search
Back to results

Comparing Two Ways to Manage Head and Neck Lymphedema

Primary Purpose

Head and Neck Cancer, Lymphedema

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home-based (a hybrid model) CDT
Clinic-based CDT
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • >18 years of age
  • <=24 months post-HNC treatment
  • Diagnosis of head and neck lymphedema and referral by their oncology providers
  • Able to perform self-manual lymphatic drainage
  • Having an electronic device (a computer, tablet, iPad, laptop, or smartphone) and internet access at home

Exclusion Criteria:

  • Active infection in soft tissues in the head and neck region
  • History of carotid artery disease
  • Significantly severe lymphedema (e.g., severe periorbital swelling)
  • Conditions impacting the safe delivery of lymphedema therapy

Sites / Locations

  • University of PennsylvaniaRecruiting
  • Thomas Jefferson UniversityRecruiting
  • Temple University Hospital and Fox Chase Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Clinic-Based Lymphedema Therapy

Home-Based (a hybrid model) Lymphedema Therapy

Arm Description

Outcomes

Primary Outcome Measures

Changes in severity of lymphedema
Compare the effects of clinic-based and home-based CDT on changes in the severity of lymphedema. This outcome measure will be assessed via Head and Neck - External Lymphedema and Fibrosis Assessment Criteria (HN-LEF Assessment Criteria).

Secondary Outcome Measures

Changes in severity of symptom burden
Compare the effects of clinic-based and home-based CDT on changes in the severity of symptom burden. This outcome measure will be assessed via Head and Neck - Lymphedema and Fibrosis Symptom Inventory (HN-LEF Symptom Inventory)
Changes in degrees of jaw range of motion
Compare the effects of clinic-based and home-based CDT on jaw range of motion. Jaw range of motion will be measured via Jaw Range of Motion Scale.
Changes in degrees of cervical range of motion
Compare the effects of clinic-based and home-based CDT on cervical range of motion. Cervical Range of Motion will be measured via Cervical Range of Motion Instrument.

Full Information

First Posted
December 12, 2021
Last Updated
August 2, 2023
Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
Patient-Centered Outcomes Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT05182229
Brief Title
Comparing Two Ways to Manage Head and Neck Lymphedema
Official Title
Comparing Two Ways to Manage Lymphedema in Head and Neck Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 11, 2022 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This randomized clinical trial aims to compare clinic-based CDT and home-based (a hybrid model) CDT on changes in the severity of lymphedema, symptom burden, functional status, and healthcare utilization in HNC survivors with lymphedema.
Detailed Description
Primary aim: To compare the effects of clinic-based and home-based (a hybrid model) CDT on changes in the severity of lymphedema. Secondary aim: To compare the effects of clinic-based and home-based (a hybrid model) CDT on symptom burden and functional status. Exploratory aim: To compare the healthcare utilization between patients receiving clinic-based versus home-based (a hybrid model) CDT

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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clinic-Based Lymphedema Therapy
Arm Type
Active Comparator
Arm Title
Home-Based (a hybrid model) Lymphedema Therapy
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Home-based (a hybrid model) CDT
Intervention Description
Participants will be provided therapist-administered, in person complete decongestive therapy (CDT) two times per week for two weeks (4 sessions), followed by real-time, virtual CDT consultations two times per week for three weeks (7 sessions) and one in person follow-up visit.
Intervention Type
Other
Intervention Name(s)
Clinic-based CDT
Intervention Description
Participants will be provided therapist administered, in-person CDT two times per week for six weeks (12 sessions).
Primary Outcome Measure Information:
Title
Changes in severity of lymphedema
Description
Compare the effects of clinic-based and home-based CDT on changes in the severity of lymphedema. This outcome measure will be assessed via Head and Neck - External Lymphedema and Fibrosis Assessment Criteria (HN-LEF Assessment Criteria).
Time Frame
Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention
Secondary Outcome Measure Information:
Title
Changes in severity of symptom burden
Description
Compare the effects of clinic-based and home-based CDT on changes in the severity of symptom burden. This outcome measure will be assessed via Head and Neck - Lymphedema and Fibrosis Symptom Inventory (HN-LEF Symptom Inventory)
Time Frame
Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention
Title
Changes in degrees of jaw range of motion
Description
Compare the effects of clinic-based and home-based CDT on jaw range of motion. Jaw range of motion will be measured via Jaw Range of Motion Scale.
Time Frame
Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention
Title
Changes in degrees of cervical range of motion
Description
Compare the effects of clinic-based and home-based CDT on cervical range of motion. Cervical Range of Motion will be measured via Cervical Range of Motion Instrument.
Time Frame
Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention
Other Pre-specified Outcome Measures:
Title
Healthcare utilization
Description
Compare healthcare utilization between patients receiving clinic-based versus home-based CDT. Healthcare Utilization Questionnaire will be used in this study.
Time Frame
Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention
Title
Healthcare utilization
Description
Compare healthcare utilization between patients receiving clinic-based versus home-based CDT. Electronic Health Records (EHR) will be used in this study.
Time Frame
Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >18 years of age <=24 months post-HNC treatment Diagnosis of head and neck lymphedema and referral by their oncology providers Able to perform self-manual lymphatic drainage Having an electronic device (a computer, tablet, iPad, laptop, or smartphone) and internet access at home Exclusion Criteria: Active infection in soft tissues in the head and neck region History of carotid artery disease Significantly severe lymphedema (e.g., severe periorbital swelling) Conditions impacting the safe delivery of lymphedema therapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Deng, PhD
Phone
215-573-2393
Email
jiedeng@nursing.upenn.edu
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Deng, PhD, RN, OCN, FAAN
Phone
215-573-2393
Email
jiedeng@nursing.upenn.edu
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bryan A Spinelli, PT, PhD
Phone
215-503-5011
Email
Bryan.Spinelli@Jefferson.edu
Facility Name
Temple University Hospital and Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey C. Liu, MD
Phone
215-707-3665
Email
Jeffrey.liu@temple.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Comparing Two Ways to Manage Head and Neck Lymphedema

We'll reach out to this number within 24 hrs