RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Promoting Self-Management in Head and Neck Cancer Survivors With Lymphedema and Fibrosis [PROMISE Trial]

Quick Facts

Study Start:2024-03-29
Study Completion:2026-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06125743

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * \>18 years of age
  2. * Post HNC primary treatment
  3. * No evidence of cancer (NED)
  4. * Completion of initial lymphedema therapy for head and neck lymphedema
  5. * Unable to obtain lymphedema therapy due to barriers noted above
  6. * History of lymphedema on the face and neck, with or without fibrosis
  7. * Ability to understand English in order to complete questionnaires
  8. * Ability to perform self-care activities for LEF management
  9. * Ability to provide informed consent
  10. * Having an electronic device (a computer, tablet, iPad, or smartphone) and internet access at home
  11. * A valid email address
  1. * Recurrent or metastatic cancer
  2. * Any other active cancer
  3. * Acute infection
  4. * Acute congestive heart failure
  5. * Acute renal failure
  6. * Cardiac or pulmonary edema
  7. * Sensitive carotid sinus
  8. * Severe carotid blockage
  9. * Uncontrolled hypertension
  10. * Venous thrombosis
  11. * Pregnant people
  12. * Incarcerated patients

Contacts and Locations

Study Contact

Jie Deng, PhD
CONTACT
2155732393
jiedeng@nursing.upenn.edu

Study Locations (Sites)

University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Barbara Murphy
Nashville, Tennessee, 37232
United States

Collaborators and Investigators

Sponsor: Abramson Cancer Center at Penn Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-29
Study Completion Date2026-08-31

Study Record Updates

Study Start Date2024-03-29
Study Completion Date2026-08-31

Terms related to this study

Keywords Provided by Researchers

  • Lymphedema
  • Fibrosis
  • Head and Neck Cancer
  • Survivorship
  • Self-Management

Additional Relevant MeSH Terms

  • Lymphedema of the Head and Neck