N/A
N=59
Self-Care for Head and Neck Cancer Survivors With Lymphedema and Fibrosis
Head and Neck Cancer · Lymphedema · Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT03030859 ↗Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Feasibility of the LEF-SCP (Self-Care Skill Training Sessions) — 20; 18 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Usual Care (Other); Usual Care plus LEF-SCP (Other); Usual Care plus LEF-SCP plus Follow-up (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of the LEF-SCP (Self-Care Skill Training Sessions) |
20; 18 | — |
| PRIMARY Feasibility of the LEF-SCP (Motivational Interviewing Sessions) |
20; 16 | — |
| PRIMARY Preliminary Efficacy of the LEF-SCP (Total Severity of External LEF) |
-0.11; -2.35; -2.25 | — |
| PRIMARY Preliminary Efficacy of the LEF-SCP (Symptom Burden) |
-0.15; -0.73; -0.53 | — |
| PRIMARY Preliminary Efficacy of the LEF-SCP (Self-Efficacy) |
1.26; 4.71; 4.85 | — |
Summary
This randomized pilot clinical trial studies how well the self-care program works in head and neck cancer survivors with lymphedema and fibrosis. A self-care program may promote self-care activities for managing chronic swelling and tough/tight tissues in the head and neck region.
Eligibility Criteria
Inclusion Criteria
- Post HNC primary treatment
- No evidence of cancer (NED)
- No more than 6 months after completion of initial lymphedema therapy for head and neck lymphedema
- > 18 years of age
- Ability to understand English in order to complete questionnaires
- Able to complete the onsite training and home self-care activities for LEF management
- Able to provide informed consent
Exclusion Criteria
- Patients will be excluded if they have any of the following medical conditions that would prohibit the safe implementation of self-care of LEF: recurrent or metastatic cancer; any other active cancer; acute infection; congestive heart failure; renal failure; cardiac or pulmonary edema; sensitive carotid sinus; severe carotid blockage; and uncontrolled hypertension
Data sourced from ClinicalTrials.gov (NCT03030859). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.