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

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

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.

Study Overview

• Status: Terminated
• Conditions: Head and Neck Cancer; Lymphedema
• Intervention / Treatment: Behavioral: Home-based Lymphedema Care Program

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt-Ingram Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home-based Lymphedema Care Program; 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.	Behavioral: Home-based Lymphedema Care Program; Undergo HBLCP; Other Names: intervention, educational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Recruitment estimates through number of patients recruited	Recruitment Log will be used to document recruitment information	Up to 3 months

Collaborators and Investigators

• Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborators: National Cancer Institute (NCI); Vanderbilt Office of Clinical and Translational Scientist Development
• Investigators: Principal Investigator: Jie Deng, Vanderbilt-Ingram Cancer Center

Publications and helpful links

Helpful Links

• Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: June 13, 2014
• First Submitted That Met QC Criteria: June 18, 2014
• First Posted (Estimate): June 23, 2014

Study Record Updates

• Last Update Posted (Actual): January 25, 2018
• Last Update Submitted That Met QC Criteria: January 23, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Lymphatic Diseases; Neoplasms by Site; Head and Neck Neoplasms; Lymphedema
• Other Study ID Numbers: VICC HN 1431; P30CA068485 (U.S. NIH Grant/Contract); NCI-2014-00867 (Registry Identifier: CTRP (Clinical Trial Reporting Program))