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

Primary Purpose

Head and Neck Cancer, Lymphedema

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home-based Lymphedema Care Program
Sponsored by
Vanderbilt-Ingram Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Cancer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Vanderbilt-Ingram Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Home-based Lymphedema Care Program

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
June 13, 2014
Last Updated
January 23, 2018
Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI), Vanderbilt Office of Clinical and Translational Scientist Development
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1. Study Identification

Unique Protocol Identification Number
NCT02170272
Brief Title
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

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
Unable to obtain funding
Study Start Date
June 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI), Vanderbilt Office of Clinical and Translational Scientist Development

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Lymphedema

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home-based Lymphedema Care Program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Home-based Lymphedema Care Program
Other Intervention Name(s)
intervention, educational
Intervention Description
Undergo HBLCP
Primary Outcome Measure Information:
Title
Change in severity rate of head and neck lymphedema
Description
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
Time Frame
Baseline to up to 3 months
Secondary Outcome Measure Information:
Title
Change in rating of severity symptom burden
Description
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
Time Frame
Baseline to up to 3 months
Title
Change in rating of jaw, neck, and shoulder range of motion
Description
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
Time Frame
Baseline to up to 3 months
Other Pre-specified Outcome Measures:
Title
Assessment of feasibility of the HBLCP for head and neck cancer survivors with lymphedema
Description
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.
Time Frame
Baseline to up to 3 months
Title
Recruitment estimates through number of patients recruited
Description
Recruitment Log will be used to document recruitment information
Time Frame
Up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie Deng
Organizational Affiliation
Vanderbilt-Ingram Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.vicc.org/ct/
Description
Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

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