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An Educational Training Program (LEF-SMP) for Promoting Self-Management in Head and Neck Cancer Survivors with Lymphedema and Fibrosis, PROMISE Trial
Trial Status: active
This clinical trial tests how well the lymphedema and fibrosis self management program (LEF-SMP) in promoting self-care activities in head and neck cancer survivors with swelling (lymphedema) and tough or tight (fibrosis) tissues that developed after treatment. Lymphedema and fibrosis (LEF) affects at least 75% of head and neck cancer survivors and can have a negative impact on symptom burden and quality of life. Although, LEF is not curable, it can be managed with effective self-management strategies to decrease adverse outcomes. LEF-SMP may be an effective method to help people learn self-care activities to manage LEF and improve quality of life in head and neck cancer survivors.
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 or 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
Patients will be excluded if they have any of the following medical conditions:
* 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
Additional locations may be listed on ClinicalTrials.gov for NCT06125743.
I. Compare the effects of in-person LEF-SMP, telehealth LEF-SMP, and usual care on LEF severity.
II. 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.
III. 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.
OUTLINE: Patients are randomized to 1 of 3 groups.
GROUP I (USUAL CARE): Patients participate in usual self-care activities prescribed by treating lymphedema therapists on study.
GROUP II (IN-PERSON): Patients receive face-to-face LEF self-management training sessions over 1 hour once weekly for 3 sessions and a telehealth motivational interviewing session over 30 minutes. Patients also receive LEF self-management educational manuals and access to the self-management video website to review at least once monthly.
GROUP III (TELEHEALTH): Patients receive telehealth LEF self-management training sessions over 1 hour weekly for 3 sessions and a telehealth motivational interviewing session over 30 minutes. Patients also receive LEF self-management educational manuals and access to the self-management video website to review at least once monthly.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
