UPCC 12323 Promoting Self-Management in Head and Neck Cancer Survivors with Lymphedema and Fibrosis (PROMISE Trial)

Self-Management Programs for Lymphedema and Fibrosis in Head and Neck Cancer Survivors

Enrolling By Invitation
18 years or above
All
Phase N/A
204 participants needed
1 Location

Brief description of study

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 of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Lymphedema of the Head and Neck
  • Age: 18 years or above
  • Gender: All

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

This study investigates the effectiveness of a self-management program for head and neck cancer survivors who experience lymphedema and fibrosis. The purpose of this study is to evaluate how well the self-management program can help manage these conditions and improve the quality of life for participants.

Participants will be assigned to one of three study arms: in-person self-management, telehealth self-management, or usual care. The study will assess the severity of lymphedema and fibrosis, as well as the impact on symptoms, functional ability, and quality of life. Participants will also be evaluated on their knowledge, skills, and adherence to self-care practices.

  • Who can participate: Participants must be over 18 years old and have completed primary treatment for head and neck cancer with no evidence of disease. They should have a history of lymphedema on the face and neck, be able to perform self-care activities, and have access to an electronic device with internet.
  • Study details: Participants will engage in self-management activities either in-person or via telehealth, or receive usual care. They will be required to use their own electronic devices to participate in telehealth sessions and complete questionnaires.
Updated on 14 Aug 2025. Study ID: 23-1125
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Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

Contact Abramson Cancer Center Navigator