Self-Management for Head and Neck Lymphedema and Fibrosis [PROMISE Trial]
NCT ID: NCT06125743
Last Updated: 2025-08-14
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
204 participants
INTERVENTIONAL
2024-03-29
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Usual Care
Usual Care
Participants will conduct self-care activities prescribed by their treating lymphedema therapists.
In-Person LEF-SMP
In-Person LEF-SMP
Participants will receive the in-person LEF-SMP intervention.
Telehealth LEF-SMP
Telehealth LEF-SMP
Participants will receive the telehealth LEF-SMP intervention.
Interventions
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Usual Care
Participants will conduct self-care activities prescribed by their treating lymphedema therapists.
In-Person LEF-SMP
Participants will receive the in-person LEF-SMP intervention.
Telehealth LEF-SMP
Participants will receive the telehealth LEF-SMP intervention.
Eligibility Criteria
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Inclusion Criteria
* Post HNC primary treatment
* No evidence of cancer (NED)
* Completion of initial lymphedema therapy for head and neck lymphedema
* Unable to obtain lymphedema therapy due to barriers noted above
* History of lymphedema on the face and neck, with or without fibrosis
* Ability to understand English in order to complete questionnaires
* Ability to perform self-care activities for LEF management
* Ability to provide informed consent
* Having an electronic device (a computer, tablet, iPad, or smartphone) and internet access at home
* A valid email address
Exclusion Criteria
* Any other active cancer
* Acute infection
* Acute congestive heart failure
* Acute renal failure
* Cardiac or pulmonary edema
* Sensitive carotid sinus
* Severe carotid blockage
* Uncontrolled hypertension
* Venous thrombosis
* Pregnant people
* Incarcerated patients
18 Years
ALL
No
Sponsors
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United States Department of Defense
FED
Abramson Cancer Center at Penn Medicine
OTHER
Responsible Party
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Locations
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
Barbara Murphy
Nashville, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Barbara Murphy, MD
Role: primary
References
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Deng J, Abene J, Huang L, Murphy BA. Study protocol for a multi-site randomized clinical trial of an intervention program to promote self-management among head and neck cancer survivors with lymphedema and fibrosis [PROMISE trial]. Trials. 2025 Oct 13;26(1):404. doi: 10.1186/s13063-025-09089-x.
Other Identifiers
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UPCC# 12323
Identifier Type: -
Identifier Source: org_study_id
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