Self-management program for lymphedema in head and neck cancer survivors
Promoting Self-Management in Head and Neck Cancer Survivors With Lymphedema and Fibrosis [PROMISE Trial]
This study is testing a self-management program for lymphedema in head and neck cancer survivors to see if in-person or telehealth support helps them feel better compared to usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 204 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abramson Cancer Center at Penn Medicine Academic / other |
| Locations | 2 sites (Philadelphia, Pennsylvania and 1 other locations) |
| Trial ID | NCT06125743 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a standardized self-management program for lymphedema and fibrosis (LEF-SMP) in head and neck cancer survivors. Participants will be assigned to one of three groups: in-person LEF-SMP, telehealth LEF-SMP, or usual care. The study aims to compare the impact of these interventions on lymphedema severity, symptom burden, functional impairments, and overall quality of life. Additionally, it will assess improvements in patients' knowledge, skills, self-efficacy, and adherence to self-care practices.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have completed primary treatment for head and neck cancer and have a history of lymphedema in the face and neck.
Not a fit: Patients with recurrent or metastatic cancer, other active cancers, or severe acute health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the quality of life and self-management capabilities of patients suffering from lymphedema and fibrosis after head and neck cancer treatment.
How similar studies have performed: Other studies have shown promise in self-management approaches for lymphedema, suggesting potential success for this program.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Philadelphia, Pennsylvania and 1 other locations
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Barbara Murphy — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Jie Deng, PhD
- Email: jiedeng@nursing.upenn.edu
- Phone: 2155732393
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.