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Trial Title:
Self-Management for Head and Neck Lymphedema and Fibrosis [PROMISE Trial]
NCT ID:
NCT06125743
Condition:
Lymphedema of the Head and Neck
Conditions: Official terms:
Lymphedema
Fibrosis
Conditions: Keywords:
Lymphedema
Fibrosis
Head and Neck Cancer
Survivorship
Self-Management
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Usual Care
Description:
Participants will conduct self-care activities prescribed by their treating lymphedema
therapists.
Arm group label:
Usual Care
Intervention type:
Behavioral
Intervention name:
In-Person LEF-SMP
Description:
Participants will receive the in-person LEF-SMP intervention.
Arm group label:
In-Person LEF-SMP
Intervention type:
Behavioral
Intervention name:
Telehealth LEF-SMP
Description:
Participants will receive the telehealth LEF-SMP intervention.
Arm group label:
Telehealth LEF-SMP
Summary:
The goal of this study is to evaluate the effectiveness of a standardized lymphedema and
fibrosis self-management program (LEF-SMP) to improve LEF self-management and reduce
LEF-associated symptom burden, functional deficits, and improve quality of life in head
and neck cancer (HNC) survivors.
Detailed description:
In HNC survivors with lymphedema and fibrosis (LEF), the investigators will: 1) compare
the effects of in-person LEF-SMP, telehealth LEF-SMP, and usual care on LEF severity; 2)
compare the effects of in-person LEF-SMP, telehealth LEF-SMP, and usual care on
LEF-related symptom burden, functional impairments, and quality of life; and 3) compare
the effects of in-person LEF-SMP, telehealth LEF-SMP, and usual care on LEF-related
knowledge, skills, self-efficacy, and self-care adherence.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- >18 years of age
- 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:
- Recurrent or metastatic cancer
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Pennsylvania
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jie Deng, PhD
Phone:
215-573-2393
Email:
jiedeng@nursing.upenn.edu
Facility:
Name:
Barbara Murphy
Address:
City:
Nashville
Zip:
37232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Barbara Murphy, MD
Start date:
March 29, 2024
Completion date:
August 31, 2026
Lead sponsor:
Agency:
Abramson Cancer Center at Penn Medicine
Agency class:
Other
Collaborator:
Agency:
United States Department of Defense
Agency class:
U.S. Fed
Source:
Abramson Cancer Center at Penn Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06125743
