Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2022-03-11
2026-11-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Clinic-Based Lymphedema Therapy
Clinic-based CDT
Participants will be provided therapist administered, in-person CDT two times per week for six weeks (12 sessions).
Home-Based (a hybrid model) Lymphedema Therapy
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.
Interventions
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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.
Clinic-based CDT
Participants will be provided therapist administered, in-person CDT two times per week for six weeks (12 sessions).
Eligibility Criteria
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Inclusion Criteria
* \<=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
* History of moderate or severe carotid artery occlusion
* Significantly severe lymphedema (e.g., severe periorbital swelling)
* Conditions impacting the safe delivery of lymphedema therapy
18 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Abramson Cancer Center at Penn Medicine
OTHER
Responsible Party
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Jie Deng
Associate Professor
Locations
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Jefferson Cherry Hospital Jefferson Health
Cherry Hill, New Jersey, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Jefferson Health
Philadelphia, Pennsylvania, United States
Jefferson Torresdale Hospital Jefferson Health
Philadelphia, Pennsylvania, United States
Temple University Hospital and Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Asplundh Cancer Pavilion Jefferson Health
Willow Grove, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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UPCC 20321
Identifier Type: -
Identifier Source: org_study_id
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