Promoting Self-Management in Head and Neck Cancer Survivors With Lymphedema and Fibrosis [PROMISE Trial]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lymphedema of the Head and Neck
- Sponsor
- Abramson Cancer Center at Penn Medicine
- Enrollment
- 204
- Locations
- 2
- Primary Endpoint
- Changes in severity of lymphedema and fibrosis
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
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.
Investigators
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
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
Outcomes
Primary Outcomes
Changes in severity of lymphedema and fibrosis
Time Frame: Baseline, 3-, 6-, and 9-months post-intervention
This outcome measure will be assessed via Head and Neck - External Lymphedema and Fibrosis Assessment Criteria (HN-LEF Assessment Criteria). The total severity score of lymphedema and fibrosis (LEF) is calculated by summing the severity score (normal = 0, mild =1, moderate =2, and severe =3) of each anatomical site affected by head and neck LEF. Higher scores mean a worse outcome.
Secondary Outcomes
- Changes in severity of symptom burden(Baseline, 3-, 6-, and 9-months post-intervention)
- Changes in degrees of jaw range of motion(Baseline, 3-, 6-, and 9-months post-intervention)
- Changes in degrees of cervical range of motion(Baseline, 3-, 6-, and 9-months post-intervention)
- Changes in quality-of-life score(Baseline, 3-, 6-, and 9-months post-intervention)
- Changes in LEF-related knowledge score(Baseline, 3-, 6-, and 9-months post-intervention)
- Changes in LEF-related skills(Baseline, 3-, 6-, and 9-months post-intervention)
- LEF-related self-efficacy score(Baseline, 3-, 6-, and 9-months post-intervention)
- LEF-related self-care adherence status(Baseline, 3-, 6-, and 9-months post-intervention)