N/A Completed N=59 Randomized Supportive Care

Self-Care for Head and Neck Cancer Survivors With Lymphedema and Fibrosis

Head and Neck Cancer · Lymphedema · Fibrosis

Source: ClinicalTrials.gov NCT03030859 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2024

Primary outcomePrimary: Feasibility of the LEF-SCP (Self-Care Skill Training Sessions) — 20; 18 Participants

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.