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Clinical Trial VICCHN1431

Title

Development and Pilot Testing of A Home-Based Program for Head and Neck Cancer Survivors with Lymphedema

Principal Investigator(s)

Jie Deng

Details

  • Protocol No. VICCHN1431
  • Open Date: 06/20/2014
  • Staging: Pilot
  • Age Group: Adults
  • Scope: Local
  • Objective: Stage 1 - To develop a HBLCP focusing on self-care of head and neck lymphedema in HNC patients who have received lymphedema therapy. The HBLCP includes one training session and home self-care of lymphedema followed by the instructions from a digital video and educational manual. Stage 2 - 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.
  • Disease Sites: Head/Neck
  • Therapies: Supportive Care
  • Drugs: None Specified
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT02170272
  • Secondary Protocol No: Not Specified

Description

The purpose of this study is to develop a useful and valid home-based care program for individuals with head and/or neck cancers that have been treated for swelling (lymphedema). Following development of this program (stage 1), participants in stage 2 will assist in testing the overall usability and worth of the program. Outcome measures will be utilized to rate the effectiveness of the program on easing signs and symptoms of swelling.

Eligibility

Ages Eligible for Study:21 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:Accepts Healthy Volunteers

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