of the HBLCP for head and neck cancer survivors with lymphedema	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.	Baseline to up to 3 months
Other	Recruitment estimates through number of patients recruited	Recruitment Log will be used to document recruitment information	Up to 3 months
Primary	Change in severity rate of head and neck lymphedema	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	Baseline to up to 3 months
Secondary	Change in rating of severity symptom burden	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	Baseline to up to 3 months
Secondary	Change in rating of jaw, neck, and shoulder range of motion	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	Baseline to up to 3 months

External Links

•   Vanderbilt-Ingram Cancer Center, Find a Clinical Trial