NCT02170272

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 23, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

9 months

First QC Date

June 13, 2014

Last Update Submit

January 23, 2018

Conditions

Head and Neck CancerLymphedema

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change in rating of severity symptom burden

    Baseline to up to 3 months

  • Change in rating of jaw, neck, and shoulder range of motion

    Baseline to up to 3 months

Other Outcomes (2)

  • Assessment of feasibility of the HBLCP for head and neck cancer survivors with lymphedema

    Baseline to up to 3 months

  • Recruitment estimates through number of patients recruited

    Up to 3 months

Study Arms (1)

Home-based Lymphedema Care Program

EXPERIMENTAL

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

Interventions

Home-based Lymphedema Care ProgramBEHAVIORAL

Undergo HBLCP

Also known as: intervention, educational
Home-based Lymphedema Care Program

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +2 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Related Links

MeSH Terms

Conditions

Head and Neck NeoplasmsLymphedema

Interventions

Methods

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsLymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Jie Deng

    Vanderbilt-Ingram Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Vanderbilt-Ingram Cancer Center

Study Record Dates

First Submitted

June 13, 2014

First Posted

June 23, 2014

Study Start

June 1, 2014

Primary Completion

March 1, 2015

Study Completion

October 1, 2017

Last Updated

January 25, 2018

Record last verified: 2018-01

Locations

US(1)