Clinical trial NCT06125743: Self-Management for Head and Neck Lymphedema and Fibrosis [PROMISE Trial]
Official title: Promoting Self-Management in Head and Neck Cancer Survivors With Lymphedema and Fibrosis [PROMISE Trial]
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lymphedema of the Head and Neck
Keywords: Lymphedema
Fibrosis
Head and Neck Cancer
Survivorship
Self-Management
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2023-11-09
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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 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

Primary outcomes:
measure: Changes in severity of lymphedema and fibrosis
timeFrame: Baseline, 3-, 6-, and 9-months post-intervention
Secondary outcomes:
measure: Changes in severity of symptom burden
timeFrame: Baseline, 3-, 6-, and 9-months post-intervention
measure: Changes in degrees of jaw range of motion
timeFrame: Baseline, 3-, 6-, and 9-months post-intervention
measure: Changes in degrees of cervical range of motion
timeFrame: Baseline, 3-, 6-, and 9-months post-intervention
measure: Changes in quality-of-life score
timeFrame: Baseline, 3-, 6-, and 9-months post-intervention
measure: Changes in LEF-related knowledge score
timeFrame: Baseline, 3-, 6-, and 9-months post-intervention
measure: Changes in LEF-related skills
timeFrame: Baseline, 3-, 6-, and 9-months post-intervention
measure: LEF-related self-efficacy score
timeFrame: Baseline, 3-, 6-, and 9-months post-intervention
measure: LEF-related self-care adherence status
timeFrame: Baseline, 3-, 6-, and 9-months post-intervention
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Nashville
country: United States
facility: Barbara Murphy
state: Tennessee
Study officials:
References: