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Behavioral Intervention
Self-Management Program for Head & Neck Cancer-related Lymphedema
N/A
Recruiting
Research Sponsored by Abramson Cancer Center at Penn Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥18 years of age
Post HNC primary treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3-, 6-, and 9-months post-intervention
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test if a self-management program can improve quality of life & reduce symptoms for survivors of head & neck cancer.
Who is the study for?
This trial is for adults over 18 who have survived head and neck cancer, are currently free of cancer, and have completed initial therapy for lymphedema in the face and neck. Participants must be able to manage their own care, understand English, have internet access with an electronic device at home, and a valid email address.
What is being tested?
The PROMISE Trial is testing how effective a standardized self-management program (LEF-SMP) is when delivered via telehealth or in-person compared to usual care. It aims to improve self-care for lymphedema and fibrosis among head and neck cancer survivors.
What are the potential side effects?
Since this trial involves self-management programs rather than medication or invasive procedures, side effects may include discomfort from performing the exercises or using technology but are generally expected to be minimal.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have completed my initial treatment for head and neck cancer.
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My cancer is currently not detectable.
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I have completed my first treatment for swelling in my head or neck.
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I can't get treatment for my lymphedema due to certain barriers.
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I have had swelling in my face and neck due to lymphedema, with or without hardening of the skin.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3-, 6-, and 9-months post-intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3-, 6-, and 9-months post-intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in severity of lymphedema and fibrosis
Secondary study objectives
Changes in LEF-related knowledge score
Changes in LEF-related skills
Changes in degrees of cervical range of motion
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Usual CareExperimental Treatment1 Intervention
Group II: Telehealth LEF-SMPExperimental Treatment1 Intervention
Group III: In-Person LEF-SMPExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Usual Care
1990
Completed Phase 4
~7700
Find a Location
Who is running the clinical trial?
Abramson Cancer Center at Penn MedicineLead Sponsor
418 Previous Clinical Trials
463,918 Total Patients Enrolled
United States Department of DefenseFED
916 Previous Clinical Trials
334,513 Total Patients Enrolled