Comparing Two Ways to Manage Head and Neck Lymphedema

Sponsor

University of Pennsylvania (Other)

Overall Status

Recruiting

CT.gov ID

NCT05182229

Collaborator

Patient-Centered Outcomes Research Institute (Other)

300

Enrollment

Locations

Arms

31.7

Anticipated Duration (Months)

100

Patients Per Site

3.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer Lymphedema	Other: Home-based (a hybrid model) CDT Other: Clinic-based CDT	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Comparing Two Ways to Manage Lymphedema in Head and Neck Cancer Survivors

Actual Study Start Date :

Mar 11, 2022

Anticipated Primary Completion Date :

Oct 31, 2024

Anticipated Study Completion Date :

Oct 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Clinic-Based Lymphedema Therapy	Other: Clinic-based CDT Participants will be provided therapist administered, in-person CDT two times per week for six weeks (12 sessions).
Active Comparator: Home-Based (a hybrid model) Lymphedema Therapy	Other: Home-based (a hybrid model) CDT 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.

Arm

Intervention/Treatment

Active Comparator: Clinic-Based Lymphedema Therapy

Other: Clinic-based CDT

Participants will be provided therapist administered, in-person CDT two times per week for six weeks (12 sessions).

Active Comparator: Home-Based (a hybrid model) Lymphedema Therapy

Other: Home-based (a hybrid model) CDT

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.

Outcome Measures

Primary Outcome Measures

Changes in severity of lymphedema [Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention]
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 [Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention]
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 [Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention]
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 [Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention]
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.

Other Outcome Measures

Healthcare utilization [Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention]
Compare healthcare utilization between patients receiving clinic-based versus home-based CDT. Healthcare Utilization Questionnaire will be used in this study.
Healthcare utilization [Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention]
Compare healthcare utilization between patients receiving clinic-based versus home-based CDT. Electronic Health Records (EHR) will be used in this study.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
2	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107
3	Temple University Hospital and Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19140

Sponsors and Collaborators

University of Pennsylvania
Patient-Centered Outcomes Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jie Deng, Associate Professor, University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT05182229

Other Study ID Numbers:

UPCC 20321

First Posted:

Jan 10, 2022

Last Update Posted:

Aug 25, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Head and Neck Neoplasms

Lymphedema

Study Results

No Results Posted as of Aug 25, 2022