← Back to Search

Behavioral Intervention

Self-Management Program for Head & Neck Cancer-related Lymphedema

N/A

Waitlist Available

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

Study 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.Check my eligibility

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.See study design

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 below

Select...

I am 18 years old or older.

Select...

I have completed my initial treatment for head and neck cancer.

Select...

My cancer is currently not detectable.

Select...

I have completed my first treatment for swelling in my head or neck.

Select...

I can't get treatment for my lymphedema due to certain barriers.

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3-, 6-, and 9-months post-intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in severity of lymphedema and fibrosis

Secondary outcome measures

Changes in LEF-related knowledge score

Changes in LEF-related skills

Changes in degrees of cervical range of motion

+5 more

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

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Abramson Cancer Center at Penn MedicineLead Sponsor

387 Previous Clinical Trials

145,460 Total Patients Enrolled

3 Trials studying Lymphedema

386 Patients Enrolled for Lymphedema

United States Department of DefenseFED

863 Previous Clinical Trials

227,395 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current openings for participation in this experiment?

"According to data hosted on clinicaltrials.gov, enrolment for this medical study has been completed. The trial was initially posted on December 1st of 2023 and last updated November 12th of the same year. Nevertheless, there are presently 500 other trials actively recruiting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Self-Management for Head and Neck Lymphedema and Fibrosis [PROMISE Trial]

2024. "Self-Management for Head and Neck Lymphedema and Fibrosis [PROMISE Trial]". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06125743.

All > Lymphedema